Legal status · United Kingdom
Is RTB101 legal in the United Kingdom?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. RTB101 is not an approved medicine in the United Kingdom; its classification is "Not licensed". 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 the United Kingdom at a glance
| Classification | Not licensed |
|---|---|
| MHRA approval status | Not approved by MHRA |
| Human studies cited | 3 of 3 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the RTB101 profile, checked against Medicines and Healthcare products Regulatory Agency (MHRA) listings at the reviewed date.
What this means
- 01
No product containing RTB101 is approved by MHRA for any use in the United Kingdom, 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 the United Kingdom. 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 MHRA treats this kind of product
Licenses medicines for the UK market. A compound without a marketing authorisation is an unlicensed medicine, which can only lawfully be supplied for human use through a prescriber under the specials scheme, not sold as a research product.
The classification above is the The Longevity Archive reading of Medicines and Healthcare products Regulatory Agency 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 the United Kingdom?
No. RTB101 is not an approved medicine in the United Kingdom; its classification is "Not licensed". 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 the United Kingdom?
No approved product exists to buy. In the United Kingdom RTB101 is classified as "Not licensed", 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 MHRA approved?
No. In the United Kingdom RTB101 is classified as "Not licensed", which is not a MHRA 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 the United Kingdom
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 the United Kingdom, current as of Sep 2026. It is not legal advice, and classifications change; check Medicines and Healthcare products Regulatory Agency 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.