SIR2501 / Sironax - LARVOL DELTA

Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Sironax USA, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel (clinicaltrials.gov) - P2 | N=18 | Not yet recruiting | Sponsor: Sironax USA, Inc.

New P2 trial • Oncology • Solid Tumor

SARM1 inhibition to prevent chemotherapy-induced peripheral neuropathy: Translational and early clinical evaluation of SIR2501. (ASCO 2026) - " SIR2501 was evaluated in rodent models of paclitaxel (PTX)-induced peripheral neuropathy using prophylactic and therapeutic dosing paradigms. These translational data support SARM1 inhibition as a disease-modifying approach for CIPN. These data have enabled initiation of a global Phase 1b/2 trial of SIR2501 in patients receiving taxane-based chemotherapy in the United States, Australia, and China."

Clinical • Pain • NEFL

Sironax’s SARM1 Inhibitor SIR2501 Granted FDA Fast Track Designation in Chemotherapy-induced Peripheral Neuropathy (CIPN) (GlobeNewswire)

Fast track • Pain

SIR2501-ALS-CIPN: A study of SIR2501 in participants with amyotrophic lateral sclerosis and in participants receiving paclitaxel chemotherapy to evaluate safety and to prevent chemotherapy-induced peripheral neuropathy (ANZCTR) - P1/2 | N=88 | Recruiting | Sponsor: Sironax, Ltd

New P1/2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders • Oncology • Pain • Solid Tumor

Dose-dependent and robust target engagement of a novel brain penetrant SARM1 inhibitor (SIR2501) in healthy adult participants (Neuroscience 2025) - "SIR2501 demonstrated dose-dependent and robust target engagement ex vivo in stimulated PBMCs, indicating it is a potent inhibitor of SARM1 and suggesting its therapeutic potential to modulate SARM1 NADase activity in humans to protect against axonal degeneration. These findings support the further evaluation of SIR2501 in clinical development, including the treatment of ALS, and prevention or lessening the severity of CIPN."

Clinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Vascular Neurology

Phase 1 Study to Investigate SIR2501 in Healthy Adult Participants (ANZCTR) - P1 | N=112 | Completed | Sponsor: Sironax Australia Pty Ltd | Recruiting ➔ Completed

Trial completion • CNS Disorders

Company Milestones: Vitalon Announces Completion of Phase I Clinical Trial of SIR2501 [Google translation] (bydrug.pharmcube.com) - "Recently, SIR2501, a candidate drug for neurological diseases independently developed by Vitallon...successfully completed the Phase I clinical trial in healthy subjects. The trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SIR2501 in healthy subjects....The Vitalon team is excited about the results of the Phase I trial of SIR2501..."

Trial completion • CNS Disorders

Phase 1 Study to Investigate SIR2501 in Healthy Adult Participants (ANZCTR) - P1 | N=112 | Recruiting | Sponsor: Sironax Australia Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: May 2024

Enrollment open • Trial initiation date • CNS Disorders

Phase 1 Study to Investigate SIR2501 in Healthy Adult Participants (ANZCTR) - P1 | N=112 | Not yet recruiting | Sponsor: Sironax Australia Pty Ltd

New P1 trial • CNS Disorders