Novo Nordisk wins FDA approval for weight-loss pill
Novo Nordisk has won U.S. regulatory approval for its long-awaited weight-loss pill, marking a major milestone in the fast-growing obesity drug market and intensifying competition with rival Eli Lilly.
The U.S. Food and Drug Administration approved the oral medication on Monday for chronic weight management in adults with obesity or overweight who have at least one related health condition, the Danish drugmaker said, News.Az reports, citing Reuters.
The daily pill contains 25 milligrams of semaglutide — the same active ingredient used in Novo’s blockbuster injectable drugs Wegovy and Ozempic — and will be sold under the Wegovy brand. Novo already markets an oral version of semaglutide for type 2 diabetes under the name Rybelsus.
The approval gives Novo a first-to-market advantage in oral weight-loss treatments, a segment widely seen as key to expanding access and overcoming patient resistance to injections.
Investors welcomed the news, with Novo’s U.S.-listed shares jumping 8% in extended trading, while Eli Lilly shares slipped 1%.
In a 64-week late-stage trial, patients taking the 25 mg oral semaglutide lost an average of 16.6% of their body weight, compared with 2.7% among those receiving a placebo, according to trial data.
The pill broadens the potential patient pool at a time when obesity-related healthcare costs are rising sharply. Roughly 40% of U.S. adults are classified as obese, and about 12% currently use GLP-1 drugs, according to recent government and survey data.
Analysts estimate the global obesity drug market could reach $150 billion annually by the early 2030s, with pills potentially capturing around 20% of the market by 2030.
Novo is seeking to regain momentum in the U.S. after losing ground to Eli Lilly’s injectable Zepbound, which currently leads weekly prescription volumes. Lilly is also developing its own next-generation weight-loss pill, orforglipron, which could receive FDA approval as early as March.
Novo executives say the convenience of a daily pill could significantly boost uptake. The company is manufacturing the drug in North Carolina and has been building inventory to ensure sufficient supply at launch.
“The pill format offers clear advantages for some patients, including ease of travel and no need for refrigeration,” analysts noted, though many are expected to continue preferring weekly injections.
Novo said the 1.5 mg starter dose of the Wegovy pill will be available in early January. The company has agreed with U.S. authorities to offer starter doses at $149 per month for Medicare and Medicaid programs and through a government-backed direct-to-consumer platform.
Despite the optimism, analysts caution that the new pill’s strict dosing requirements — including taking it on an empty stomach — could limit its appeal compared with competitors.
Whether the oral version of semaglutide can fully revive Novo’s slowing growth remains an open question, but the FDA approval firmly positions the company at the forefront of the next phase in obesity treatment.
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