"Triple-Hormone-Receptor Agonist Retatrutide for Obesity." NEJM 2023;389:514526 FDA Prescription Drug User Fee Act (PDUFA) Guidelines FDA Center for Drug Evaluation and Research (CDER): NDA review process ClinicalTrials.gov: TRIUMPH Phase 3 program trial registry Historical obesity drug approval precedents: Semaglutide, Tirzepatide, Liraglutide Frequently Asked Questions Based on the current timeline, retatrutide FDA approval is expected in late 2027 to Q1 2028
GIP receptors in fat tissue influence how efficiently the body stores and releases fat
A plausible scenario, then, looks like this: Phase 3 primary completion in late 2025, NDA submission in the second half of 2025, FDA filing acceptance and review initiation in early 2026, and a PDUFA (Prescription Drug User Fee Act) action date likely in mid to late 2026
Ethics declarations Conflict of interest Dina Halegoua-DeMarzio: Consultant- Pfizer
Reviews from real Noom users The bottom line: Could orforglipron help you lose weight
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