FDA Approves Higher Dose Wegovy for Weight Loss
The Food and Drug Administration (FDA) approved a new, higher dose version of the weight loss drug Wegovy on March 19, 2026. This new formulation, called Wegovy HD, delivers 7.2 milligrams of semaglutide weekly via injection, a significant increase from the previous 2.4 mg dose.
Why the Higher Dose?
Novo Nordisk developed the higher dose as some individuals do not achieve their weight loss goals with the 2.4 mg weekly injection, according to a 2025 trial. The increased dosage aims to provide a more effective therapeutic option for adults struggling with obesity or overweight with weight-related medical conditions.
Efficacy of Wegovy HD
During the STEP UP phase 3b trial, the 7.2 mg dose of Wegovy resulted in an average weight loss of 18.7%. Approximately one in three participants experienced at least a 25% reduction in body weight.
Safety Profile and Common Side Effects
The FDA stated that the higher dose of Wegovy demonstrated a safety profile consistent with known side effects of semaglutide. Common adverse reactions include:
- Nausea
- Diarrhea
- Constipation
- Vomiting
- Abdominal pain
Reports of altered skin sensations, such as sensitivity, pain, or burning, were more frequent with the higher dose, but generally resolved with dose reduction or on their own.
Potential Risk of Ischemic Optic Neuropathy (ION)
Recent research suggests a potentially higher risk of ischemic optic neuropathy (ION), sometimes referred to as “eye stroke,” with higher doses of Wegovy, particularly in males. ION can lead to sudden vision loss or blindness. The FDA is currently conducting further investigations regarding this drug reaction.
Expert Perspective
“I’m cautiously optimistic,” said Meghan Garcia-Webb, MD, a triple board-certified physician in internal medicine, lifestyle medicine, and obesity medicine, who was not involved in the trial. “This has already been approved in the E.U. And the U.K. The safety data showed that serious adverse events were actually a little bit lower for the 7.2 mg group, but as always, we will have to see how this plays out in real clinical practice.”
Wegovy Pill Also Approved
In addition to the higher dose injection, the FDA approved an oral formulation of Wegovy in December 2025. This marks the first oral GLP-1 medication for obesity in the U.S. The pill is available in a 25 mg dosage and has demonstrated an average weight loss of approximately 17% in clinical trials. A 1.5 mg starting dose is available for $149 per month with savings offers.
“The launch of Wegovy in 2021 changed how obesity was viewed and treated in the US. Now, with Wegovy pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials,” said Dave Moore, executive vice president, US Operations at Novo Nordisk.
Looking Ahead
The approval of both Wegovy HD and the oral Wegovy pill expands treatment options for individuals with obesity and overweight, offering the potential for greater weight loss and improved cardiovascular health. Continued monitoring of safety data and further research into the risk of ION will be crucial as these medications become more widely used.
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