Orforglipron PDUFA Date (Eli Lilly)
FDA PDUFA decision date for Orforglipron is April 10, 2026. Developed by Eli Lilly. Indication: Obesity / overweight (oral GLP-1 receptor agonist). Current status: Approved.
Indication
Obesity / overweight (oral GLP-1 receptor agonist)
Notes
Blockbuster potential. First oral GLP-1 for obesity. ADCOMM vote expected prior to PDUFA. Delayed from March 28.
Regulatory details
- Company: Eli Lilly
- Therapeutic area: Metabolic / Endocrine
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-04-10
- Outcome: Approved