- FDA approves Ozempic\u00ae tablets 1.5 mg, 4 mg, and 9 mg for type 2 diabetes.
- Ozempic\u00ae pill offers enhanced bioavailability for comparable therapeutic value.
- Launch in the US scheduled for Q2 2026.
- Supplemental application for 25 mg tablets pending FDA decision by end of 2026.
FDA Approval
The US Food and Drug Administration (FDA) has approved Ozempic® tablets in 1.5 mg, 4 mg, and 9 mg doses for adults with type 2 diabetes. These tablets are designed to improve blood sugar levels alongside diet and exercise and reduce the risk of major adverse cardiovascular events in high-risk patients.
Enhanced Bioavailability
The Ozempic® pill offers enhanced bioavailability, achieving comparable therapeutic value to the previously approved 3 mg, 7 mg, and 14 mg doses of oral semaglutide. The active ingredient remains the semaglutide molecule.
Launch Timeline
The launch of the Ozempic® pill in the US is scheduled for the second quarter of 2026. Until then, patients are advised to continue their current Rybelsus® medication as prescribed and consult healthcare professionals before making any changes.
Future Developments
Novo Nordisk has also filed a supplemental drug application for Ozempic® tablets in a 25 mg dose for adults with type 2 diabetes. The company anticipates an FDA decision on this application by the end of 2026.
