AAV-FGF21 Gene Therapy Extends Healthspan 20.5% in Geriatric Mice via Multi-Organ Effects
Single-dose AAV-FGF21 gene therapy delivered to skeletal muscle produced durable, multi-organ healthspan benefits and a 20.5% life-expectancy increase in already aged mice. The work moves FGF21 from metabolic-disease reversal into systemic aging biology but remains preclinical. Next required studies are primate durability and chronic safety before any human aging trial.
Key gaps remain before human translation. Vector biodistribution, immunogenicity after decades, and off-target oncogenic risk were not fully quantified in aged mice. No non-human primate longevity data exist, and the 20.54% survival gain must be replicated under Good Laboratory Practice conditions. Regulatory precedent cited for MASH may accelerate IND filing, yet FDA reviewers will require chronic toxicology studies in two species before any aging indication trial can open.
Bosch group or licensee will file IND for FGF21 gene therapy in metabolic aging within 48 months if GLP primate durability data meet FDA toxicology thresholds.
Sources (3)
- [1]Primary Source(https://www.cell.com/molecular-therapy/fulltext/S1525-0016(26)00345-6)
- [2]Supporting Source(https://www.nature.com/articles/s41591-019-0457-1)
- [3]Supporting Source(https://www.nejm.org/doi/10.1056/NEJMoa2114833)