Steel Therapeutics Inc., an early-stage pharmaceutical company, has launched a pivotal toxicology study for Fizurex, its patent-pending topical wipe for treating anal fissures.
The study is being conducted with Altasciences, a contract research organization with more than 30 years of experience in preclinical and clinical development services. The Good Laboratory Practice-compliant study, conducted in minipigs, is a step toward the company’s planned Investigational New Drug submission in early 2026, which would allow first-in-human clinical trials to begin.
“The start of this pivotal toxicology study marks a critical inflection point for Steel Therapeutics,” said Matt Stahl, CEO and founder of Steel Therapeutics. “Fizurex is already massively de-risked from a clinical use perspective, having been prescribed by compounding pharmacies as a standard of care for years. Partnering with Altasciences ensures that our preclinical program is executed with the rigor, speed, and quality necessary to build on that foundation and deliver a fully approved, GMP product to patients.”
“It’s a privilege to work with Steel Therapeutics as they advance their Fizurex preclinical program,” said Steve Mason, co-chief operating officer at Altasciences. “By combining our teams’ expertise and shared commitment to patient-driven research, we’re helping move this promising therapy one step closer to those who need it.”
Fizurex is designed to address inconsistencies in compounded treatments by moving through the FDA regulatory pathway. The company said the product aims to expand access to treatment and improve outcomes for patients with anal fissures.
“We’re excited to be working with the Altasciences team, whose experience and collaborative approach will be instrumental as we move through this pivotal stage of development,” Mr. Stahl said.
Steel Therapeutics, founded by pharmacists with experience in retail compounding, has selected Fizurex as its first product. The wipe uses a commonly compounded combination therapy in a single-use format, with the goal of improving consistency, safety and access for patients.
