for chronic weight management in adults with obesity or overweight with weight-related conditions
NDA· Commissioner's National Priority Voucher (CNPV)
FDA approved Foundayo (orforglipron) on April 1, 2026 — approved under the Commissioner's National Priority Voucher (CNPV) Pilot Program just 50 days after filing. Fastest approval of a new molecular entity since 2002. First oral non-peptide GLP-1 agonist; can be taken daily without food or water restrictions (differentiated from oral semaglutide / Rybelsus). ATTAIN-1 showed weight loss up to 12.4% at 72 weeks. T2D filing planned later in 2026 based on ACHIEVE program.
About
Foundayo is a daily pill that mimics a natural gut hormone called GLP‑1, which helps regulate appetite and fullness signals in the brain. Unlike injectable or other oral GLP‑1 medicines, this small-molecule drug is taken once a day without food or water restrictions. By activating the body's GLP‑1 pathways, Foundayo can help adults with obesity manage their weight, with clinical studies showing significant weight reduction over time.
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase
