Biotech companies do not need regulators to recognize aging itself as a disease to gain drug approvals. According to Alex Zhavoronkov, a viable regulatory path involves conducting traditional clinical trials for specific diseases while using secondary biomarker outcome measures, such as proteomic aging clocks, to evaluate and validate a drug's gerotherapeutic longevity benefits.
While epigenetic methylation clocks accurately predict chronological age, clinical trials face strict data collection constraints tied to target monitoring and investigator buy-in. Zhavoronkov points out that proteomic data is routinely collected and highly accepted in trials, making it the most viable, actionable data type for deploying aging clocks and tracking biological age reversal.
Major pharmaceutical companies are entering the longevity sector not through dedicated anti-aging discovery programs, but by measuring biological aging biomarkers in existing metabolic programs. Unreleased trial data from Eli Lilly and Novo Nordisk demonstrated that approved GLP-1 drugs, such as semaglutide and tirzepatide, reversed biological age by three to four years on epigenetic and proteomic clocks.
Rather than targeting aging in isolation, Insilico prioritizes therapeutic targets that simultaneously influence both aging processes and specific diseases. For their lead IPF program, target TNIK was identified because it modulates fibrosis while displaying anti-senescence effects, creating 'dual-purpose therapeutics' that can treat indication-specific pathology and reverse broader biological age.
Western drug discovery companies face their primary competition not from fellow AI startups, but from highly efficient traditional Chinese biopharma companies. To remain competitive and learn local performance standards, companies must build physical infrastructure and establish significant operational footprints directly in China.