FDA reviews Novo’s oral Wegovy for obesity treatment

USA – Novo Nordisk is moving closer to making history with the first FDA-approved weight-loss pill based on GLP-1.

On Friday, the U.S. Food and Drug Administration accepted Novo’s New Drug Application for an oral version of Wegovy, its well-known injectable obesity drug.

If approved, the new tablet would offer adults with obesity or overweight conditions a more convenient, once-daily alternative to injections.

The oral Wegovy pill would contain a 25-mg dose and be intended for adults who are obese or overweight and have at least one related health issue, such as high blood pressure or type 2 diabetes.

Although Novo hasn’t provided a specific approval date, the FDA is expected to decide by the fourth quarter of 2025.

The application is backed by data from the Phase III OASIS 4 clinical trial. According to results shared in November 2024, the pill performed just as well as the injectable version in helping patients lose weight.

Participants who took the oral Wegovy lost an average of 13.6% of their body weight, compared to just 2.4% in the placebo group.

The pill also showed a similar safety profile, with side effects like nausea, constipation, and stomach pain.

Novo has previously launched another oral GLP-1 drug called Rybelsus, approved in 2019 to treat type 2 diabetes. However, unlike Wegovy, Rybelsus is not indicated for weight loss.

Novo faces strong competition from Eli Lilly, which is also racing to launch a GLP-1 weight-loss pill.

In recent trials, Lilly’s drug orforglipron helped participants lose almost 8% of their body weight and improved blood sugar levels.

Lilly plans to file for FDA approval for weight management later this year, followed by a type 2 diabetes indication in 2026.