Wegovy® HD demonstrated a mean weight loss of 20.7%1, and around one-third of patients achieved 25% or greater weight loss in the STEP UP trial
First US FDA approval of a GLP-1 treatment under the Commissioner’s National Priority Voucher pilot programme, for products addressing critical US national health priorities
Wegovy® HD complements Wegovy® 2.4 mg, which is already approved in the US for weight management and cardiovascular risk reduction
Novo Nordisk expects to launch Wegovy® HD in the US in April 2026
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Wegovy® HD (once-weekly injectable semaglutide 7.2 mg) to reduce excess body weight and maintain weight reduction long-term. The FDA awarded a Commissioner’s National Priority Voucher for Wegovy® HD, accelerating its review and underscoring its potential to address critical patient needs and national health priorities in the US.
The accelerated approval is based on results from the STEP UP trial programme. In the STEP UP trial, semaglutide 7.2 mg injected once weekly demonstrated 20.7%1 mean weight loss in participants with obesity, and approximately one in three people experienced 25% or greater weight loss. In the STEP UP type 2 diabetes (T2D) trial, in participants with obesity and type 2 diabetes, semaglutide 7.2 mg demonstrated a mean weight loss of 14.1%1. In both trials, the well-known safety and tolerability profile of semaglutide was reaffirmed with semaglutide 7.2 mg, which was comparable to previous trials with semaglutide for weight management.
“Since its launch in 2021, Wegovy® has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in cardiovascular risk,” said Mike Doustdar, president and CEO of Novo Nordisk. “Earlier this year, we launched the Wegovy® pill, and with the accelerated approval of Wegovy® HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%. At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy® HD to help even more people reach their weight and health goals.”
Novo Nordisk expects to launch Wegovy® HD in a single-dose pen in the US in April 2026.
Wegovy® 7.2 mg is already approved for adults with obesity in the EU and the UK. Novo Nordisk expects regulatory decisions in the EU and the UK on semaglutide 7.2 mg in a single-dose pen in the second half of 2026.
