After ushering in a new era of obesity treatment with its GLP-1 medicine Wegovy earlier in the decade, Novo Nordisk is making history again with the first FDA approval of a GLP-1 pill for weight loss.
On Monday, the FDA gave a thumbs-up to Novo’s oral formulation of Wegovy (semaglutide) as a once-daily pill for weight management and cardiovascular risk reduction in people with obesity or who are overweight. The drug can be given at a maintenance dose of up to 25 mg.
“Wegovy pill is the next chapter in our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity,” Dave Moore, Novo’s EVP of U.S. operations said in a Dec. 22 statement. “We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities.”
Novo said it will make the starting dose of 1.5 mg available in pharmacies and select telehealth providers in early January, with discount offerings of just $149 per month.
Despite the introduction of potent weight loss drugs in the form of Novo’s GLP-1 receptor agonist Wegovy and Eli Lilly’s rival GIP/GLP-1 medicine Zepbound (tirzepatide) in recent years, there is still only a “small percentage” of patients with obesity who seek pharmacological treatment, Jason Brett, M.D., principal medical head at Novo Nordisk, said in a recent interview with Fierce.
In fact, the proportion of people in the U.S. with obesity who receive an obesity medication stands at just around 2%, Novo’s chief scientific officer, Martin Holst Lange, M.D., Ph.D., estimated earlier this year.
With Wegovy in a pill, Brett figures Novo has the potential to “improve care on a population level” by expanding access to Wegovy and bringing the drug to more patients.
The newly approved oral form of Novo’s drug could be preferable for patients who dislike injections, Brett explained, and eliminates the need for a cold chain and refrigeration of the final product. The key, to hear Brett tell it, is that “patients and healthcare professionals need options.”
“There is no one-size-fits-all in medicine in general, and especially in obesity treatment,” he added.
The GLP-1 class has risen to prominence—and generated tens of billions of dollars in sales—thanks to the success of Wegovy and its sister medicine for Type 2 diabetes, Ozempic, as well as Lilly’s rival metabolic medicines Zepbound and Mounjaro. But Wegovy in a pill marks a first for the class insofar as it is now the only oral GLP-1 available to help patients with obesity lose weight.
Novo secured an FDA nod for a separate dose of oral semaglutide back in 2019 under the Rybelsus moniker, where the drug is approved to treat Type 2 diabetes as a counterpart to Ozempic that can be taken by mouth.
The FDA endorsed Novo’s Wegovy pill after reviewing data from the company’s late-stage Oasis-4 trial.
In the study, patients on oral Wegovy that adhered to treatment achieved an average weight loss of 16.6%, compared to just 2.7% average weight loss among patients who received placebo. Brett noted that the results seen with Wegovy in a pill were “very consistent” with data from the Step 1 trial that helped win injectable Wegovy its original FDA nod in obesity.
In an indirect treatment comparison between oral and subcutaneous semaglutide presented at ObesityWeek 2025 in Atlanta this past November, Novo noted that the two Wegovy formulations “offer comparable efficacy for weight management in adults with obesity and overweight.”
And while subcutaneous Wegovy “showed limited numerical advantages across some endpoints, these were small and not clinically meaningful,” the Danish drugmaker noted in a poster presented at the conference last month.
The Wegovy pill green light puts Novo ahead of its chief obesity rival Lilly, at least on the regulatory front. For its part, Lilly has submitted its own oral GLP-1, orforglipron, with the FDA for an weight-loss approval. Thanks to an FDA national priority voucher—part of a controversial new regulatory pathway in the U.S.—the expectation is that the candidate could pick up an approval early next year.
In its phase 3 Attain-1 study, Lilly has tied the highest dose of once-a-day orforglipron at 36 mg to 12.4% average weight loss at 72 weeks.
Novo has been on a quest to reinvigorate itself in the second half of 2025, driven by newly installed CEO Maziar Mike Doustdar. Doustdar was tapped to replace Novo’s longtime helmsman Lars Fruergaard Jørgensen in July, with Novo’s board hoping the fresh perspective would help the company reinvigorate its share price and maintain its lead in the global obesity market over Lilly.
Aiming to up the ante with injectable Wegovy too, Novo in late November also submitted an application to the FDA for a higher 7.2 mg subcutaneous Wegovy dose with an FDA national priority voucher slated to hasten its review. Novo is hoping the higher dose can “bring patients and healthcare professionals a new option for greater weight loss potential,” Anna Windle, Ph.D., the company’s SVP of clinical development, medical and regulatory affairs, said in a statement at the time.
Novo last month reported total third-quarter sales of 74.9 billion Danish kroner (around $11.5 billion), up around 5% from the same period in 2024. The company’s GLP-1 sales, which primarily include Wegovy and Ozempic, reached 36.7 billion kroner during the three-month stretch, up around 5% from the previous year.
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