Drugs / MTX-001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase not stated1 trial | ||||||
| — | NCT06730022 | — | decubitus ulcer, ulcer disease | Merakris Therapeutics | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04647240 Comparator | Feb 2022 → Mar 2027 expected | ulcer of lower limbs | Merakris Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Merakris Therapeutics | Regulatory FDA Grants Fast Track Designation to Merakris’ MTX-001, Opening Potential Accelerated Path to Market for Venous Leg Ulcer Therapy merakris.com ↗
Merakris Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MTX-001, the Company’s lead biologic candidate for the treatment of chronic, non-infected venous stasis ulcers, commonly known as venous leg ulcers (VLU). |
| 2026-04-14 | Merakris Therapeutics | Results Merakris Therapeutics and iFyber Collaboration Receives Top SAWC Research Award for MTX-001 Wound Healing Study in Human Skin Model merakris.com ↗
The award recognizes preclinical data demonstrating that Merakris’ lead asset, MTX-001, delivers statistically significant wound healing in a human-relevant model—positioning the program as a potential first-in-class entrant in a stagnant, multi-billion-dollar market. |
| 2026-04-07 | Merakris Therapeutics | Results Merakris Therapeutics Provides FDA Update and Reports Interim Findings for MTX-001 in Venous Leg Ulcers merakris.com ↗
In this subgroup, MTX-001 was associated with statistically significant ulcer size reduction by Week 8 and Week 12. |
| 2025-08-19 | Merakris Therapeutics | Regulatory Merakris Therapeutics Receives USPTO Notice of Allowance for Foundational Patent Supporting MTX-001 Biologic Drug Platform merakris.com ↗ |
| 2025-03-26 | Merakris Therapeutics | Results International Wound Journal Publishes Positive Phase 2 Interim Data on Cell-free Amniotic Fluid Injectable Biologic for the Treatment of Venous Leg Ulcers merakris.com ↗
Merakris Therapeutics announced the publication of positive clinical trial results from the first part of its ongoing Phase 2, multicenter trial. |
| 2024-02-20 | Merakris Therapeutics | Results Merakris Therapeutics to Release Final Part 1 Data From Phase 2 Multicenter Investigational Drug Study for Dermacyte® Liquid merakris.com ↗
Preliminary data indicate an 84% average reduction in ulcer surface area for the 9 patients completing the 12-week study. |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MTX-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06730022 ↗ |
| Known as | Dermacyte Liquid | “MTX-001 (Dermacyte Liquid)” NCT06730022 ↗ |
| Route | Subcutaneous | “Subcutaneous injection into and/or around wound bed weekly” NCT04647240 ↗ |