Eli Lilly targets alleged black market sales of its experimental GLP-1 drug

Eli Lilly is suing six entities that it alleges are selling black market versions of its experimental weight-loss drug retatrutide. 

Lilly’s lawsuits target U.S. entities selling illegal retatrutide products, including compounding pharmacies, medical spas and online sellers that sell retatrutide as a weight-loss “hack.” 

Those entities falsely claim their drugs are for “research-use only” when they are really intended for human use.  

Retatrutide is an investigational GLP-1 drug still in late-phase clinical trials. No medicine containing retatrutide has yet been approved for human use by any regulatory agency in the world, Lilly said.  

The company is expected to submit retatrutide to the Food and Drug Administration (FDA) for approval by the end of the year. Studies have shown it is more effective than other GLP-1 drugs already on the market. 

Lilly’s lawsuits involve entities known as Aesthetic Envy, Astra Peptides, Legendary Peptides, Striker Pharmacy, Texas Peptides and Lone Star Peptide. They are filed in courts in California and Texas. 

The FDA has said retatrutide cannot legally be compounded or sold, and that selling unapproved drugs can pose significant risks for patients.

The entities selling retatrutide are using a loophole in federal regulations that allow the sale of “experimental use only” compounds. But the drugs being sold are frequently made by unregulated foreign manufacturers in facilities that haven’t been inspected or licensed by the FDA, and contain unverified ingredients.  

“Retatrutide is being rigorously studied as part of a comprehensive clinical trial development program,” David A. Hyman, Lilly’s chief medical officer, said in a statement. “We take the responsibility of evaluating the safety and efficacy of our investigational medicines seriously. What is being sold on the black market is not a medicine – it is entirely unverified, unapproved and not worth the risk.” 

Lilly said it has also referred more than 200 individuals and entities to the FDA, the U.S. Department of Justice, state attorneys general, law enforcement and professional licensing boards, and is working with global regulators, law enforcement and customs authorities to stop the illegal market. 

Lilly called on e-commerce companies and social media platforms to stop enabling — and in some cases fueling — the illegal market, and to take proactive steps to block the conduct before it reaches consumers.