Is Halofuginone legal in the United States?

Extended male mouse median lifespan by 8.8 percent in the 2021 Interventions Testing Program cohort, one of the larger single-cohort male effects the programme has reported, with no effect in females. In people it has only ever been given in a 24-patient oncology phase 1 where nausea limited dosing, small topical studies, and a Duchenne programme that was terminated.

Halofuginone is a synthetic derivative of febrifugine, the active alkaloid of the Chinese herb Dichroa febrifuga. It is used as a veterinary antiprotozoal, and in the 2000s it was developed as an oral anti-fibrotic and anti-angiogenic cancer drug under the name tempostatin, then as HT-100 for Duchenne muscular dystrophy.

Mechanism: Halofuginone binds glutamyl-prolyl-tRNA synthetase and inhibits its prolyl-tRNA synthetase activity, which is reversed by adding proline. That triggers the amino acid starvation response, an arm of the integrated stress response, and in mouse and human T cells in culture it selectively blocks Th17 differentiation.

Regulatory history: Not approved for human use. No halofuginone product appears in the FDA approved drugs database. Oral (tempostatin) and Duchenne (HT-100) programmes did not reach approval; the Duchenne trials are recorded as terminated. Used as a veterinary antiprotozoal. The lifespan result is in male mice.

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 Halofuginone 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.