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denovoSkin(TM)
denovoSkin(TM) is a Regenerative medicine Biologic drug developed by CUTISS AG. It is currently in Phase 3 development for Treatment of severe burns. Also known as: EHSG-KF.
denovoSkin(TM) is a regenerative medicine treatment that uses a patient's own skin cells to repair damaged skin.
denovoSkin(TM) is a regenerative medicine treatment that uses a patient's own skin cells to repair damaged skin. Used for Treatment of severe burns.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | denovoSkin(TM) |
|---|---|
| Also known as | EHSG-KF |
| Sponsor | CUTISS AG |
| Drug class | Regenerative medicine |
| Modality | Biologic |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
denovoSkin(TM) works by using a patient's own skin cells to create a personalized skin graft, which is then transplanted back onto the damaged area. This approach aims to promote natural healing and regeneration of the skin, reducing the risk of rejection and scarring.
Approved indications
- Treatment of severe burns
Common side effects
- Infection
- Scarring
- Rejection
Key clinical trials
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:
- denovoSkin(TM) CI brief — competitive landscape report
- denovoSkin(TM) updates RSS · CI watch RSS
- CUTISS AG portfolio CI
Frequently asked questions about denovoSkin(TM)
What is denovoSkin(TM)?
How does denovoSkin(TM) work?
What is denovoSkin(TM) used for?
Who makes denovoSkin(TM)?
Is denovoSkin(TM) also known as anything else?
What drug class is denovoSkin(TM) in?
What development phase is denovoSkin(TM) in?
What are the side effects of denovoSkin(TM)?
Related
- Drug class: All Regenerative medicine drugs
- Manufacturer: CUTISS AG — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Treatment of severe burns
- Also known as: EHSG-KF
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing