Phase 2 SIR2501 SARM1 inhibitor aims to prevent paclitaxel-induced peripheral neuropathy.

This Phase 2, open-label, sequential-cohort study evaluates SIR2501 in adults with solid tumors who are scheduled to receive paclitaxel-based chemotherapy, with primary goals of characterizing safety, tolerability, and pharmacokinetics and exploring signals of benefit on chemotherapy-induced peripheral neuropathy (CIPN). SIR2501 is a small-molecule inhibitor of SARM1 (sterile alpha and TIR motif-containing protein 1), an axon-degeneration driver implicated in multiple preclinical neuropathy models, positioning this as a mechanism-based neuroprotection approach rather than symptomatic management. Sironax USA, Inc. sponsors dose cohorts (30 mg, 45 mg, 60 mg) to support dose selection for further development. The commercial/scientific angle is that CIPN remains a major dose-limiting toxicity for taxanes and often persists after treatment, yet care today is largely preventive counseling plus chemotherapy dose modifications when neuropathy emerges, with limited proven drug options to prevent onset. Sironax has also publicly noted FDA Fast Track designation for SIR2501 in CIPN, underscoring unmet need and potential regulatory momentum.