Legal status · Australia
Is RTB101 legal in Australia?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. RTB101 is not an approved medicine in Australia; its classification is "Not approved". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. On the evidence, 3 human studies are cited on its profile.
RTB101 in Australia at a glance
| Classification | Not approved |
|---|---|
| TGA approval status | Not approved by TGA |
| Human studies cited | 3 of 3 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the RTB101 profile, checked against Therapeutic Goods Administration (TGA) listings at the reviewed date.
What this means
- 01
No product containing RTB101 is approved by TGA for any use in Australia, so nothing on the market is authorized for people.
- 02
"Research use only" is a vendor label, not a legal category that permits human use. It does not exempt a product from medicines law.
- 03
Importing, supplying or promoting it for human use can fall under medicines legislation in Australia. This page is general information, not legal advice.
What RTB101 is
The most important failed trial in geroscience. Positive in phase 2a and 2b, then nothing in a 1,024-person phase 3, while the biomarker it targeted still moved in both.
If you read one page on this site about why biomarkers are not results, it should be this one. RTB101 was the drug that carried the mTOR longevity hypothesis into definitive human testing.
Mechanism: A low-dose inhibitor of TORC1. At the higher doses originally developed for oncology, dactolisib is a dual inhibitor of phosphoinositide 3-kinase and mTOR.
Regulatory history: Never approved. The phase 3 programme did not meet its endpoint and development for this indication did not continue.
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 RTB101 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.
RTB101 in other countries
Frequently asked questions
Is RTB101 legal in Australia?
No. RTB101 is not an approved medicine in Australia; its classification is "Not approved". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. On the evidence, 3 human studies are cited on its profile.
Can I buy RTB101 in Australia?
No approved product exists to buy. In Australia RTB101 is classified as "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 RTB101 TGA approved?
No. In Australia RTB101 is classified as "Not approved", which is not a TGA marketing approval. For comparison, the US FDA status is: Never approved. The phase 3 programme did not meet its endpoint and development for this indication did not continue.. On the evidence, 3 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 RTB101 live on its compound profile.
RTB101 profileThis page is general information about the regulatory status of RTB101 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.