Overview
Onion allergenic extract is used in allergenic testing.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Report on Onion Allergenic Extract (DB10548) and the Investigational Anesthetic ABP-700 (DB15411)
Part I: Onion (Allium cepa) Allergenic Extract (DB10548): A Diagnostic and Immunological Profile
1.0 Introduction to Onion as a Food Allergen
1.1 Overview
Onion (Allium cepa), a species within the Allium genus, is a vegetable cultivated and consumed globally, serving as a foundational ingredient in a vast array of culinary traditions.[1] Despite its ubiquity in the human diet, it is also a source of allergic reactions, which, while rare, can be severe.[1] The immunological response to onion is complex, capable of inducing both immediate (Type I) and delayed hypersensitivity reactions through various routes of exposure, including ingestion, direct skin contact, and inhalation of vapors during food preparation.[2]
To diagnose these allergic sensitivities, standardized allergenic extracts are employed in clinical settings. Onion Allergenic Extract (DrugBank ID: DB10548) is a non-standardized food allergenic extract derived from onion bulb tissue.[7] It is formulated for diagnostic use in skin testing to identify the presence of onion-specific immunoglobulin E (IgE) antibodies in sensitized individuals.[7] The extract is typically supplied in a phenol-preserved saline or glycerin-based solution for percutaneous or intradermal administration.[8] The diagnostic principle relies on the interaction between the allergenic proteins in the extract and IgE antibodies fixed to the surface of cutaneous mast cells. This interaction triggers mast cell degranulation, releasing histamine and other chemical mediators that produce a characteristic wheal-and-flare reaction, indicative of a positive test.[8]
1.2 Epidemiology and Prevalence
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2014/07/02 | Phase 4 | Completed | |||
2013/05/23 | Phase 3 | Completed | |||
2008/09/17 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Nutritional Specialties, Inc. | 83027-0052 | ORAL | 1 [hp_X] in 1 mL | 5/15/2025 | |
Bestmade Natural Products | 82969-5004 | ORAL | 30 [hp_C] in 30 [hp_C] | 5/27/2025 | |
Deseret Biologicals, Inc. | 43742-2108 | ORAL | 6 [hp_X] in 1 mL | 5/27/2025 | |
Boiron | 0220-9303 | ORAL | 5 [hp_C] in 1 1 | 5/12/2025 | |
Allergy Laboratories, Inc. | 54575-422 | PERCUTANEOUS, SUBCUTANEOUS | 1 g in 20 mL | 3/15/2011 | |
Nelco Laboratories, Inc. | 36987-1474 | INTRADERMAL, SUBCUTANEOUS | 0.05 g in 1 mL | 12/9/2009 | |
Nelco Laboratories, Inc. | 36987-1477 | INTRADERMAL, SUBCUTANEOUS | 0.1 g in 1 mL | 12/9/2009 | |
Deseret Biologicals, Inc. | 43742-2178 | ORAL | 6 [hp_X] in 1 mL | 4/22/2025 | |
King Bio Inc. | 57955-0762 | ORAL | 12 [hp_X] in 59 mL | 5/20/2025 | |
King Bio Inc. | 57955-4809 | ORAL | 12 [hp_X] in 118 mL | 5/2/2025 |
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 |
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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. |
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