FDA decision calendar

Expected FDA Prescription Drug User Fee Act target action date for retatrutide, Eli Lilly's triple agonist (GLP-1/GIP/glucagon). Phase 3 TRIUMPH trial ongoing.

Novo Nordisk's semaglutide + cagrilintide combination (CagriSema) expected to file with FDA in 2026-2027 timeframe based on phase 3 REDEFINE program.

Boehringer Ingelheim survodutide (dual GLP-1/glucagon agonist) Phase 3 SYNCHRONIZE-1 trial readout expected Q2 2027. Will inform FDA filing timeline.

Novo Nordisk's amycretin (semaglutide + amylin combination) progressing through clinical development. Phase 3 program initiation expected 2027-2028.

FDA Prescription Drug User Fee Act target action date for orforglipron, Eli Lilly's once-daily oral GLP-1 receptor agonist for weight management and type 2 diabetes.

Outcome: Approved for chronic weight management and type 2 diabetes. Launching via LillyDirect at $149/month, first daily-oral GLP-1 at sub-injectable pricing.

Novo Nordisk launched NovoCare self-pay program offering brand-name Wegovy at $499/month for cash-paying patients, undercutting compounded pricing and creating direct competition for compounding pharmacies.

Outcome: $499/month direct-pay live. Eligible US residents with valid prescription, no insurance required. Bypasses prior-authorization process entirely.

Hims & Hers announced exit from compounded GLP-1 prescribing following a Novo Nordisk lawsuit. Settlement included compounded-semaglutide cessation. Affected approximately 100,000 active subscribers.

Outcome: Hims transitioned existing subscribers to brand-name Wegovy via insurance OR direct-pay channels. Compounded semaglutide largely unavailable from major telehealth platforms after this milestone.

Eli Lilly updated Zepbound prescribing information to formalize alopecia as a reported adverse event (mirroring Wegovy label) and to add explicit 2-month pre-pregnancy washout recommendation.

Outcome: Label updated. Alopecia officially listed; pre-pregnancy 2-month washout aligned with Wegovy guidance.

FDA officially declared the semaglutide (Wegovy/Ozempic) shortage resolved, ending the 503A compounding-pharmacy carve-out that allowed compounded semaglutide during the shortage.

Outcome: Shortage status removed. Compounded semaglutide production wound down with 60-day grace period. Telehealth platforms relying on compounded sources discontinued the offering or transitioned to brand-name supply.

FDA approved Zepbound (tirzepatide) for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity, based on SURMOUNT-OSA trials. First and only prescription medication approved for OSA.

Outcome: Approved. Opens a separate insurance pathway for patients with documented OSA — often simpler PA than weight-loss indication alone.

FDA declared the tirzepatide (Zepbound/Mounjaro) shortage resolved after Eli Lilly increased manufacturing capacity. Ended the 503A compounding-pharmacy carve-out for compounded tirzepatide.

Outcome: Shortage status removed. Compounded tirzepatide production wound down. Brand-name Zepbound supply now adequate at most retail and specialty pharmacies.

Eli Lilly launched LillyDirect Self-Pay offering brand-name Zepbound vials at $349-549/month direct-pay pricing, lower for smaller doses (2.5 mg = $349, 5 mg = $499, 7.5+ mg = $549).

Outcome: $349-549/month direct-pay live. Vial dosing (drawn into syringe) rather than pen, lowering cost. Available to US patients with valid prescription, no insurance required.

FDA expanded Wegovy approval to include reducing the risk of major cardiovascular events (MACE) in adults with established cardiovascular disease and BMI ≥27. Based on SELECT trial showing 20% MACE reduction.

Outcome: Approved. Patients with established CVD now have a separate authorization pathway — does NOT require 6-month lifestyle attempt OR step therapy that obesity indication typically demands.

FDA approved Wegovy for chronic weight management in adolescents aged 12 and older with obesity (BMI at or above 95th percentile for age and sex). First weight-loss GLP-1 approved for pediatric use.

Outcome: Approved. Same dose ladder as adults (0.25 → 2.4 mg weekly). Now covered for adolescent populations under most commercial plans with prior authorization.