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Legal status · Canada

Is Halofuginone legal in Canada?

Written by Reviewed Sep 2026

Not approvedLongevityHuman studies cited: 4

Direct answer

No. Halofuginone is not approved for any medical use in Canada; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 4 human studies are cited on its profile.

Halofuginone in Canada at a glance

ClassificationInvestigational, not approved
Health Canada approval statusNot approved by Health Canada; investigational
Human studies cited4 of 8 citations on the profile
ReviewedSep 2026

Classification and note come from the Halofuginone profile, checked against Health Canada, Health Products and Food Branch (Health Canada) listings at the reviewed date.

What this means

  • 01

    Halofuginone is being studied in registered clinical trials but has not received Health Canada marketing approval in Canada.

  • 02

    Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.

  • 03

    Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.

What Halofuginone is

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.

How Health Canada treats this kind of product

Authorises drugs for sale through a Notice of Compliance and Drug Identification Number. A compound that is not authorised for sale cannot lawfully be sold for human use, and personal importation of prescription drugs is limited.

The classification above is the The Longevity Archive reading of Health Canada, Health Products and Food Branch 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.

Halofuginone in other countries

Frequently asked questions

Is Halofuginone legal in Canada?

No. Halofuginone is not approved for any medical use in Canada; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 4 human studies are cited on its profile.

Can I buy Halofuginone in Canada?

No approved product exists to buy. In Canada Halofuginone is classified as "Investigational, not approved", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors.

Is Halofuginone Health Canada approved?

No. In Canada Halofuginone is classified as "Investigational, not approved", which is not a Health Canada marketing approval. For comparison, the US FDA status is: 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.. On the evidence, 4 human studies are cited on its profile.

Related compounds in Canada

Full research profile

Mechanism, cited studies, FDA status and the full legal summary for Halofuginone live on its compound profile.

Halofuginone profile

This page is general information about the regulatory status of Halofuginone in Canada, current as of Sep 2026. It is not legal advice, and classifications change; check Health Canada, Health Products and Food Branch directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.