42% faster closure by Day 7. ~90% closure in a diabetic model by Day 10. Zero adverse events across all tox cohorts. A breakdown...
Read MoreA first-in-class, shelf-stable small-molecule therapeutic engineered to accelerate healing in chronic and complex wounds — biologic-level efficacy, small-molecule simplicity, and ambient-temperature deployment, anywhere on Earth.
Over 8.2 million Americans live with chronic, non-healing wounds. The current standard of care fails one in four — leading to amputation, infection, and avoidable death. The world needs a smarter, simpler, more deployable solution.
Existing growth-factor biologics like becaplermin require refrigeration and have hours-long usable life once reconstituted — unusable in rural, military or emergency contexts.
Biologics suffer from feedback inhibition; 94% of US DFU patients never receive advanced therapy and rely on dressings and pressure therapy that don’t address the underlying biology.
Cellular and tissue-based products cost thousands per course and require complex handling — making them unattainable for the majority of healthcare systems.
Our proprietary small molecule activates upstream regulators of the body’s own healing cascade — driving keratinocyte proliferation, angiogenesis, and re-epithelialization through a mechanism never previously exploited by an approved therapeutic.
Built on rigorous science, validated in preclinical models, and engineered for the real world.
A new pharmacological target class with no approved therapeutic in the space — clean IP runway and category-defining potential.
Complete preclinical package: in-vitro efficacy across 3 cell lines, murine wound model, non-GLP tox, ICH-compliant stability.
Cold-chain-free formulation unlocks deployment in rural, military, trauma, disaster, and low-resource markets that biologics cannot serve.
A growing $18B+ global wound-care market expanding at 6.2% CAGR — driven by diabetes, obesity and aging populations.
Pre-IND meeting, IND filing, and Phase I readout — three near-term value milestones within 24 months.
Engineered for out-licensing or co-development with major pharma and specialty wound-care companies post Phase I.
Behind every statistic is a person. A grandparent who wants to walk their grandchild to school. A veteran who deserves to heal. A patient in a rural village whose nearest clinic has no refrigerator. ZegeneX exists so that wound healing is no longer a privilege of geography or income.
Lower-limb amputations every year in the US alone — most preceded by a non-healing diabetic foot ulcer.
Mortality after DFU amputation is worse than most cancers. We’re changing the math.
Preclinical complete. GLP toxicology underway. First-in-human study planned for 2026.
In-vitro efficacy across 3 keratinocyte cell lines, excisional murine wound model (42% faster closure), non-GLP tox, and ICH Q1A stability all completed.
GLP toxicology studies in pig models, CMC scale-up initiated, FDA pre-IND interaction requested.
Open-label safety, tolerability and preliminary efficacy in diabetic-foot-ulcer patients (Australia).
180-patient randomized, controlled trial vs. standard of care, primary endpoint complete closure at 12 weeks. Pharma partnership / NDA preparation to follow.
42% faster closure by Day 7. ~90% closure in a diabetic model by Day 10. Zero adverse events across all tox cohorts. A breakdown...
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94% of DFU patients in low-resource settings never receive advanced therapy. Refrigeration requirements are a silent policy failure — one ZegeneX was built to...
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Most growth-factor biologics hit a ceiling: the body downregulates its own receptors in response to exogenous PDGF. Our small-molecule approach sidesteps that problem entirely...
Read MoreWe work with strategic partners, foundations, and forward-looking capital who share our conviction that healing should be universal — not dependent on infrastructure, geography, or income.
A preclinical-stage biopharmaceutical company developing first-in-class, shelf-stable wound healing therapeutics — making advanced care accessible everywhere.