{"dataset":{"name":"FDA-Approved Weight-Loss and GLP-1 Medications","description":"Reference rows for the FDA-approved medications the register writes about: the GLP-1 and GIP/GLP-1 molecules and their US brands, plus the two approved non-GLP-1 combination weight-management drugs, Contrave and Qsymia. Each row carries generic and brand names, the marketing-authorization holder, FDA status and approval date, route of administration, available strengths, and the official FDA prescribing information, linked. Every row is approved. Investigational compounds are not here; they live in the pipeline dataset.","url":"https://glpwatchdog.org/glp1","creator":"GLP Watchdog","license":"https://creativecommons.org/licenses/by/4.0/","licenseName":"CC BY 4.0","dateModified":"2026-11-06","temporalCoverage":"2026-10-30/2026-11-06","rowCount":12,"csv":"https://glpwatchdog.org/api/datasets/glp1-medications.csv","catalog":"https://glpwatchdog.org/api/datasets/index.json","fields":[{"name":"name","description":"Name of the molecule or the brand this row describes."},{"name":"slug","description":"URL slug used by /drugs/{slug}."},{"name":"generic_name","description":"Non-proprietary name."},{"name":"brand_names","description":"US brand names, pipe-separated."},{"name":"manufacturer","description":"Marketing-authorization-holder company name."},{"name":"fda_status","description":"FDA approval status, written out, including indication-specific brand approvals and their dates where the molecule carries more than one."},{"name":"approval_date","description":"Earliest FDA approval date for the molecule, ISO-formatted."},{"name":"indication","description":"Approved indications text."},{"name":"drug_class","description":"Pharmacologic class as labeled: GLP-1 receptor agonist, dual GIP/GLP-1 agonist, and so on."},{"name":"admin_route","description":"Route or routes of administration."},{"name":"dosage_form","description":"Dosage forms: subcutaneous injection, oral tablet, and so on."},{"name":"available_strengths","description":"FDA-approved strengths, pipe-separated."},{"name":"prescribing_info_url","description":"URL of the FDA-hosted prescribing information PDF."},{"name":"detail_url","description":"Canonical drug detail page on glpwatchdog.org."}]},"summary":{"asOf":"2026-11-06","rowCount":12,"license":"https://creativecommons.org/licenses/by/4.0/","licenseName":"CC BY 4.0","citation":"GLP Watchdog, \"FDA-Approved Weight-Loss and GLP-1 Medications\", data as of 2026-11-06. https://glpwatchdog.org/glp1","about":"FDA-Approved Weight-Loss and GLP-1 Medications: 12 rows. Data as of 2026-11-06."},"rows":[{"name":"Semaglutide","slug":"semaglutide","generic_name":"Semaglutide","brand_names":"Ozempic|Wegovy|Rybelsus","manufacturer":"Novo Nordisk A/S","fda_status":"FDA-approved for type 2 diabetes as Ozempic (injection, 2017; tablets on sale since May 4, 2026) and Rybelsus (2019); FDA-approved for chronic weight management as Wegovy (injection 2021, tablets December 2025). Labels also cover fewer major cardiovascular events (Ozempic, Rybelsus/Ozempic tablets, Wegovy), chronic kidney disease in type 2 diabetes (Ozempic injection, January 2025) and noncirrhotic MASH with liver fibrosis (Wegovy, August 2025). In the US, Rybelsus tablets are being replaced by Ozempic tablets.","approval_date":"2021-06-04","indication":"Chronic weight management in adults with obesity, or overweight with at least one weight-related comorbid condition (trials enrolled at BMI ≥30, or ≥27 with a comorbidity), and in children 12 and older with obesity (Wegovy); type 2 diabetes mellitus glycemic control (Ozempic, Rybelsus); major cardiovascular event reduction (Wegovy, Ozempic, Rybelsus and Ozempic tablets); kidney outcomes in type 2 diabetes with chronic kidney disease (Ozempic injection); noncirrhotic MASH with moderate to advanced liver fibrosis (Wegovy)","drug_class":"GLP-1 receptor agonist","admin_route":"Subcutaneous injection (Ozempic, Wegovy) / Oral (Ozempic tablets, Wegovy tablets; Rybelsus being discontinued in the US)","dosage_form":"Subcutaneous injection / Oral tablet","available_strengths":"Wegovy injection: five weekly doses, 0.25 up to 2.4 mg|Wegovy HD injection: 7.2 mg|Ozempic injection: four weekly doses, 0.25 up to 2 mg|Ozempic tablets: 1.5, 4 or 9 mg daily|Wegovy tablets: 1.5, 4, 9 or 25 mg daily|Rybelsus tablets: 3, 7 or 14 mg daily (being discontinued in the US)","prescribing_info_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf","detail_url":"https://glpwatchdog.org/drugs/semaglutide"},{"name":"Tirzepatide","slug":"tirzepatide","generic_name":"Tirzepatide","brand_names":"Mounjaro|Zepbound","manufacturer":"Eli Lilly and Company","fda_status":"FDA-approved for type 2 diabetes as Mounjaro (May 2022; ages 10 and up since December 2025; fewer major cardiovascular events in adults with type 2 diabetes at high risk since August 2026); FDA-approved for chronic weight management as Zepbound (November 2023) and in adults with obesity, for moderate to severe obstructive sleep apnea (December 2024)","approval_date":"2023-11-08","indication":"Chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity, and, in adults with obesity, moderate to severe obstructive sleep apnea (Zepbound); glycemic control in type 2 diabetes from age 10, and major cardiovascular event reduction in adults with type 2 diabetes at high risk (Mounjaro)","drug_class":"GIP and GLP-1 receptor agonist (dual incretin)","admin_route":"Subcutaneous injection (KwikPen and single-dose vial)","dosage_form":"Subcutaneous injection","available_strengths":"2.5 mg/0.5 mL|5 mg/0.5 mL|7.5 mg/0.5 mL|10 mg/0.5 mL|12.5 mg/0.5 mL|15 mg/0.5 mL","prescribing_info_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf","detail_url":"https://glpwatchdog.org/drugs/tirzepatide"},{"name":"Wegovy","slug":"wegovy","generic_name":"Semaglutide","brand_names":"Wegovy","manufacturer":"Novo Nordisk A/S","fda_status":"FDA-approved for chronic weight management in adults with obesity or overweight with comorbidity (June 2021); cardiovascular risk reduction in adults with established CVD (March 2024); weight reduction in pediatric patients aged 12+ (December 2022); noncirrhotic MASH with moderate-to-advanced liver fibrosis in adults (August 2025, accelerated approval); and an oral tablet form for cardiovascular risk reduction or weight reduction in adults (December 2025), alongside the original injection","approval_date":"2021-06-04","indication":"Chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity (trials enrolled at BMI ≥30, or ≥27 with a comorbidity); weight reduction in pediatric patients aged 12+; cardiovascular risk reduction in adults with obesity and established cardiovascular disease; noncirrhotic MASH with moderate-to-advanced liver fibrosis in adults (August 2025). The oral tablet form (December 2025) covers the cardiovascular risk reduction and adult weight reduction indications only.","drug_class":"GLP-1 receptor agonist","admin_route":"Subcutaneous injection once weekly (single-dose pre-filled pen or syringe, or the 4-dose Wegovy FlexTouch pen for the 2.4 mg dose) or, since December 2025, an oral tablet taken once daily","dosage_form":"Subcutaneous injection; oral tablet (approved December 2025)","available_strengths":"0.25 mg/0.5 mL (injection)|0.5 mg/0.5 mL (injection)|1 mg/0.5 mL (injection)|1.7 mg/0.75 mL (injection)|2.4 mg/0.75 mL (injection)|2.4 mg per dose, 9.6 mg/3 mL (3.2 mg/mL) Wegovy FlexTouch 4-dose pen (injection)|7.2 mg/0.75 mL, Wegovy HD (injection)|1.5 mg (tablet)|4 mg (tablet)|9 mg (tablet)|25 mg (tablet)","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b","detail_url":"https://glpwatchdog.org/drugs/wegovy"},{"name":"Ozempic","slug":"ozempic","generic_name":"Semaglutide","brand_names":"Ozempic","manufacturer":"Novo Nordisk A/S","fda_status":"Injection: FDA-approved for glycemic control in type 2 diabetes (December 2017), to reduce major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease (2020), and to reduce kidney function decline, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (January 2025). Ozempic tablets, taken once daily and on sale since May 4, 2026, share Rybelsus's label: glycemic control in adults with type 2 diabetes and fewer major cardiovascular events in those at high risk. Weight loss is off-label use.","approval_date":"2017-12-05","indication":"Injection: glycemic control in adults with type 2 diabetes mellitus; cardiovascular risk reduction in adults with type 2 diabetes and established cardiovascular disease; reduction of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. Ozempic tablets: glycemic control in adults with type 2 diabetes; cardiovascular risk reduction in adults with type 2 diabetes at high risk of major cardiovascular events.","drug_class":"GLP-1 receptor agonist","admin_route":"Subcutaneous injection once weekly (single-patient-use pen or single-dose prefilled syringe); Ozempic tablets by mouth once daily","dosage_form":"Subcutaneous injection; oral tablet (Ozempic tablets)","available_strengths":"2 mg/3 mL pen (0.25 mg or 0.5 mg doses)|4 mg/3 mL pen (1 mg doses)|8 mg/3 mL pen (2 mg doses)|0.25 mg/0.5 mL single-dose syringe|0.5 mg/0.5 mL single-dose syringe|1 mg/0.5 mL single-dose syringe|1.5 mg tablet|4 mg tablet|9 mg tablet","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79","detail_url":"https://glpwatchdog.org/drugs/ozempic"},{"name":"Mounjaro","slug":"mounjaro","generic_name":"Tirzepatide","brand_names":"Mounjaro","manufacturer":"Eli Lilly and Company","fda_status":"FDA-approved for type 2 diabetes in adults (May 2022) and in children 10 and older (December 2025), and to reduce major cardiovascular events in adults with type 2 diabetes at high risk (August 2026). Off-label use for weight loss is common; the weight management indication is covered by Zepbound (FDA-approved November 2023).","approval_date":"2022-05-13","indication":"Glycemic control in adults and pediatric patients 10 years and older with type 2 diabetes mellitus; reduction of major adverse cardiovascular events in adults with type 2 diabetes at high risk for these events (August 2026)","drug_class":"GIP and GLP-1 receptor agonist (dual incretin)","admin_route":"Subcutaneous injection (single-dose pre-filled pen)","dosage_form":"Subcutaneous injection","available_strengths":"2.5 mg/0.5 mL|5 mg/0.5 mL|7.5 mg/0.5 mL|10 mg/0.5 mL|12.5 mg/0.5 mL|15 mg/0.5 mL","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0","detail_url":"https://glpwatchdog.org/drugs/mounjaro"},{"name":"Zepbound","slug":"zepbound","generic_name":"Tirzepatide","brand_names":"Zepbound","manufacturer":"Eli Lilly and Company","fda_status":"FDA-approved for chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity (trials enrolled at BMI ≥30, or ≥27 with a comorbidity) (November 2023), and in adults with obesity, for moderate to severe obstructive sleep apnea (December 2024)","approval_date":"2023-11-08","indication":"Chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity (trials enrolled at BMI ≥30, or ≥27 with a comorbidity); obstructive sleep apnea in adults with obesity","drug_class":"GIP and GLP-1 receptor agonist (dual incretin)","admin_route":"Subcutaneous injection (single-dose pre-filled pen and vial)","dosage_form":"Subcutaneous injection","available_strengths":"2.5 mg/0.5 mL|5 mg/0.5 mL|7.5 mg/0.5 mL|10 mg/0.5 mL|12.5 mg/0.5 mL|15 mg/0.5 mL","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b","detail_url":"https://glpwatchdog.org/drugs/zepbound"},{"name":"Foundayo","slug":"foundayo","generic_name":"Orforglipron","brand_names":"Foundayo","manufacturer":"Eli Lilly and Company","fda_status":"FDA-approved for chronic weight management in adults with obesity, or overweight with weight-related medical problems, alongside a reduced-calorie diet and increased physical activity (April 1, 2026). Not approved for pediatric use. Cannot be used with other GLP-1 receptor agonists.","approval_date":"2026-04-01","indication":"Chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity","drug_class":"GLP-1 receptor agonist (oral non-peptide small molecule)","admin_route":"Oral, once daily","dosage_form":"Oral tablet","available_strengths":"0.8 mg tablet (starting dose)|2.5 mg tablet|5.5 mg tablet|9 mg tablet|14.5 mg tablet|17.2 mg tablet (maximum dose)","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ac446c5-feba-474f-a103-23facb9b5c62","detail_url":"https://glpwatchdog.org/drugs/foundayo"},{"name":"Saxenda","slug":"saxenda","generic_name":"Liraglutide","brand_names":"Saxenda","manufacturer":"Novo Nordisk A/S","fda_status":"FDA-approved for chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity (trials enrolled at BMI ≥30, or ≥27 with a comorbidity) (December 23, 2014); pediatric indication for patients aged 12 years and older with body weight greater than 60 kg and obesity added December 4, 2020. Being discontinued by Novo Nordisk: FDA's drug shortage database lists Saxenda as 'Limited Availability' and says 'Product will be available until discontinuation in January 2027' (reason: discontinuation of manufacture, posted August 25, 2026).","approval_date":"2014-12-23","indication":"Chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity, or overweight with at least one weight-related comorbidity (trials enrolled at BMI ≥30, or ≥27 with a comorbidity), and in pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity","drug_class":"GLP-1 receptor agonist","admin_route":"Subcutaneous, once daily","dosage_form":"Subcutaneous injection (single-patient-use pre-filled pen)","available_strengths":"0.6 mg/dose|1.2 mg/dose|1.8 mg/dose|2.4 mg/dose|3 mg/dose (delivered from a 6 mg/mL, 3 mL single-patient-use pre-filled pen)","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143","detail_url":"https://glpwatchdog.org/drugs/saxenda"},{"name":"Trulicity","slug":"trulicity","generic_name":"Dulaglutide","brand_names":"Trulicity","manufacturer":"Eli Lilly and Company","fda_status":"FDA-approved for glycemic control in adults with type 2 diabetes mellitus (September 18, 2014); FDA-approved to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established CVD or multiple cardiovascular risk factors (February 2020); pediatric indication for type 2 diabetes in patients aged 10 years and older added in 2022. Not approved for chronic weight management.","approval_date":"2014-09-18","indication":"Glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus; reduction of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors","drug_class":"GLP-1 receptor agonist","admin_route":"Subcutaneous, once weekly","dosage_form":"Subcutaneous injection (single-dose pre-filled pen)","available_strengths":"0.75 mg/0.5 mL|1.5 mg/0.5 mL|3 mg/0.5 mL|4.5 mg/0.5 mL","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309","detail_url":"https://glpwatchdog.org/drugs/trulicity"},{"name":"Rybelsus","slug":"rybelsus","generic_name":"Semaglutide","brand_names":"Rybelsus","manufacturer":"Novo Nordisk A/S","fda_status":"FDA-approved September 20, 2019 for blood sugar control in adults with type 2 diabetes; also approved to lower the risk of major cardiovascular events in adults with type 2 diabetes at high risk. Discontinued in the US: the FDA listed Rybelsus 3 mg, 7 mg and 14 mg as discontinued on June 4, 2026, to be replaced by Ozempic tablets (1.5 mg, 4 mg, 9 mg) on the same label. Not approved for weight loss. The oral semaglutide approved for weight reduction is the Wegovy tablet, which includes a 25 mg dose; Ozempic tablets have no 25 mg strength.","approval_date":"2019-09-20","indication":"Glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise; reduction of major adverse cardiovascular events in adults with type 2 diabetes at high risk for these events (2025). Being replaced in the US by Ozempic tablets, which carry the same indications.","drug_class":"GLP-1 receptor agonist (oral peptide formulation)","admin_route":"Oral, once daily on empty stomach (≤30 minutes before first food, drink, or other oral medication; taken with ≤4 oz plain water)","dosage_form":"Oral tablet (peptide co-formulated with SNAC absorption enhancer)","available_strengths":"3 mg tablet (starter, first 30 days)|7 mg tablet|14 mg tablet (maximum dose)","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98","detail_url":"https://glpwatchdog.org/drugs/rybelsus"},{"name":"Contrave","slug":"contrave","generic_name":"Naltrexone hydrochloride / Bupropion hydrochloride","brand_names":"Contrave","manufacturer":"Azurity Pharmaceuticals, Inc.","fda_status":"FDA-approved for chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity (September 10, 2014). Originally developed by Orexigen Therapeutics; Orexigen filed Chapter 11 in 2018 and the Contrave assets were acquired by Nalpropion Pharmaceuticals (a joint venture of Pernix Therapeutics and a Highbridge-led investor group). Nalpropion was subsequently rolled up into Currax Pharmaceuticals. Azurity Pharmaceuticals announced it had acquired Contrave in June 2026; Drugs@FDA now lists Azurity as sponsor of NDA 200063. Not FDA-approved for pediatric use.","approval_date":"2014-09-10","indication":"Chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity, or overweight with at least one weight-related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia","drug_class":"Combination: opioid receptor antagonist (naltrexone) + dopamine/norepinephrine reuptake inhibitor (bupropion)","admin_route":"Oral, twice daily (morning and evening); not with a high-fat meal","dosage_form":"Extended-release oral tablet (fixed-dose combination)","available_strengths":"8 mg naltrexone HCl / 90 mg bupropion HCl extended-release tablet (single fixed-dose strength)","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=485ff360-32c8-11df-928b-0002a5d5c51b","detail_url":"https://glpwatchdog.org/drugs/contrave"},{"name":"Qsymia","slug":"qsymia","generic_name":"Phentermine and topiramate extended-release","brand_names":"Qsymia","manufacturer":"VIVUS LLC","fda_status":"FDA-approved for chronic weight management in adults (July 17, 2012); pediatric indication for patients aged 12 years and older with obesity added June 2022. Distributed only through a Risk Evaluation and Mitigation Strategy (REMS) program because of teratogenicity and suicidality risks. Phentermine component is a DEA Schedule IV controlled substance.","approval_date":"2012-07-17","indication":"Chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity, or overweight with at least one weight-related comorbidity (such as hypertension, type 2 diabetes mellitus, or dyslipidemia), and in pediatric patients aged 12 years and older with obesity (BMI ≥95th percentile for age and sex)","drug_class":"Combination: sympathomimetic amine (phentermine) + anticonvulsant (topiramate)","admin_route":"Oral, once daily in the morning","dosage_form":"Oral capsule (fixed-dose combination, extended-release)","available_strengths":"3.75 mg phentermine / 23 mg topiramate ER (starting dose)|7.5 mg phentermine / 46 mg topiramate ER (recommended dose)|11.25 mg phentermine / 69 mg topiramate ER (titration dose)|15 mg phentermine / 92 mg topiramate ER (maximum dose)","prescribing_info_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40dd5602-53da-45ac-bb4b-15789aba40f9","detail_url":"https://glpwatchdog.org/drugs/qsymia"}]}