FDA Approves Oral Version of Wegovy, First GLP-1 Pill Approved Specifically for Weight Management

FDA Approves Oral Version of Wegovy, First GLP-1 Pill Approved Specifically for Weight Management

Elizabeth Yuko and Helen Carefoot

Mon, December 29, 2025 at 8:18 PM UTC

6 min read

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Update: FDA Approves Wegovy Pill, First Oral GLP-1 Approved Specifically for Weight Management

Just before the end of 2025, the idea of taking GLP-1 pills instead of injections moved much closer to reality. On December 22, the U.S. Food and Drug Administration (FDA) approved an oral version of Wegovy (semaglutide), a weight management medication that is currently only available as an injection.

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The Wegovy pill contains 25 mg of semgalutide and is meant to be taken once per day. Novo Nordisk, the drug’s manufacturer, announced in a news release that the Wegovy pill will be available starting in January 2026.

“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,” Mike Doustdar, president and CEO of Novo Nordisk, said in a news release about the approval. The company also submitted the Wegovy pill to European regulatory authorities for possible approval.

The Wegovy pill is the second GLP-1 pill approved by the federal agency, but the first approved specifically for weight management. In 2019, the FDA approved Rybelsus, another oral GLP-1 manufactured by Novo Nordisk, to treat Type 2 diabetes (this fall, the agency also approved Rybelsus to reduce the risk of cardiovascular issues for people with Type 2 diabetes).

The approval comes after results from a clinical trial funded by Novo Nordisk, the drug’s manufacturer, showed that the daily pills are about as effective as the injectable version of Wegovy in terms of weight loss. According to trial data, after 71 weeks, people who took the Wegovy pill lost about 13.6% of their total body weight compared to people who took a placebo and lost about 2% of their total body weight. Many of the people who took the Wegovy pill during the trial experienced similar side effects as those who inject GLP-1s, such as gastrointestinal issues like nausea.

More oral GLP-1s are likely on the way: Eli Lilly, the company that manufactures Zepbound and Mounjaro, recently submitted its own semaglutide pill called orforglipron for FDA approval.

Curious about what all this means? Read on for everything you need to know about oral GLP-1s.

Update by Helen Carefoot

Are There Other Oral Formulations of GLP-1s?

Currently, there are two oral versions of a GLP-1 on the market: Rybelsus and the Wegovy pill. The FDA approved the drug in 2019 for the treatment of type 2 diabetes, though it’s also prescribed off-label for weight loss.

Additionally, in April, Eli Lilly announced that their oral formulation of a GLP-1, orforglipron, has performed well in clinical trials for both type 2 diabetes and weight management. The drug manufacturer submitted orforglipron for weight management to global regulatory agencies this month. It also plans to submit it for the treatment of type 2 diabetes in 2026.

In addition to chronic weight management in adults living with obesity, oral Wegovy has also been shown in clinical trials to help people who are overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events in adults with obesity and established cardiovascular disease.

Why Might Some People Opt to Take an Oral Version of Wegovy Instead of Injections?

There are multiple reasons why someone might decide to take the oral formulation of a GLP-1 like Wegovy, but first and foremost is the fact that a lot of people strongly dislike needles.

“Up to 25% of patients report injection-related anxiety or hesitation,” said Dr. Michael Snyder, a physician, obesity specialist and medical advisor at FuturHealth. “An oral version eliminates that friction, making it easier for patients to start and stick with treatment.”

Plus, for people managing chronic conditions, “a pill feels more familiar and less medicalized”—something that could also significantly improve adherence to the drug and lead to better results over time, he points out. “By removing barriers like needle aversion, oral GLP-1s have the potential to bring this powerful therapy to a broader population and help them sustain success with the right lifestyle support,” Synder said.

Cost is also a major selling point for oral GLP-1s, said Dr. Wiljon Beltre, a board-certified bariatric surgeon and founder of Beltre Bariatrics. “The cost of oral meds tends to be less compared to the injections that require needles and syringes to administer,” he said.

Additionally, for patients who are typically sensitive to new medications—especially those who experience gastrointestinal issues—an oral daily option could provide more control, said Dr. Rebecca Emch, vice president of pharmacy and medical operations at Eden. With an oral formulation, it’s easier for your doctor to adjust the amount you’re taking daily to help manage side effects. “The half-life of oral GLP-1s is conventionally shorter than the half-life of injectables meaning it will clear from your system faster which could allow for tighter control if you experience side effects,” Emch explained.

Would an Oral Version of Wegovy Work as Well as the Injections?

Possibly. Results from the Oral Semaglutide Treatment Effect in People with Obesity (OASIS) 1 trial discussed in an editorial published in August 2025 in JAMA Internal Medicine found that people who took oral GLP-1 for obesity only, not diabetes, experienced “clinically meaningful” weight loss. These results add to the idea that oral pills could be an effective way to harness the benefits of these medicines sans injections.

But according to Dr. Jennifer Brown, a physician board-certified in obesity medicine and family medicine, more information is needed. A 2024 trial of oral Wegovy at a 25 mg daily dose showed a mean weight loss of 13.6%, while, in a different trial, injectable Wegovy showed a mean weight loss of around 15%, Brown noted. While a higher dose of oral Wegovy (50 mg) is as effective as injectable Wegovy, the side effects were significantly worse when compared to the 25 mg oral dose. “There are no direct comparison studies between oral Wegovy and injectable Wegovy yet,” she said.

It’s also important to note that oral medications and injectables enter the body in different ways. “Injected GLP-1s bypass the gut and go straight into the bloodstream, which is part of what makes them so effective,” Snyder said. “Oral versions must survive the digestive process and still trigger comparable appetite-regulating and metabolic effects.”

What Would Having an Oral Wegovy Option Mean for Women in Midlife?

Having an oral version of Wegovy could help midlife women deal with the extra weight management challenges they face. “For women in midlife, particularly those navigating perimenopause and menopause, weight gain isn’t just about lifestyle choices,” Snyder explained. “It’s tied to hormonal shifts, insulin resistance, chronic inflammation and a natural decline in metabolic rate.” This leads to women feeling stuck, even when they’re doing “everything right” to stay healthy.

Additionally, an oral formulation of Wegovy would expand weight management options for midlife women. “Oral Wegovy offers a more convenient way for women in midlife to lose weight as compared to the injection—no needles, no refrigeration, no weekly phone alarms and more control,” Brown said.

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