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EscharEx (EX-03)
EscharEx (EX-03) is a Enzymatic debriding agent Small molecule drug developed by MediWound Ltd. It is currently in Phase 3 development for Thermal burns requiring eschar removal, Enzymatic debridement of burn wounds. Also known as: EX-03.
EscharEx is a topical enzymatic debriding agent that selectively removes necrotic tissue from burns and wounds.
EscharEx (EX-03) is a treatment being studied for the debridement of Venous Leg Ulcers (VLUs) in a clinical trial. The study, NCT06568627, is a double-blind, placebo-controlled trial comparing EscharEx to a gel vehicle in patients with VLUs.
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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 | EscharEx (EX-03) |
|---|---|
| Also known as | EX-03 |
| Sponsor | MediWound Ltd |
| Drug class | Enzymatic debriding agent |
| Target | Proteolytic enzymes (bromelain-derived) |
| Modality | Small molecule |
| Therapeutic area | Wound Care / Burn Treatment |
| Phase | Phase 3 |
Mechanism of action
EscharEx contains a purified mixture of proteolytic enzymes derived from bromelain that digest and break down dead, damaged tissue (eschar) while preserving healthy tissue. This selective enzymatic debridement promotes faster wound healing and reduces the need for surgical intervention in burn patients.
Approved indications
- Thermal burns requiring eschar removal
- Enzymatic debridement of burn wounds
Common side effects
- Local irritation or erythema at application site
- Bleeding or oozing from debrided wound
- Pain at application site
Key clinical trials
- A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE) (PHASE3)
- Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers (PHASE2)
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:
- EscharEx (EX-03) CI brief — competitive landscape report
- EscharEx (EX-03) updates RSS · CI watch RSS
- MediWound Ltd portfolio CI
Frequently asked questions about EscharEx (EX-03)
What is EscharEx (EX-03)?
How does EscharEx (EX-03) work?
What is EscharEx (EX-03) used for?
Who makes EscharEx (EX-03)?
Is EscharEx (EX-03) also known as anything else?
What drug class is EscharEx (EX-03) in?
What development phase is EscharEx (EX-03) in?
What are the side effects of EscharEx (EX-03)?
What does EscharEx (EX-03) target?
Related
- Drug class: All Enzymatic debriding agent drugs
- Target: All drugs targeting Proteolytic enzymes (bromelain-derived)
- Manufacturer: MediWound Ltd — full pipeline
- Therapeutic area: All drugs in Wound Care / Burn Treatment
- Indication: Drugs for Thermal burns requiring eschar removal
- Indication: Drugs for Enzymatic debridement of burn wounds
- Also known as: EX-03
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing