2005-04-28
Byetta (exenatide) approved
First GLP-1 receptor agonist approved by FDA for type 2 diabetes. Twice-daily subcutaneous injection. Marketed by Amylin Pharmaceuticals / Eli Lilly.
2010-01-25
Victoza (liraglutide) approved
Second GLP-1 receptor agonist, once-daily. Novo Nordisk. FDA-approved for type 2 diabetes.
2014-09-18
Saxenda (liraglutide 3 mg) approved
First daily-dose GLP-1 approved for chronic weight management. Same molecule as Victoza, different label.
2014-09-19
Trulicity (dulaglutide) approved
Weekly GLP-1 for T2D. Eli Lilly. Auto-injector pen format.
2017-12-05
Ozempic (semaglutide for T2D) approved
FDA approval of semaglutide for type 2 diabetes. Once-weekly subcutaneous. Novo Nordisk. Began the modern wave of GLP-1 prescribing.
2019-09-20
Rybelsus (oral semaglutide) approved
First oral GLP-1 receptor agonist. Same molecule as Ozempic, daily oral tablet. Bioavailability ~1%.
2020-01-16
Ozempic CV indication added
FDA expansion to include cardiovascular risk reduction in T2D + established CVD. Basis: SUSTAIN-6 (NEJM 2016, PMID 27633186).
2021-06-04
Wegovy (semaglutide 2.4 mg) approved for weight
FDA approval for chronic weight management in adults with BMI ≥30 or BMI ≥27 with weight-related comorbidity. Basis: STEP-1 (NEJM 2021).
2022-05-13
Mounjaro (tirzepatide) approved
First dual GIP / GLP-1 receptor agonist, weekly. Eli Lilly. T2D indication.
2022-08
Semaglutide added to FDA Drug Shortage List
Allowed 503A and 503B compounding of semaglutide under the shortage-list framework.
2022-12-16
Wegovy approved for pediatric obesity (12+)
Adolescent indication for chronic weight management.
2023-11
SELECT trial published in NEJM (PMID 37952131)
Semaglutide 2.4 mg produced 20% MACE reduction in non-diabetic adults with overweight/obesity + established CVD. Median follow-up 39.8 months.
2023-11-08
Zepbound (tirzepatide for weight) approved
FDA approval for chronic weight management.
2024-03-08
Wegovy CV indication added
FDA expansion to include cardiovascular event reduction in adults with BMI ≥27 + established CVD. Basis: SELECT. First weight-management drug ever approved for a CV outcome.
2024-05
FLOW trial readout (NEJM 2024, PMID 38785189)
Semaglutide reduced major kidney/CV events 24% in T2D + CKD. Stopped early for efficacy.
2024-08
FDA: Tirzepatide removed from shortage list
503B bulk compounding of tirzepatide largely ended.
2024-12-20
Zepbound approved for moderate-to-severe OSA + obesity
First drug ever FDA-approved for OSA. Basis: SURMOUNT-OSA. Note: this OSA indication is for tirzepatide (Zepbound), not semaglutide.
2025-02
FDA: Semaglutide removed from shortage list
503B bulk compounding of semaglutide phased out. 503A patient-specific compounding continued under different rules.
2026-03
Foundayo (orforglipron) approved
First oral, small-molecule (non-peptide) GLP-1 receptor agonist for chronic weight management. Eli Lilly. FDA-approved under the Commissioner's National Priority Voucher pilot (50-day review).
2026-04-14
FDA announces intent to restrict ingredients in mass-marketed compounded GLP-1 medications
Action targets salt-form semaglutide (sodium, acetate) and misleading DTC marketing. Compounded semaglutide base via licensed 503A and 503B remains lawful.
2026-04-28
CMS expands Medicare Part D coverage of Wegovy under SELECT-aligned pathway
Coverage now available for adults with BMI ≥27 + established CVD. First material weight-management GLP-1 coverage expansion under Medicare Part D since 2003.
2026-05-05
ESSENCE phase 3 interim: semaglutide produces MASH resolution in ~62%
Phase 3 trial of semaglutide 2.4 mg in MASH with F2–F3 fibrosis. Full readout expected late 2026.
2026-05-14
Foundayo phase 3 cardiovascular safety clears
Commercial launch on track for Q4 2026.