Novo Nordisk has received approval from the US Food and Drug Administration for Wegovy HD, a once-weekly injectable formulation of semaglutide 7.2 mg, for chronic weight management in adults with obesity.

The approval enables the drug to be used for reducing excess body weight and maintaining long-term weight loss. The FDA also granted a Commissioner’s National Priority Voucher for Wegovy HD, accelerating its review process and highlighting its potential to address a major public health challenge.

The decision is based on data from the Phase III STEP UP clinical trial programme. In the main STEP UP trial, participants with obesity achieved a mean weight loss of 20.7 percent, with nearly one-third of patients losing 25 percent or more of their body weight. In a separate STEP UP trial involving patients with both obesity and Type 2 Diabetes, the treatment demonstrated a mean weight loss of 14.1 percent.

Across both studies, the safety and tolerability profile of semaglutide 7.2 mg remained consistent with earlier trials of the drug, reinforcing its established clinical profile in weight management.

Wegovy HD builds on the success of existing Wegovy formulations, which have been widely used since their launch to support weight reduction and improve cardiometabolic health, including reducing cardiovascular risk in certain patient populations.

Novo Nordisk plans to launch Wegovy HD in the United States in April 2026, offering the drug in a single-dose pen format. The higher-dose formulation is already approved in the European Union and the United Kingdom, with additional regulatory decisions for the single-dose pen expected later in 2026.

The STEP UP trials evaluated semaglutide 7.2 mg over a 72-week period in adults with obesity, both with and without type 2 diabetes, comparing its efficacy and safety against lower-dose semaglutide and placebo alongside lifestyle interventions.

Wegovy is currently available in multiple formulations, including once-weekly injections and an oral pill version and is indicated for weight management in adults and adolescents aged 12 years and older. It is also approved in certain cases to reduce the risk of major cardiovascular events in patients with obesity or overweight and existing heart disease.

The approval of Wegovy HD further strengthens Novo Nordisk’s portfolio in obesity care, reflecting its continued focus on developing innovative therapies to address chronic metabolic diseases and improve long-term health outcomes.