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 (orforglipron) is a daily pill that activates the GLP-1 receptor, mimicking a natural hormone that helps regulate appetite and blood sugar. Unlike injectable GLP-1 drugs, it works without food restrictions and may offer more convenient weight management. By stimulating this biological pathway, Foundayo could help adults with obesity achieve sustained weight loss while avoiding the challenges of frequent injections.
The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.
