For deep partial thickness (DPT) and/or full thickness (FT) thermal burns. Sold as Nexobrid. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Anacaulase-Bcdb (sold as Nexobrid), first approved Dec 28, 2022, with 1 new use approved and 1 published complete response letter.
| 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 UlcersVenous Leg Ulcer (VLU) · MediWound Ltd | Phase 2 | Not yet recruiting | Jul 9, 2026 |
| Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)Venus Leg Ulcers · MediWound Ltd | Phase 2 | Not yet recruiting | Nov 15, 2024 |
| A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)Venous Leg Ulcer (VLU) · MediWound Ltd | Phase 3 | Recruiting | Aug 23, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 28, 2022 | NexobridBLA 761192 · New molecular entity | Mediwound, Ltd | 1 | Marketed |
| Letter | Product | Now |
|---|---|---|
| Jun 25, 2021 | BLA 761192Product Quality, Facility Inspections, Clinical Site Inspections | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
