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R&D & Clinical Strategy

Advancing a High-Value
Therapeutic Pipeline.

Structured preclinical validation driving toward rapid Phase I/II clinical readouts and strategic biopharmaceutical partnership milestones.

Asset Portfolio

Development Programs & Clinical Stages

Four targeted indications addressing acute, chronic, and emergency wound-healing deficits using distinct delivery formulations.

ZGX-101 Zegen-X5 Preclinical Complete

Diabetic Foot Ulcers (DFU)

Delivery Formulation: Topical Hydrogel (0.1% - 0.5%)

Target Milestone
FDA Pre-IND Interaction / Phase Ib 60-patient trial (Australia)

Targeted formulation for stalled chronic neuropathic and neuroischemic diabetic foot ulcers. Demonstrates 42% acceleration in closure rate by Day 7 and ~90% closure by Day 10.

Stage: IND-Enabling / Phase 1 Prep 75%
Discovery Preclinical Phase I Phase II Phase III
ZGX-102 Zegen-X5 Active Preclinical

Venous Leg Ulcers (VLU)

Delivery Formulation: Bio-resorbable Matrix Film

Target Milestone
Ex-vivo human skin barrier restoration assay completion

Slow-release bioactive membrane designed to work synergistically under multi-layer compression wraps for chronic venous insufficiency wounds.

Stage: Preclinical Optimization 50%
Discovery Preclinical Phase I Phase II Phase III
ZGX-103 Zegen-X5 In Vivo Validation

Deep Partial-Thickness Burns & Trauma

Delivery Formulation: Aerosolized Bioactive Spray / Gel

Target Milestone
Porcine thermal burn model readout & BARDA engagement

Rapid field deployment formulation for thermal burn debridement and military combat wound triage without requiring cold chain logistics.

Stage: Preclinical Validation 40%
Discovery Preclinical Phase I Phase II Phase III
ZGX-104 Zegen-X5 Lead Optimization

Surgical Incision Dehiscence & High-Tension Closures

Delivery Formulation: Injectable Sub-dermal Depot / Suture Coating

Target Milestone
Biocompatible polymer pharmacokinetic characterization

Sustained-release formulation to enhance tensile burst strength and prevent surgical breakdown in high-risk laparotomy and orthopedic incisions.

Stage: Discovery & Formulation 25%
Discovery Preclinical Phase I Phase II Phase III
Financing & Execution Plan

Capital Efficiency & Targeted Use of Funds

Structured to maximize clinical value inflection points through Phase Ib human readouts.

55%

Phase Ib Clinical Trial

Execution of 60-patient DFU open-label safety and preliminary re-epithelialization trial.

20%

GLP Tox & CMC Scale-Up

Porcine GLP safety validation and commercial-grade cGMP hydrogel batch manufacturing.

15%

Pipeline Indication Expansion

Preclinical validation for VLU matrix film and aerosol spray burn formulations.

10%

Regulatory & G&A

Legal, regulatory filings, and general operating costs through Phase Ib.

Partner With ZegeneX

Explore co-development collaborations, territory licensing rights, and institutional investment opportunities in our lead and pipeline assets.

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Help write the next chapter of wound care.

We work with strategic biopharma partners, foundation grants, and visionary investors who share our conviction that healing should be universal — not constrained by infrastructure, refrigeration, or geography.