This section highlights FDA-related milestones and regulatory updates for drugs developed by MediWound (MDWD).
Over the past two years, MediWound has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EscharEx and NexoBrid. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EscharEx - FDA Regulatory Timeline and Events
EscharEx is a drug developed by MediWound for the following indication: Chronic Wounds.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EscharEx
- Announced Date:
- May 13, 2025
- Indication:
- Chronic Wounds
Announcement
MediWound Ltd. announced the publication of a peer-reviewed post hoc analysis in Wounds.
AI Summary
MediWound Ltd. announced the publication of a peer-reviewed post hoc analysis in the journal Wounds. The analysis comes from data in the Phase II ChronEx clinical trial, which compared the performance of EscharEx® against SANTYL®, an FDA-cleared enzymatic debridement agent for treating venous leg ulcers. Researchers studied a subgroup of patients treated with either EscharEx or SANTYL. They found that 63% of patients who used EscharEx achieved complete debridement at two weeks, while none in the SANTYL group did. Additionally, EscharEx led to faster wound bed preparation with a median time of 11 days. The study supports that EscharEx may work more effectively and speedily in preparing wounds for healing. These results match previous clinical findings and may signal further advantages for EscharEx in the treatment of chronic wounds.
Read Announcement- Drug:
- EscharEx
- Announced Date:
- March 19, 2025
- Indication:
- Chronic Wounds
Announcement
MediWound Ltd. Provides Corporate Update
AI Summary
MediWound Ltd. provided a corporate update highlighting significant progress with their EscharEx® program. The company has launched the VALUE global Phase III pivotal trial to assess EscharEx’s effectiveness in treating venous leg ulcers, enrolling 216 patients across 40 sites in the US and Europe. An interim evaluation will be conducted after 65% of patients complete their treatments, with results expected by mid-2026. Additionally, MediWound is expanding its partnerships with industry leaders, including a new collaboration with Kerecis for a Phase II/III trial targeting diabetic foot ulcers. Kerecis will supply its MariGen Fish-Skin graft as the designated skin substitute during the healing phase of the study. CEO Ofer Gonen stated that these initiatives, along with robust strategic alliances and clinical advancements, set a strong foundation for continued growth and innovation in wound care.
Read Announcement- Drug:
- EscharEx
- Announced Date:
- February 12, 2025
- Estimated Event Date Range:
- January 1, 2026 - June 30, 2026
- Target Action Date:
- H1 2026
- Indication:
- Chronic Wounds
Announcement
MediWound Ltd announced that Interim analysis planned after 65% of patients complete treatment, expected in mid-2026
AI Summary
MediWound Ltd has launched a global Phase III trial called VALUE to evaluate EscharEx®, a treatment intended to improve healing in patients with venous leg ulcers. The study will enroll 216 patients at 40 sites in the U.S. and Europe, randomly assigning them to receive either EscharEx® or a placebo. Patients will receive daily treatments for up to two weeks, followed by a period of standardized wound management. The trial will measure how well patients achieve complete debridement and wound closure as primary goals.
An important aspect of the study is the interim analysis. This review is planned after 65% of the patients have completed treatment, with the analysis expected to occur by mid-2026. This step is designed to help researchers make any necessary adjustments to ensure the study meets its objectives effectively.
Read Announcement- Drug:
- EscharEx
- Announced Date:
- February 12, 2025
- Indication:
- Chronic Wounds
Announcement
MediWound Ltd. announced the initiation of VALUE, a global, pivotal Phase III trial evaluating EscharEx® for the treatment of venous leg ulcers (VLUs).
AI Summary
MediWound Ltd. announced the start of the VALUE study, a global, pivotal Phase III trial aimed at evaluating the safety and efficacy of EscharEx® in treating venous leg ulcers (VLUs). This large, multicenter trial will be randomized, double-blind, and placebo-controlled, and it will be conducted across 40 sites in the United States and Europe. The study will enroll 216 patients to assess how effectively EscharEx debrides chronic wounds and prepares them for healing.
An interim analysis is planned after 65% of the patients complete treatment, with results expected in mid-2026. This trial is significant as it is one of the most comprehensive studies in more than a decade for new treatment options in VLUs, potentially redefining care standards for chronic wound debridement.
Read Announcement- Drug:
- EscharEx
- Announced Date:
- October 10, 2024
- Indication:
- Chronic Wounds
Announcement
MediWound Ltd. announced that it will be initiating a controlled, multicenter Phase II clinical study evaluating EscharEx® against collagenase ointment (marketed as SANTYL® in the U.S. and IRUXOL® in Europe) for the treatment of venous leg ulcers (VLUs).
AI Summary
MediWound Ltd. announced it will begin a controlled, multicenter Phase II clinical study in 2025 to evaluate its product, EscharEx®, against the collagenase ointment (known as SANTYL® in the U.S. and IRUXOL® in Europe) for treating venous leg ulcers (VLUs). This trial will enroll 45 patients across various sites in the United States and Europe, where patients will be randomly assigned to receive either EscharEx, placebo, or collagenase in a 1:1:1 ratio. The study, which will run concurrently with an ongoing Phase III trial, aims to assess key safety endpoints such as the incidence and severity of adverse events and the time to complete wound closure. The findings are intended to support a Biologics License Application (BLA) submission for EscharEx and enhance the commercialization strategy, with expectations of demonstrating superior efficacy over the current treatment option.
Read Announcement- Drug:
- EscharEx
- Announced Date:
- July 29, 2024
- Indication:
- Chronic Wounds
Announcement
MediWound Ltd. announces the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eClinicalMedicine, a journal under THE LANCET Discovery Science umbrella.
AI Summary
MediWound Ltd. has announced a significant milestone with the publication of its Phase II ChronEx study in eClinicalMedicine, a respected journal under THE LANCET Discovery Science umbrella. The study assessed the safety and effectiveness of EscharEx, a bromelain-based enzymatic debridement therapy, for treating Venous Leg Ulcers (VLU). Results showed that EscharEx was much better at removing non-viable tissue and promoting healthy granulation tissue compared to non-surgical standard care and a placebo. The study demonstrated that patients treated with EscharEx achieved optimal wound bed preparation significantly faster, indicating its potential to improve healing outcomes in chronic wounds. These promising results have paved the way for an upcoming Phase III trial, which will further evaluate EscharEx’s benefits as a non-surgical treatment alternative for VLUs.
Read Announcement- Drug:
- EscharEx
- Announced Date:
- April 25, 2024
- Indication:
- Chronic Wounds
Announcement
MediWound Ltd announced that recent clinical data from EscharEx® Phase II studies will be presented throughout May 2024 at the largest, most prestigious annual meetings in the field of chronic wound care: the European Wound Management Association (EWMA), the Wound Healing Society (WHS), and the Symposium on Advanced Wound Care (SAWC).
AI Summary
MediWound Ltd. announced that recent clinical data from its EscharEx® Phase II studies will be presented in May 2024 at three leading international chronic wound care meetings: the European Wound Management Association (EWMA), the Wound Healing Society (WHS), and the Symposium on Advanced Wound Care (SAWC). The oral presentations will share additional comparative data between EscharEx® and the current leading enzymatic debridement agent, SANTYL®, showcasing EscharEx®’s superior performance. New analyses from the ChronEx study demonstrate a strong correlation between wound bed preparation and wound healing. These findings not only highlight the potential of EscharEx® to improve patient outcomes by delivering effective debridement with a favorable safety profile but also validate the planned design and endpoints for its upcoming Phase III study in venous leg ulcers. This innovative, multimodal debridement therapy could redefine chronic wound care, offering significant potential benefits over current treatments.
Read Announcement
NexoBrid - FDA Regulatory Timeline and Events
NexoBrid is a drug developed by MediWound for the following indication: Enzymatically removes nonviable burn tissue.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NexoBrid
- Announced Date:
- February 25, 2025
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
MediWound Ltd. announced the publication of its Phase III Children Innovative Debridement Study (CIDS) in Burns, the peer-reviewed Journal of the International Society for Burn Injuries (ISBI).
AI Summary
MediWound Ltd. recently announced that its Phase III Children Innovative Debridement Study (CIDS) has been published in Burns, the peer‐reviewed journal of the International Society for Burn Injuries (ISBI). This study, conducted in multiple centers across the US, EU, Israel, and India, focused on evaluating the safety and effectiveness of NexoBrid® compared to standard care in pediatric patients with deep partial- and full-thickness thermal burns. The results demonstrated that NexoBrid provided faster removal of eschar, reduced the need for surgical intervention, and preserved healthy tissue, offering a rapid non-surgical alternative for young burn victims. These findings supported the recent label expansion for pediatric use in key regions including the U.S., E.U., and Japan and further underline NexoBrid’s clinical benefits and potential to transform burn care for children.
Read Announcement- Drug:
- NexoBrid
- Announced Date:
- August 15, 2024
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns.
AI Summary
MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for pediatric use. This new indication allows pediatric patients from newborn through eighteen years old with deep partial- and full-thickness thermal burns to receive NexoBrid for eschar removal. The treatment helps remove the dead burn tissue without damaging healthy tissue, offering a less invasive and more effective alternative to traditional surgical methods.
This approval is based on the strong safety and efficacy data gathered from a global Phase III clinical trial, which focused on hospitalized pediatric patients. With pediatric burn victims making up a significant portion of the burn patient population, this milestone is expected to reduce trauma for both the children and their families. MediWound’s commitment to advancing burn care is highlighted by this significant step in expanding treatment options for young burn victims in the U.S.
Read Announcement- Drug:
- NexoBrid
- Announced Date:
- August 5, 2024
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
MediWound Ltd. announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid® in burn centers until its commercialization.
AI Summary
MediWound Ltd. announced positive results from the NEXT Expanded Access Protocol, which was initiated in 2019 to ensure that burn centers had continuous access to NexoBrid® until its full commercialization. The NEXT program played a key role in keeping the treatment available, allowing physicians to maintain their expertise and providing burn victims with ongoing access to this life-saving therapy. By using NexoBrid®, clinicians were able to quickly remove burned tissue, reduce the need for surgical interventions, and improve patient recovery outcomes. In addition, the protocol facilitated the collection of valuable real-world safety and clinical data that supported previous trial findings. These encouraging results show that maintaining access to innovative treatments like NexoBrid® is essential for advancing burn care and improving the overall standard of treatment for severe burn injuries.
Read Announcement
