A Comprehensive Monograph on Corn Allergenic Extract (DB10572): Biochemical Profile, Clinical Utility, and Regulatory Status

Executive Summary

This report provides a comprehensive analysis of Corn Allergenic Extract, identified by DrugBank Accession Number DB10572. This substance is not a conventional synthetic drug but a complex biological product classified as a Non-Standardized Food Allergenic Extract derived from Zea mays. Its primary clinical utility lies in the diagnosis of IgE-mediated corn allergy through skin testing and, in select cases, for therapeutic use in allergen-specific immunotherapy (AIT) to induce hyposensitization. The allergenic activity of the extract is attributed to a complex proteome, with the Lipid Transfer Protein (LTP), Zea m 14, identified as the major allergen responsible for severe, systemic reactions due to its high stability against heat and gastrointestinal digestion.

The clinical application of Corn Allergenic Extract is governed by a significant and life-threatening safety risk: anaphylaxis. Consequently, all non-standardized allergenic extracts carry a U.S. Food and Drug Administration (FDA) Boxed Warning. Administration is strictly limited to medical settings equipped to manage anaphylaxis, and the product is contraindicated in patients with severe or uncontrolled asthma and those using beta-blocker medications, which can render anaphylaxis treatment ineffective.