FDA GLP-1 Tracker: Approvals & Indications
Complete history of FDA GLP-1 approvals and current indication landscape, plus pipeline submissions in review.
FDA Approval Timeline
| Year | Drug | Event |
|---|---|---|
| 2024 | Zepbound | FDA expanded indication to obstructive sleep apnea + obesity |
| 2024 | Wegovy | FDA expanded indication to cardiovascular event reduction in adults with obesity + heart disease |
| 2023 | Zepbound (tirzepatide) | FDA approval for chronic weight management |
| 2022 | Mounjaro (tirzepatide) | FDA approval for type 2 diabetes |
| 2021 | Wegovy (semaglutide 2.4 mg) | FDA approval for chronic weight management |
| 2020 | Ozempic | FDA expanded indication for cardiovascular risk reduction in T2D |
| 2019 | Rybelsus (oral semaglutide) | FDA approval — first oral GLP-1 |
| 2017 | Ozempic (semaglutide) | FDA approval for type 2 diabetes |
| 2014 | Saxenda (liraglutide 3.0) | FDA approval for chronic weight management |
| 2014 | Trulicity (dulaglutide) | FDA approval for type 2 diabetes |
| 2010 | Victoza (liraglutide) | FDA approval for type 2 diabetes |
Currently in FDA Review
- Orforglipron (Lilly) — submission accepted 2025, approval expected 2026
- Retatrutide (Lilly) — Phase 3 ongoing, submission expected late 2026
- CagriSema (Novo) — Phase 3 results 2025, submission expected 2026
- Survodutide (BI / Zealand) — Phase 3 ongoing
- Pemvidutide (Altimmune) — Phase 3 ongoing
Frequently Asked Questions
What new GLP-1 drugs is the FDA reviewing?
Eli Lilly's orforglipron (oral) submission was accepted in 2025 with 2026 approval expected. Retatrutide submission expected late 2026. Novo Nordisk's CagriSema submission expected 2026.
What is the latest GLP-1 FDA approval?
The 2024 expansion of Wegovy for cardiovascular risk reduction. Zepbound for sleep apnea + obesity (also 2024).