Array ( [0] => {{Short description|Anti-diabetic and anti-obesity medication}} [1] => {{Use dmy dates|date=February 2024}} [2] => {{cs1 config |name-list-style=vanc |display-authors=6}} [3] => {{Infobox drug [4] => | image = Semaglutid 3Letter.svg [5] => | width = 350 [6] => | alt = Structure of Semaglutide [7] => | image2 = File:Semaglutide PDB=7ki0.png [8] => | caption = Experimentally determined structure of semaglutide while complexed with the [[Glucagon-like peptide-1|GLP-1]] receptor. {{PDB|7KI0}} [9] => [10] => [11] => | pronounce = {{IPAc-en|s|ɛ|m|ˈ|æ|g|l|ʊ|t|aɪ|d}} {{respell|sem|AG|luu|tyde}} or {{IPAc-en|ˌ|s|ɛ|m|ə|ˈ|g|l|uː|t|aɪ|d}} {{respell|SEM|ə|GLOO|tyde}} [12] => | tradename = Ozempic, Rybelsus, Wegovy, others [13] => | Drugs.com = {{Drugs.com|monograph|semaglutide}} [14] => | MedlinePlus = a618008 [15] => | DailyMedID = Semaglutide [16] => | pregnancy_AU = D [17] => | pregnancy_AU_comment = {{cite web |date=22 February 2022 |title=Rybelsus APMDS |url=https://www.tga.gov.au/resources/auspmd/rybelsus |access-date=23 February 2022 |website=Therapeutic Goods Administration (TGA)}} [18] => | pregnancy_category = [19] => | routes_of_administration = [[Subcutaneous injection|Subcutaneous]], [[Oral administration|oral]] [20] => | class = [21] => | ATC_prefix = A10 [22] => | ATC_suffix = BJ06 [23] => | ATC_supplemental = [24] => [25] => [26] => | legal_AU = S4 [27] => | legal_AU_comment = {{cite web |title=Summary for ARTG Entry: 346198 Rybelsus semaglutide 3 mg tablet blister pack |url=https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=346198 |url-status=live |archive-url=https://web.archive.org/web/20220224072337/https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=346198 |archive-date=24 February 2022 |access-date=23 February 2022 |website=Therapeutic Goods Administration (TGA)}}{{cite web | title=Wegovy (Novo Nordisk Pharmaceuticals Pty Ltd) | website=Therapeutic Goods Administration (TGA) | date=7 October 2022 | url=https://www.tga.gov.au/resources/prescription-medicines-registrations/wegovy-novo-nordisk-pharmaceuticals-pty-ltd | access-date=7 April 2023 | archive-date=14 April 2023 | archive-url=https://web.archive.org/web/20230414192908/https://www.tga.gov.au/resources/prescription-medicines-registrations/wegovy-novo-nordisk-pharmaceuticals-pty-ltd | url-status=live }} [28] => | legal_BR = [29] => | legal_BR_comment = [30] => | legal_CA = Rx-only [31] => | legal_CA_comment = /{{nbsp}}Schedule D{{cite report |url=https://pdf.hres.ca/dpd_pm/00058023.PDF |title=Product Monograph Including Patient Medication Information – Ozempic semaglutide injection |date=21 August 2020 |publisher=Novo-Nordisk Canada |access-date=6 June 2021 |archive-url=https://web.archive.org/web/20210607034549/https://pdf.hres.ca/dpd_pm/00058023.PDF |archive-date=7 June 2021 |url-status=live |orig-date=Initial approval 4 January 2018}}{{cite report |url=https://pdf.hres.ca/dpd_pm/00055582.PDF |title=Product Monograph Including Patient Medication Information – Rybelsus semaglutide tablets |date=30 March 2020 |publisher=Novo-Nordisk Canada |access-date=6 June 2021 |archive-url=https://web.archive.org/web/20211214093723/https://pdf.hres.ca/dpd_pm/00055582.PDF |archive-date=14 December 2021 |url-status=live}}{{cite web |date=23 October 2014 |title=Regulatory Decision Summary – Rybelsus |url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?linkID=RDS00625 |url-status=live |archive-url=https://web.archive.org/web/20220605060327/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?linkID=RDS00625 |archive-date=5 June 2022 |access-date=4 June 2022 |website=Health Canada}}{{cite web | title=Drug and medical device highlights 2018: Helping you maintain and improve your health | website=[[Health Canada]] | date=14 October 2020 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2018.html | access-date=17 April 2024}} [32] => | legal_DE = [33] => | legal_DE_comment = [34] => | legal_NZ = [35] => | legal_NZ_comment = [36] => | legal_UK = POM [37] => | legal_UK_comment = {{cite web |date=9 April 2021 |title=Ozempic 0.25 mg solution for injection in pre-filled pen – Summary of Product Characteristics (SmPC) |url=https://www.medicines.org.uk/emc/product/9748/smpc |url-status=live |archive-url=https://web.archive.org/web/20210606181424/https://www.medicines.org.uk/emc/product/9748/smpc |archive-date=6 June 2021 |access-date=6 June 2021 |website=(emc)}}{{cite web |date=25 November 2020 |title=Rybelsus – Summary of Product Characteristics (SmPC) |url=https://www.medicines.org.uk/emc/product/11507/smpc |url-status=live |archive-url=https://web.archive.org/web/20210606181424/https://www.medicines.org.uk/emc/product/11507/smpc |archive-date=6 June 2021 |access-date=6 June 2021 |website=(emc)}} [38] => | legal_US = Rx-only [39] => | legal_US_comment = [40] => | legal_EU = Rx-only [41] => | legal_EU_comment = [42] => | legal_UN = [43] => | legal_UN_comment = [44] => | legal_status = Rx-only [45] => [46] => [47] => | bioavailability = 89% [48] => | protein_bound = [49] => | metabolism = [[Proteolysis]] [50] => | metabolites = [51] => | onset = [52] => | elimination_half-life = 7 days [53] => | duration_of_action = 63.6 h [54] => | excretion = Urine and feces [55] => [56] => [57] => | CAS_number = 910463-68-2 [58] => | CAS_supplemental = [59] => | PubChem = 56843331 [60] => | IUPHAR_ligand = [61] => | DrugBank = DB13928 [62] => | ChemSpiderID = 34981134 [63] => | UNII = 53AXN4NNHX [64] => | KEGG = D10025 [65] => | ChEBI = 167574 [66] => | ChEMBL = [67] => | NIAID_ChemDB = [68] => | PDB_ligand = [69] => | synonyms = [70] => [71] => [72] => | IUPAC_name = 18-[[(1R)-4-[2-[2-[2-[2-[2-[2-[[(5S)-5-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-2-[[2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-2-methylpropanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-methylbutanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-5-oxopentanoyl]amino]propanoyl]amino]propanoyl]amino]-6-[[(2S)-1-[[(2S)-1-[[(2S,3S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-5-carbamimidamido-1-[[2-[[(2S)-5-carbamimidamido-1-(carboxymethylamino)-1-oxopentan-2-yl]amino]-2-oxoethyl]amino]-1-oxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-6-oxohexyl]amino]-2-oxoethoxy]ethoxy]ethylamino]-2-oxoethoxy]ethoxy]ethylamino]-1-carboxy-4-oxobutyl]amino]-18-oxooctadecanoic acid [73] => | C = 187 [74] => | H = 291 [75] => | N = 45 [76] => | O = 59 [77] => | SMILES = CCC(C)C(C(=O)NC(C)C(=O)NC(CC1=CNC2=CC=CC=C21)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)C(CC3=CC=CC=C3)NC(=O)C(CCC(=O)O)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(C(=O)O)NC(=O)CCCCCCCCCCCCCCCCC(=O)O)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(=O)N)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CC4=CC=C(C=C4)O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(C(C)C)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CC5=CC=CC=C5)NC(=O)C(C(C)O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(CC6=CN=CN6)N [78] => | StdInChI = 1S/C187H291N45O59/c1-18-105(10)154(180(282)208-108(13)159(261)216-133(86-114-89-200-119-50-40-39-49-117(114)119)170(272)218-129(82-102(4)5)171(273)228-152(103(6)7)178(280)215-121(53-44-72-199-186(192)193)162(264)201-91-141(242)209-120(52-43-71-198-185(190)191)161(263)204-94-151(257)258)230-172(274)131(83-111-45-33-31-34-46-111)219-167(269)126(64-69-149(253)254)214-166(268)122(51-41-42-70-195-144(245)98-290-79-78-289-76-74-197-145(246)99-291-80-77-288-75-73-196-139(240)66-61-127(183(285)286)211-140(241)54-37-29-27-25-23-21-19-20-22-24-26-28-30-38-55-146(247)248)212-158(260)107(12)206-157(259)106(11)207-165(267)125(60-65-138(189)239)210-142(243)92-202-163(265)123(62-67-147(249)250)213-168(270)128(81-101(2)3)217-169(271)130(85-113-56-58-116(238)59-57-113)220-175(277)135(95-233)223-177(279)137(97-235)224-179(281)153(104(8)9)229-174(276)134(88-150(255)256)221-176(278)136(96-234)225-182(284)156(110(15)237)231-173(275)132(84-112-47-35-32-36-48-112)222-181(283)155(109(14)236)227-143(244)93-203-164(266)124(63-68-148(251)252)226-184(287)187(16,17)232-160(262)118(188)87-115-90-194-100-205-115/h31-36,39-40,45-50,56-59,89-90,100-110,118,120-137,152-156,200,233-238H,18-30,37-38,41-44,51-55,60-88,91-99,188H2,1-17H3,(H2,189,239)(H,194,205)(H,195,245)(H,196,240)(H,197,246)(H,201,264)(H,202,265)(H,203,266)(H,204,263)(H,206,259)(H,207,267)(H,208,282)(H,209,242)(H,210,243)(H,211,241)(H,212,260)(H,213,270)(H,214,268)(H,215,280)(H,216,261)(H,217,271)(H,218,272)(H,219,269)(H,220,277)(H,221,278)(H,222,283)(H,223,279)(H,224,281)(H,225,284)(H,226,287)(H,227,244)(H,228,273)(H,229,276)(H,230,274)(H,231,275)(H,232,262)(H,247,248)(H,249,250)(H,251,252)(H,253,254)(H,255,256)(H,257,258)(H,285,286)(H4,190,191,198)(H4,192,193,199)/t105-,106-,107-,108-,109+,110+,118-,120-,121-,122-,123-,124-,125-,126-,127+,128-,129-,130-,131-,132-,133-,134-,135-,136-,137-,152-,153-,154-,155-,156-/m0/s1 [79] => | StdInChI_comment = [80] => | StdInChIKey = DLSWIYLPEUIQAV-CCUURXOWSA-N [81] => | StdInChIKey_Ref = {{stdinchicite|correct|pubchem}} [82] => | density = [83] => | density_notes = [84] => | melting_point = [85] => | melting_high = [86] => | melting_notes = [87] => | boiling_point = [88] => | boiling_notes = [89] => | solubility = [90] => | sol_units = [91] => | specific_rotation = [92] => }} [93] => [94] => [95] => '''Semaglutide''' is an [[antidiabetic medication]] used for the treatment of [[type 2 diabetes]] and an [[anti-obesity medication]] used for long-term [[weight management]].{{cite journal | vauthors = Singh G, Krauthamer M, Bjalme-Evans M | title = Wegovy (semaglutide): a new weight loss drug for chronic weight management | journal = Journal of Investigative Medicine | volume = 70 | issue = 1 | pages = 5–13 | date = January 2022 | pmid = 34706925 | pmc = 8717485 | doi = 10.1136/jim-2021-001952 }}{{cite journal | vauthors = Phillips A, Clements JN | title = Clinical review of subcutaneous semaglutide for obesity | journal = Journal of Clinical Pharmacy and Therapeutics | volume = 47 | issue = 2 | pages = 184–193 | date = February 2022 | pmid = 34964141 | doi = 10.1111/jcpt.13574 | s2cid = 245538758 }}{{cite journal | vauthors = Amaro A, Sugimoto D, Wharton S | title = Efficacy and safety of semaglutide for weight management: evidence from the STEP program | journal = Postgraduate Medicine | volume = 134 | issue = sup1 | pages = 5–17 | date = January 2022 | pmid = 36691309 | doi = 10.1080/00325481.2022.2147326 | s2cid = 256192982 | doi-access = free }} It is a [[peptide]] similar to the hormone [[glucagon-like peptide-1]] (GLP-1), modified with a [[side chain]]. It can be administered by [[subcutaneous injection]] or taken [[oral administration|orally]].{{cite journal | vauthors = Hughes S, Neumiller JJ | title = Oral Semaglutide | journal = Clinical Diabetes | volume = 38 | issue = 1 | pages = 109–111 | date = January 2020 | pmid = 31975761 | pmc = 6969659 | doi = 10.2337/cd19-0079 }} It is sold under the brand names '''Ozempic''' and '''Rybelsus''' for diabetes, and under the brand name '''Wegovy''' for weight loss. [96] => [97] => [98] => Semaglutide is a [[glucagon-like peptide-1 receptor agonist]]. The most common side effects include nausea, vomiting, diarrhea, abdominal pain, and constipation.{{cite web | title=Ozempic Drug Trial Snapshot | website=U.S. [[Food and Drug Administration]] (FDA) | date=5 December 2017 | url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-ozempic | access-date=31 December 2023 | archive-date=31 December 2023 | archive-url=https://web.archive.org/web/20231231230740/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-ozempic | url-status=live }} {{PD-notice}} [99] => [100] => [101] => It was approved for medical use in the US in 2017. In 2021, it was the 90th most commonly prescribed medication in the United States, with more than 8{{nbsp}}million prescriptions.{{cite web | title=The Top 300 of 2021 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=14 January 2024 | archive-date=15 January 2024 | archive-url=https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}{{cite web | title = Semaglutide - Drug Usage Statistics | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/Semaglutide | access-date = 14 January 2024 | archive-date = 8 October 2022 | archive-url = https://web.archive.org/web/20221008035433/https://clincalc.com/DrugStats/Drugs/Semaglutide | url-status = live }} [102] => [103] => ==Medical uses== [104] => Semaglutide is [[Indication (medicine)|indicated]] as an adjunct to diet and exercise to improve [[glycemic control]] in adults with type{{nbsp}}2 diabetes.{{cite web |title=Ozempic- semaglutide injection, solution |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79 |url-status=live |archive-url=https://web.archive.org/web/20210605224054/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79 |archive-date=5 June 2021 |access-date=5 June 2021 |website=DailyMed}}{{cite web |title=Rybelsus- oral semaglutide tablet |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98 |url-status=live |archive-url=https://web.archive.org/web/20210605223601/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98 |archive-date=5 June 2021 |access-date=5 June 2021 |website=DailyMed}} [105] => [106] => The higher-dose formulation of semaglutide is indicated as an adjunct to diet and exercise for long-term weight management in adults with [[obesity]] (initial [[body mass index]] (BMI) ≥ 30 kg/m2) or who are overweight (initial BMI ≥ 27 kg/m2) and have at least one weight-related [[comorbidity]].{{cite press release |title=FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014 |date=4 June 2021 |url=https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014 |access-date=5 June 2021 |url-status=live |archive-url=https://web.archive.org/web/20210604235421/https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014 |archive-date=4 June 2021 |website=U.S. [[Food and Drug Administration]] (FDA)}} [107] => [108] => In March 2024, the FDA expanded the indication for semaglutide (Wegovy), in combination with a reduced calorie diet and increased physical activity, to reduce the risk of cardiovascular death, heart attack and stroke in obese or overweight adults with cardiovascular disease.{{cite web | title=FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight | website=U.S. Food and Drug Administration | date=8 March 2024 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or | access-date=12 March 2024}} {{PD-notice}} [109] => [110] => === Eating disorders === [111] => Semaglutide and similar drugs, such as [[dulaglutide]] and [[liraglutide]], have been used to treat [[binge eating disorder]] (BED), as they can successfully minimize obsessive thoughts about food and [[Binge eating|binging]] urges.{{cite journal | vauthors = Hayashi D, Edwards C, Emond JA, Gilbert-Diamond D, Butt M, Rigby A, Masterson TD | title = What Is Food Noise? A Conceptual Model of Food Cue Reactivity | journal = Nutrients | volume = 15 | issue = 22 | page = 4809 | date = November 2023 | pmid = 38004203 | pmc = 10674813 | doi = 10.3390/nu15224809 | doi-access = free | veditors = Trakada G }}{{cite journal | vauthors = Järvinen A, Laine MK, Tikkanen R, Castrén ML | title = Beneficial Effects of GLP-1 Agonist in a Male With Compulsive Food-Related Behavior Associated With Autism | journal = Frontiers in Psychiatry | volume = 10 | pages = 97 | year = 2019 | pmid = 30881319 | pmc = 6405420 | doi = 10.3389/fpsyt.2019.00097 | doi-access = free }} Some users of these drugs have reported significant reduction in what is colloquially known as "food noise" (constant, unstoppable thoughts about eating despite not being physically hungry), which can be a factor of BED.{{Cite news | vauthors = Kuhn C |date=25 September 2023 |title=Patients say drugs like Ozempic help with 'food noise.' Here's what that means |url=https://www.pbs.org/newshour/health/patients-say-drugs-like-ozempic-help-with-food-noise-heres-what-that-means |url-status=live |archive-url=https://web.archive.org/web/20240113171557/https://www.pbs.org/newshour/health/patients-say-drugs-like-ozempic-help-with-food-noise-heres-what-that-means |archive-date=13 January 2024 |access-date=13 January 2024 |work=[[PBS]]}}{{Cite news | vauthors = Blum D |date=21 June 2023 |title=People on Drugs Like Ozempic Say Their 'Food Noise' Has Disappeared |url=https://www.nytimes.com/2023/06/21/well/eat/ozempic-food-noise.html |url-status=live |archive-url=https://web.archive.org/web/20240111211548/https://www.nytimes.com/2023/06/21/well/eat/ozempic-food-noise.html |archive-date=11 January 2024 |access-date=13 January 2024 |work=[[The New York Times]]}} [112] => [113] => ==Adverse effects== [114] => Possible side effects include [[nausea]], [[diarrhea]], [[vomiting]], [[constipation]], [[abdominal pain]], [[headache]], [[fatigue]], [[indigestion]]/[[heartburn]], [[dizziness]], [[abdominal distension]], [[belching]], [[hypoglycemia]] (low blood [[glucose]]) in people with type{{nbsp}}2 diabetes, [[flatulence]], [[gastroenteritis]], and [[gastroesophageal reflux disease]] (GERD). It can also cause [[pancreatitis]], [[gastroparesis]], and [[bowel obstruction]].{{cite journal | vauthors = Sodhi M, Rezaeianzadeh R, Kezouh A, Etminan M | title = Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss | journal = The Journal of the American Medical Association | date = October 2023 | volume = 330 | issue = 18 | pages = 1795–1797 | pmid = 37796527 | doi = 10.1001/jama.2023.19574 | pmc = 10557026 }} [115] => [116] => The US FDA label for semaglutide contains a [[boxed warning]] for [[Thyroid C cell tumor|thyroid C-cell tumors]] in [[rodent]]s. It is unknown whether semaglutide causes thyroid C-cell tumors, including [[medullary thyroid carcinoma]], in humans.{{cite journal | vauthors = Sande CM, Tondi Resta I, Livolsi VA | title = The Thyroid Pathologist Meets Therapeutic Pharmacology | journal = Endocrine Pathology | volume = 34 | issue = 1 | pages = 48–56 | date = March 2023 | pmid = 36723855 | pmc = 9890439 | doi = 10.1007/s12022-023-09749-1 }} [117] => [118] => == Contraindications == [119] => Data from rodent studies of GLP-1-mediated thyroid [[Thyroid C cell tumor|C-cell hyperplasia]]{{cite journal | vauthors = Bjerre Knudsen L, Madsen LW, Andersen S, Almholt K, de Boer AS, Drucker DJ, Gotfredsen C, Egerod FL, Hegelund AC, Jacobsen H, Jacobsen SD, Moses AC, Mølck AM, Nielsen HS, Nowak J, Solberg H, Thi TD, Zdravkovic M, Moerch U| title = Glucagon-like Peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation | journal = Endocrinology | volume = 151 | issue = 4 | pages = 1473–1486 | date = April 2010 | pmid = 20203154 | doi = 10.1210/en.2009-1272 | s2cid = 20934882 | title-link = doi | doi-access = free }} indicates that use is [[Contraindication|contraindicated]] in people with a personal or family history of medullary thyroid carcinoma or with [[multiple endocrine neoplasia type 2]]. [120] => [121] => ==Mechanism of action== [122] => Semaglutide is a glucagon-like peptide-1 receptor agonist. The drug decreases blood sugar levels. The decrease is theorized to be caused by the mimicking of the [[incretin]] [[glucagon-like peptide-1]] (GLP-1).{{cite journal |vauthors=Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T|date=November 2016 |title=Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes |journal=The New England Journal of Medicine |volume=375 |issue=19 |pages=1834–1844 |doi=10.1056/NEJMoa1607141 |pmid=27633186 |doi-access=free |title-link=doi }} It also appears to enhance growth of pancreatic [[beta cells]], which are responsible for insulin production and release.{{cite journal |vauthors=Li Y, Hansotia T, Yusta B, Ris F, Halban P, Drucker D |date=2003 |title=Glucagon-like Peptide-1 Receptor Signaling Modulates β Cell Apoptosis |journal=The Journal of Biological Chemistry |volume=278 |issue=1 |pages=471–478 |doi=10.1074/jbc.M209423200 |pmid=12409292 |doi-access=free |title-link=doi }} Additionally, it inhibits the production of [[glucagon]], the hormone that increases [[glycogenolysis]] (release of stored carbohydrate from the liver) and [[gluconeogenesis]] (synthesis of new glucose). It reduces food intake by lowering appetite and slowing down digestion in the stomach,{{cite journal |vauthors=Doggrell SA |date=March 2018 |title=Semaglutide in type 2 diabetes - is it the best glucagon-like peptide 1 receptor agonist (GLP-1R agonist)? |url=https://eprints.qut.edu.au/121664/2/121664.pdf |url-status=live |journal=Expert Opinion on Drug Metabolism & Toxicology |volume=14 |issue=3 |pages=371–377 |doi=10.1080/17425255.2018.1441286 |pmid=29439603 |archive-url=https://web.archive.org/web/20200505082922/https://eprints.qut.edu.au/121664/2/121664.pdf |archive-date=5 May 2020 |access-date=12 December 2019 |s2cid=3421553}} helping reduce body fat.{{cite journal |vauthors=Dhillon S |date=February 2018 |title=Semaglutide: First Global Approval |journal=Drugs |volume=78 |issue=2 |pages=275–284 |doi=10.1007/s40265-018-0871-0 |pmid=29363040 |s2cid=46851453}}{{cite journal | vauthors = Blundell J, Finlayson G, Axelsen M, Flint A, Gibbons C, Kvist T, Hjerpsted JB | title = Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity | journal = Diabetes, Obesity & Metabolism | volume = 19 | issue = 9 | pages = 1242–1251 | date = September 2017 | pmid = 28266779 | pmc = 5573908 | doi = 10.1111/dom.12932 | doi-access = free | title-link = doi }} [123] => [124] => ==Structure and pharmacology== [125] => [[File:Semaglutide vs. liraglutide v01.svg|thumb|upright=1.5|Schematic representation of the structures of semaglutide and liraglutide, compared to GLP-1]] [126] => Semaglutide is chemically similar to human GLP-1. The first six [[amino acid]]s of GLP-1 are missing. Substitutions are made at GLP positions 8 and 34 (semaglutide positions 2 and 28), where [[alanine]] and [[lysine]] are replaced by [[2-aminoisobutyric acid]] and [[arginine]], respectively.{{cite journal |vauthors=Lau J, Bloch P, Schäffer L, Pettersson I, Spetzler J, Kofoed J, Madsen K, Knudsen LB, McGuire J, Steensgaard DB, Strauss HM, Gram DX, Knudsen SM, Nielsen FS, Thygesen P, Reedtz-Runge S, Kruse T |date=September 2015 |title=Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide |journal=Journal of Medicinal Chemistry |volume=58 |issue=18 |pages=7370–80 |doi=10.1021/acs.jmedchem.5b00726 |pmid=26308095 |s2cid=20228358}} The substitution of the alanine prevents chemical breakdown by [[dipeptidyl peptidase-4]]. The lysine at GLP position 26 (semaglutide position 20) has a long chain attached, ending with a chain of 17 carbon atoms and a [[carboxyl group]]. This increases the drug's binding to blood protein (albumin), which enables longer presence in the blood circulation.{{cite journal |vauthors=Gotfredsen CF, Mølck AM, Thorup I, Nyborg NC, Salanti Z, Knudsen LB, Larsen MO|date=July 2014 |title=The human GLP-1 analogs liraglutide and semaglutide: absence of histopathological effects on the pancreas in nonhuman primates |journal=Diabetes |volume=63 |issue=7 |pages=2486–97 |doi=10.2337/db13-1087 |pmid=24608440 |doi-access=free |title-link=doi |s2cid=35102048}} [127] => [128] => Semaglutide's [[half-life]] in the blood is about seven days (165–184 hours).{{cite journal |vauthors=Goldenberg RM, Steen O |date=March 2019 |title=Semaglutide: Review and Place in Therapy for Adults With Type 2 Diabetes |journal=Canadian Journal of Diabetes |volume=43 |issue=2 |pages=136–145 |doi=10.1016/j.jcjd.2018.05.008 |pmid=30195966 |doi-access=free |title-link=doi }}{{cite journal |vauthors=Kapitza C, Nosek L, Jensen L, Hartvig H, Jensen CB, Flint A |date=May 2015 |title=Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel |journal=Journal of Clinical Pharmacology |volume=55 |issue=5 |pages=497–504 |doi=10.1002/jcph.443 |pmc=4418331 |pmid=25475122}} [129] => [130] => ==History== [131] => In June 2008, a [[phase II clinical trial]] began studying semaglutide.{{ClinicalTrialsGov|NCT00696657|A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide}} [132] => [133] => In 2012, a team of researchers at [[Novo Nordisk]] led by the scientist [[Lotte Bjerre Knudsen]] developed semaglutide{{cite journal |date=October 2012 |title=Abstracts of the 48th EASD (European Association for the Study of Diabetes) Annual Meeting of the European Association for the Study of Diabetes. October 1–5, 2012. Berlin, Germany |journal=Diabetologia |volume=55 |issue=S1 |pages=S7–537 |doi=10.1007/s00125-012-2688-9 |pmid=22918257 |doi-access=free |title-link=doi }} for a once-weekly diabetes therapy as a longer-acting alternative to [[liraglutide]].{{cite journal |vauthors=Kalra S, Gupta Y |date=July 2015 |title=Once-weekly glucagon-like peptide 1 receptor agonists |url=https://jpma.org.pk/article-details/7416?article_id=7416 |url-status=live |journal=The Journal of the Pakistan Medical Association |volume=65 |issue=7 |pages=796–8 |pmid=26160096 |archive-url=https://web.archive.org/web/20220930044839/https://jpma.org.pk/article-details/7416?article_id=7416 |archive-date=30 September 2022 |access-date=10 April 2022}} It was given the brand name Ozempic. Clinical trials started in January 2016 and ended in May 2017.{{Cite journal |date=October 2019 |title=Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes |url=https://clinicaltrials.gov/ct2/show/NCT02648204 |journal=ClinicalTrials.gov |access-date=3 March 2023 |archive-date=31 July 2018 |archive-url=https://web.archive.org/web/20180731093405/https://clinicaltrials.gov/ct2/show/NCT02648204 |url-status=live }} [134] => [135] => In March 2021, in a phase III randomized, double-blind, trial, 1,961 adults with a [[body mass index]] of 30 or greater were assigned in a 2:1 ratio to a treatment with once-weekly subcutaneous semaglutide or placebo, plus lifestyle intervention. The trials occurred at 129 sites in 16 countries in Asia, Europe, North America, and South America. The mean percentage change in body weight at week 68 was −14.9% in the semaglutide group vs −2.4% with placebo, for an estimated treatment difference of −12.4 [[percentage points]] (95% CI, −13.4 to −11.5).{{cite journal | vauthors = Wilding JP, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MT, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF| title = Once-Weekly Semaglutide in Adults with Overweight or Obesity | journal = The New England Journal of Medicine | volume = 384 | issue = 11 | pages = 989–1002 | date = March 2021 | pmid = 33567185 | doi = 10.1056/NEJMoa2032183 | s2cid = 231883214 | title-link = doi | doi-access = free }}{{Cite news |vauthors=Blum D |date=22 November 2022 |title=What Is Ozempic and Why Is It Getting So Much Attention? |work=The New York Times |url=https://www.nytimes.com/2022/11/22/well/ozempic-diabetes-weight-loss.html |access-date=30 March 2023 |issn=0362-4331 |archive-date=29 March 2023 |archive-url=https://web.archive.org/web/20230329233558/https://www.nytimes.com/2022/11/22/well/ozempic-diabetes-weight-loss.html |url-status=live }}{{cite journal | vauthors = Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jódar E, Kandler K, Rigas G, Wadden TA, Wharton S | title = Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial | journal = Nature Medicine | volume = 28 | issue = 10 | pages = 2083–2091 | date = October 2022 | pmid = 36216945 | doi = 10.1038/s41591-022-02026-4 | pmc = 9556320 }}{{Cite web |vauthors=Dillinger K |date=29 March 2023 |title=WHO advisers to consider whether obesity medication should be added to Essential Medicines List |url=https://www.cnn.com/2023/03/29/health/who-essential-medicines-liraglutide/index.html |access-date=30 March 2023 |website=CNN |archive-date=30 March 2023 |archive-url=https://web.archive.org/web/20230330160921/https://www.cnn.com/2023/03/29/health/who-essential-medicines-liraglutide/index.html |url-status=live }} [136] => [137] => A 2022 review of anti-obesity treatments found that semaglutide as well as [[tirzepatide]] (which has an overlapping mechanism of action) were more promising than previous anti-obesity drugs, although less effective than [[bariatric surgery]].{{cite journal |vauthors=Müller TD, Blüher M, Tschöp MH, DiMarchi RD |date=March 2022 |title=Anti-obesity drug discovery: advances and challenges |journal=Nature Reviews. Drug Discovery |volume=21 |issue=3 |pages=201–223 |doi=10.1038/s41573-021-00337-8 |pmc=8609996 |pmid=34815532 |doi-access=free |title-link=doi }} [138] => [139] => In March 2023, a [[Novo Nordisk]] official said that patients using semaglutide to lose weight can regain their original weight within 5 years of stopping treatment.{{cite news |title=Novo Nordisk says stopping obesity drug may cause full weight regain in 5 years |url=https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-says-stopping-obesity-drug-may-cause-full-weight-regain-5-years-2023-03-30/ |access-date=12 February 2024 |work=Reuters |date=30 March 2023 |archive-date=10 June 2023 |archive-url=https://web.archive.org/web/20230610192149/https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-says-stopping-obesity-drug-may-cause-full-weight-regain-5-years-2023-03-30/ |url-status=live }} [140] => [141] => The US [[Food and Drug Administration]] (FDA) approved semaglutide based on evidence from seven clinical trials of 4087 participants with type{{nbsp}}2 diabetes. The trials were conducted at 536 sites in 33 countries, including Canada, Mexico, the Russian Federation, Ukraine, Turkey, India, South Africa, Japan, Hong Kong, multiple European countries, Argentina, and the United States. In two of these trials (NCT #02054897 and NCT#02305381), participants were randomly assigned to receive either semaglutide or placebo injection weekly. Neither the participant nor the health care provider knew which treatment was being given until after the trials were completed. Treatment was given for 30 weeks. In the other five trials (NCT #01930188, 01885208, 02128932, 02207374, 02254291), participants were randomly assigned to receive either semaglutide or another antidiabetic medication, and the participant and provider knew which medication was being given in four trials. Treatment was given for 30 weeks or 56 weeks. [142] => [143] => In each trial, HbA1c was measured from the start of the trial to the end of the trial and compared between the semaglutide group and the other groups. [144] => [145] => The FDA also considered data from one separate trial (NCT #01720446) of 3297 participants with type{{nbsp}}2 diabetes who were at high risk for cardiovascular events. This trial was conducted in 20 countries in Europe, the Russian Federation, Turkey, Brazil, Israel, Malaysia, Brazil, Mexico, Thailand, Taiwan, Canada, and the United States. The participants were randomly assigned to receive semaglutide or placebo. Neither the participant nor the health care provider knew which treatment was being given. Treatment was given for 104 weeks (2 years), and the occurrence of cardiovascular events, including heart attacks, strokes and hospitalization due to unstable angina (near heart attack) were recorded and compared in the two groups of participants. [146] => [147] => In March 2024, the FDA expanded the indication for semaglutide (Wegovy) to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. The efficacy and safety for this new indication were studied in a multi-national, multi-center, placebo-controlled double-blind trial that randomly assigned over 17,600 participants to receive either semaglutide (Wegovy) or placebo. Participants in both groups also received standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity). Semaglutide (Wegovy) significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack and stroke), which occurred in 6.5% of participants who received semaglutide (Wegovy) compared to 8% of participants who received placebo. [148] => [149] => == Society and culture == [150] => === Legal status === [151] => In December 2016, the US FDA [[New Drug Application]] (NDA) was filed, and in October 2017, the FDA Advisory Committee approved it unanimously.{{cite news |date=2017 |title=Development Status and FDA Approval Process for semaglutide |work=Drugs.com |url=https://www.drugs.com/history/semaglutide.html |url-status=live |access-date=24 October 2017 |archive-url=https://web.archive.org/web/20171024205830/https://www.drugs.com/history/semaglutide.html |archive-date=24 October 2017}} [152] => [153] => In December 2017, the injectable version with the brand name Ozempic was approved for use by people with diabetes in the United States,{{cite web |date=16 January 2018 |title=Drug Approval Package: Ozempic (semaglutide) Injection |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000TOC.cfm |url-status=live |archive-url=https://web.archive.org/web/20210301022302/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000TOC.cfm |archive-date=1 March 2021 |access-date=26 September 2020 |publisher=U.S. [[Food and Drug Administration]] (FDA)}}{{cite press release |title=Ozempic (semaglutide) approved in the US |date=5 December 2017 |url=https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=712 |access-date=5 June 2021 |url-status=live |archive-url=https://web.archive.org/web/20210605223522/https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=712 |archive-date=5 June 2021|publisher=[[Novo Nordisk]]}} and, in January 2018, in Canada.{{cite web |date=23 October 2014 |title=Regulatory Decision Summary – Ozempic |url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00317 |url-status=live |archive-url=https://web.archive.org/web/20190517173304/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00317 |archive-date=17 May 2019 |access-date=2 April 2019 |publisher=[[Health Canada]] }} [154] => [155] => In February 2018, authorization was granted in the European Union,{{cite web |title=Ozempic EPAR |date=17 September 2018 |url=https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic |url-status=live |archive-url=https://web.archive.org/web/20201025204658/https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic |archive-date=25 October 2020 |access-date=26 September 2020 |publisher=[[European Medicines Agency]] (EMA)}}{{cite press release |title=Novo Nordisk A/S: Ozempic (semaglutide) approved in the EU for the treatment of type 2 diabetes |date=9 February 2018 |publisher=[[Novo Nordisk]] A/S |url=https://globenewswire.com/news-release/2018/02/09/1338393/0/en/Novo-Nordisk-A-S-Ozempic-semaglutide-approved-in-the-EU-for-the-treatment-of-type-2-diabetes.html |access-date=19 August 2018 |url-status=live |archive-url=https://web.archive.org/web/20190402075511/https://www.globenewswire.com/news-release/2018/02/09/1338393/0/en/Novo-Nordisk-A-S-Ozempic-semaglutide-approved-in-the-EU-for-the-treatment-of-type-2-diabetes.html |archive-date=2 April 2019 |via=GlobeNewswire}} in March 2018 in Japan,{{cite press release |title=Ozempic approved in Japan for the treatment of type 2 diabetes |date=23 March 2018 |publisher=[[Novo Nordisk]] A/S |url=https://www.globenewswire.com/news-release/2018/03/23/1449172/0/en/Ozempic-approved-in-Japan-for-the-treatment-of-type-2-diabetes.html |access-date=2 April 2019 |url-status=live |archive-url=https://web.archive.org/web/20190402081052/https://www.globenewswire.com/news-release/2018/03/23/1449172/0/en/Ozempic-approved-in-Japan-for-the-treatment-of-type-2-diabetes.html |archive-date=2 April 2019 |via=GlobeNewswire}} and in August 2019 in Australia.{{cite web |date=2 December 2020 |title=AusPAR: Semaglutide |url=https://www.tga.gov.au/auspar/auspar-semaglutide |url-status=live |archive-url=https://web.archive.org/web/20220224072457/https://www.tga.gov.au/auspar/auspar-semaglutide |archive-date=24 February 2022 |access-date=23 February 2022 |website=Therapeutic Goods Administration (TGA)}}{{cite web |title=Summary for ARTG Entry:315107 Ozempic 1 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen |url=https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=315107 |url-status=live |archive-url=https://web.archive.org/web/20220224072340/https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=315107 |archive-date=24 February 2022 |access-date=6 June 2021 |website=Therapeutic Goods Administration (TGA)}} [156] => [157] => In September 2019, a version that can be taken orally (Rybelsus) was approved for medical use in the United States,{{cite web |date=10 June 2020 |title=Drug Approval Package: Rybelsus |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000TOC.cfm |url-status=live |archive-url=https://web.archive.org/web/20201102161121/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000TOC.cfm |archive-date=2 November 2020 |access-date=26 September 2020 |publisher=U.S. [[Food and Drug Administration]] (FDA)}}{{cite press release |title=FDA approves first oral GLP-1 treatment for type 2 diabetes |date=20 September 2019 |publisher=U.S. [[Food and Drug Administration]] (FDA) |url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-glp-1-treatment-type-2-diabetes |access-date=20 September 2019 |url-status=live |archive-url=https://web.archive.org/web/20190923102804/https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-glp-1-treatment-type-2-diabetes |archive-date=23 September 2019}} and in the European Union in April 2020.{{cite web |date=29 January 2020 |title=Rybelsus EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus |url-status=live |archive-url=https://web.archive.org/web/20200814215223/https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus |archive-date=14 August 2020 |access-date=26 September 2020 |website=[[European Medicines Agency]] (EMA)}} [158] => [159] => In June 2021, a higher-dose version for injectable use sold under the brand name Wegovy was approved by the US [[Food and Drug Administration]] (FDA) as an [[anti-obesity medication]] for long-term weight management in adults.{{cite web |date=4 June 2021 |title=Wegovy- semaglutide injection, solution |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b |url-status=live |archive-url=https://web.archive.org/web/20211214080941/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b |archive-date=14 December 2021 |access-date=11 March 2022 |website=DailyMed}} In November 2021, the [[Committee for Medicinal Products for Human Use]] (CHMP) of the [[European Medicines Agency]] (EMA) recommended to grant a [[marketing authorization]] for Wegovy to [[Novo Nordisk]] A/S.{{cite web |date=11 November 2021 |title=Wegovy : Pending EC decision |url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/wegovy |url-status=live |archive-url=https://web.archive.org/web/20211113052426/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/wegovy |archive-date=13 November 2021 |access-date=13 November 2021 |website=European Medicines Agency}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. In January 2022, Wegovy was approved for medical use in the European Union.{{cite web |date=11 November 2021 |title=Wegovy EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy |url-status=live |archive-url=https://web.archive.org/web/20220702222728/https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy |archive-date=2 July 2022 |access-date=11 March 2022 |website=European Medicines Agency}}{{cite web | title=Wegovy Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1608.htm | access-date=3 March 2023 | archive-date=30 October 2022 | archive-url=https://web.archive.org/web/20221030000246/https://ec.europa.eu/health/documents/community-register/html/h1608.htm | url-status=live }} [160] => [161] => In January 2023, the label for Rybelsus was updated to reflect that it can be used as a [[first-line treatment]] for adults with type 2 diabetes.{{cite press release |title=Novo Nordisk announces FDA approval of label update for Rybelsus (semaglutide) allowing use as a first-line option for adults with type 2 diabetes |url=https://www.prnewswire.com/news-releases/novo-nordisk-announces-fda-approval-of-label-update-for-rybelsus-semaglutide-allowing-use-as-a-first-line-option-for-adults-with-type-2-diabetes-301720965.html |publisher=[[Novo Nordisk]] |via=PR Newswire |access-date=16 January 2023 |date=12 January 2023 |archive-date=16 January 2023 |archive-url=https://web.archive.org/web/20230116044101/https://www.prnewswire.com/news-releases/novo-nordisk-announces-fda-approval-of-label-update-for-rybelsus-semaglutide-allowing-use-as-a-first-line-option-for-adults-with-type-2-diabetes-301720965.html |url-status=live }} [162] => [163] => [[Grey market]] sellers offer unauthorized products claimed to be semaglutide online. This practice is illegal in the United States, but some buyers turn to unauthorized retailers due to being denied insurance coverage and not being able to afford the name brand drug.{{cite news | vauthors = Messer S, Kindelan K | date = 18 May 2023 |title=Woman says she got less expensive drug for weight loss after being denied by insurance |url=https://abcnews.go.com/GMA/Wellness/high-cost-drugs-weight-loss-ozempic-mounjaro-users/story?id=99424157 |access-date=26 September 2023 |work=ABC News |archive-date=26 September 2023 |archive-url=https://web.archive.org/web/20230926193018/https://abcnews.go.com/GMA/Wellness/high-cost-drugs-weight-loss-ozempic-mounjaro-users/story?id=99424157 |url-status=live }}{{cite news | vauthors = Lovelace Jr B | date = 3 May 2023 |title=Safety worries over copycat versions of Ozempic and Wegovy prompt state crackdowns |url=https://www.nbcnews.com/health/health-news/ozempic-wegovy-weight-loss-compounded-crackdowns-rcna82405 |access-date=26 September 2023 |work=NBC News |archive-date=25 September 2023 |archive-url=https://web.archive.org/web/20230925124826/https://www.nbcnews.com/health/health-news/ozempic-wegovy-weight-loss-compounded-crackdowns-rcna82405 |url-status=live }}{{cite magazine | vauthors = Jones CT |title=The FDA Warned Ozempic Users. They Don't Give a F-ck |url=https://www.rollingstone.com/culture/culture-features/ozempic-semaglutide-fda-warning-compound-drug-1234766348/ |access-date=26 September 2023 |magazine=Rolling Stone |date=8 June 2023 |archive-date=26 September 2023 |archive-url=https://web.archive.org/web/20230926193019/https://www.rollingstone.com/culture/culture-features/ozempic-semaglutide-fda-warning-compound-drug-1234766348/ |url-status=live }}{{cite news | vauthors = Gilbert D | date = 19 September 2023 |title=Inside the gold rush to sell cheaper imitations of Ozempic |url=https://www.washingtonpost.com/business/2023/09/19/ozempic-semaglutide-compounding-pharmacies/ |access-date=26 September 2023 |newspaper=Washington Post }}{{cite news | vauthors = Lovelace Jr B, Lewis R, Kopf M |title=The high price of Ozempic is pushing many to unregulated, copycat drugs for weight loss |url=https://www.nbcnews.com/health/health-news/ozempic-wegovy-semaglutide-compounding-weight-loss-safe-rcna72990 |access-date=26 September 2023 |work=NBC News |date=19 March 2023 |archive-date=26 September 2023 |archive-url=https://web.archive.org/web/20230926193018/https://www.nbcnews.com/health/health-news/ozempic-wegovy-semaglutide-compounding-weight-loss-safe-rcna72990 |url-status=live }} [164] => [165] => In October 2023, Belgium announced it was considering a temporary ban on Ozempic for use as a weight loss medication amid a sharp increase in demand leading to a shortage of the drug, which was expected to last into mid-2024. The government had previously advised medical professionals to prescribe the drug only to diabetics. A similar order had been issued by the government of the United Kingdom earlier that month, additionally prohibiting new prescriptions for type{{nbsp}}2 diabetics.{{Cite news | vauthors = Strauss M |date=24 October 2023 |title=Belgium plans temporary ban on use of Ozempic for weight loss |work=Reuters |url=https://www.reuters.com/business/healthcare-pharmaceuticals/belgium-plans-temporary-ban-use-ozempic-weight-loss-2023-10-24/ |access-date=24 October 2023 |archive-date=24 October 2023 |archive-url=https://web.archive.org/web/20231024130130/https://www.reuters.com/business/healthcare-pharmaceuticals/belgium-plans-temporary-ban-use-ozempic-weight-loss-2023-10-24/ |url-status=live }} [166] => [167] => ===Generics=== [168] => [169] => Semaglutide is expected to become patent-free in the United States no earlier than December 2031.{{cite web |title=OZEMPIC Drug Patent Profile |url=https://www.drugpatentwatch.com/p/tradename/OZEMPIC |website=Drug Patent Watch |access-date=23 March 2024}} [170] => [171] => The patent was scheduled to expire in 2026, but a Chinese court ruled in 2022 that all patents on semaglutide were invalid. [[Novo Nordisk]] appealed the ruling.{{cite news | vauthors = He L |title=Ozempic is taking China by storm. Drugmakers are scrambling to boost supplies | work = CNN Business |url=https://www.cnn.com/2023/06/06/business/china-ozempic-drug-shortage-intl-hnk/index.html |access-date=1 December 2023 |date=7 June 2023 |archive-date=15 December 2023 |archive-url=https://web.archive.org/web/20231215045157/https://www.cnn.com/2023/06/06/business/china-ozempic-drug-shortage-intl-hnk/index.html |url-status=live }} [172] => [173] => In Brazil, the Supreme Court refused to extend semaglutide's patent protection, which expires in 2026.{{cite news | vauthors = Masters W |title=Brazilian federal court denies semaglutide patent extension |url=https://www.pharmaceutical-technology.com/pricing-and-market-access/brazilian-federal-court-semaglutide-patent-extension/?cf-view |access-date=1 December 2023 |work=Pharmaceutical Technology |date=9 May 2023 |archive-date=6 January 2024 |archive-url=https://web.archive.org/web/20240106215444/https://www.pharmaceutical-technology.com/pricing-and-market-access/brazilian-federal-court-semaglutide-patent-extension/ |url-status=live }} [174] => [175] => === Economics === [176] => "Ozempic, the semaglutide injection used for T2D treatment, has a list price of $936 in the United States and $169 in Japan. Prices were $147 in Canada, $144 in Switzerland, $103 in Germany and Netherlands, $96 in Sweden, $93 in the United Kingdom, and $87 in Australia. France had the lowest price at $83." (21 August 2023; figures refer to a one-month supply){{cite web | url=https://www.medicaleconomics.com/view/u-s-leads-the-world-in-list-prices-for-diabetes-antiobesity-meds | title=U.S. Leads the world in list prices for diabetes, antiobesity meds | date=21 August 2023 | access-date=20 January 2024 | archive-date=20 January 2024 | archive-url=https://web.archive.org/web/20240120024751/https://www.medicaleconomics.com/view/u-s-leads-the-world-in-list-prices-for-diabetes-antiobesity-meds | url-status=live }}{{cite web | url=https://www.advisory.com/daily-briefing/2023/08/21/weight-loss-drug-cost | title=Charted: The cost of weight-loss drugs in the US vs. Other countries | access-date=8 April 2024 | archive-date=20 January 2024 | archive-url=https://web.archive.org/web/20240120050405/https://www.advisory.com/daily-briefing/2023/08/21/weight-loss-drug-cost | url-status=live }} [177] => [178] => In the US, Wegovy has a list price of $1,349.02 per month as of 2022 suggesting that because of the [[Medication costs|high costs]] many people "who could most benefit from weight loss may be unable to afford such expensive drugs".{{cite news | vauthors = Kolata G |title=Patients Taking Experimental Obesity Drug Lost More Than 50 Pounds, Maker Claims |url=https://www.nytimes.com/2022/04/28/health/obesity-drug-eli-lilly-tirzepatide-wegovy.html |access-date=13 May 2022 |work=[[The New York Times]] |date=28 April 2022 |archive-date=27 June 2022 |archive-url=https://web.archive.org/web/20220627163838/https://www.nytimes.com/2022/04/28/health/obesity-drug-eli-lilly-tirzepatide-wegovy.html |url-status=live |url-access=subscription}} High costs of Ozempic prompted some insurance companies to investigate and refuse to cover patients with what the companies considered was insufficient evidence to support a diabetes diagnosis, alleging [[off-label]] prescribing for weight loss. [179] => [180] => In the UK, semaglutide is available on [[NHS]] prescription for diabetes at [[National Health Service (England)#Prescription charges|nominal or no cost to patients]].{{cite news | title=NICE recommended weight-loss drug to be made available in specialist NHS services | publisher=[[National Institute for Health and Care Excellence]] (NICE) | date=8 March 2023 | url=https://www.nice.org.uk/news/article/nice-recommended-weight-loss-drug-to-be-made-available-in-specialist-nhs-services| archive-date=9 March 2023 | archive-url=https://web.archive.org/web/20230309113155/https://www.nice.org.uk/news/article/nice-recommended-weight-loss-drug-to-be-made-available-in-specialist-nhs-services | url-status=live }} It is also available for obesity, limited to treatment for two years.{{cite news | vauthors=Marcus R | title=I lost 40 pounds on Ozempic. But I'm left with even more questions| newspaper=[[The Washington Post]] | date=6 June 2023 | url=https://www.washingtonpost.com/opinions/2023/06/06/ozempic-weight-loss-ruth-marcus/| archive-url=https://web.archive.org/web/20230607022758/https://www.washingtonpost.com/opinions/2023/06/06/ozempic-weight-loss-ruth-marcus/ | archive-date=7 June 2023 | url-status=live }} [181] => [182] => High demand caused worldwide supply shortages of semaglutide in 2023;{{cite web |url=https://www.washingtonpost.com/business/2023/06/11/weight-loss-ozempic-wegovy-insurance/ |newspaper=[[The Washington Post]] |title=Insurers clamping down on doctors who prescribe Ozempic for weight loss | vauthors = Gilbert D | date=12 June 2023 }} new UK prescriptions were not issued during the shortage. [183] => [184] => '''Economic impact on Danish society''' [185] => [186] => By 2023, [[Novo Nordisk]] had become the most valuable corporation in the European Union, worth more than {{US$|500 billion}}, and accounting for almost all of recent economic growth in [[Denmark]].{{cite web | url=https://www.abc.net.au/news/2023-12-19/ozempic-obesity-diabetes-health-challenges-impact-global-economy/103244056 | title=How Ozempic could affect the health of the global economy in more ways than one | date=19 December 2023 | vauthors = Verrender I | publisher=ABC News | access-date=18 December 2023 | archive-date=18 December 2023 | archive-url=https://web.archive.org/web/20231218223436/https://www.abc.net.au/news/2023-12-19/ozempic-obesity-diabetes-health-challenges-impact-global-economy/103244056 | url-status=live }} By end of 2023, the [[Gross Domestic Product (GDP)]] of Denmark was estimated to be $354 billion,{{Cite web |title=Denmark {{!}} GDP {{!}} 2023 {{!}} 2024 {{!}} Economic Data |url=https://www.worldeconomics.com/Country-Size/Denmark.aspx |access-date=2024-04-02 |website=World Economics}} thus the value of Novo Nordisk exceeded the entire Danish GDP by almost $150 billion. [187] => [188] => Profits from Novo Nordisk generate returns for the [[Novo Nordisk Foundation]], which holds the controlling stake in Novo Nordisk. The profits results in increased Danish tax revenues and employment. Novo Nordisk added 3,500 jobs in Denmark in 2022, bringing the total in the country to 21,000 employees, out of 59,000 worldwide.{{Cite web |title=Novo Nordisk's Wegovy bonanza looms large in Denmark |website=[[Reuters]] |url=https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisks-wegovy-bonanza-looms-large-denmark-2023-10-05/ |access-date=2024-04-05}} [189] => [190] => ===Counterfeits=== [191] => In October 2023, there were reports of counterfeit Ozempic pens being sold in Europe.{{cite press release | title=EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens | website=[[European Medicines Agency]] | date=18 October 2023 | url=https://www.ema.europa.eu/en/news/ema-alerts-eu-patients-and-healthcare-professionals-reports-falsified-ozempic-pens | access-date=6 January 2024 | archive-date=4 January 2024 | archive-url=https://web.archive.org/web/20240104102518/https://www.ema.europa.eu/en/news/ema-alerts-eu-patients-and-healthcare-professionals-reports-falsified-ozempic-pens | url-status=live }} The pens possibly contained [[Insulin (medication)|insulin]], and led to several people being hospitalised with [[hypoglycaemia]] and [[Non-epileptic seizure|seizures]].{{cite web | title=Ozempic (semaglutide) and Saxenda (liraglutide): vigilance required due to potentially harmful falsified products | website=[[Medicines and Healthcare products Regulatory Agency]] | date=23 November 2023 | url=https://www.gov.uk/drug-safety-update/ozempicv-semaglutide-and-saxenda-liraglutide-vigilance-required-due-to-potentially-harmful-falsified-products | access-date=6 January 2024 | archive-date=26 December 2023 | archive-url=https://web.archive.org/web/20231226114314/http://www.gov.uk/drug-safety-update/ozempicv-semaglutide-and-saxenda-liraglutide-vigilance-required-due-to-potentially-harmful-falsified-products | url-status=live }}{{Cite news |title=European regulator warns EU, UK about fake Ozempic pens |publisher=[[Reuters]] |date=18 October 2023 |url=https://www.reuters.com/business/healthcare-pharmaceuticals/eu-medicines-regulator-warns-eu-uk-fake-ozempic-pens-2023-10-18/ |access-date=24 October 2023 |archive-date=24 October 2023 |archive-url=https://web.archive.org/web/20231024111149/https://www.reuters.com/business/healthcare-pharmaceuticals/eu-medicines-regulator-warns-eu-uk-fake-ozempic-pens-2023-10-18/ |url-status=live }}{{Cite news |title=Several hospitalised in Austria after using suspected fake diabetes drug |agency=Reuters |newspaper=[[The Guardian]] |date=24 October 2023 |url=https://www.theguardian.com/world/2023/oct/24/several-hospitalised-in-austria-after-using-suspected-fake-diabetes-drug |access-date=24 October 2023 |archive-date=24 October 2023 |archive-url=https://web.archive.org/web/20231024153414/https://www.theguardian.com/world/2023/oct/24/several-hospitalised-in-austria-after-using-suspected-fake-diabetes-drug |url-status=live }} In December 2023, the FDA issued a warning about counterfeit Ozempic in the United States.{{cite web | title=FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain | website=U.S. [[Food and Drug Administration]] (FDA) | date=21 December 2023 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain | access-date=22 December 2023 | archive-date=22 December 2023 | archive-url=https://web.archive.org/web/20231222061933/https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain | url-status=live }} [192] => [193] => Some counterfeits have been found to contain [[salts]] of semaglutide including the [[sodium]] and the [[acetate]] in an attempt to avoid the patent of the base semaglutide product and are not considered safe or effective by the US [[Food and Drug Administration]] (FDA).{{cite web |title=Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss |url=https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss |publisher=U.S. [[Food and Drug Administration]] (FDA) |access-date=29 December 2023 |date=21 December 2023 |archive-date=29 December 2023 |archive-url=https://web.archive.org/web/20231229201803/https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss |url-status=live }} [194] => [195] => == Research == [196] => A 2014 meta-analysis found that semaglutide may be effective in lowering liver enzymes ([[transaminitis]]) and improving certain radiologically observed features of [[metabolic dysfunction–associated steatotic liver disease]].{{cite journal |vauthors=Dutta D, Kumar M, Shivaprasad KS, Kumar A, Sharma M |date=June 2022 |title=Impact of semaglutide on biochemical and radiologic measures of metabolic-dysfunction associated fatty liver disease across the spectrum of glycaemia: A meta-analysis |journal=Diabetes & Metabolic Syndrome |volume=16 |issue=6 |pages=102539 |doi=10.1016/j.dsx.2022.102539 |pmid=35709586 |s2cid=249584781}} [197] => French national health care insurance system database had previously suggested 1–3 years use of glucagon like peptide-1 receptor agonists like exenatide, liraglutide and dulaglutide may be linked with increased occurrence of thyroid cancer. Semaglutide belongs to the same family of medicine. A meta-analysis involving data from 37 randomized controlled trials and 19 real world studies (46,719 patients) showed that semaglutide use over 18 months was not associated with increased risks of any cancer, supported by a high grade of evidence.{{cite journal | vauthors = Nagendra L, Bg H, Sharma M, Dutta D | title = Semaglutide and cancer: A systematic review and meta-analysis.. | journal = Diabetes Metab Syndr | volume = 17 | issue = 9 | date = July 2023 | pages = 102834 | pmid = 37531876 | doi = 10.1016/j.dsx.2023.102834 | s2cid = 260261877 }} [198] => [199] => A study funded by [[Eli Lilly and Company|Eli Lilly]], producer of [[tirzepatide]], in 2021 found that semaglutide, when used once weekly as add-on therapy to [[metformin]] in people with type{{nbsp}}2 diabetes, was found to be inferior to tirzepatide (sold under the brand name Mounjaro) in both endpoints of reduction in [[glycated hemoglobin|glycohemoglobin, A1C]], and body weight, with a roughly similar safety profile. The same study pointed out that semaglutide was found to cause less serious adverse events compared to tirzepatide.{{cite journal | collaboration = SURPASS-2 Investigators |vauthors=Frías JP, Davies MJ, Rosenstock J, Pérez Manghi FC, Fernández Landó L, Bergman BK, Liu B, Cui X, Brown K |date=August 2021 |title=Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes |journal=The New England Journal of Medicine |volume=385 |issue=6 |pages=503–515 |doi=10.1056/NEJMoa2107519 |pmid=34170647 |doi-access=free |title-link=doi |s2cid=235635529}} [200] => [201] => In July 2023, the Icelandic Medicines Agency reported two cases of [[suicidal thoughts]] and one case of [[self-injury]] of users of the injection, prompting a safety assessment of Ozempic,{{Cite web | vauthors = Blanchet B |date=27 July 2023 |title=Ozempic, Drugs for Weight Loss Being Reviewed for Links to Suicide Risk |url=https://people.com/ozempic-wegovy-weight-loss-drug-suicide-risks-uk-7566473 |access-date=28 July 2023 |website=People |archive-date=28 July 2023 |archive-url=https://web.archive.org/web/20230728122850/https://people.com/ozempic-wegovy-weight-loss-drug-suicide-risks-uk-7566473 |url-status=live }} Wegovy, Saxenda, and similar drugs.{{Cite news|url=https://www.bbc.com/news/health-66119059|title=Weight-loss jabs investigated for suicide risk|work=BBC News|date=10 July 2023|access-date=10 July 2023|archive-date=10 July 2023|archive-url=https://web.archive.org/web/20230710230924/https://www.bbc.com/news/health-66119059|url-status=live}} In January 2024, a preliminary review conducted by the FDA confirmed no evidence had been found to suggest that the medicine causes suicidal thoughts or actions.{{cite news |title=FDA reports no link between weight-loss drugs and suicidal thoughts |url=https://www.washingtonpost.com/health/2024/01/11/fda-ozempic-wegovy-suicide-safety/ |newspaper=[[The Washington Post]] |access-date=19 January 2024 |archive-date=14 January 2024 |archive-url=https://web.archive.org/web/20240114143652/https://www.washingtonpost.com/health/2024/01/11/fda-ozempic-wegovy-suicide-safety/ |url-status=live }}{{cite web |title=Update on FDA's ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity |date=11 January 2024 |url=https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type |publisher=U.S. [[Food and Drug Administration]] (FDA) |access-date=19 January 2024 |archive-date=19 January 2024 |archive-url=https://web.archive.org/web/20240119013836/https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type |url-status=live }} [202] => [203] => == References == [204] => {{reflist}} [205] => [206] => == External links == [207] => {{Commonscat}} [208] => {{Wiktionary}} [209] => {{Scholia}} [210] => * {{cite web |title=Semaglutide tablet |url=https://medlineplus.gov/druginfo/meds/a619057.html |website=MedlinePlus}} [211] => * {{ClinicalTrialsGov|NCT03574597|Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT)}} [212] => [213] => {{Oral hypoglycemics and insulin analogs}} [214] => {{Portal bar | Medicine}} [215] => {{Authority control}} [216] => [217] => [[Category:GLP-1 receptor agonists]] [218] => [[Category:Peptide therapeutics]] [219] => [[Category:Peptide hormones]] [220] => [[Category:Drugs developed by Novo Nordisk]] [221] => [[Category:Experimental drugs developed for non-alcoholic fatty liver disease]] [] => )
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Semaglutide

Semaglutide is a medication used for the treatment of type 2 diabetes and obesity. It belongs to the class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists, which work by stimulating the production of insulin and suppressing the release of glucagon.

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It belongs to the class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists, which work by stimulating the production of insulin and suppressing the release of glucagon. Developed by the pharmaceutical company Novo Nordisk, semaglutide is administered via subcutaneous injection once weekly. In addition to improving blood sugar control, it has shown promising results in reducing body weight in individuals with obesity. The medication has been approved for medical use in various countries, including the United States and Europe. However, it is not recommended for use in people with type 1 diabetes or diabetic ketoacidosis. Common side effects of semaglutide include nausea, vomiting, and diarrhea.

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