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

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. The data from this trial will establish the foundation of a Phase 2 clinical trial in 2026, with strong potential for a Breakthrough Therapy designation in early 2027.

“This first-in-human trial is a defining moment for Eluciderm. ELU42 has the potential to change the standard of care for patients worldwide who suffer from non-healing wounds and underscores our commitment to transforming wound care,” said John P. Delgado, MD, Chief Medical Officer of Eluciderm. “We believe everyone can be a SuperHealer^TM.”

About Eluciderm, Inc.

Eluciderm is a San Diego-based clinical-stage pharmaceutical company pioneering topical small-molecule therapies that awaken the body’s innate healing capacity. The company’s approach is grounded in a targeted mechanism of action that selectively modulates the Wnt signaling pathway, with the goal of redefining wound healing and clinical outcomes. Eluciderm’s platform, anchored by ELU42, includes therapeutics designed to promote healing and regenerative repair of a wide variety of wound injuries, including those from third-degree burns, surgical incisions, elastic cartilage reconstructions, pulmonary fibrotic damage from environmental factors, and inflammatory skin diseases. Based on favorable data from the National Cancer Institute’s NCI-60 screening program, Eluciderm is also in the early stages of investigating oncological applications of their mechanistic methodology. For more information, visit www.eluciderm.com and follow Eluciderm on LinkedIn.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to the initiation, timing, and progress of clinical trials; the potential therapeutic benefits of ELU42; and the development plans for Eluciderm, Inc.’s pipeline. These forward-looking statements are based on current expectations and beliefs and are subject to a number of risks and uncertainties, including those related to clinical development, regulatory approvals, manufacturing, and commercialization. Actual results may differ materially from those expressed or implied in the forward-looking statements. Eluciderm, Inc. disclaims any obligation to update these statements except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250708620364/en/