Eli Lilly has filed six new lawsuits against US entities allegedly selling illegal, unapproved retatrutide products, as the company steps up efforts to protect patients from the growing black market for the investigational drug.
The company said the illegal market also includes compounding pharmacies, medical spas and online sellers that falsely claim their drugs are for “research use only” when they are actually intended for human use.
Lilly has also referred more than 200 individuals and entities to the US Food and Drug Administration (FDA), the US Department of Justice, state attorneys general, law enforcement agencies and professional licensing boards. Lilly said it is working with regulators, law enforcement and customs authorities worldwide to stop this illegal market.
Retatrutide is an investigational molecule currently in Phase 3 clinical trials for obesity, type 2 diabetes and other related indications. No medicine containing retatrutide has been approved for human use by any regulatory agency worldwide, and the drug cannot legally be sold to consumers.
Lilly Chief Medical Officer David A. Hyman said, “Retatrutide is being rigorously studied as part of a comprehensive clinical trial development program. 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.”
The FDA has warned that unapproved drugs sold for human use may pose significant risks and are illegal. The agency has also stated that retatrutide cannot be lawfully compounded and that products marketed as “research-use only” may be of unknown quality and potentially harmful.
Despite these warnings, Lilly said some medical spas, wellness clinics and online sellers continue to sell retatrutide as a weight loss “hack.” The company said many of these illegal products are made by unregulated foreign manufacturers.
The six lawsuits target Aesthetic Envy; Astra Peptides; Legendary Peptides; Striker Pharmacy; Texas Peptides; and Lone Star Peptide.
Lilly has also reported more than 14,000 websites, advertisements, social media posts and product listings that allegedly market retatrutide illegally across more than 100 countries to internet service providers, social media platforms and e-commerce companies.
The company is calling on regulators, customs agencies and law enforcement authorities to treat the sale of unapproved retatrutide as an “urgent public health crisis” and prioritize enforcement and cross-border coordination to dismantle the “criminal networks” selling these drugs.
It urged social media and e-commerce platforms to prevent illegal products from reaching consumers and called on payment processors, credit card companies, shipping and logistics providers and other service providers to cut off infrastructure supporting this illegal trade.
Lilly also urged healthcare providers to raise awareness of the risks associated with unapproved retatrutide products and encouraged the public to report suspected illegal sales to relevant authorities and the Lilly Answers Center.
