The Food and Drug Administration on Monday approved the oral version of Novo Nordisk’s injectable weight loss drug Wegovy, making it the first GLP-1 pill to be cleared by regulators for obesity and possibly allowing many more Americans to access a highly effective treatment.
The Wegovy pill, whose approval for weight loss was widely anticipated, has also been approved to reduce cardiovascular risks, similar to the injectable version.
Novo plans to launch the drug in January. In a late-stage study, the highest dose that will be sold, 25 milligrams, led patients to lose about 14% of their weight, similar to the efficacy seen with injectable Wegovy.
Novo did not immediately release details on pricing.
Injectable Wegovy, along with Eli Lilly’s injectable drug Zepbound, has already seen immense demand. Novo argues that there could be even more interest in a GLP-1 pill, since it could be more convenient to take and can be distributed without cold storage. (Novo already sells Rybelsus, a GLP-1 pill containing the same ingredient, but it’s approved only to treat type 2 diabetes.)
The approval comes as Novo has been struggling to recoup its lead in the obesity market, as more patients gravitate towards Lilly’s Zepbound than injectable Wegovy. It’s not yet clear whether the oral version will significantly boost Novo’s market share and expand access for Americans.
Novo’s pill consists of large molecules called peptides, making it harder for the body to absorb and thus requiring a large amount of pharmaceutical ingredients to be effective. It also must be taken by patients in the morning at least 30 minutes before any food.
Lilly, meanwhile, has developed its own GLP-1 pill called orforglipron, which is currently under FDA review and is expected to be approved in the next few months. Orforglipron is a small molecule, which experts say could make it easier to manufacture. It doesn’t carry restrictions around when patients need to take it, but it didn’t show as much efficacy in its trials as oral Wegovy.
Pricing will also be a significant factor affecting demand. Novo and Lilly have already reached an agreement with the Trump administration to sell their pills, once approved, at $150 a month for the lowest dose through direct-to-consumer channels, in which patients pay cash prices without using insurance. That’s lower than the cash price for low-dose injectables, but the drugmakers haven’t indicated what they will ultimately charge for higher doses of the pills or what they’ll charge payers.