CIPN is a common nerve-damaging side effect of chemotherapy with no FDA-approved treatment options
Fast Track designation reflects the significant unmet need and enables potential accelerated drug development
WALTHAM, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Sironax, a global clinical-stage biotechnology company developing transformative therapies for neurodegenerative, inflammatory and immunologic, metabolic, and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has designated its SARM1 inhibitor SIR2501 as a Fast Track product for chemotherapy-induced peripheral neuropathy (CIPN). SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in a broad range of neurological diseases.
The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions, fill unmet medical needs, and bring promising therapies to patients more quickly. Drugs granted this designation are eligible for more frequent interactions with the agency regarding development plans, a rolling NDA/BLA review, and potential priority review and accelerated approval.
"Fast Track designation for SIR2501 in CIPN is a meaningful recognition of the urgent unmet medical need and the potential of our entire SARM1 program," said Dr. Shefali Agarwal, Sironax President and CEO. "The FDA's designation not only validates our approach in CIPN, but also the broader potential of SARM1 inhibition to address additional neurological diseases. We are inspired to advance this potential therapy for millions of patients around the world."
CIPN is a common nerve-damaging side effect of chemotherapy that affects the hands and feet. Symptoms include burning or shooting pain, loss of temperature and tactile sensation, muscle weakness, and impaired fine motor skills. A significant number of cancer patients receive high-risk chemotherapy (e.g., taxanes, platinum, vinca alkaloids), develop CIPN, and subsequently discontinue or reduce chemo regimen due to the disease.
"For too long, millions of cancer patients have found themselves in the difficult position of experiencing painful symptoms while receiving their cancer treatment," said Dr. Robert Coleman, Gynecologic Oncologist, Texas Oncology, and Chief Medical Officer of Vaniam Group; and one of the country's preeminent gynecologic oncologists. "Unfortunately, the severity of these symptoms has led many patients to either curtail or completely stop their treatment regimens. I'm pleased that a potential treatment for CIPN is advancing that could at last address this condition."
About SIR2501
SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in diseases such as CIPN and amyotrophic lateral sclerosis (ALS). By binding SARM1 away from its active site and maintaining the enzyme in an inactive state, SIR2501 is designed to protect nerves and prevent degeneration, while avoiding potential adverse effects observed with orthosteric inhibitors. SIR2501 has demonstrated strong neuroprotective effects in multiple preclinical models, and global Phase 1b/2 clinical trials evaluating SIR2501 in patients with CIPN and ALS are ongoing.
About Sironax
Sironax is a clinical-stage biotechnology company developing transformative therapies for neurodegenerative, inflammatory and immunologic, metabolic, and rare diseases. Founded in 2017, the company has built a diverse pipeline of programs by targeting contributors of aging, degeneration, metabolic dysfunction, and inflammation. Sironax is conducting clinical studies with SARM1 inhibitor SIR2501, NAMPT activator SIR4156, and RIPK1 inhibitor SIR9900, in addition to ongoing preclinical research. The company was named to the 2025 Endpoints 11 list of the most promising biotech startups. For more information, visit sironax.com.
Forward-looking Statements
This press release contains forward-looking statements related to SIR2501's potential benefits and clinical progress, which are subject to risks and uncertainties. Actual outcomes may differ based on technical, regulatory, and market factors.
Contact Information
Investors/Media
Erik Kopp
Executive Director, Corporate Communications and Investor Relations
PR@sironax.com
Business Development
Yan Lu, Ph.D.
Senior Director, Business Development and Corporate Strategy
BD@sironax.com
