Wegovy Pill Receives FDA Approval as First Oral GLP-1 for Weight-Loss

Once-daily oral semaglutide (Wegovy) 25 mg received FDA approval on Monday for weight management, according to a Novo Nordisk news release.¹ This announcement marks Wegovy as the prescription drug market’s very first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist approved to treat excess body weight.

“There's an entire demographic that can benefit from the pills,” said Fatima Stanford, MD, MPH, MPA, according to NPR.² “For me, it's not just about who gets it across the finish line first. It's about having these options available to patients.”

Amid the current boom of GLP-1 medications, Wegovy’s approval gives manufacturer Novo Nordisk a leg up on notable competitor Eli Lilly, whose oral drug, orforglipron, is currently under FDA review. Furthermore, regarding the current manufacturer rivalry in one of the highest-spending drug categories, each drugmaker’s injectable GLP-1s have led the US drug market, as Wegovy (Novo Nordisk) and Zepbound (Eli Lilly) have reached millions of patients since their launch.

To receive FDA approval, patients from Novo Nordisk’s clinical trials achieved a mean weight loss of 16.6% when taking the once-weekly oral Wegovy. The FDA approved the drug to reduce excess body weight and maintain that reduction long-term while also reducing cardiovascular disease risks.¹

READ MORE: Pharmacists Must Consider Benefits and Risks for GLP-1 Medication for Pediatric Patients | ASHP Midyear 2025

Why Oral Wegovy Comes at a Crucial Moment in the US Drug Market

This approval comes at a pivotal time for millions of patients because of a multitude of factors. First, despite a significant decline in obesity rates from 2022 to 2025, millions of US patients still report obesity. While obesity trends persist alongside a sharp increase in GLP-1 use, these medications have moved into the spotlight as common prescription drugs for Americans looking to lose weight.^2,3

Concurrent with manufacturer competition in the development of cardiometabolic and weight-loss medications, as well as the sheer demand for these drugs among patient populations, this is also an unprecedented time for prescription drug coverage.

On May 12, 2025, President Trump signed the Most Favored Nation executive order, which put into motion a series of events that aims to lower prescription drugs toward a benchmark similar to the price patients of other nations commonly pay for their medications. Involving manufacturer agreements to market drugs through a direct-to-consumer (DTC) model as well as a government-funded website with similar medication options, actions surrounding this order could make GLP-1 medications more accessible than ever before.⁴

Now with a less invasive, oral GLP-1 set to hit the market in 2026, access could be bolstered even further. Companies like Eli Lilly had already been planning to give patients discounts of close to $600 for dulaglutide (Trulicity), while other manufacturers agreed to make GLP-1s indicated for weight loss available on the expected-to-launch TrumpRx DTC prescription drug website.

“The pill is here. With today's approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” said Mike Doustdar, president and CEO of Novo Nordisk, according to the release.¹ “As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight-loss journey.”

Oral Wegovy’s Approval Process

Patient results from the OASIS trial program and SELECT trial² paved the way for Wegovy’s approval, as patients from the OASIS 4 trial¹ reached a mean weight loss of over 15%. The trial was completed by a group of adult participants with obesity or overweight who also reported 1 or more comorbidities. During the trial, the pill was taken once a week over the trial’s 64-week period.

Although 1 in 8 adult patients say they are already taking an injectable GLP-1, use is expected to increase even more with the oral option.⁵ While the Novo Nordisk release mentions the Wegovy pill’s similar effects to its injectable version, authors noted that 1 in 3 participants of the OASIS 4 trial¹ experienced 20% greater weight loss than with injectable Wegovy.¹

Finally, the pill also exhibited a safety profile that mirrored its previous GLP-1 formulations indicated for weight loss, making way for greater manufacturer development of these oral weight-loss drugs and increased access reserved for the large patient populations indicated for them.

“No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy® pill, and we are very excited for what this will mean for patients in the US,” concluded Doustdar.¹

READ MORE: Obesity Management Resource Center

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REFERENCES

1. Wegovy pill approved in the US as first oral GLP-1 for weight management. News Release. Novo Nordisk. December 22, 2025. Accessed December 23, 2025. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details

2. US regulators approve Wegovy pill for weight loss. NPR. December 23, 2025. Accessed December 23, 2025. https://www.npr.org/2025/12/23/g-s1-103424/us-approve-pill-for-weight-loss

3. Witters D, James MP. Obesity rate declining in US. Gallup. October 28, 2025. Accessed December 23, 2025. https://news.gallup.com/poll/696599/obesity-rate-declining.aspx

4. Federal update: Trump administration announces deal to bring most-favored-nation pricing to GLP-1s. Academy of Managed Care Pharmacy. December 22, 2025. Accessed December 23, 2025. https://www.amcp.org/letters-statements-analysis/federal-update-trump-administration-announces-deal-bring-most-favored-nation-pricing-glp-1s

5. Poll: 1 in 8 adults say they are currently taking a GLP-1 drug for weight loss, diabetes or another condition, even as half say the drugs are difficult to afford. KFF. November 14, 2025. Accessed December 23, 2025. https://www.kff.org/public-opinion/poll-1-in-8-adults-say-they-are-currently-taking-a-glp-1-drug-for-weight-loss-diabetes-or-another-condition-even-as-half-say-the-drugs-are-difficult-to-afford/