FDA Accepts Application for Wegovy Weight Loss Pill: A Game-Changing Development
Federal regulators have accepted Novo Nordisk's application for an oral version of Wegovy, their injectable weight loss medication. The pills could be available by early next year, offering a needle-free alternative for patients.
Novo Nordisk logo on company flags
The new formulation will be a 25mg daily pill, compared to the current weekly injection. This development follows successful clinical trials, including a 64-week OASIS 4 phase 3 study involving 307 adults with obesity.
Early phase 1 trial results showed promising outcomes, with participants experiencing a 13% reduction in body weight over three months. The full phase 3 trial results are pending.
Key Benefits of Oral Wegovy:
- Easier administration without needles
- No refrigeration required
- Potentially lower manufacturing costs
- May improve treatment adherence
- Could be more accessible to patients
Important Considerations:
- Must be taken daily (versus weekly injections)
- Needs to be taken on an empty stomach
- May have more gastrointestinal side effects
- Effectiveness compared to injectable form still being studied
A 2021 research review suggested that oral semaglutide (the active ingredient) could be as effective or more effective than injectable versions for weight loss and blood sugar control. Additionally, a March 2025 study indicated that oral semaglutide reduced heart attack and stroke risks compared to placebo.
Competition in the Market:
- Eli Lilly is developing orforglipron, their oral weight loss medication
- Both companies currently offer injectable GLP-1 medications
- Medications use either semaglutide or tirzepatide as active ingredients
Medical experts emphasize that while oral options may increase accessibility, weight loss medications are just one component of a comprehensive treatment plan that should include lifestyle changes and addressing underlying behavioral and psychological factors.
Patient adoption will likely depend on several factors:
- Insurance coverage
- Cost comparison with injectable versions
- Individual treatment response
- Personal preferences
- Storage convenience
The FDA's decision on Novo Nordisk's application is expected by late this year, with potential market availability shortly after approval.