December 23, 2025
3 min read
Key takeaways:
- Oral semaglutide 25 mg is a once-daily medication approved to reduce body weight for adults with overweight or obesity.
- In the OASIS 4 trial, adults receiving oral semaglutide lost 16.6% of weight at 64 weeks.
The FDA approved the first oral GLP-1 for lowering body weight according to a press release from Novo Nordisk.
Oral semaglutide 25 mg (Wegovy pill, Novo Nordisk) was also approved for reduction of risk for major adverse cardiovascular events, according to the release.
The FDA approved oral semaglutide 25 mg as the first oral GLP-1 to treat obesity.
The drug is a once-daily GLP-1 designed to reduce excess body weight for adults with obesity or overweight with at least one weight-related comorbidity. The medication was approved by the FDA based on the findings from the OASIS 4 trial.
As Healio previously reported, for OASIS 4, researchers randomly assigned 307 adults with overweight or obesity to receive once-daily oral semaglutide 25 mg or placebo for 64 weeks. In on-treatment data, adults receiving oral semaglutide 25 mg lost 16.6% of their body weight at 64 weeks compared with a 2.7% weight loss with placebo. Those receiving oral semaglutide were also 12.2 times more likely to lose at least 20% of their body weight than the placebo group. According to the press release, about one in three adults receiving oral semaglutide 25 mg lost at least 20% of their body weight.
The safety profile for oral semaglutide 25 mg in OASIS 4 was similar to other obesity trials of injectable semaglutide 2.4 mg (Wegovy, Novo Nordisk). Most adverse events with oral semaglutide 25 mg were gastrointestinal-related, with the most common symptoms being nausea, vomiting and constipation.
The approval for the indication of reduced risk for major adverse CV events was based on findings from the SELECT trial, supported with data from the STEP trial program and the PIONEER PLUS trial, according to the release. As Healio previously reported, adults with overweight or obesity and preexisting heart disease who received once-weekly injectable semaglutide 2.4 mg in SELECT had a 20% lower risk for CV death, nonfatal myocardial infarction or nonfatal stroke compared with placebo over approximately 40 months of follow-up.
“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 press release. “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 U.S.”
Scott Isaacs, MD, FACP, FACE, adjunct associate professor of medicine at Emory University, president of the American Association of Clinical Endocrinology and a Healio | Endocrine Today Editorial Board Member, said the approval of oral semaglutide 25 mg is the biggest development in endocrinology in 2025. He said the drug will have a huge impact on patients, as it provides a pharmacotherapy option with a different mode of administration than injectable drugs.
Scott Isaacs
“To have an oral medication expands the number of people that can take it,” Isaacs told Healio. “The more options that are available, the more people you can treat, because there’s always reasons why people can’t use one treatment or another.”
Isaacs said health care professionals will need to pay attention to tolerability with patients given the medication is different from other FDA-approved agents for obesity.
“It is not a new compound, but it’s a much higher dose,” Isaacs said. “The weight loss numbers seem to be pretty similar to injectable Wegovy. The pill is absorbed through the stomach, not through the intestine. It requires you to have an empty stomach, and they say they want you to eat 30 minutes after you take it. The reason for that is if you wait longer, more is absorbed. They don’t want you to have more side effects. It’s not easy to do.”
In the press release, Novo Nordisk said it plans to launch oral semaglutide 25 mg in the U.S. in early January 2026.
For more information:
Scott Isaacs, MD, FACP, FACE, can be reached at sisaacs@aace.com.
Sources/Disclosures
Source:
Press Release
Disclosures:
Doustdar is an employee of Novo Nordisk. Isaacs reports no relevant financial disclosures.
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