Telehealth company Hims & Hers has abandoned plans to sell a compounded version of Novo Nordisk’s weight-loss pill Wegovy, just two days after unveiling the offering and one day after the U.S. Food and Drug Administration signaled it would restrict access to key ingredients used to replicate popular obesity drugs.
The San Francisco-based company said Saturday it would no longer offer the compounded semaglutide pill, following swift pushback from Novo Nordisk and regulatory warnings from the FDA. Novo, which launched the FDA-approved Wegovy pill last month, had threatened legal action shortly after Hims announced its lower-cost alternative.
On Friday, the FDA said it plans to take “decisive steps” to limit access to active pharmaceutical ingredients used in blockbuster GLP-1 medications, including Wegovy, Ozempic and Eli Lilly’s Zepbound. The announcement raised immediate questions about the future of compounded versions of the drugs, which are not FDA-approved and have not undergone clinical trials to demonstrate safety or effectiveness.
Despite the reversal, Hims’ website on Saturday afternoon continued to promote the semaglutide pill—hours after the company posted on X that it was discontinuing the product. Semaglutide is the active ingredient in Wegovy.
“Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry,” Hims said in a statement. “As a result, we have decided to stop offering access to this treatment. We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.”
The company did not say whether the FDA’s move would affect its sales of compounded injectable weight-loss drugs, which it continues to offer.
Hims had planned to sharply undercut Novo’s pricing, advertising its version of the pill at $49 for the first month and $99 per month thereafter, compared with Novo’s $149 monthly price. The strategy reflected a broader push by Hims and similar telehealth firms, which initially built their businesses on low-cost generics for conditions such as hair loss and erectile dysfunction before expanding into the lucrative obesity drug market.
Novo is set to promote its new Wegovy pill in a celebrity-filled Super Bowl advertisement on Sunday. The Danish pharmaceutical company declined to comment Saturday on Hims’ decision. Rival Eli Lilly has said it expects FDA approval for an oral version of its weight-loss drug orforglipron later this spring, though Wegovy remains the first pill in the category to reach the market.
Under FDA rules, compounding pharmacies are permitted to make versions of brand-name drugs during shortages. Surging demand for GLP-1 treatments in recent years opened the door for compounded alternatives, often paid for out of pocket by patients. However, in 2024 the FDA declared that GLP-1 drugs were no longer in shortage—a move widely seen as curbing the practice. Some companies, including Hims, continued compounding under an exception that allows customized prescriptions for individual patients.
The FDA’s latest warning suggests that regulatory scrutiny of the booming weight-loss drug market is set to intensify.
