Wedoany.com Report-Dec.1, Novo Nordisk has submitted a regulatory filing to the U.S. Food and Drug Administration (FDA) seeking approval for a new 7.2 mg maintenance dose of Wegovy (semaglutide) injection, its treatment for chronic weight management.

The application requests an accelerated review through the FDA’s Commissioner’s National Priority Voucher program, which can shorten the standard review timeline to one or two months. Novo Nordisk received this voucher from the agency earlier in November 2025.

Clinical evidence supporting the higher dose comes from the phase III STEP UP trial. Over 72 weeks, participants receiving the 7.2 mg dose achieved an average weight reduction of 20.7%, compared with 17.5% on the current maximum 2.4 mg dose and 2.4% on placebo. Additionally, 33.2% of patients on the 7.2 mg dose lost at least 25% of body weight, versus 16.7% in the 2.4 mg group.

A parallel application for the same dose is under review by the European Medicines Agency, with a decision expected in the first quarter of 2026.

Wegovy is currently available in doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg. The proposed higher dose aims to offer patients an additional option for greater weight loss when clinically appropriate.

The obesity treatment market continues to expand rapidly. Research from Goldman Sachs projects the U.S. market alone could reach $100 billion by 2030. Novo Nordisk and Eli Lilly remain the leading players, with Wegovy competing directly against Lilly’s Zepbound (tirzepatide).

Both companies are advancing next-generation therapies. Novo Nordisk is developing an oral formulation of semaglutide as well as CagriSema, a combination of semaglutide and cagrilintide. Eli Lilly is progressing orforglipron, a once-daily oral GLP-1 candidate, and retatrutide, a triple-agonist injectable. Regulatory submissions for orforglipron are planned before the end of 2025.

Other pharmaceutical firms are also active in the field. Viking Therapeutics has initiated late-stage studies for its subcutaneous candidate VK2735, while Pfizer recently acquired Metsera, adding several early- and mid-stage incretin and amylin-based programs to its portfolio.

Novo Nordisk continues to strengthen supply of existing Wegovy doses and expand manufacturing capacity to meet sustained global demand for effective weight-management treatments. The company’s broader diabetes and obesity portfolio, including Ozempic and Rybelsus (both semaglutide-based), remains a key growth driver across multiple markets worldwide.