Lilly says it referred 200-plus sellers to authorities over unapproved retatrutide
Retatrutide is not approved anywhere and Lilly does not plan to file for approval until early 2027, so products sold under that name are unverified.
Eli Lilly says it has referred more than 200 people and businesses to the FDA, the Department of Justice, state attorneys general and law enforcement, and has reported more than 14,000 websites, advertisements, social media posts and product listings that market retatrutide, an experimental weight-loss drug that no regulator has approved [1][2].
The listings cover more than 100 countries [2]. Retatrutide is a once-weekly injectable designed to target three hormone receptors involved in appetite and metabolism: GLP-1, GIP and glucagon [2]. It is still in Phase 3 trials, and Lilly plans to file for approval in the first quarter of 2027 [2].
On Aug. 12, Lilly filed the first six lawsuits in its campaign against the retatrutide market [2]. The complaints name Striker Pharmacy, a compounding pharmacy near Houston; Aesthetic Envy, a medical spa chain based in Sacramento, California; and online Texas sellers Astra Peptides of Austin, Texas Peptides and Lone Star Peptide Co. of Houston, and Legendary Peptides of Lumberton [2]. Legendary Peptides declined to comment, and four of the other businesses did not respond to requests for comment; an email sent to Astra was returned as undeliverable [2].
Lilly used a similar approach last year, suing two compounding pharmacies and four telehealth companies over compounded versions of tirzepatide, the active ingredient in its approved obesity drug Zepbound and its Type 2 diabetes drug Mounjaro [2]. The FDA has warned telehealth companies, active pharmaceutical ingredient distributors and outsourcing facilities about compounding retatrutide, which the agency says is illegal [2].
The lawsuits argue that sellers hide behind research-use labels. The Lone Star complaint says the company's website offers a "Retatrutide Dosage Calculator" with instructions to enter vial strength, added bacteriostatic water and a target dose [2]. "Retatrutide cannot legally be sold for human use to anyone, anywhere, for any reason," that complaint says [2].
"What is being sold on the black market is not a medicine — it is entirely unverified, unapproved and not worth the risk," Lilly Chief Medical Officer Dr. David Hyman said in an announcement of the lawsuits [2]. Lilly spokesperson Jared Shapiro said patients have reported serious harms after buying black-market retatrutide online, including hospitalizations, and that social media and e-commerce platforms are not doing enough to block the listings [2].
George Ball, an associate professor at Indiana University's Kelley School of Business, called the market "a harbinger of trouble." "If they're facing this before it's even approved, that's pretty remarkable," he said [2].
Retatrutide has not been submitted for approval and has not completed late-stage trials [2]. Phase 3 results released in May found that, among 2,339 patients, those taking 12 milligrams lost an average of 70.3 pounds, or 28% of body weight, after 80 weeks, and nearly half of that group lost an average of 30% [2]. The 4 milligram group lost an average of 47.2 pounds, and the 9 milligram group an average of 64.4 pounds [2]. In an extension study, participants with a body mass index of 35 or higher lost an average of 85 pounds, or 30.3% of body weight, after 104 weeks [2]. For comparison, people using Wegovy or Zepbound can lose up to about 20% of body weight, according to the company [2].
Why it matters for patients
Nothing sold as retatrutide today is an approved drug. It has not been cleared by the FDA or any other regulator, and the products in circulation are made outside Lilly's clinical trial program and its supply chain [2].
Reported harms include a rising number of calls to the Washington Poison Center tied to illegal retatrutide, and six cases of liver toxicity in people who used the unapproved drug, reported by Australian health authorities this summer [2]. A preprint paper published in August by three Boston-area researchers says black-market retatrutide is associated with lower weight loss and increased cardiovascular symptoms [2]. Preprints have not gone through journal peer review.
Lilly's complaints say the black market will leave patients associating the name retatrutide with "danger, illegality, and reduced or total lack of efficacy," and that the company will have to rehabilitate the drug's reputation before launch [2].
An 11% share of trial participants stopped taking retatrutide because they felt they were losing too much weight, Lilly reported; a separate statement said about 11% of participants on the highest dose discontinued treatment because of side effects [2]. The most common side effects reported in the trial were gastrointestinal problems such as nausea, diarrhea, vomiting and constipation [2].
What happens next
Lilly plans to file for approval in the first quarter of 2027 [2]. Court dates in the six lawsuits have not been reported, and the outcomes of the referrals to the FDA, the Justice Department, state attorneys general and law enforcement have not been disclosed [1][2]. It is also not yet known how many of the 14,000-plus reported listings have been removed.
Sources
Semaglutides.org provides information only, not medical advice. Talk to a licensed provider about your own care before making changes. Some telehealth links are affiliate links and are labeled where they appear.