Eli Lilly has filed six new lawsuits in the United States as part of its effort to combat the sale of unapproved versions of its experimental obesity medicine retatrutide. The drug has not been approved by the U.S. Food and Drug Administration (FDA), and Lilly has said it does not plan to submit an application for FDA approval until next year.
The lawsuits target six companies that Lilly alleges are selling illegal versions of retatrutide. According to the company, some sellers market the products as being intended for “research use only” while offering them for human use. The defendants named in the lawsuits are California-based Aesthetic Envy Cosmetic Centers and five Texas companies: Astra Peptides, Striker Pharmacy, Lone Star Peptide, Legendary Peptides and Texas Peptides.
Lilly said the legal actions are part of a broader effort involving courts, regulators, and law enforcement agencies to address a growing black market for the medicine.
FDA Warnings and Concerns About Unapproved Products
Retatrutide has attracted attention because of the weight-loss results reported in Lilly’s clinical research. However, the medicine remains under investigation and has not been approved by any regulatory agency anywhere in the world.
According to Lilly, some consumers seeking access to the drug have turned to online merchants, clinics, compounders and foreign companies that claim to offer versions of retatrutide. The company said these products could be fake, impure, or improperly dosed.
Two months before Lilly announced the lawsuits, the FDA warned buyers and sellers about unapproved versions of retatrutide and other weight-loss drugs, including Lilly’s tirzepatide and Novo Nordisk’s semaglutide.
The FDA said some products are labeled as being for research purposes or not intended for human consumption but are sold directly to consumers with dosing instructions included. The agency stated that the products are of unknown quality and may be harmful to consumers’ health.
The agency had also warned healthcare professionals as early as March 2025 about the illegality of compounded versions of retatrutide and the risks they could pose.
Company Reports Extensive Black-Market Activity
Lilly said it has referred more than 200 people and entities involved in the illegal market to the FDA, the Department of Justice, state attorneys general, law enforcement agencies, professional licensing boards and regulators.
The company also reported identifying more than 14,000 websites, advertisements, social media posts and product listings offering retatrutide in over 100 countries.
In a statement, Lilly Chief Medical Officer David Hayman said, “What is being sold on the black market is not a medicine; it is entirely unverified, unapproved, and not worth the risk.”
Lilly also stated that some black-market sellers and businesses posing as legitimate medical providers openly market retatrutide as a weight-loss solution despite the lack of regulatory approval.
Retatrutide Development Continues Ahead of Planned Filing
Lilly plans to seek FDA approval for retatrutide early next year. The medicine targets three hormone receptors: GLP-1, GIP, and glucagon.
According to the company, retatrutide produced up to 29% weight loss in a phase 3 clinical trial. Lilly has also said that in some cases the results observed in its research were comparable to weight loss achieved through bariatric surgery.
The new lawsuits follow previous legal actions by Lilly involving obesity medicines. In 2023, the company sued eight businesses in five states that were producing or selling compounded versions of Mounjaro. Less than a year later, it filed lawsuits against six companies over alleged false advertising related to copycat products.
Legendary Peptides had no immediate comment on the lawsuit. Representatives for Aesthetic Envy, Astra Peptides, Striker Pharmacy, Lone Star Peptide and Texas Peptides did not immediately respond to requests for comment.
Eli Lilly Takes Legal Action Over Retatrutide
Eli Lilly has filed six lawsuits targeting entities it says are involved in the unlawful sale and distribution of unapproved retatrutide products. The legal action reflects Eli Lilly’s efforts to protect patients and its investigational medicine from unauthorized versions entering the market.
Retatrutide is an investigational medicine being developed by Eli Lilly for conditions including obesity and type 2 diabetes. It has not been approved by the U.S. Food and Drug Administration.
Eli Lilly Targets Alleged Unauthorized Sellers
According to the company, Eli Lilly filed lawsuits against businesses allegedly marketing, selling, or distributing products represented as retatrutide without authorization. The cases are part of a broader effort by Eli Lilly to address what it considers misleading or potentially unsafe products.
The company has warned consumers about purchasing unapproved medicines from online sources where the identity, quality, dosage, and manufacturing standards may not be verified.
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