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EX-03

Phase 2

Venous Leg Ulcer (VLU) | Small molecule | Other |MediWound Ltd.|Last Updated: Jul 9, 2026

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

EX-03 · 1 trial · 1 indication

Phase 2 1
NCT07692178An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg UlcersVenous Leg Ulcer (VLU)
NOT YET_RECRUITING20 Analytics
PHASE2NOT YET_RECRUITING
An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers
Venous Leg Ulcer (VLU)
NCT0769217820
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Study Endpoints

Primary Endpoints

PK Evaluation
Up to 2 weeks

Cmax (maximal observed serum concentration),

Safety and Tolerability Endpoints
up to 5 weeks

Incidence and severity of systemic and local adverse events (AEs),

Secondary Endpoints

Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications)
up to 2 weeks
Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically
up to 2 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EscharEx (EX-03)ACTIVE_COMPARATOREX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is blended with excipients. EX-03 5% powder, should be diluted with Water for Injection (WFI) prior usage.

Interventions

NameTypeDescription
EX-03DRUGa sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the w
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Men or women, older than 18 years of age, 2. Participants with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency), 3. Wound is present for at least 4 weeks but no longer than 2 years, 4. The adheren...

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Recent Changes (Last 90 Days)

LOWJul 9, 2026NCT07692178NEW_TRIAL: changed
LOWJul 9, 2026NCT07692178NEW_TRIAL: changed

Frequently asked questions about EX-03

What is EX-03 used for?

EX-03 is an investigational small molecule being developed for the treatment of Venous Leg Ulcer (VLU). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes EX-03?

EX-03 is being developed by MediWound Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MDWD.

What phase is EX-03 in?

EX-03 is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval for any use.

What clinical trials is EX-03 in?

EX-03 is being studied in a Phase 2 clinical trial registered as NCT07692178. This open-label, single-arm, multiple-dose study evaluates the pharmacokinetics, safety, and clinical performance of EX-03 in participants with Venous Leg Ulcers. The trial is not yet recruiting and plans to enroll 20 participants.

Is EX-03 the same as EscharEx?

Yes, EX-03 is also known as EscharEx. The Phase 2 clinical trial NCT07692178 refers to the drug as EscharEx (EX-03) in its official title.