Novo Nordisk A/S filed a supplemental New Drug Application with the U.S. Food and Drug Administration on November 26, 2025 for a 7.2‑mg dose of its semaglutide injection, Wegovy. The filing is part of the company’s Commissioner's National Priority Voucher (CNPV) program, which accelerates review and could lead to a decision within one to two months.
The 7.2‑mg dose is supported by the STEP UP phase 3 trial, which enrolled 1,407 adults with obesity and excluded patients with diabetes. At 72 weeks, the trial reported an average weight loss of 20.7 %, a significant improvement over the current 2.4‑mg maximum dose. Gastrointestinal side effects were more common at the higher dose, but serious adverse events were lower (6.8 % versus 10.9 % for 2.4 mg).
Novo Nordisk’s filing is a strategic move to broaden its obesity portfolio and maintain a competitive edge against rivals such as Eli Lilly’s tirzepatide (Zepbound). The company also has the 7.2‑mg dose under review in the EU, with a decision expected in the first quarter of 2026. The new dose could capture a larger share of the growing global obesity market and provide a higher‑potency option for patients who have not achieved sufficient weight loss with the current dose.
Senior Vice President Anna Windle said the submission “marks an exciting step forward” and that the 7.2‑mg dose “offers patients and healthcare professionals a new option for greater weight loss potential.” She added that the filing underscores the efficacy of the semaglutide molecule across indications.
Investors reacted positively to the filing, citing the accelerated review timeline and the potential for a new revenue stream. The announcement also came shortly after a disappointing Alzheimer’s trial, providing a counterbalancing positive narrative for the company’s pipeline.
If approved, the 7.2‑mg Wegovy could open a new revenue stream for Novo Nordisk, adding to the company’s existing weight‑management portfolio and reinforcing its leadership position in the GLP‑1 drug market.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.