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Regulatory history

GLP-1 FDA Timeline: 21 Years of Approvals, Shortages & Policy

Fact-checked by Dr. Adam Kennah, MD on . See our fact-checking policy.

Every FDA approval, label expansion, shortage declaration, and enforcement-discretion deadline that has shaped the U.S. GLP-1 landscape from 2005 through 2026. Useful for understanding why compounded GLP-1s exist, what their regulatory status is, and what's coming next.

  1. Apr 28, 2005
    FDA approves Byetta (exenatide) for type 2 diabetes — first GLP-1 receptor agonist in the U.S.
  2. Jan 25, 2010
    FDA approves Victoza (liraglutide) for type 2 diabetes.
  3. Dec 23, 2014
    FDA approves Saxenda (liraglutide 3 mg) for chronic weight management — first GLP-1 RA approved specifically for obesity.
  4. Dec 5, 2017
    FDA approves Ozempic (semaglutide) for type 2 diabetes — first once-weekly GLP-1 RA from Novo Nordisk.
  5. Sep 20, 2019
    FDA approves Rybelsus (oral semaglutide) — first oral GLP-1 RA.
  6. Jun 4, 2021
    FDA approves Wegovy (semaglutide 2.4 mg) for chronic weight management.
  7. May 13, 2022
    FDA approves Mounjaro (tirzepatide) for type 2 diabetes — first dual GIP/GLP-1 receptor agonist.
  8. Aug 3, 2022
    FDA declares semaglutide injection in shortage.
  9. Dec 15, 2022
    FDA declares tirzepatide injection in shortage.
  10. Nov 8, 2023
    FDA approves Zepbound (tirzepatide) for chronic weight management.
  11. Sep 22, 2023
    FDA updates Ozempic label to include gastroparesis as a potential adverse reaction.
  12. Mar 8, 2024
    FDA approves Wegovy for cardiovascular risk reduction in adults with overweight/obesity and established cardiovascular disease — first weight-loss medication with CV outcomes indication.
  13. Dec 20, 2024
    FDA approves Zepbound for moderate-to-severe obstructive sleep apnea in adults with obesity — first GLP-1 RA approved for OSA.
  14. Oct 2, 2024
    FDA removes tirzepatide from the drug shortage list.
  15. Dec 19, 2024
    FDA removes semaglutide injection from the drug shortage list.
  16. Feb 18, 2025
    End of enforcement discretion for 503A pharmacies compounding tirzepatide.
  17. Mar 19, 2025
    End of enforcement discretion for 503B outsourcing facilities compounding tirzepatide.
  18. Apr 22, 2025
    End of enforcement discretion for 503A pharmacies compounding semaglutide.
  19. May 22, 2025
    End of enforcement discretion for 503B outsourcing facilities compounding semaglutide.
  20. Jul 30, 2025
    FDA approves semaglutide for chronic kidney disease in adults with type 2 diabetes (based on FLOW trial).
  21. Mar 14, 2026
    FDA approves Foundayo (orforglipron) — first oral non-peptide GLP-1 RA with weight-loss efficacy approaching injectables.

Why this timeline matters

Three patterns to notice:

  • Shortage drove compounding. The 2022-2024 shortage of semaglutide and tirzepatide is the proximate cause of the U.S. compounded GLP-1 telehealth industry. The 2024-2025 resolution of those shortages is the proximate cause of FDA's enforcement-discretion deadlines.
  • Indication expansion is accelerating. The 18-month period from March 2024 to mid-2025 produced three major indication expansions: Wegovy for cardiovascular risk reduction, Zepbound for OSA, semaglutide for CKD. More indications are expected.
  • Oral formulations are arriving. Orforglipron's 2026 approval is the first oral GLP-1 RA to approach injectable efficacy without fasting requirements. Multiple oral candidates from other manufacturers are in late-phase development.

For the underlying source documents, see our research bibliography.