Legal status · Australia
Is Halofuginone legal in Australia?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Halofuginone is not approved for any medical use in Australia; its classification is "Investigational, not registered". 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 Australia at a glance
| Classification | Investigational, not registered |
|---|---|
| TGA approval status | Not approved by TGA; investigational |
| Human studies cited | 4 of 8 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Halofuginone profile, checked against Therapeutic Goods Administration (TGA) listings at the reviewed date.
What this means
- 01
Halofuginone is being studied in registered clinical trials but has not received TGA marketing approval in Australia.
- 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 TGA treats this kind of product
Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.
The classification above is the The Longevity Archive reading of Therapeutic Goods 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.
Halofuginone in other countries
Frequently asked questions
Is Halofuginone legal in Australia?
No. Halofuginone is not approved for any medical use in Australia; its classification is "Investigational, not registered". 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 Australia?
No approved product exists to buy. In Australia Halofuginone is classified as "Investigational, not registered", 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 TGA approved?
No. In Australia Halofuginone is classified as "Investigational, not registered", which is not a TGA 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 Australia
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Halofuginone live on its compound profile.
Halofuginone profileThis page is general information about the regulatory status of Halofuginone in Australia, current as of Sep 2026. It is not legal advice, and classifications change; check Therapeutic Goods Administration 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.