Is Bofanglutide legal in the United States?

In a phase 2b trial in 272 Chinese adults with type 2 diabetes it lowered glycated haemoglobin more than semaglutide 1 mg, and gastrointestinal side effects hit 82 to 87 percent of people on it against 52 percent on semaglutide. No phase 3 has reported.

Bofanglutide is a long-acting GLP-1 receptor agonist from Gan and Lee Pharmaceuticals in Beijing, developed under the code GZR18 and designed to be given once every two weeks rather than once a week. It is worth separating from the compound it is routinely confused with: HEC88473, a dual GLP-1 and FGF21 agonist from a different company, which this site covers on its own page.

Mechanism: A GLP-1 receptor agonist engineered for a long circulating half-life, measured at approximately seven days in healthy American and Chinese adults, which is what allows a once every two weeks schedule rather than the weekly schedule of semaglutide and dulaglutide. Receptor pharmacology is conventional for the class: activation of the GLP-1 receptor on pancreatic beta cells increases glucose-dependent insulin secretion, suppresses glucagon, slows gastric emptying and reduces food intake through central pathways.

Regulatory history: Not approved in the United States or anywhere else. Two phase 2b trials are published and two phase 3 trials are registered but not yet recruiting as of this review.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Bofanglutide at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.