Is Clusterin legal in the United States?

An exercise-induced plasma protein that reduced brain inflammation in aged and Alzheimer-model mice, and is higher in people who exercise. The only human interventional clusterin trials lowered it, for cancer, and one was terminated.

A 2021 Nature paper collected plasma from voluntarily running mice and infused it into sedentary mice, which reduced baseline neuroinflammatory gene expression and experimentally induced brain inflammation. Proteomic analysis found a coordinated increase in complement cascade inhibitors, clusterin among them.

Mechanism: In mice, intravenously injected clusterin binds brain endothelial cells and reduces neuroinflammatory gene expression, in both an acute brain inflammation model and an Alzheimer model. The broader context in the same paper is a coordinated rise in complement cascade inhibitors in the plasma of exercising animals, which fits clusterin's long-established role as a complement lysis inhibitor and extracellular chaperone.

Regulatory history: Clusterin has never been administered to a human as a therapy and is not approved anywhere. The only clusterin-directed agent to reach human trials is custirsen, which lowers clusterin, was developed in oncology, and is not approved.

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 Clusterin 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.