Overview
Broccoli allergenic extract is used in allergenic testing.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Pharmacological and Clinical Review of Broccoli (Brassica oleracea): From Allergenic Extract to a Source of Bioactive Sulforaphane
Executive Summary
This report provides a comprehensive analysis of broccoli (Brassica oleracea) within a pharmacological and clinical context, navigating its dual identity as both a source for a regulated allergenic extract and a rich reservoir of therapeutically significant phytochemicals. The substance identified in DrugBank as DB10511 is a non-standardized allergenic extract used exclusively for the percutaneous, intradermal, or subcutaneous diagnosis of Type I hypersensitivity to broccoli. This application stands in stark contrast to the vast body of scientific research focused on the health benefits of broccoli consumption, which are attributed not to its allergenic proteins but to its unique phytochemical profile.
The primary bioactive potential of broccoli stems from the glucosinolate-myrosinase system. The plant contains high concentrations of glucoraphanin, a stable but biologically inert glucosinolate. Upon tissue damage, such as chewing or cutting, the enzyme myrosinase is released, hydrolyzing glucoraphanin into sulforaphane—a highly reactive and potent isothiocyanate. Sulforaphane is responsible for the majority of broccoli's observed health benefits, acting as a powerful indirect antioxidant and anti-inflammatory agent. Its principal mechanism of action is the potent activation of the Nrf2 transcriptional pathway, which upregulates a vast array of cytoprotective genes, including Phase II detoxification and antioxidant enzymes. Furthermore, sulforaphane exhibits pleiotropic anticancer activity through the induction of apoptosis, cell cycle arrest, and epigenetic modulation, including histone deacetylase (HDAC) inhibition.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/01/18 | Early Phase 1 | Completed | |||
2016/01/15 | Phase 1 | Completed | |||
2013/12/30 | Early Phase 1 | Completed | Julie E. Bauman, MD, MPH | ||
2013/05/03 | Phase 2 | Completed | |||
2012/12/20 | Early Phase 1 | Completed | |||
2012/04/02 | Early Phase 1 | Completed | |||
2012/02/01 | Not Applicable | Completed | |||
2011/09/21 | Phase 2 | Completed | |||
2010/04/21 | Not Applicable | Terminated | |||
2009/10/14 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Nelco Laboratories, Inc. | 36987-1411 | INTRADERMAL, SUBCUTANEOUS | 0.05 g in 1 mL | 12/9/2009 | |
| Nelco Laboratories, Inc. | 36987-1412 | INTRADERMAL, SUBCUTANEOUS | 0.1 g in 1 mL | 12/9/2009 | |
| Allergy Laboratories, Inc. | 54575-356 | PERCUTANEOUS, SUBCUTANEOUS | 1 g in 20 mL | 3/15/2011 | |
| Nelco Laboratories, Inc. | 36987-1410 | INTRADERMAL, SUBCUTANEOUS | 0.05 g in 1 mL | 12/9/2009 | |
| Antigen Laboratories, Inc. | 49288-0049 | SUBCUTANEOUS, INTRADERMAL | 0.05 g in 1 mL | 11/17/2009 | |
| Nelco Laboratories, Inc. | 36987-1413 | INTRADERMAL, SUBCUTANEOUS | 0.1 g in 1 mL | 12/9/2009 |
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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