Eli Lilly has filed lawsuits against six U.S. companies regarding the alleged illegal sale of its experimental obesity drug, retatrutide. The lawsuits target entities including compounding pharmacies, medical spas, and online sellers.
Eli Lilly stated that the named defendants are Aesthetic Envy Cosmetic Centers, Astra LLC, Legendary Peptides, Striker Pharmacy, Texas Peptides, and Lone Star Peptide Co. Eli Lilly stated that these businesses allegedly marketed retatrutide products to consumers despite the drug remaining under clinical development.
According to Eli Lilly, retatrutide is currently in Phase 3 clinical trials for obesity, type 2 diabetes, and other related conditions. Eli Lilly says retatrutide is an experimental once-weekly drug designed to target three hormone receptors: GLP-1, GIP, and glucagon. The drug has not received regulatory approval from any authority.
According to Eli Lilly, participants in the highest dose group during a Phase 3 trial lost an average of 28.3% of their body weight over 80 weeks.
Eli Lilly reported more than 200 individuals and organizations to the US Food and Drug Administration (FDA), the US Department of Justice, state attorneys general, law enforcement agencies, and professional licensing bodies. The company has also requested that social media platforms, online shopping sites, payment companies, credit card companies, and shipping companies take measures to block the sale of unapproved products.
Regulatory and enforcement response
The FDA stated that retatrutide cannot be prepared as a compounded drug under federal law. The agency noted that some products sold online labeled 'research only' or 'not for human consumption' are actually delivered directly to consumers with usage instructions. Additionally, the FDA stated that unapproved GLP-1 products have not undergone agency review for safety, efficacy, and quality.
According to industry analysts, the demand for weight-loss drugs is growing faster than official approval and production processes, creating an illegal market for new-generation treatments not yet on pharmacy shelves. Some Americans have turned to medical spas and pharmacies that sell peptides for compounded versions of retatrutide, according to reports. Eli Lilly alleges that the entities sued falsely claim their retatrutide drugs are for 'research-use only.'
According to US Customs and Border Protection, more than 31,000 illegal GLP-1 products were seized in fiscal year 2025.
According to US Customs and Border Protection, more than 690 shipments carrying illegal GLP-1 drugs were stopped in fiscal year 2025. In July 2026, more than 1,400 seizures of illegal GLP-1 products were made, with approximately 90,000 bottles of products seized in a single month.
The safety and efficacy of retatrutide are being evaluated in ongoing clinical programs.
According to industry analysts, Novo Nordisk and Eli Lilly are the two major players in the approved weight-loss and diabetes drug market. Eli Lilly is escalating its campaign against unauthorized sellers before retatrutide has won regulatory approval, according to Reuters.