12/23/2025
FDA Approves Wegovy Weight-Loss Pill
— First oral GLP-1 agent indicated for obesity
by Kristen Monaco, Senior Staff Writer, MedPage Today
December 23, 2025 • 2 min read
FDA APPROVED semaglutide pill (Wegovy) over a photo of a prescription bottle of semaglutide pills.
The FDA approved a pill version of the GLP-1 receptor agonist semaglutide (Wegovy), making it the first oral GLP-1 agent indicated for weight loss, Novo Nordisk announced on Monday.
The once-daily 25 mg pill is approved to lower weight and maintain long-term weight reduction along with diet and exercise, and to reduce risk of major adverse cardiovascular events (MACE).
However, it is not indicated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) or pediatric weight management like injectable semaglutide.
Once-weekly injectable semaglutide was first approved for chronic weight management in 2021. A lower dose (7-mg, 14-mg) semaglutide pill is also available under the brand name Rybelsus, but it is approved only for glucose management and MACE reduction in adults with type 2 diabetes.
The pill version of semaglutide must be taken on an empty stomach in the morning with up to 4 ounces of water. Patients must swallow tablets whole and wait at least 30 minutes before eating food, drinking beverages or taking other oral medications.
Underpinning the new approval were findings from the OASIS 4 trial, which included 307 adults with obesity or overweight with one or more weight-related comorbidities. People with diabetes were excluded from the study.
In the trial, participants on oral semaglutide and a reduced calorie diet and exercise regimen averaged a 13.6% weight loss. This weight loss fell just below that of injectable semaglutide, which yielded an average 14.9% weight loss in an initial clinical trial.
Participants who adhered to treatment lost an average of 16.6% of their body weight. About 30% of oral semaglutide-treated participants achieved at least a 20% weight loss by week 64.
"With more choices, healthcare providers 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," said OASIS 4 co-investigator Timothy Garvey, MD, of the University of Alabama at Birmingham, in a statement.
"The availability of [the] Wegovy 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," he added.
Safety was similar to injectable semaglutide, with gastrointestinal side effects including nausea, vomiting, constipation, and diarrhea topping the list of adverse events. Other side effects included stomach pain, headache, fatigue, upset stomach, dizziness, feeling bloated, belching, hypoglycemia in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.
Warnings on the label include pancreatitis, gall bladder problems, dehydration, severe stomach problems, change in vision in those with type 2 diabetes, increased heart rate, depression, suicidal ideation, and aspiration under deep sedation.
The label also carries a boxed warning for risk of thyroid C-cell tumors.
A starting dose of 1.5 mg will be available in early January through pharmacies and select telehealth providers for $149 per month with savings offers, said Novo Nordisk.
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