A regulator recognises ageing itself as a condition a drug can be approved to treat
Drugs are approved for diseases, and ageing is not one on any regulator's list; so a drug that slowed ageing itself would have no label to carry it, and every drug on this tree is being tested instead against one disease of age at a time. In 2015 the designers of the TAME metformin trial met the United States regulator and came away saying it would accept a trial whose main measure was the time to any of several age-related diseases together, which is as close as a regulator has come to treating ageing as an indication. The trial has not run. Nothing has been written into any regulator's rules, and no drug has been approved for ageing anywhere.
What would count
A regulator approves a drug with ageing, or the delay of age-related disease in general, as its indication, in the regulator's own record; that is the clinic rung. The first-human rung is a registered, running trial whose main measure is time to age-related disease in general, or a measure of ageing itself, run with a regulator's written agreement. There is no animal rung for a regulatory act, and the idea-only rung means neither has happened.
Who settles it: The regulator's own approval record or written agreement; the trial registry entry of the running trial.
Where it stands
Idea only. Not yet shown to work in any living animal, so there is no record to point at. Next rung within 5 to 20 years.
When it reaches the clinic: the project's estimate
This is the one thing on this page that is a judgment rather than a record. The project's estimate of the year it reaches the clinic is 2045, no earlier than 2034 and no later than 2100; the model draws from that range every run, with the likely year the most probable draw. Set 16 October 2026, a first pass awaiting an outside review.
| Rung | No earlier than | Most likely | No later than | |
|---|---|---|---|---|
| First human | 2027 | 2029 | 2045 | |
| In clinical use | 2034 | 2045 | 2100 | feeds the year at the top |
Why. The first-human rung needs a trial such as TAME to run, which is a funding question with a likely answer of 2029 and a real chance of never; the clinic rung, an approval with ageing on the label, needs that trial or a successor to read out positive and a regulator to accept the indication, likely in the mid 2040s. The earliest assumes the trial starts next year and reads out positive on schedule with a label to match; the latest says it may not happen this century.
Changes to this record
None since it was written on 16 October 2026. Every change to the stage or the estimate lands here with its date, the old value, the new one and the reason, and a change to the estimate never happens because a number looked wrong: it needs a dated reason and a source.
The last readings
- 17 October 2026 Quiet
Nothing in the window: no regulator has approved a drug with ageing as its indication, and the TAME metformin trial has not started. Trade reports of 2026-09-26 (Technology Org and Innovita Research, titled 'TAME: the aging trial that never enrolled a patient') say the trial is still awaiting funding with no one enrolled, which is the same September 2026 coverage the record's verify list already rests on and which still could not be opened; a few consumer pages claiming enrolment is complete or on schedule were again judged unreliable. Coverage of the ARDD 2026 meeting (about 2026-10-03, before the window) says the United States regulator will name ageing and longevity among the topics of a forthcoming regulatory-science focus-areas document, which is a stated intention and not a rule, an approval or a written agreement.source 1, source 2, source 3, source 4
What the story so far says about it
On the record
- October 2019TAME: A Genuinely Good Use of 75 Million Dollars
Notes
The metformin leaf on the energy branch is the same trial seen from the drug's side; this leaf is the rule change, which would carry every other drug. The two measuring-branch regulatory leaves are kept separate because a regulator could accept a marker (the other leaf) and still require a disease on the label, or the reverse.
Not yet verified
These facts in the record were written from memory or from a secondary source and have not yet been checked against the paper, the regulator's record or the registry. Nothing here is presented as settled until it is cleared, by checking it and either deleting the line or correcting the record.
- The papers on TAME's design (Justice and colleagues 2018) say the United States regulator was consulted and favoured an outcome based on disease, but give no date and no promise to accept time to any of several age-related diseases; the 2015 meeting and that acceptance rest on trade coverage and a 2015 Science news feature (Hall) that was not opened, and should be checked.
- That the TAME trial had enrolled no one as of mid-2026 is from September 2026 trade reports (not opened) and is consistent with there being no ClinicalTrials.gov registration found on 2026-10-17; AFAR's own status page was not found, and web pages saying enrolment was complete were judged unreliable.
- The World Health Organization's 2022 disease classification dropped the title 'old age' (code MG2A, now titled 'ageing-associated decline in intrinsic capacity') and carries an extension code XT9T 'ageing-related'; this is from a peer-reviewed review (PMC10894070) and not yet from the organization's own browser, and the record's earlier wording of 'added an extension code' should be reworded once checked. A classification code is not a regulator's indication and does not meet the test.