Eli Lilly takes legal action over black market sales of experimental diabetes drug retatrutide

Pharmaceutical giant Eli Lilly has launched its first lawsuits against six US companies, aiming to curb illegal sales of its unapproved weight-loss and diabetes treatment, retatrutide, amid growing risks to consumer safety.

Eli Lilly has begun legal action against six US companies over what it says are illegal sales of retatrutide, an experimental diabetes and weight-loss treatment that is still in clinical trials and has not been approved for use by regulators. The case marks the company’s first wave of retatrutide-related lawsuits, widening its fight against unauthorised versions of its obesity medicines beyond the compounded copies of tirzepatide sold as Mounjaro and Zepbound.

In a statement cited by the company, Eli Lilly’s chief medical officer, David Hyman, said: “What is being sold on the black market is not a medicine , it is entirely unverified, unapproved and not worth the risk.” The complaints, filed on Wednesday, target compounders, medical spas and online sellers in California and Texas, including Aesthetic Envy, Astra Peptides, Legendary Peptides, Striker Pharmacy, Texas Peptides and Lone Star Peptide Co.

Lilly says the sellers are pushing a product that has no FDA approval and that, in some cases, is being marketed under the pretext of “research use only” while actually being promoted for human injection. In the suit against Lone Star Peptide Co, the company alleges the seller offers dosage tools on its website that guide customers on how to use the product, which Lilly argues shows it is being sold as a drug rather than a laboratory chemical.

The company says the illicit market is putting consumers at risk by exposing them to substances of unknown composition, purity, potency and sterility. ABC News reported in June that Lilly had warned counterfeit retatrutide products could carry serious health risks, including potential liver failure, while the BMJ reported that the company has also been working with social media platforms to remove listings for unapproved versions of the drug. ITV meanwhile reported in June that unlicensed clinics in Wales were advertising retatrutide for weight loss, underscoring how the market has spread beyond the US.

Retatrutide remains in Phase 3 trials, with Lilly planning to seek approval in the first quarter of 2027. Alongside the lawsuits, the company said it has referred more than 200 people and entities to federal and state regulators and enforcement agencies and reported more than 14,000 websites, ads, social media posts and product listings in more than 100 countries to internet service providers, social media platforms and e-commerce firms. Endpoints News said it contacted five of the six defendants for comment but received no response, and that Texas Peptides appeared to have shut down its website.

Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.