People buy unapproved retatrutide online as Lilly presses payment processors

People in the United States are buying vials of retatrutide, an experimental weight-loss drug that no regulator has approved, from online sellers, mixing the powder at home and dosing from instructions supplied by the vendors, according to reporting published Aug. 31 ^[1]. Its maker, Eli Lilly, is separately pushing payment processors and social platforms to cut off those sales ^[2].

Retatrutide does not work the same way as the GLP-1 drugs already on the market. Ozempic targets one hormone receptor, and tirzepatide, sold as Mounjaro and Zepbound, targets two. Retatrutide is a "triple agonist," acting on GLP-1, GIP and glucagon ^[1]. In an 80-week clinical trial, patients with severe obesity and heart disease who took the highest weekly doses lost an average of 22% of their body weight, or 55 pounds, according to Eli Lilly ^[1]. Lilly has not yet filed the drug with the FDA ^[1][2].

The gray market has grown anyway. A Reddit group devoted to retatrutide draws more than 179,000 visits each week and includes a "beginner's guide" to buying the drug, with dosing instructions and the advice to "find communities (not on Reddit)" and "vet vet vet" ^[1]. The Guardian described a man in his thirties in the Pacific Northwest, identified only as Henry, who began with Ozempic for hypertension, sleep apnea and body image concerns, then switched because of constipation and bought retatrutide from sellers in China. He told the paper he has lost 30 pounds, has not told his doctor, and has extra-sensitive skin, which the article describes as a common side effect of the drug ^[1].

No regulator has reviewed the products sold this way for identity, purity or sterility ^[1]. Dr. Caroline Messer, an endocrinologist in New York, said patients do not know how much of the drug a product contains or its purity ^[1]. In June, the Victoria state government in Australia reported six cases of acute liver toxicity among people who consumed a product labeled as retatrutide ^[1].

Lilly has gone beyond lawsuits. On Aug. 12 the company publicly demanded that credit card companies, payment processors, social media platforms, e-commerce sites and shipping firms block advertising and payment processing for vendors selling products marketed as retatrutide, alongside six new lawsuits ^[2]. Lilly says it has reported more than 14,000 listings across more than 100 countries and that patients have been hospitalized after using black-market product; that harm claim comes from the company, not from a regulator ^[2]. Two of the defendants named in the Guardian are Lone Star Peptide, a Texas company that markets the drug for "research use only," and Aesthetic Envy Cosmetic Centers, a med-spa in Sacramento, California. Lone Star Peptide declined to comment, and Aesthetic Envy did not respond to a request ^[1]. The lawsuits state that "illegal drugs made outside of a regulated, inspected supply chain are more likely to contain bacteria and other harmful contaminants and impurities" ^[1].

In August, Lilly said it would provide a limited number of patients access to the drug before FDA approval, Reuters reported ^[1]. Messer said the process is "just so unbelievably difficult" to qualify for that it could take years ^[1].

Why it matters for patients

Prescribed GLP-1 medicines reach patients through a chain that includes FDA review of the manufacturing, dosing instructions on a label, and a clinician who can check labs and vital signs. The retatrutide sold online sits outside all of that: no agency has verified what is in the vial, how much active drug it holds, or whether it is sterile ^[1].

That gap changes what a bad reaction looks like. A patient who injects an unknown amount of an unapproved peptide may not be able to tell a provider what was in it. Dr. David Shafer, a New York plastic surgeon who takes retatrutide and obtained it from a compounding pharmacy, said patients should disclose use to their provider anyway: "The doctors are not the police, and they are not going to turn you in for buying something online" ^[1].

Demand appears to be coming largely from people who have already tried approved drugs. Messer said she is asked about retatrutide about five times a day, mostly by patients who "have maxed out on Zepbound and still are not at their target weight." She said some who had plateaued on tirzepatide lost an additional 20 to 30 pounds on retatrutide. She also said she would recommend the drug "wholeheartedly — but not through the gray market" ^[1].

It is not known how many people in the US are buying retatrutide this way, what contaminants the products contain, or what the drug's long-term safety profile is, since it remains in trials ^[1].

What happens next

The six lawsuits and Lilly's push on payment processors and platforms are ongoing, and no rulings have been reported ^[1][2]. Lilly has not filed retatrutide with the FDA, and no approval date has been set ^[1][2]. Details of the limited early-access program announced in August, including how many patients it will cover, have not been disclosed ^[1]. Shafer argued that the FDA should move faster: "I don't think it's something that should take 10 years for them to do studies on" ^[1].