FDA GLP-1 approval timeline 2017-2026

The complete timeline

1. 2017-12-05

   Ozempic (Semaglutide)

   For: Type 2 diabetes

   First Novo Nordisk semaglutide approval. Weekly injection.

2. 2019-09-20

   Rybelsus (Semaglutide (oral))

   For: Type 2 diabetes

   First oral GLP-1. 7-14 mg daily with fasting protocol.

3. 2021-06-04

   Wegovy (Semaglutide 2.4 mg)

   For: Chronic weight management

   First semaglutide approved for weight loss. 14-15% mean loss in STEP-1.

4. 2022-05-13

   Mounjaro (Tirzepatide)

   For: Type 2 diabetes

   First dual GLP-1/GIP agonist. Eli Lilly. Weekly injection.

5. 2023-11-08

   Zepbound (Tirzepatide 15 mg)

   For: Chronic weight management

   20-22% mean weight loss. SURMOUNT-1 trial.

6. 2024-03-08

   Wegovy (Semaglutide 2.4 mg)

   For: CV risk reduction

   SELECT trial: 20% MACE reduction in adults with CV disease + overweight/obesity.

7. 2024-12-20

   Zepbound (Tirzepatide 15 mg)

   For: Sleep apnea (OSA)

   First GLP-1 FDA-approved for moderate-severe OSA. SURMOUNT-OSA data: 51-52% AHI reduction.

8. 2025-12-01

   Wegovy pill (Semaglutide 25 mg (oral))

   For: Chronic weight management

   First oral semaglutide for weight loss. ~13.6% mean loss (OASIS-4).

9. 2026-04-01

   Foundayo (Orforglipron)

   For: Chronic weight management

   First true oral GLP-1 — no fasting, no needles. ATTAIN-1: 11.2% mean loss. 294 days early under expedited review.

10. 2026-Q3 (expected)

    TBD (Lilly) (Retatrutide)

    For: Chronic weight management

    Triple agonist GLP-1/GIP/glucagon. Phase 2 showed 24% loss at 48 weeks. FDA filing expected 2026-2027.

    FDA filing expected

11. 2027 (estimated)

    TBD (Lilly) (Oral tirzepatide)

    For: Chronic weight management

    Oral dual GLP-1/GIP. Phase 3 SURPASS-ORAL trials ongoing.

    Phase 3 trials

What's next in the pipeline

Retatrutide (Lilly) is the triple agonist GLP-1/GIP/glucagon. Phase 2 TRIUMPH trials showed ~24% weight loss at 48 weeks — approaching bariatric-surgery range. Expected FDA filing 2026-2027.

Oral tirzepatide (Lilly) — phase 3 SURPASS-ORAL trials are ongoing. Same dual mechanism as Mounjaro/Zepbound but in pill form.

CagriSema (Novo Nordisk) — cagrilintide + semaglutide combination. Showed 22.7% weight loss in REDEFINE-1 phase 3. FDA filing expected late 2026.