Eli Lilly has filed six lawsuits against US companies accused of selling unauthorized versions of its experimental obesity drug retatrutide. The Indianapolis-based drugmaker announced the legal action on Wednesday, escalating its campaign against unauthorized sellers before the medicine has won regulatory approval. According to reports from Reuters, the lawsuits target a range of businesses including compounding pharmacies, medical spas and online sellers that allegedly marketed retatrutide products to consumers despite the drug remaining under clinical development. The pharmaceutical company has referred more than 200 individuals and entities to various regulatory bodies including the FDA, US Justice Department, state attorneys general, law enforcement agencies and professional licensing boards. As reported by CNBC, Lilly has also reported more than 14,000 websites, advertisements, social media posts, and product listings that unlawfully market retatrutide in more than 100 countries to internet service providers, social media platforms, and e-commerce companies. Lilly Chief Medical Officer Dr. David Hyman described the products being sold on the black market as 'entirely unverified' and 'unapproved', warning consumers about the associated risks.
Retatrutide is currently in Phase 3 clinical trials for obesity, type 2 diabetes and related conditions, as reported by Reuters. No regulator has approved the compound for human use, according to Lilly. In June, the US Food and Drug Administration stated that sales of retatrutide and other unapproved versions of GLP-1 products to consumers are illegal and cannot lawfully be compounded. Lilly Chief Medical Officer Dr. David Hyman emphasized that ''''What is being sold on the black market is not a medicine — it is entirely unverified, unapproved and not worth the risk,'''' according to Reuters. The company reports that some sellers falsely market retatrutide products as being for 'research use only' when they are intended for human use, and that products are frequently sourced from unregulated foreign manufacturers. Demand for obesity treatments has fueled a thriving online market for products claiming to contain weight-loss drugs.
US Customs and Border Protection intercepted more than 690 shipments comprising over 31,000 units of illicit GLP-1 drugs during fiscal year 2025, according to Reuters. In July alone, the number of seizures more than doubled with over 1,400 seizures involving nearly 90,000 vials. Lilly has called on social media and e-commerce platforms, payment processors, credit card companies, shipping firms and regulators to take stronger action against sellers of unapproved retatrutide products. The company's Dr. Max Denning, Associate Vice President, Therapeutic Area Lead — Global Patient Safety, Cardiometabolic Health, warned that consumers taking these products could be exposing themselves to significant risks, stating 'Every single time that someone takes one of these, they're exposing themselves to a huge amount of risk,' according to CNBC.
According to Reuters, the six lawsuits were filed against Aesthetic Envy Cosmetic Centers, Astra LLC, Legendary Peptides, Striker Pharmacy, Texas Peptides and Lone Star Peptide Co. The defendants include a range of businesses, including medical spas, wellness clinics, compounding pharmacies, and online sellers, that often try to sidestep US regulations by labelling products as 'research-use only'. Lilly has also called on various stakeholders to take stronger action against the unauthorized sales, including social media platforms, e-commerce companies, payment processors and shipping firms. The company's comprehensive approach reflects the scale of the black-market problem affecting its experimental drug development process, with some sellers marketing retatrutide through websites, social media posts and businesses presenting themselves as medical providers despite sourcing products from unregulated manufacturers.
Five late-stage trials for retatrutide have produced positive results, with participants on the highest dose losing an average of 28.3% of their body weight over 80 weeks, as reported by CNBC. Lilly confirmed earlier this month that it would allow a limited number of patients meeting specific medical criteria to apply for early access to retatrutide before FDA approval. The company has pushed back its FDA approval timeline, now planning to file for approval in the first quarter of 2027, attributing the delay to additional time needed to assemble manufacturing and quality-control data. This represents a significant delay from earlier timelines that had pointed to a possible submission before the end of this year.
