Will at least one aging clock be accepted by a regulator as a surrogate endpoint?
Chance it happens
60%Belief the predicted event happens at all — every “yes / by-a-date” outcome added together. “Other” is tracked as its own third slice.
Outcomes
Resolution criteria
A regulator (FDA or EMA) accepts at least one aging clock as a surrogate endpoint in a drug approval or in a formal surrogate-endpoint qualification. Resolution horizon: 2032-12-31. Source: FDA, EMA.
Description
A higher bar than qualification as a drug-development tool (Q28) or biomarker qualification (Q30).
Evidence & context
Trials, publications and reports our research found on this prognosis. Each links to the original source.
This is a scientific publication describing and validating DunedinPACE, a DNA methylation-based aging clock/biomarker. It bears on the prediction because regulator acceptance of an aging clock as a surrogate endpoint would likely depend on evidence of this kind establishing analytical validity and links to aging-related outcomes.
This is a policy publication arguing for new incentives, validation efforts, and a streamlined FDA pathway for biomarkers and surrogate endpoints related to aging. It bears on the prognosis because it implies such regulatory acceptance does not yet exist and outlines concrete steps advocates think are needed to achieve it.
This is a scientific publication describing DunedinPACE, a DNA methylation-based aging clock/biomarker. It bears on the prognosis because regulatory acceptance of an aging clock as a surrogate endpoint would likely depend in part on the maturation, validation, and clinical credibility of biomarkers like this one, even though the paper itself is not a regulatory acceptance document.
This appears to be a PMC-hosted scientific publication discussing whether changes in an epigenetic aging clock could serve as a surrogate endpoint or comparable biomarker for intervention effects. That is directly relevant to the forecast because it bears on the scientific and translational case regulators would need before FDA or EMA acceptance, even though it is not itself a regulatory decision.