This market asks whether the U.S. Food and Drug Administration will publicly accept a functionally aging-focused clinical endpoint as sufficient to establish efficacy in a pivotal or approval-supporting human study.

## Resolution

This market resolves YES if, before January 1, 2036, the FDA publicly documents that an endpoint based on delaying multiple distinct age-related clinical outcomes is acceptable as a primary or co-primary efficacy endpoint in a pivotal or approval-supporting study.

The endpoint must include at least three distinct outcome categories from the following:

- mortality;

- cardiovascular events;

- cancer;

- dementia or clinically meaningful cognitive decline;

- major mobility impairment;

- frailty or loss of physical function;

- another separately diagnosed age-related disease or clinically meaningful functional decline.

At least one qualifying public document must describe the endpoint or development program as measuring or testing an intervention against aging, biological aging, geroscience, multimorbidity, healthspan, age-related decline, or a substantially equivalent concept.

Qualifying evidence includes:

- final or draft FDA guidance;

- an FDA biomarker or clinical-outcome-assessment qualification decision;

- an FDA approval package;

- official FDA meeting minutes publicly released by a sponsor;

- an FDA special protocol assessment publicly released in sufficient detail;

- another formal FDA document explicitly accepting the endpoint for a pivotal or approval-supporting study.

The endpoint need not be called “aging.” A composite clinical endpoint designed to measure delayed age-related multimorbidity or preserved multi-domain function can qualify.

## Non-qualifying events

The following do not by themselves qualify:

- FDA allowing an early-stage IND or Phase I/II study to proceed;

- registration of a trial on ClinicalTrials.gov;

- use of the endpoint only as an exploratory or secondary outcome;

- use of an aging biomarker only for participant selection, risk prediction, target engagement, or pharmacodynamic response;

- approval for one named disease merely because the treatment targets a biological mechanism associated with aging;

- statements by NIH, NIA, HHS, Congress, WHO, EMA, or a company that are not accompanied by qualifying FDA evidence.

## Resolution sources

Primary sources should be used whenever available:

- FDA.gov;

- Drugs@FDA and FDA approval packages;

- FDA Drug Development Tool qualification decisions;

- FDA guidance documents;

- official sponsor publications reproducing or linking to FDA correspondence or meeting minutes.

If the evidence is incomplete or disputed at the market close, the market should remain unresolved until the relevant FDA record becomes sufficiently clear. If no qualifying event occurred before January 1, 2036, resolve NO.