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.
Trulicity (dulaglutide) FDA-approved
Weekly GLP-1 RA for T2D.
Saxenda (liraglutide 3.0 mg) FDA-approved
First GLP-1 RA approved for chronic weight management.
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 (14.9% vs 2.4% mean weight loss at 68 weeks).
Mounjaro (tirzepatide) FDA-approved
First dual GIP/GLP-1 RA, for T2D.
Wegovy adolescent indication
Approved for obesity in patients 12 and older.
Zepbound (tirzepatide) FDA-approved
Chronic weight management. Basis: SURMOUNT-1 (20.9% mean weight loss at 15 mg over 72 weeks, treatment-regimen estimand).
Wegovy CV indication
Reduction of major adverse CV events in adults with established CV disease and obesity or overweight. First weight-management drug approved to reduce CV risk. Basis: SELECT.
Tirzepatide shortage resolved
October 2: FDA said the tirzepatide shortage was resolved; it reaffirmed the decision on December 19, 2024.
Zepbound OSA indication
Moderate-to-severe OSA in adults with obesity. First drug FDA-approved for OSA. Basis: SURMOUNT-OSA.
Ozempic kidney indication
Reduction of kidney-disease progression and CV death in adults with T2D and chronic kidney disease. Basis: FLOW.
Semaglutide shortage resolved
February 21: FDA said the semaglutide shortage was resolved.
Wegovy MASH indication (accelerated approval)
August 15: noncirrhotic MASH with moderate to advanced fibrosis (F2 to F3) in adults. Basis: ESSENCE part 1 (NEJM 2025).
Wegovy pill FDA-approved
Once-daily oral semaglutide for chronic weight management and CV risk reduction; first oral GLP-1 approved for weight management.
Suicidal-ideation label language removed
January 13: FDA asked to remove suicidal behavior and ideation language from the Wegovy, Zepbound and Saxenda labels.
Foundayo (orforglipron) FDA-approved
April 1: first oral non-peptide GLP-1 RA, for chronic weight management. Sold through LillyDirect.
FDA 503B bulks proposal
April 30: FDA proposed not to place semaglutide, tirzepatide or liraglutide on the 503B bulks list (91 FR 23431). Comments closed July 30, 2026; no final decision as of October 15, 2026.
Medicare GLP-1 Bridge begins (CMS)
July 1: $50 copay for eligible Part D enrollees for Foundayo, Wegovy or the Zepbound KwikPen, through December 31, 2027. Not for people with T2D, moderate-to-severe sleep apnea or fatty liver disease, whose Part D plan might cover a GLP-1.
Zepbound diabetic-retinopathy warning revised
August 26: label section 5.8 revised; patients with a history of diabetic retinopathy should be monitored for progression.
Mounjaro CV indication
August 27: reduction of major adverse CV events in adults with T2D at high CV risk. Basis: SURPASS-CVOT, non-inferior to Trulicity (HR 0.92; 95.3% CI 0.83 to 1.01).
FDA warning letter to Empower Pharmacy
September 18 (posted September 22): compounded tirzepatide/niacinamide and semaglutide/cyanocobalamin "appear to be essentially copies" of FDA-approved products; insanitary conditions cited.