A complete chronology of FDA actions, drug approvals, and regulatory inflection points in the GLP-1 receptor agonist class.
Byetta (exenatide) FDA-approved
First GLP-1 receptor agonist approved in the U.S., for type 2 diabetes.
Victoza (liraglutide) FDA-approved
Daily GLP-1 RA for T2D.
Saxenda (liraglutide 3.0 mg) FDA-approved
First GLP-1 RA approved for chronic weight management.
Trulicity (dulaglutide) FDA-approved
Weekly GLP-1 RA for T2D.
Victoza CV indication
Liraglutide CV risk reduction in T2D + CVD. Basis: LEADER.
Ozempic (semaglutide) FDA-approved
Weekly semaglutide for T2D.
Rybelsus (oral semaglutide) FDA-approved
First oral GLP-1 RA, for T2D.
Ozempic CV indication
Expanded for CV risk reduction in T2D + CVD.
Trulicity CV indication
CV risk reduction in T2D with or without established CVD. Basis: REWIND.
Wegovy (semaglutide 2.4 mg) FDA-approved
Chronic weight management. Basis: STEP-1.
Mounjaro (tirzepatide) FDA-approved
First dual GIP/GLP-1 RA, for T2D.
Wegovy adolescent indication
Approved for pediatric obesity 12+.
Zepbound (tirzepatide) FDA-approved
Chronic weight management. Basis: SURMOUNT-1 (up to 20.9% weight loss).
Wegovy CV indication
CV event reduction in BMI ≥27 + established CVD. First weight-management drug ever approved for a CV outcome. Basis: SELECT.
Tirzepatide shortage resolved
FDA declared tirzepatide off the official shortage list.
Zepbound OSA indication
Moderate-to-severe OSA in adults with obesity. First drug ever FDA-approved for OSA. Basis: SURMOUNT-OSA.
Semaglutide shortage resolved
FDA declared semaglutide off the official shortage list.
Foundayo (orforglipron) FDA-approved
First oral non-peptide GLP-1 RA, for chronic weight management.
FDA action on compounded GLP-1 ingredients
April 14: FDA action restricting unapproved salt-form active ingredients.
Medicare Part D Wegovy expansion
April 28: CMS expanded Part D coverage under SELECT-aligned CV pathway.
ESSENCE phase 3 interim — semaglutide MASH
May 5: ~62% MASH resolution at 72 weeks (NEJM).
State pharmacy board investigations
May 8: Florida, Texas, California opened formal investigations.
Foundayo phase 3 CV safety clears
May 14: Eli Lilly phase 3 CV safety complete. Q4 2026 launch confirmed.