- Novo Nordisk says the US FDA has approved a once daily pill version of Wegovy, described as the first approved pill of its kind
- The company said trials showed average weight loss of 16.6%, with about a third of roughly 1,300 participants losing 20% or more
- Novo Nordisk expects a US launch in early January 2026, with investors pushing shares up sharply after the announcement amid strong competition in the weight loss market
US regulators have approved an oral version of Wegovy for chronic weight management, giving Novo Nordisk the first daily pill in this drug class cleared for obesity treatment, according to the company and US media reports.
Novo Nordisk said the tablet contains semaglutide, the same active ingredient used in its injectable Wegovy, and is designed to offer an alternative for people who prefer not to use injections.
The company said it expects to launch the pill in the United States in early January 2026.
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The approval was supported by results from the OASIS 4 phase 3 trial, with Novo Nordisk reporting a mean weight loss of 16.6% over 64 weeks.
The company has also said a substantial share of participants achieved very large weight reductions during the trial.
The move is a commercial win for Novo Nordisk at a moment of intense competition in the weight loss market, where rival firms are racing to develop pills that could broaden access beyond injections.
Reuters reported that the approval strengthens Novo Nordisk’s position against competitors, including Eli Lilly, which has an oral candidate still under review.
Analysts and clinicians have long seen pills as a potential next step for wider uptake, but access, affordability and supply are still expected to shape how quickly prescribing expands.
Reuters reported that Novo Nordisk has been preparing supply and has been adjusting pricing approaches for Wegovy in the US market
