Novo Nordisk, the firm that helped transform obesity care earlier in the decade with its injectable GLP-1 therapy Wegovy, has now marked another milestone by securing the first FDA clearance for a GLP-1 weight-loss pill.
The FDA approved Novo’s oral version of Wegovy (based on semaglutide) as a once-daily tablet for chronic weight management and for reducing cardiovascular risk in adults with obesity or those who are overweight. The oral treatment is authorized for use at a maintenance dose of up to 25 milligrams.
Dave Moore, Novo’s executive vice president for U.S. operations, said in a December 22 statement that the Wegovy pill represents a new phase in the company’s long-standing GLP-1 expertise, backed by its lowest self-pay pricing yet for obesity. He added that Novo is ready for a rollout in early January 2026, with production underway in North Carolina plants.
Even with the arrival of highly effective weight loss therapies such as Novo’s GLP-1 drug Wegovy and Eli Lilly’s dual GIP/GLP-1 treatment Zepbound (tirzepatide), only a small fraction of people with obesity are turning to prescription medicines, said Jason Brett, Novo Nordisk’s medical head, in an interview.
According to an estimate shared earlier this year by Novo’s chief scientific officer, Martin Holst Lange, only about 2% of individuals with obesity in the U.S. currently receive a pharmacological obesity treatment.
With Wegovy now available as a pill, Brett believes Novo has an opportunity to improve treatment at a population scale by widening access and reaching patients who may not otherwise use the drug.
He said the newly cleared oral version could appeal to people who are uncomfortable with injections and removes the logistical requirement for refrigerated storage and distribution. Ultimately, Brett emphasized that meaningful progress depends on giving both patients and clinicians a range of therapeutic choices, because there’s no single approach that will work for everything.
The GLP-1 category has become a major commercial force, bringing in tens of billions of dollars in revenue, on the back of Novo Nordisk’s Wegovy and its Type 2 diabetes counterpart Ozempic, along with Eli Lilly’s competing metabolic therapies Zepbound and Mounjaro. However, Novo’s pill version of Wegovy represents a milestone for the class, as it is the first oral GLP-1 specifically approved for weight loss in people with obesity.
Novo had previously won FDA approval in 2019 for an oral dose of semaglutide under the brand name Rybelsus, which is indicated for Type 2 diabetes and serves as an oral alternative to injectable Ozempic.
The FDA’s clearance of the Wegovy tablet was based on results from Novo’s late-stage Oasis-4 clinical study. In the trial, patients who stayed on oral Wegovy achieved a mean weight reduction of nearly 17%, compared with an average loss of 2.7% among those given a placebo. Brett said the weight loss observed with the pill closely mirrored the results from the Step 1 study that supported the original FDA approval of injectable Wegovy for obesity.
In addition to weight loss, researchers also observed promising improvements in cardiovascular risk markers across trial participants, suggesting dual benefits for both metabolic health and heart disease prevention. These dual benefits may further enhance the appeal of Novo Nordisk gets FDA green light for Wegovy weight-loss pill, especially among patients with multiple comorbid conditions.
Healthcare providers are optimistic that the oral formulation might reduce barriers to treatment, particularly in primary care settings where injectable therapies have historically seen slower adoption. By lowering logistical and psychological hurdles, the pill could meaningfully increase the number of people with obesity who seek medical treatment — an outcome clinicians have long hoped for in addressing a disease that affects millions worldwide.
Industry analysts also note that the introduction of an oral GLP-1 weight-loss therapy may spur competition that leads to broader insurance coverage and more affordable treatment options. As rivals like Eli Lilly pursue approval for their own oral obesity pills, patients could ultimately benefit from a wider set of choices tailored to their needs.
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