Lilly sues six sellers of unapproved retatrutide and asks payment firms to cut them off

No regulator anywhere in the world has approved a retatrutide product. Lilly aims its ask at card networks, payment processors and marketplaces, which could cut sellers off faster than six cases can, Business Model Analyst reported. The companies did not respond to requests for comment on Wednesday, CBS News said.

In a Phase 3 extension study, participants with an initial BMI of at least 35 lost an average of 30.3% of body weight after 104 weeks on the highest dose, Labroots reported.

Six cases, five of them in Texas

Five of the six defendants are in Texas. Four trade under a peptide name, one is a pharmacy and one is a med spa, Business Model Analyst reported.

Lilly filed in two states and four federal districts. It sued Astra Peptides and Texas Peptides in the Western District of Texas, Legendary Peptides in the Eastern District, and Striker Pharmacy and Lone Star Peptide in the Southern District. Aesthetic Envy, a California med spa, faces its case in the Northern District of California.

Four firms advertise the drug "for research use" without a prescription: Astra Peptides, Legendary Peptides, Texas Peptides and Lone Star Peptide, CBS News reported. The allegation is consistent across all six filings: the defendants sell products labelled research-use only while intending and marketing them for human consumption. Lilly's chief medical officer, David A. Hyman, said what is sold on the black market is not medicine. It is unverified, unapproved and not worth the risk, he said.

The ask behind the filings

The lawsuits are the smaller half of the announcement. Lilly titled its own release "Lilly calls on online platforms, payment companies and regulators to shut down the illegal retatrutide black market", with the litigation in the deck line underneath, Business Model Analyst noted.

Lilly said it has reported more than 14,000 websites, advertisements, social media posts and product listings to internet service providers, platforms and e-commerce companies across more than 100 countries. It has referred more than 200 individuals and entities to the FDA, the Department of Justice, state attorneys general, law enforcement and licensing boards. Some of those recipients kept amplifying the content anyway, the company said.

Business Model Analyst put the gap bluntly: payment rails can reach 14,000 listings in an afternoon while six lawsuits never will.

Max Denning, an associate vice president at Lilly, told CBS News that supply comes from "overseas manufacturers". "This is a global problem and it's an enormous one," he said. "Six lawsuits is not going to be the solution to everything, but it is a start."

Why sue over a drug Lilly cannot sell yet

Retatrutide is in Phase 3 trials for obesity, type 2 diabetes and related conditions. Lilly said the drug is "entirely unverified, unapproved and not worth the risk". In one study it led to average weight loss of 28.3% over 80 weeks in obese patients; in another, overweight or obese patients with diabetes lost an average of 20.8% over 80 weeks.

Lilly plans to submit the drug for FDA approval in the first quarter of 2027. Some analysts expect peak annual sales of up to $25 billion.

The filings describe two kinds of harm. In the case against Striker Pharmacy, Lilly says consumers are "switching from Lilly's FDA-approved medicines to illegal retatrutide products, citing purported lower costs and perceived superior efficacy". Bad reactions to those products, the company argues, would be tied to its own drug and would poison the market for retatrutide medicines. Against Aesthetic Envy, Lilly alleges the med spa advertises retatrutide without disclosing that it is unapproved by the FDA or any other regulator. Striker does not publicly list retatrutide as a product.

The tirzepatide playbook

Lilly has run this play before. Tirzepatide sat on the FDA shortage list for roughly two years, which made compounded copies legal under the supply-gap exemption.

In June 2024 Lilly sued six wellness centers and med spas, on top of more than two dozen it had already pursued. The FDA declared the shortage resolved in December 2024, removing the legal basis for mass compounding. In April 2025 the company sued Strive and Empower, then four telehealth companies including Mochi Health, Willow Health, Fella Health and Henry Meds, and sent about 50 cease and desist letters. Business Model Analyst's assessment is that Lilly won that fight on paper and the market did not shrink.

What happens next

Lone Star Peptide, Texas Peptides and Aesthetic Envy took down webpages advertising retatrutide, CBS News reported.

The FDA has said retatrutide cannot lawfully be compounded for consumer use. Until the submission, the drug stays investigational and is not available as an approved treatment. The next fixed date is the first quarter of 2027, when Lilly plans to file.