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TCP-25 gel
TCP-25 gel is a Small molecule drug developed by Xinnate AB. It is currently in Phase 2 development.
TCP-25 gel is a small molecule being studied as a potential treatment for various skin conditions, including Epidermolysis Bullosa, Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Blister, and Wound of Skin. A Phase 2 clinical trial (NCT06594393) is evaluating the efficacy, safety, and tolerability of TCP-25 gel in patients with these conditions.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | TCP-25 gel |
|---|---|
| Sponsor | Xinnate AB |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study (PHASE2)
- Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa. (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TCP-25 gel CI brief — competitive landscape report
- TCP-25 gel updates RSS · CI watch RSS
- Xinnate AB portfolio CI
Frequently asked questions about TCP-25 gel
What is TCP-25 gel?
Who makes TCP-25 gel?
What development phase is TCP-25 gel in?
Related
- Manufacturer: Xinnate AB — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing