- Novo Nordisk's oral semaglutide (GLP-1) tablets 1.5 mg, 4 mg and 9 mg will be available in the US starting May 4.
- The tablets are a reformulation of Rybelsus (previous 3, 7, 14 mg) and have the same reported efficacy and safety profile.
- FDA approval covers glycemic control and reduction of major adverse cardiovascular events (primary and secondary prevention) in adults with type 2 diabetes at high CV risk.
- Manufactured end-to-end in the US and distributed through 70,000+ pharmacies; insurance coverage from $25 (up to 3 months) and self-pay $149/$199/$299 per month for 1.5/4/9 mg.
Product launch
Novo Nordisk will make Ozempic (semaglutide) tablets 1.5 mg, 4 mg and 9 mg available in the US starting May 4; the oral formulation is approved to improve glycemic control and to reduce major adverse cardiovascular events (MACE) in adults with type 2 diabetes at high CV risk.
Formulation and regulatory context
The tablets are a reformulation of previously approved oral semaglutide (Rybelsus, originally 3 mg, 7 mg, 14 mg first approved in 2019) and are reported to have the same efficacy and safety profile; Rybelsus will continue to be marketed outside the US. A supplemental application for a 25 mg tablet is pending with an FDA decision expected by the end of 2026.
Access, pricing and channels
Ozempic tablets will be manufactured end-to-end in the US and distributed via 70,000+ pharmacies; insurance coverage may be as low as $25 for up to a three-month prescription, while self-pay through NovoCare Pharmacy and select telehealth providers is priced at $149 (1.5 mg starter), $199 (4 mg) and $299 (9 mg) per month, with exclusions and eligibility restrictions.
Clinical indications beyond glycemic control
Ozempic injection retains indications to reduce MACE in adults with known heart disease and to reduce risk of worsening kidney disease and cardiovascular death in adults with chronic kidney disease; tablets are approved for primary and secondary prevention of MACE in high‑risk adults with type 2 diabetes.
Safety and contraindications
Key risks include possible thyroid C‑cell tumors observed in rodents, pancreatitis, vision changes, hypoglycemia (with insulin or sulfonylureas), dehydration/renal issues, severe GI events, allergic reactions, gallbladder problems and aspiration risk during anesthesia; contraindicated in patients with personal/family history of medullary thyroid carcinoma or MEN 2.
