Legal status · Australia
Is Nemifitide legal in Australia?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Nemifitide 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, 5 human studies are cited on its profile.
Nemifitide in Australia at a glance
| Classification | Investigational, not registered |
|---|---|
| TGA approval status | Not approved by TGA; investigational |
| Human studies cited | 5 of 6 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Nemifitide profile, checked against Therapeutic Goods Administration (TGA) listings at the reviewed date.
What this means
- 01
Nemifitide 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 Nemifitide is
A pentapeptide antidepressant injected daily for 5 to 10 days, tested in three small placebo controlled trials (52, 55 and 81 people) between 2000 and 2006 whose positive findings rest on post hoc plasma level groupings, a single post-treatment timepoint and a severity subgroup. No confirmatory trial was published and development stopped.
Nemifitide is a synthetic five amino acid peptide, a modified analogue of melanocyte inhibiting factor (MIF-1), developed by Innapharma as a rapid acting antidepressant given by subcutaneous injection in short courses. It was called INN 00835 in early papers and briefly netamiftide.
Mechanism: In people, the only mechanistic measurement is a 1999 study reporting a change in platelet serotonin uptake in treated patients, and the pharmacokinetics: rapid absorption, a half-life of 15 to 30 minutes, dose proportional exposure and no accumulation over five daily doses. How a peptide that is gone from the blood within an hour would produce a mood effect lasting weeks was never established.
Regulatory history: Not FDA approved. Development ceased after phase 2; no trial registered on ClinicalTrials.gov; no regulatory submission located.
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 Nemifitide 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.
Nemifitide in other countries
Frequently asked questions
Is Nemifitide legal in Australia?
No. Nemifitide 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, 5 human studies are cited on its profile.
Can I buy Nemifitide in Australia?
No approved product exists to buy. In Australia Nemifitide 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 Nemifitide TGA approved?
No. In Australia Nemifitide is classified as "Investigational, not registered", which is not a TGA marketing approval. For comparison, the US FDA status is: Not FDA approved. Development ceased after phase 2; no trial registered on ClinicalTrials.gov; no regulatory submission located.. On the evidence, 5 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 Nemifitide live on its compound profile.
Nemifitide profileThis page is general information about the regulatory status of Nemifitide 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.