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 food intake. As a small molecule, it activates the same brain and gut receptors as injectable GLP-1 drugs but without meal or water restrictions. This convenient oral option may help adults manage their weight as part of a long-term health plan.
This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.
