FDA has approved Wegovy HD, a higher-dose 7.2 mg injectable semaglutide, based on Phase III data showing a mean weight loss of 20.7% in adults with obesity.
The FDA approved Wegovy HD, a higher-dose injectable version of semaglutide, delivering greater weight loss than the existing Wegovy formulation.
Emerging Pharma Leaders nominations are now open!
Do you know someone who can make tough decisions that continue to face manufacturers? Are they destined to change the future of pharma?
Nominate a colleague with impressive leadership and career intentions – even yourself! – for the Pharmaceutical Executive 2026 Emerging Pharma Leaders Awards.
The approval expands Novo Nordisk's position in the obesity treatment market and makes Wegovy the first GLP-1 treatment approved under the
FDA approved Wegovy HD as a once-weekly injectable semaglutide at 7.2 mg for long-term weight reduction in adults with obesity.1 The agency
The approval is based on results from two 72-week Phase III trials. In the STEP UP trial, which enrolled approximately 1,400 adults with obesity, semaglutide 7.2 mg produced a mean weight loss of 20.7%, with roughly one in three participants losing 25% or more of their body weight.2 In the STEP UP T2D trial, which enrolled approximately 500 adults with obesity and type 2 diabetes, the drug produced a mean weight loss of 14.1%, while the safety and tolerability profile remained consistent with previously observed reactions in prior semaglutide trials.2
In both trials, the new higher dose version of Wegovy compared favorably to the existing 2.4 mg Wegovy formulation, producing approximately 15% mean weight loss in its pivotal trials, positioning the higher dose as a meaningful step forward for patients who need greater weight reduction.1
“The STEP UP trial demonstrated that we can increase the dose of semaglutide and achieve greater weight loss than previously seen, and in line with semaglutide’s established safety profile. This may offer another option to people who do not attain their weight goals,” lead study author Sean Wharton, medical director of the Wharton Medical Clinic, Canada, said in a press release. “We are already aware that semaglutide can have health benefits for people with heart disease, liver disease, knee osteoarthritis, type 2 diabetes and prediabetes. These findings help to give patients with obesity more options for improvements in their weight and overall health.”
Novo Nordisk is expected to launch Wegovy HD in a single-dose pen in the U.S. later this year in April.1 The 7.2 mg dose is already approved in the EU and the UK, with regulatory decisions on the single-dose pen format in those markets expected in the second half of 2026.
The approval adds a third distinct offering to Novo Nordisk's semaglutide portfolio for obesity, alongside the existing injectable Wegovy and the
Mike Doustdar, president and CEO of Novo Nordisk, said the company's goal is to provide options across the spectrum of patient need.
“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. 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,” said Doustdar.
For Novo Nordisk, which has faced pressure on its financial outlook partly due to
