Novo Nordisk Awaits FDA Decision on Oral Wegovy Pill for Obesity

Novo Nordisk has submitted a New Drug Application to the FDA for a once-daily 25 mg oral version of Wegovy (semaglutide) targeted at adults with obesity or overweight and at least one comorbid condition124.

The proposed indications are chronic weight management and reduction of major adverse cardiovascular events for adults who are overweight or obese and have established cardiovascular disease12.

If approved, this would be the first oral GLP-1 therapy specifically for obesity and weight management, differentiating it from existing injectable GLP-1 drugs124.

The FDA decision is expected in Q4 2025, with Novo Nordisk positioning this asset as a potential market leader amid increasing competition, particularly from Eli Lilly's orforglipron124.

The NDA is based on robust clinical data, including results from the OASIS-4 trial, where patients lost an average of 13.6% of their body weight with oral Wegovy compared to 2.2% with placebo over 64 weeks (p<0.0001)1.

Novo Nordisk already markets Rybelsus, a lower-dose oral semaglutide, for diabetes, but the new formulation and dosage is specifically aimed at obesity24.

The obesity pill race is accelerating, as major pharmas vie for dominance in a market projected to exceed $100 billion annually next decade4.

Sources:

1. https://www.primetherapeutics.com/glp-1-pipeline-update-may-2025

2. https://njbiz.com/novo-nordisk-oral-wegovy-fda-weight-loss-pill/

4. https://www.biopharmadive.com/news/novo-oral-semaglutide-fda-approval-application-obesity/745882/