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# Agency Accepts Oral Wegovy NDA for Obesity
- URL: https://www.fdaweb.com/agency-accepts-oral-wegovy-nda-for-obesity/
- Published: 2025-05-02T12:00:00.000Z
- Updated: 2026-09-14T15:10:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159112

FDA has accepted for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in obese adults or those who are or overweight with one or more comorbid conditions, and to reduce the risk of major adverse cardiovascular events (MACE) in these adults. If approved, Wegovy would become the first oral GLP-1 indicated for chronic weight management, the company says.

The submission is based on data from the Phase 3 OASIS 4 trial evaluating the efficacy and safety of the drug versus placebo in 307 adults with obesity or who are overweight with one or more comorbidities, Novo Nordisk says. Patients with diabetes were excluded, it notes. Data show that the average percentage weight loss in the oral semaglutide group was 13.6% compared with 2.2% in the placebo group.

A number of drug companies have been seeking to develop an oral obesity drug as an alternative to current high-profile injectable therapies. Last month, Pfizer said it was discontinuing development of danuglipron, an experimental oral GLP-1 receptor agonist being evaluated for chronic weight management. Despite promising results from recent dose-optimization studies, including successful achievement of key pharmacokinetic goals and a formulation with potential Phase 3 viability, the company opted to stop further development after reviewing comprehensive safety data and receiving input from FDA and other regulatory authorities.

Pfizer noted that its decision followed an isolated case of a potential drug-induced liver injury in one asymptomatic participant from a study, which resolved after discontinuation of the drug. While the overall incidence of liver enzyme elevations in the danuglipron clinical program was consistent with other approved GLP-1 treatments, Pfizer stated that the totality of safety data — combined with recent regulatory feedback — prompted the move.