Eluciderm, Inc. Announces U.S. FDA Clearance of IND Application for ELU42

• Eluciderm cleared to conduct Phase 1/2a trial of ELU42 for Wagner 1 and 2 DFUs
• ELU42 safety and efficacy results expected in Q4 2025
• Company on track for Phase 2 clinical trial of ELU42 in Q1 2026

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–Eluciderm, Inc., a clinical-stage pharmaceutical company developing small molecule therapeutics designed to promote healing and regenerative repair of injured tissue, announced today that on June 30, 2025 the company received clearance from the U.S. Food & Drug Administration (FDA) for its Investigational New Drug (IND), ELU42, for a Phase 1/2a open-label study evaluating safety and efficacy in patients with diabetic foot ulcers (DFUs). ELU42 is a novel, topical, small molecule Wnt modulator with bacteriostatic properties for the treatment of chronic open wounds.

“The FDA’s IND clearance of ELU42 marks an exciting transition for Eluciderm from preclinical research to full clinical-stage company,” said Daniel D. Holsworth, PhD, Chief Executive Officer of Eluciderm. “ELU42 is the first in our pipeline of Wnt signaling modulators developed around a novel mechanistic approach to tissue healing and repair that we believe will shift the paradigm from simply managing patients’ wounds to truly healing them.”

The ELU42 Phase 1/2a trial is an open-label study evaluating the topical spray for safety and efficacy in a cohort of 15 patients with diabetic foot ulcers (DFUs). The study is set to begin the first week of August 2025 at three U.S. sites and will assess multiple clinical endpoints, including wound area reduction, closure rates, and safety metrics.

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