Is PEG-loxenatide legal in the United States?

Approved in China in 2019, based on two large studies with a dummy-shot group, one of 361 patients and one of about 360. It lowered average blood sugar (HbA1c) by about 1.0 to 1.3 points. Its effect on weight in those studies was small. The big weight numbers come from later single-hospital studies using doses well above the approved ones.

PEG-loxenatide, usually called PEX168 in study papers, is a changed version of exenatide with a PEG chain attached. PEG is a long chemical chain that slows how fast the body clears a drug.

How it works: It is a changed version of exenatide, a lizard hormone that works on the same switch as the gut hormone GLP-1. A PEG chain is attached at one set spot.

Approval history: Not approved in the United States. Approved in China in 2019 for type 2 diabetes, and widely used there. We found no application to any Western regulator.

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for PEG-loxenatide on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.

Check FDA directly

Whether PEG-loxenatide is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up PEG-loxenatide by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.

• WADA Prohibited List
• Global DRO (check a named product)
• USADA (US athletes)
• Operation Supplement Safety (US service members)

The rules you compete or serve under decide this, not this page.