The growing evidence that existing cardio-renal-metabolic therapies, such as GLP-1 receptor agonists and SGLT2 inhibitors, confer all-cause mortality benefits has positioned them as the first wave of potential gerotherapeutics. However, repurposing these drugs for a lifespan extension indication remains constrained by trial duration, misaligned incentives, and the lack of a viable regulatory path. We highlight two parallel strategies to address these barriers: (1) identifying and validating precise surrogate endpoints, and (2) modifying the 505(b)(2) pathway to allow accelerated approval of already-approved drugs with demonstrated mortality benefit and favorable post-marketing safety. Veterinary medicine's expanded conditional approval framework already applies these strategies, offering precedent for human gerotherapeutics development.
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Peloquin et al. (2026) studied this question.
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