GLP-1RAs approved by the FDA
| API and trade name | Original approval date | Administration | Therapeutic indication | References |
|---|---|---|---|---|
| Exenatide (ByettaTM) | Apr-28-2005 | Twice-daily 250 mcg/mL | To improve glycemic control in adults with T2DM | [33, 36] |
| Liraglutide (VictozaTM) | Jan-25-2010 | Once-daily 18 mg/3 mL (6 mg/mL) | To reduce the risk of major adverse cardiovascular events in T2DM adult patients, and an adjunct to diet and exercise to improve glycemic control in T2DM patients 10 years and older | [34] |
| Liraglutide (SaxendaTM) | Dec-23-2010 | Once-daily 18 mg/3 mL (6 mg/mL) | For chronic weight management in adult patients as an adjunct to a reduced-caloric diet and increased physical activity | [61, 62] |
| Exenatide1 (BydureonTM) | Jan-27-2012 | Once-weekly 2 mg/vial (extended-release) | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [39] |
| Lixisenatide (LyxumiaTM) | Jan-31-2013 | Once-daily 10 mcg/0.2 mL, or 20 mcg/0.2 mL | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [12, 52, 104] |
| Exenatide1 (Bydureon PenTM) | Feb-28-2014 | Once-weekly 2 mg (extended-release) | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [35] |
| Dulaglutide (TrulicityTM) | Sep-18-2014 | Once-weekly 1.5 mg/0.5 mL | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [46, 70] |
| Albiglutide1 (TanzeumTM) | Apr-15-2014 | Once-weekly 30 mg or 50 mg in a single-dose pen | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [48, 49] |
| Lixisenatide1 (AdlyxinTM) | Jul-28-2016 | Once-daily 50 mcg/mL or 100 mcg/mL | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [51] |
| Exenatide (Bydureon BCise TM) | Oct-20-2017 | Once-weekly 2 mg/0.85 mL (auto-injector) | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [38, 40, 105] |
| Semaglutide (OzempicTM) | Dec-5-2017 | Once-weekly 2 mg/1.5 mL (1.34 mg/mL), 4 mg/3 mL (1.34 mg/mL), or 8 mg/3 mL (2.68 mg/mL) | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [54, 56] |
| Semaglutide (RybelsusTM) | Sep-20-2019 | Once-daily/oral tablets: 3 mg, 7 mg, or 14 mg | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [106] |
| Semaglutide (WegovyTM) | Jun-4-2021 | Once-weekly 0.25 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, or 2.4 mg/0.75 mL | For chronic weight management in patients 12 years and older as an adjunct to a reduced-caloric diet and increased physical activity | [8, 55, 107] |
| Tirzepatide (MounjaroTM) | May-13-2022 | Once-weekly 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, or 15 mg/0.5 mL in single-dose pen | To improve glycemic control in adults with T2DM as an adjunct to diet and exercise | [86, 108] |
Data found in Table 1 was retrieved from the FDA databases, including the Orange Book, and the European Medicines Agency website. The availability of the mentioned drugs varies across countries, and not all dosage forms and strengths are universally accessible [109, 110]. 1 Status discontinued. API: active pharmaceutical ingredient
