Legal status · United States
Is RTB101 legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. RTB101 is not an approved medicine in the United States. Its legal category is "Not approved; research use only". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile.
- People given it
- 1,024
- Found nothing
- 0
Legal category
Not approved; research use only
The final-stage study missed its main goal. Not approved and not available. The company behind it, resTORbio, did not bring it to market.
Reviewed Sep 2026. This is a legal category, not legal advice.
A "research use only" label on a vial does not make it legal to use on people.
RTB101 in the United States at a glance
| Legal category | Not approved; research use only |
|---|---|
| Note | The final-stage study missed its main goal. Not approved and not available. The company behind it, resTORbio, did not bring it to market. |
| FDA approval status | Never approved. The final-stage studies missed their main goal, and work on it for this use stopped. |
| Studies in people | 3 of 3 sources on the profile |
| Reviewed | Sep 2026 |
The legal category and note come from the RTB101 profile. We checked them against U.S. Food and Drug Administration (FDA) listings on the reviewed date.
What this means
- 01
No product containing RTB101 is approved by FDA for any use in the United States. So nothing on sale is allowed for use in people.
- 02
"Research use only" is a label sellers put on. It is not a legal category that allows use in people, and it does not get a product out of medicines law.
- 03
Importing it, supplying it or promoting it for use in people can fall under medicines law in the United States. This page is general information, not legal advice.
What RTB101 is
The most important failed trial in ageing research. It looked good in two mid-stage trials, then did nothing in a 1,024 person final-stage trial. The lab marker it targeted still moved in both of the later trials.
If you read one page on this site about why a moving lab marker is not a result, make it this one. RTB101 was the drug that carried the mTOR longevity idea into a final test in people.
How it works: It blocks TORC1 at a low dose. At the higher doses first developed for cancer, dactolisib blocks two things, an enzyme called PI3K and mTOR.
Approval history: Never approved. The final-stage studies missed their main goal, and work on it for this use stopped.
How FDA treats this kind of product
Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.
The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for RTB101 on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.
RTB101 in sport and the military
Whether RTB101 is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up RTB101 by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
RTB101 in other countries
Frequently asked questions
Is RTB101 legal in the United States?
No. RTB101 is not an approved medicine in the United States. Its legal category is "Not approved; research use only". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile. Note: The final-stage study missed its main goal. Not approved and not available. The company behind it, resTORbio, did not bring it to market.
Can I buy RTB101 in the United States?
There is no approved product to buy. In the United States, RTB101 has the legal category "Not approved; research use only". So no licensed pharmacy product exists. Sellers who list it "for research use only" are not selling it for use in people, and that label does not change its legal status. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything. Note: The final-stage study missed its main goal. Not approved and not available. The company behind it, resTORbio, did not bring it to market.
Is RTB101 FDA approved?
No. FDA status: Never approved. The final-stage studies missed their main goal, and work on it for this use stopped.. Current US legal category: "Not approved; research use only". On the evidence, 1 completed human trial is cited on its profile.
Related compounds in the United States
Full research profile
How RTB101 works, the studies we cite, FDA status and the full legal summary are all on its compound profile.
RTB101 profileThis page is general information about the legal status of RTB101 in the United States, current as of Sep 2026. It is not legal advice. Legal status changes. For your own situation, check with U.S. Food and Drug Administration or ask a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.