Drugs / TCP-25
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05378997 | Apr 2022 → Mar 2024 | epidermolysis bullosa dystrophica, ulcer of lower limbs | Xinnate AB | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06594393 | Jan 2026 → Jun 2027 expected | epidermolysis bullosa dystrophica, junctional epidermolysis bullosa | Xinnate AB | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-02 | Xinnate AB | Regulatory Xinnate Receives FDA Rare Pediatric Disease Designation for TCP-25 for the Treatment of Epidermolysis Bullosa xinnate.com ↗
Xinnate AB, a Swedish clinical -stage biotechnology company developing novel therapies based on its groundbreaking peptide technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TCP -25 for the treatment of Epidermolysis Bullosa (EB). |
| 2026-06-10 | Xinnate AB | Regulatory Xinnate receives FDA Fast Track Designation for TCP-25 for the Treatment of Epidermolysis Bullosa xinnate.com ↗
Xinnate receives FDA Fast Track Designation for TCP-25 for the Treatment of Epidermolysis Bullosa |
| 2025-12-22 | Xinnate AB | Results First Scientific Publication Reporting Clinical Trial Results for Xinnate’s Proprietary Drug Candidate TCP-25 xinnate.com ↗
In this Phase 1 study, topical administration of TCP-25 gel was safe and well tolerated in patients with dystrophic EB, with no detectable systemic uptake. |
| 2025-01-14 | Xinnate AB | Regulatory Xinnate receives Orphan Drug Designation from US FDA for TCP-25 xinnate.com ↗
Xinnate AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the company’s drug candidate TCP-25 for the treatment of the severe disease Epidermolysis Bullosa (EB). |
| 2024-09-27 | Xinnate AB | Results Phase I Study Results of a Novel Immunomodulatory Peptide, TCP-25, for Treatment of Dystrophic Epidermolysis Bullosa xinnate.com ↗
The results showed that TCP-25 gel not only reduced bacterial levels while preserving beneficial skin flora but also exhibited anti-inflammatory effects, contributing to improved wound healing. |
| 2024-09-05 | Xinnate AB | Results Xinnate presents TCP-25 data at international dermatology congress xinnate.com ↗
Key findings from the study demonstrate that TCP-25 gel not only significantly reduces bacterial levels in and around wounds but also selectively preserves beneficial commensal bacteria. |
| 2024-05-07 | Xinnate AB | Results Xinnate reports positive results from Phase 1 study with TCP-25, in patients with Epidermolysis Bullosa xinnate.com ↗
The results now show a good safety and tolerability of TCP-25 gel, when administered topically in this patient population. |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TCP-25 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05378997 ↗ |
| Modality | Peptide | “TCP-25, a thrombin-derived C-terminal peptide” PMID 41327356 ↗ Dec 2025 |
| Route | Topical | “topically applied TCP-25” PMID 41327356 ↗ Dec 2025 |