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FDA Approves Semaglutide (Wegovy) Pill As First Oral GLP-1 for Weight Loss
The approval is based on the 64-week phase 3 OASIS 4 trial showing anaverage weight loss of ~17% if all patients stayed on treatment with semaglutide and ~14% regardless of if patients stayed on treatment.
The US Food and Drug Administration has approved Novo Nordisk’s once-daily semaglutide (Wegovy) pill, the first oral GLP-1 medicine for obesity in the US.1
As described in a December 22, 2025, release from the Company, semaglutide pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. It is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with overweight or obesity and established cardiovascular disease.1
"With more choices, HCPs are better equipped to tailor treatment approaches and support patients who want to gain control of their weight, and this milestone approval underscores exactly that kind of choice," Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham, said in a statement.1 "The availability of [semaglutide] pill expands the possibilities for weight management with semaglutide, giving healthcare professionals a powerful, efficacious medicine in a new method of delivery, allowing the ability to help meet more patients where they are."
On October 17, 2025, the Agency approved oral semaglutide 7 mg and 14 mg (Rybelsus) for cardiovascular (CV) risk reduction in patients with type 2 diabetes who are at high risk, irrespective of prior CV events. The decision made semaglutide the only oral GLP-1 medicine approved to reduce the risk of MACE in adults with type 2 diabetes who are at high risk for these events.3
The approval of oral semaglutide for obesity is based on results from the OASIS 4 phase 3 clinical trial, a 64-week medical study that included adults with obesity or overweight with ≥ 1 weight-related comorbidities, without diabetes. The trial included a 64-week treatment period, including a 12-week dose escalation, and a 7-week off-treatment follow-up period.1
A total of 307 participants were randomized in a 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, alongside lifestyle intervention for 64 weeks. For those taking semaglutide pill, 76% achieved ≥ 5% body weight loss from a baseline body weight of 235 lbs versus 31% taking placebo from a baseline body weight of 231 lbs.1
Results showed that if all patients stayed on treatment, people taking semaglutide pill once-daily along with a reduced calorie diet and exercise achieved an average weight loss of about 17% (16.6%) versus about 3% (2.7%) with placebo. When looking at the efficacy regardless of if all patients stayed on treatment, an average weight loss of about 14% (13.6%) was achieved by people taking semaglutiode pill compared to about 2% (2.4%) for placebo.1
In OASIS 4, common adverse reactions were similar to those previously seen in clinical trials with semaglutide injection 2.4 mg, including nausea, diarrhea, and vomiting.1
As described in the release from Novo Nordisk, the starting dose of 1.5 mg will be available in pharmacies and select telehealth providers in early January 2026 with savings offers for just $149 per month.1
"After many years advocating for people living with obesity, one thing has always been clear: patient safety has to come first. That's why it's critical we rely on treatments that are rigorously tested and FDA-approved," said Joe Nadglowski, president and CEO of the Obesity Action Coalition.1 "A brand new effective pill for weight loss gives people greater flexibility to choose a GLP-1 treatment that can fit in their daily routine and preferences."
References
Novo Nordisk. FDA approves Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults. December 22, 2025. Accessed December 22, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916473
Novo Nordisk. Novo Nordisk to present new data in oral semaglutide 25 mg (Wegovy® in a pill*) and obesity pipeline at ObesityWeek® 2025. October 20, 2025. Accessed December 22, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916436
Livingston R. FDA Approves Oral Semaglutide (Rybelsus) for CV Risk Reduction in Type 2 Diabetes. HCPLive. October 20, 2025. Accessed December 22, 2025. https://www.hcplive.com/view/fda-approves-oral-semaglutide-rybelsus-for-cv-risk-reduction-in-type-2-diabetes
