Overview
The primary therapeutic use for which stem bromelain is currently and formally indicated is as a burn wound eschar debridement agent that has been approved by the EMA since 2012 and marketed under the brand name Nexobrid . Bromelain itself belongs to a category of protein-digesting enzymes that are obtained commercially from the fruit or stem of pineapples . Although both fruit and stem bromelain are prepared differently and contain different enzymatic compositions, the general term bromelain typically refers to stem bromelain . Bromelain is consequently a composite mixture of several different endopeptidases that can facilitate many different reactions with many different substrates. This action allows bromelain to demonstrate a wide range of therapeutic benefits ranging from cardiovascular to anticancer therapy - but the specific mechanisms of action by which it can elicit these effects are currently not properly understood.
Indication
The primary medical purpose for which stem bromelain (SB) is currently indicated for is the removal of eschar in adults with deep partial- and full-thickness thermal burns . Besides this official indication, however, it is also believed that SB may be used as a treatment for several other purposes as well, including cardiovascular health, osteoarthritis, autoimmunity, blood clotting, diarrhea, cancer, surgery, and debridement - although the specific mechanisms of action for these indications remain to be elucidated .
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/08/01 | N/A | APPROVED_FOR_MARKETING | |||
2014/10/30 | Phase 3 | UNKNOWN | |||
2014/05/28 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals | 13411-856 | ORAL | 10 mg in 1 1 | 3/31/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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