NEXOBRID (anacaulase-bcdb)
Nexobrid (anacaulase-bcdb) is a topical therapy indicated for the removal of eschar in adult and pediatric patients with deep partial-thickness and full-thickness thermal burns. The drug provides a proteolytic method for debriding severe burn wounds, though its use is restricted to specific anatomical locations and patient populations. It is not indicated for chemical or electrical burns, nor for use on the face, perineum, genitalia, or in patients with significant cardiopulmonary disease.
How NEXOBRID Works
Nexobrid is a mixture of proteolytic enzymes that functions by dissolving burn wound eschar. These enzymes act on the dead tissue that develops after a thermal injury to facilitate its removal from the wound bed. While the specific enzymatic components responsible for this therapeutic effect have not been identified, the biological action of the mixture breaks down the damaged tissue.
Details
- Status
- Prescription
- First Approved
- 2022-12-28
- Patent Cliff
- 2031
- Routes
- TOPICAL
- Dosage Forms
- GEL
NEXOBRID Approval History
What NEXOBRID Treats
1 indicationsNEXOBRID is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thermal Burns
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02278718 results posted | MW2012-01-01 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care |
| NCT02148705 results posted | MW 2010-03-02 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEXOBRID FDA Label Details
Indications & Usage
FDA Label (PDF)NEXOBRID is indicated for the treatment of Thermal Burns.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.