Wegovy in a pill for obesity and weight loss: When will it be approved?
Is Wegovy available as a pill?
In the near future, the Wegovy pill, taken once daily, may be available for adults with obesity or who are overweight to help with weight loss and to reduce cardiovascular disease risks. If Wegovy in a pill becomes FDA approved, it would be the first oral GLP-1 treatment for weight loss, weight management, and to reduce the risk of cardiovascular complications in specific patients. Currently, Wegovy (semaglutide) is only available as a weekly injection.
Novo Nordisk has filed a New Drug Application to the FDA for an investigational once-daily oral semaglutide 25 mg tablet, “Wegovy in a pill” for chronic weight management in adults with obesity or overweight.
Specifically, the indications that have been applied for are:
- for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions
- to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.
How well does Wegovy pill work?
The application to the FDA was supported by phase 3 OASIS-4 (NCT05564117), which demonstrated at week 64:
- 13.6% reduction in body weight in the semaglutide group
- 2.2% reduction in body weight for the placebo group by week 64.
Results were published in The New England Journal of Medicine.
The FDA is expected to make a decision on the approval in the last 3 months of 2025. If accepted, it would be the first oral GLP-1 specifically for the treatment of obesity in the U.S.
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Warnings and side effects
Because the Wegovy tablet is still investigational, its final U.S. Prescribing Information, including boxed warnings and contraindications, is not yet known. However, Wegovy injection carries an FDA boxed warning for risk of thyroid C-cell tumors: semaglutide caused thyroid C-cell tumors in rodents, and it is unknown whether it causes thyroid C-cell tumors (including medullary thyroid carcinoma, MTC) in humans. Wegovy injection is contraindicated in patients with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN2), and in those with serious hypersensitivity to semaglutide; it is not indicated for type 1 (insulin-dependent) diabetes and should not be used to treat diabetic ketoacidosis (DKA).
Current side effects (Wegovy injection): the most common include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, and dizziness (hypoglycemia can occur in people with type 2 diabetes using glucose-lowering drugs); serious risks include pancreatitis, gallbladder disease, acute kidney injury, and diabetic retinopathy complications
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Ozempic, Mounjaro, Wegovy and Zepbound can all lead to long-term weight loss, but only Wegovy and Zepbound are approved by the FDA for this use. In studies, Zepbound has led to a 21% weight loss in adults using the highest dose, while Wegovy has led to about a 15% weight loss.
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