Drugs / anacaulase-bcdb
anacaulase-bcdb
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NEXOBRID | — | 2024-08-15 | fda.gov ↗ |
| Filed | US (FDA) | NexoBrid | pediatric thermal burns | 2024-01-09 | “accepted a supplement to the NexoBrid ® biologics license application (sBLA) for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns.” mediwound.com ↗ “the U.S. Food and Drug Administration (FDA) has completed their filing review and accepted a supplement to the NexoBrid ® biologics license application (sBLA)” mediwound.com ↗ |
| Filed | EU (EMA) | NexoBrid | pediatric severe thermal burns | 2023-03-16 | “Announced that the European Medicines Agency (EMA) accepted for review MediWound’s application for the extended indication for NexoBrid to treat pediatric patients with severe...” mediwound.com ↗ |
| Approved | US (FDA) | NEXOBRID | — | 2022-12-28 | fda.gov ↗ |
| Filed | EU (EMA) | NexoBrid | severe burns in children | 2022-09-20 | “Type II Variation submitted by MediWound in order to expand the current approved indication for NexoBrid into the pediatric population.” mediwound.com ↗ |
| Filed | US (FDA) | NexoBrid | thermal burns | 2022-08-03 | “Announced acceptance by the U.S. Food and Drug Administration (FDA) of the re-submitted Biologics License Application (BLA) filing for NexoBrid” mediwound.com ↗ “BLA filing for NexoBrid ® for the debridement of deep partial-thickness and/or full thickness thermal burns.” mediwound.com ↗ “FDA has accepted for review its recently re-submitted Biologics License Application (BLA) for NexoBrid ®” mediwound.com ↗ |
| Rejected (CRL) | US (FDA) | NexoBrid | severe burns | 2021-06-28 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid” mediwound.com ↗ “BLA for NexoBrid for treatment of severe burns in the United States following the receipt of a complete response for NexoBrid on June 28, 2021” mediwound.com ↗ “Received a Complete Response Letter (CRL) from U.S. FDA for NexoBrid biologics license application (BLA)” mediwound.com ↗ |
| Approved | EU (EMA) | NexoBrid | — | 2012-12-18 | europa.eu ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06690177 | Apr 2025 → Dec 2027 expected | ulcer of lower limbs | MediWound Ltd | Not yet recruiting | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT02148705 | May 2015 → Jun 2018 | — | MediWound Ltd | Completed | Met primary |
| Phase 3 | NCT02278718 | May 2015 → Apr 2021 | — | MediWound Ltd | Completed | Met primary |
| Phase 3 | NCT00324311 | Dec 2005 → Oct 2009 | — | MediWound Ltd | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT07692178 Comparator | Aug 2026 → Aug 2028 expected | ulcer of lower limbs | MediWound Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06568627 Comparator | Jun 2025 → Dec 2026 expected | ulcer of lower limbs | MediWound Ltd | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2025-12-10 | MediWound Ltd | Results MediWound Reports New Clinical Data Demonstrating NexoBrid®’s Effectiveness in Preventing Traumatic Tattoos After Abrasion and Blast Injuries mediwound.com ↗ |
| 2025-09-25 | MediWound Ltd | Regulatory MediWound Expands Global Reach with Marketing Approval of NexoBrid® in Australia mediwound.com ↗
today announced that Australia’s Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid ® , the Company’s innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns. |
| 2025-09-02 | MediWound Ltd | Results MediWound’s NexoBrid® to be Highlighted in 36 Scientific Presentations at the 21st European Burns Association Congress mediwound.com ↗
The presentations include data on pediatric, elderly, and critically burned patients demonstrating consistent benefits in survival, recovery, and scar outcomes, as well as value in infection control and modulation of systemic inflammatory responses. |
| 2025-02-25 | MediWound Ltd | Results MediWound Announces Phase III CIDS Publication on NexoBrid® for Pediatric Burn Care mediwound.com ↗
The publication, titled “Open-Label RCT of the Efficacy and Safety of NexoBrid Compared to SOC in Children with Burns,” presents findings that supported the label expansion of NexoBrid for pediatric patients in the E.U. (2023) and U.S. (2024). |
| 2024-08-15 | MediWound Ltd | Regulatory MediWound Announces U.S. Food and Drug Administration Approval of NexoBrid® for the Treatment of Pediatric Patients with Severe Thermal Burns mediwound.com ↗
today 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. |
| 2024-08-05 | MediWound Ltd | Results MediWound Announces Positive Results from the U.S. NexoBrid® Expanded Access Protocol (NEXT) mediwound.com ↗
MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced the positive results of the NEXT—an Expanded Access Protocol. |
| 2024-01-09 | MediWound Ltd | Regulatory MediWound Announces that FDA has Accepted for Review the Supplement to the NexoBrid BLA to Include Pediatric Patients with Severe Thermal Burns mediwound.com ↗ |
| 2023-11-13 | MediWound Ltd | Regulatory MediWound Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric Patients mediwound.com ↗
The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently. |
| 2022-12-29 | MediWound Ltd | Regulatory MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults mediwound.com ↗ |
| 2022-12-23 | MediWound Ltd | Regulatory MediWound Expands NexoBrid’s Global Presence with Marketing Approval in Japan mediwound.com ↗
The Japanese Ministry of Health , Labor, and Welfare (MHLW) has granted NexoBrid marketing authorization for non-surgical eschar removal of deep-partial and full-thickness thermal burns for the adult and pediatric population. |
| 2022-12-20 | MediWound Ltd | Regulatory MediWound Strengthens European Presence of NexoBrid® mediwound.com ↗ |
| 2022-12-13 | MediWound Ltd | Regulatory MediWound Expands Global Presence as NexoBrid® Gains Approval in India mediwound.com ↗
MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced it has gained marketing approval of NexoBrid ® in India . |
| 2022-09-20 | MediWound Ltd | Regulatory EMA Accepts MediWound’s Application for Extended Indication for NexoBrid to Treat Pediatric Patients with Severe Thermal Burns mediwound.com ↗
EMA has initiated evaluation of the application to extend the use of NexoBrid to children aged newborn through eighteen. |
| 2022-08-09 | MediWound Ltd | Regulatory MediWound Reports Second Quarter 2022 Financial Results and Provides Company Updates mediwound.com ↗
FDA Assigned PDUFA Target Date of January 1 , 202 3 for NexoBrid BLA |
| 2022-08-03 | MediWound Ltd | Regulatory MediWound Announces U.S. FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns mediwound.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review its recently re-submitted Biologics License Application (BLA) for NexoBrid ® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. |
| 2021-11-18 | MediWound Ltd | Regulatory EMA Provides Regulatory Path for Pediatric Label Extension for NexoBrid mediwound.com ↗
Based on the feedback, the Company anticipates submitting a pediatric label extension request in the first half of 2022. |
| 2021-07-20 | MediWound Ltd | Results MediWound Announces Positive Topline Results from Phase 3 Pediatric Study (CIDS) of NexoBrid for Eschar Removal of Severe Thermal Burns mediwound.com ↗
The study met its three primary endpoints with a high degree of statistical significance. |
| 2021-06-29 | MediWound Ltd | Regulatory MediWound Receives Complete Response Letter from U.S. FDA for NexoBrid Biologics License Application mediwound.com ↗
The FDA communicated that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form. |
| 2020-09-16 | MediWound Ltd | Regulatory MediWound Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns mediwound.com ↗ |
| 2020-08-06 | MediWound Ltd | Regulatory MediWound Reports Second Quarter 2020 Financial Results and Provides Corporate Update mediwound.com ↗
We are pleased to have submitted the BLA for NexoBrid on schedule despite the disruptions of the COVID-19 pandemic. |
| 2020-06-30 | MediWound Ltd | Regulatory MediWound Announces Submission of Biologics License Application to the U.S. FDA for NexoBrid for the Treatment of Severe Thermal Burns mediwound.com ↗ |
| 2019-06-04 | MediWound Ltd | Regulatory NexoBrid® Receives Marketing Authorization from Peru’s Ministry of Health mediwound.com ↗
Avalon Pharmaceutical Peru S.A.C, MediWound’s exclusive distribution partner in Peru , received the marketing authorization and intends to launch NexoBrid in Peru in the first half of 2020. |
| 2019-01-22 | MediWound Ltd | Results MediWound Announces Positive Top-Line Results from Its Pivotal Phase 3 Study (DETECT) in NexoBrid® for Eschar Removal of Severe Thermal Burns mediwound.com ↗ |
| 2018-09-05 | MediWound Ltd | Regulatory NexoBrid® Receives Marketing Authorization from Russia's Ministry of Health mediwound.com ↗
Genfa Medica S.A. , MediWound’s exclusive distribution partner in Russia , received the marketing authorization and intends to launch NexoBrid in Russia in the first half of 2019. |
| 2018-06-19 | MediWound Ltd | Regulatory MediWound Expands Its NexoBrid® Phase 3 Children Innovation Debridement Study (CIDS) to the U.S. mediwound.com ↗ |
| 2018-06-04 | MediWound Ltd | Regulatory NexoBrid® Receives Marketing Authorization From South Korea’s Ministry of Health mediwound.com ↗
BL&H Co., Ltd. , MediWound’s exclusive distribution partner in South Korea , received the marketing authorization and intends to launch NexoBrid in South Korea in the second half of 2018 |
| 2018-05-29 | MediWound Ltd | Regulatory FDA Clears Development Pathway for NexoBrid® for Sulfur Mustard Injuries mediwound.com ↗
The FDA also agreed that single animal species trials would suffice, subject to adequate safety and efficiency data from the planned studies. |
| 2017-06-16 | MediWound Ltd | Results Independent Study in Germany Shows NexoBrid® Reduces Average Burn Treatment Costs by nearly 30% Versus Standard of Care mediwound.com ↗
The findings were based on treatment costs listed in the pricing system for German hospitals (G-DRG) and showed a nearly 30% reduction in the total cost of care, per patient, when treating burn patients with NexoBrid ® compared with SOC. |
| 2017-06-02 | MediWound Ltd | Results Poster Presentation Highlighting NexoBrid® Awarded "Best Poster" at the 52nd Congress of the Spanish Society of Aesthetic, Plastic and Reconstructive Surgery mediwound.com ↗
The presentation reported on 12 patients with intermediate to deep dermal burns of the hand, who underwent selective enzymatic eschar removal with NexoBrid. |
All press releases naming this drug 61 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | anacaulase-bcdb | “EX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of...” NCT07692178 ↗2“A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is...” NCT06690177 ↗ “A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is...” NCT06568627 ↗ |
| Known as | NexoBrid | “with the debriding enzyme NexoBrid™ (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC.” PMID 24074719 ↗ Sep 2013 |
| Known as | NXB | “with the debriding enzyme NexoBrid™ (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC.” PMID 24074719 ↗ Sep 2013 |
| Modality | Protein / enzyme biologic | “with the debriding enzyme NexoBrid™ (NXB)” PMID 24074719 ↗ Sep 2013 |
| Route | Topical | “mixed with gel,for topical application.” NCT00324311 ↗ |