US border seizures of GLP-1 knockoffs surge as the drugmaker presses platforms to cut sellers off
Eli Lilly has sued six US companies it accuses of selling unapproved copies of its experimental obesity drug retatrutide, moving against the sellers well before the medicine has any path to market.
The drugmaker said on Wednesday the suits target compounding pharmacies, medical spas, and online vendors that marketed the drug to consumers while it remains in late-stage clinical trials, according to Reuters.
Retatrutide is still in Phase 3 testing for obesity, type 2 diabetes, and related conditions, and no regulator anywhere has approved it for human use.
The once-weekly injection acts on three hormone receptors, GLP-1, GIP, and glucagon, and Lilly is expected to send retatrutide to US regulators early next year, with a Food and Drug Administration decision anticipated in 2027 or early 2028.
The compound produced up to 29 percent weight loss in a Phase 3 trial, according to reporting by Fierce Pharma.
What is being sold on the black market "is not a medicine," Lilly chief medical officer David Hyman said in a statement, describing the products as "entirely unverified, unapproved and not worth the risk."
Lilly said it has referred more than 200 individuals and entities to the FDA, the US Department of Justice, state attorneys general, law enforcement, and professional licensing boards, and has flagged more than 14,000 websites, advertisements, and product listings across over 100 countries.
The company also called on social media and e-commerce platforms, payment processors, credit card firms, shipping companies, and regulators to cut off the sellers.
Enforcement data underscores the scale of the trade.
US Customs and Border Protection told Reuters it intercepted more than 690 shipments, totalling over 31,000 units, of illicit GLP-1 drugs in fiscal 2025, with July figures more than doubling to over 1,400 seizures and nearly 90,000 vials.
Every time someone takes one of the products, said Lilly's Max Denning, they are "exposing themselves to a huge amount of risk."
The defendants are Aesthetic Envy Cosmetic Centers in California, along with Astra, Legendary Peptides, Striker Pharmacy, Texas Peptides, and Lone Star Peptide in Texas.
Four of the firms advertised the product for research use without a prescription, while Aesthetic Envy is a med spa that promoted it and Striker Pharmacy made a version, CBS News reported.
In its complaint against Striker, Lilly argued that bad reactions to knockoffs would end up "poisoning the well for the future of retatrutide medicines."
None of the six has answered the allegations in court, and a complaint is an accusation rather than a finding.
Legendary Peptides had no immediate comment and the other five did not immediately respond to requests for comment, BioPharma Dive reported, while CBS News noted that Lone Star Peptide, Texas Peptides, and Aesthetic Envy took down webpages advertising the drug.
The action follows a pattern of litigation across the weight-loss market.
Novo Nordisk sued telehealth firm Hims & Hers in February over compounded copies of its Wegovy franchise, seeking a permanent ban and damages, per CNBC.
Hims countered that the suit was a "blatant attack" and accused the drugmaker of "weaponizing the US judicial system to limit consumer choice."
Lilly itself sued eight companies across five states in 2023 over compounded versions of Mounjaro, then filed against six more for false advertising, Fierce Pharma reported.
The suits sit entirely in US federal courts and lean on US regulators, but the underlying product is off-limits in Canada as well, where no retatrutide medicine is authorized either.
Health Canada warned in January against fake and unauthorized GLP-1 drugs, said it had already found retailers selling them in stores and online, and confirmed it was working with the Canada Border Services Agency to block unauthorized shipments, CBC News reported.
Only specific versions are authorized in Canada: semaglutide as Ozempic and Wegovy injections and Rybelsus tablets, and tirzepatide as Mounjaro and Zepbound injections, all by prescription for type 2 diabetes and obesity.
