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The first-ever oral GLP-1 medication for weight loss has been approved for use in the U.S.
The Wegovy pill, from drugmaker Novo Nordisk, was cleared by the Food and Drug Administration to reduce excess body weight, maintain long-term weight reduction and lower the risk of major cardiovascular events.
Approval of the once-daily 25mg semaglutide pill was based on the results of two clinical trials — the OASIS trial program and the SELECT trial.
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The Wegovy pill demonstrated a mean weight loss of 16.6% in the OASIS 4 trial among adults who were obese or overweight and had one or more comorbidities (other medical conditions), according to a press release. In the same trial, one in three participants experienced 20% or greater weight loss.
The first-ever oral GLP-1 medication for weight loss has been approved for use in the U.S. (iStock)
Novo Nordisk reported that the weight loss achieved with the pill is similar to that of injectable Wegovy and has a similar safety profile.
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“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, in the press release.
Novo Nordisk reported that the weight loss achieved with the pill is similar to that of injectable Wegovy and has a similar safety profile. (James Manning/PA Images via Getty Images)
“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.”
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The oral GLP-1 is expected to launch in the U.S. in early January 2026. Novo Nordisk has also submitted oral semaglutide for obesity to the European Medicines Agency (EMA) and other regulatory authorities.
“Most side effects will be GI-related and should be similar to the injectable, such as nausea, vomiting and constipation,” an expert said. (iStock)
Dr. Sue Decotiis, a medical weight loss doctor in New York City, confirmed in an interview with Fox News Digital that studies show oral Wegovy is comparable to the weekly injectable, just without the needles.
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Although the pill may result in better compliance and ease of use, Decotiis warned that some patients may not absorb the medication through the gastrointestinal tract as well as with the injectable version due to individual idiosyncrasies in the body.
“Most side effects will be GI-related and should be similar to the injectable, such as nausea, vomiting and constipation,” she said.
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“In my practice, I have found tirzepatide (Mounjaro and Zepbound) to yield more weight loss and fat loss than semaglutide by about 20%,” the doctor added. “This has been shown in studies, often [with] fewer side effects.”
More oral GLP-1s may be coming down the pike in 2026, according to Decotiis, including an Orforglipron application by Lilly and a new combination Novo Nordisk drug, which is pending approval later next year.
One expert warned that some patients may not absorb the medication through the gastrointestinal tract as well as with the injectable version. (iStock)
“There will be more new drugs available in the future that will be more effective for patients who are more insulin-resistant and have not responded as well to semaglutide and/or tirzepatide,” the doctor said. “This is great news, as novel drugs affecting more receptors mean better long-term results in more patients.”
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As these medications become cheaper and easier to access, Decotiis emphasized that keeping up with healthy lifestyle habits — including proper nutrition with sufficient protein and fiber, as well as increased hydration — is essential to ensuring lasting results.
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“If not, patients will regain weight and could lose muscle and not enough body fat,” she said.
Fox News Digital reached out to Novo Nordisk for comment.