The telehealth company Hims & Hers Health said it will begin offering a low-cost version of the Wegovy pill for weight loss — a move that could dramatically lower the price barrier for people interested in GLP-1 medications. But the announcement has raised concerns among obesity specialists and regulators about safety, effectiveness, and quality.
For people who have struggled to afford GLP-1 medications, often because insurance coverage is limited or nonexistent, the price difference could be significant.
But experts say cost is only one part of the story.
Compounded Semaglutide Drugs Are Not FDA-Approved
Hims & Hers said its new compounded pill contains semaglutide, the same active ingredient found in injectable Wegovy and Ozempic and the new Wegovy pill.
Unlike those medications, however, compounded drugs — made by pharmacies to meet the needs of an individual patient — are not approved by the FDA, which means the agency does not review the products’ safety, effectiveness, or quality.
Still, experts stress that compounded drugs are fundamentally different from FDA-approved medications.
“Compounded versions of semaglutide are not FDA-approved and are not required to undergo the rigorous clinical trials that approved medications must complete to demonstrate safety, efficacy, dosing accuracy, and manufacturing consistency,” says Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston.
For that reason, Dr. Stanford does not prescribe or recommend compounded drugs for obesity treatment.
Jorge Moreno, MD, an assistant professor and an obesity medicine doctor at Yale Medicine in New Haven, Connecticut, agrees. “Wegovy isn’t just a brand name — it’s an FDA-approved medication with a very specific, highly controlled formulation,” he says.
Will the Compounded Wegovy Pill Work the Same Way?
That’s one of the biggest unanswered questions. Stanford points to an absence of high-quality clinical trial data showing that compounded semaglutide formulations work the same way or have the same safety profile as FDA-approved ones.
“Assuming equivalence without data is not scientifically sound or medically responsible,” she says.
Hims & Hers disputed that claim. The company said its compounded pill uses what it called “liposomal technology that is intended to support absorption,” without giving more detail.
But the company has not released clinical trial data demonstrating that its pill delivers comparable weight loss or blood levels of semaglutide.
Dr. Moreno compares it to making a croissant: The recipe and preparation have to be exact. “Small changes in ingredients or technique can change the outcome, so something that looks similar may not behave the same way in the body,” he says.
Novo Nordisk holds a patent for the precise ingredients and formulation of the Wegovy pill, says Moreno. “These ingredients [in the compounded pill] were not tested in the clinical studies and could result in different efficacy and side effect profiles. I would not feel comfortable and would not advise using these medications,” he says.
Is the New Compounded Semaglutide Pill Safe?
Compounded medications are not inherently unsafe, but experts say they come with more unknowns.
“These products have not been tested in large, randomized clinical trials, may vary in strength or purity, and may not even contain the same active ingredient as FDA-approved semaglutide,” Stanford says. There is also limited oversight of manufacturing and quality control, she adds.
That uncertainty matters, because GLP-1 medications can cause side effects ranging from nausea and vomiting to serious complications. Without standardized data, it may be harder for clinicians to anticipate or manage problems if they arise.
Moreno also raises questions about accountability. “What if patients develop side effects that are unexpected? Who will be responsible? Where will the patients be referred — their primary care provider, the emergency department? And what will we look for if we don’t know what side effects to expect?” he asks.
Does Expanding Access Justify the Risk?
Stanford acknowledges that access is a problem, but says lowering standards is not the solution. “Yes, this will expand access — but I believe the downside is too risky,” she says.
“Obesity is a chronic disease that deserves evidence-based treatment. Lowering standards for safety and efficacy for people with obesity reinforces harmful inequities in care. Patients should not be asked to accept unproven therapies simply because effective, FDA-approved options are expensive or difficult to access,” says Stanford.
Is the New Pill Legal?
But large-scale marketing of compounded versions of brand-name drugs exists in a regulatory gray area.
According to Reuters, Novo Nordisk has said it plans to pursue legal action against Hims & Hers, arguing that mass compounding of a Wegovy pill copy is illegal and undermines the FDA’s drug-approval framework. The FDA in September issued a warning to Hims regarding its marketing of compounded semaglutide injections. Claims that compounded versions contain “the same active ingredient as Ozempic and Wegovy” are misleading, the agency told Hims, because compounded drugs are not FDA-approved.
Should You Try the New Copycat Wegovy Pill?
Experts say anyone considering compounded semaglutide should understand that it is not the same as FDA-approved Wegovy, even if it contains semaglutide.
“I don’t believe there is a truly ‘safe’ way to use compounded semaglutide for weight management, given the lack of clinical trial data and regulatory oversight,” Stanford says. She recommends using FDA-approved medications prescribed by clinicians trained in obesity medicine whenever possible.
Moreno adds that if people do decide to try the compounded options, they should remain under close medical supervision and report any new symptoms promptly, though he would not advise using these products himself.
“As an obesity physician, my priority is always patient safety, so I would still evaluate and support a patient if concerns arise, regardless of where the medication came from,” he says.
Great Job Becky Upham & the Team @ google-discover for sharing this story.
