Eli Lilly has filed six lawsuits against U.S. entities it accuses of illegally selling versions of its experimental obesity drug retatrutide.
The lawsuits target compounding pharmacies, medical spas and online sellers that allegedly sold retatrutide products, according to an Aug. 12 news release. Retatrutide is an investigational molecule 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 in the world.
Lilly has also referred more than 200 individuals and entities to the FDA, Justice Department, state attorneys general, law enforcement and professional licensing boards. The company has reported more than 14,000 websites, advertisements, social media posts and product listings that it said unlawfully market retatrutide in more than 100 countries.
The company is calling on regulators, law enforcement, social media and e-commerce platforms, payment companies, shipping companies and other entities to take action against the sale of unapproved retatrutide.
The lawsuits come shortly after Lilly established a formal expanded access program for retatrutide. The company told Becker’s Aug. 4 that authentic retatrutide could be made available before FDA approval to a limited number of patients who meet specific medical criteria and cannot enroll in a clinical trial. Lilly plans to submit the drug for FDA approval in early 2027.
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