The U.S. FDA has accepted Novo Nordisk’s New Drug Application (NDA) submission for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions.
If approved, Wegovy would become the first oral formulation of a GLP-1 indicated for chronic weight management.
The FDA application is based on results from OASIS 4, a 64-week phase 3 randomized, controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity with one or more comorbidities. For the co-primary endpoint, change in body weight at week 64 (including 52-week maintenance and 7-week follow-up periods), there was a drop of 13.6% with oral semaglutide vs just 2.2% with placebo. For the analysis including just the on-treatment period, those reductions were 16.6% and 2.7%, respectively. For the other co-primary endpoint, 79.2% semaglutide vs 31.1% placebo lost at least 5% of their body weight, 63% vs 14.4% lost ≥ 10%, 50% vs 5.6% lost ≥ 15%, and 29.7% vs 3.3% lost ≥ 20%.
The FDA action date to decide on the Wegovy oral formulation NDA will be in Q4 2025.
Recently, Eli Lilly announced positive topline results from a phase 3 trial evaluating the safety and efficacy of its oral small molecule GLP-1 receptor agonist, orforglipron, in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Earlier this month, Pfizer said it will discontinue development of its oral GLP-1, danuglipron, after a single participant in one of the dose-optimization studies experienced a potential drug-induced liver injury which resolved after discontinuation of the drug.