Four years after the launch of the injectable GLP-1 receptor agonist semaglutide (Wegovy), on December 22, 2025, Novo Nordisk announced the FDA has approved an oral version of the same drug, which is expected to launch in early January 2026. This is the first oral GLP-1 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) such as death, heart attack, or stroke. The drug works by mimicking the naturally occurring GLP-1 hormone to regulate appetite and caloric intake.
GLP-1s changed the way obesity was viewed and treated in the United States, and this once-daily pill gives healthcare providers more choices to support patients’ weight loss and management.
Leading to the approval was a clinical trial of 307 obese or overweight adults with one or more weight-related comorbidities. People with diabetes were excluded from the study. Participants on the oral semaglutide, combined with a reduced calorie diet and exercise regimen, averaged a 13.6% weight loss. This was slightly less than those participating in an initial clinical trial of the injectable semaglutide, which yielded an average 14.9% weight loss.
While approved to manage weight in adults, oral semaglutide is not indicated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) or pediatric weight management like the injectable formulation.
Dose variations
- 1.5 mg, 4 mg, 9 mg, and 25 mg tablets
- 1.5 mg starting dose will be available in early January per Novo Nordisk.
- Treatment with semaglutide tablets starts with 1.5 mg daily for 30 days. The dosage escalation schedule should be followed every 30 days until reaching the recommended maintenance dose of 25 mg once daily.
- 3 mg, 7 mg, and 14 mg semaglutide tablets available under the brand name Rybelsus are approved only for glucose management and MACE reduction in adults with type 2 diabetes.
Side effects
Like the injectable semaglutide, the pill version shares gastrointestinal side effects including nausea, vomiting, constipation, and diarrhea. Other side effects included stomach pain, headache, fatigue, upset stomach, dizziness, feeling bloated, belching, and low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.
MyMatrixx by Evernorth Actions
MyMatrixx by Evernorth is dedicated to helping our clients monitor and manage the cost and utilization of injury-related medications and the medications that may aid in an injured worker’s overall recovery. We will continue to evaluate workers' compensation claim-related uses for GLP-1 agonists/GIP dual agonists to determine if they are an appropriate addition to our formularies. If you have any questions, please reach out to your MyMatrixx account team.