FDA approves Lilly's Foundayo (orforglipron), oral GLP‑1 for anytime dosing
- Foundayo (orforglipron) approved as an oral small‑molecule GLP‑1 receptor agonist for chronic weight management with once‑daily dosing anytime with or without food.
- In ATTAIN‑1 (72 weeks) highest‑dose orforglipron produced mean weight loss of 27.3 lb (12.4%) versus 2.2 lb (0.9%) for placebo; all treated participants averaged 25 lb (11.1%) versus 5.3 lb (2.1%) for placebo.
- The ATTAIN program enrolled over 4,500 participants across two 72‑week Phase 3 randomized, double‑blind, placebo‑controlled studies (ATTAIN‑1: 3,127; ATTAIN‑2: >1,600).
- Prescriptions accepted immediately with LillyDirect shipments starting April 6; pricing: as low as $25/month with a commercial savings card, $149/month self‑pay (lowest dose), and $50/month for eligible Medicare Part D patients starting July 1, 2026.
Approval and indication
FDA approved Foundayo (orforglipron) for adults with obesity or adults who are overweight with related medical problems, to be used with a reduced‑calorie diet and increased physical activity.
Dosing and formulation
Foundayo is an oral small‑molecule (non‑peptide) GLP‑1 receptor agonist taken once daily at any time, with or without food or water.
Clinical efficacy
The 72‑week Phase 3 ATTAIN program enrolled over 4,500 participants; in ATTAIN‑1 (n=3,127) highest‑dose orforglipron produced mean weight loss of 27.3 lb (12.4%) versus 2.2 lb (0.9%) for placebo among completers, and treated participants averaged 25 lb (11.1%) versus 5.3 lb (2.1%) for placebo; ATTAIN‑2 randomized >1,600 participants with type 2 diabetes.
Safety
Use with other GLP‑1 receptor agonists is not recommended and pediatric safety is unknown; Foundayo may cause thyroid tumors including cancer—report neck lumps, hoarseness, difficulty swallowing, or shortness of breath—and common adverse events included nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain, headache, abdominal swelling, fatigue, belching, heartburn, gas, and hair loss.
Availability and pricing
Prescriptions accepted immediately with LillyDirect shipments starting April 6 and broader pharmacy availability to follow; pricing starts as low as $25/month with a commercial savings card, $149/month self‑pay (lowest dose), and $50/month for eligible Medicare Part D patients beginning July 1, 2026.
Source: Lilly