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Direct Oral challenge
Direct Oral challenge is a Small molecule drug developed by Johns Hopkins University. It is currently FDA-approved for Confirmation of suspected food allergy, Confirmation of suspected drug allergy or intolerance, Assessment of allergic reaction severity.
Direct oral challenge is a diagnostic procedure that administers an allergen or suspected trigger orally under controlled medical supervision to assess allergic or adverse reactions.
Direct oral challenge is a diagnostic procedure that administers an allergen or suspected trigger orally under controlled medical supervision to assess allergic or adverse reactions. Used for Confirmation of suspected food allergy, Confirmation of suspected drug allergy or intolerance, Assessment of allergic reaction severity.
At a glance
| Generic name | Direct Oral challenge |
|---|---|
| Sponsor | Johns Hopkins University |
| Modality | Small molecule |
| Therapeutic area | Allergy/Immunology |
| Phase | FDA-approved |
Mechanism of action
This is a clinical diagnostic test rather than a therapeutic drug. The procedure involves giving a patient a measured dose of a suspected allergen or food/drug trigger by mouth while monitoring for objective signs of reaction (rash, respiratory changes, gastrointestinal symptoms, etc.). It is used to confirm or rule out IgE-mediated allergies, food intolerances, or drug sensitivities when history and skin/serological testing are inconclusive.
Approved indications
- Confirmation of suspected food allergy
- Confirmation of suspected drug allergy or intolerance
- Assessment of allergic reaction severity
Common side effects
- Allergic reaction (urticaria, angioedema, anaphylaxis)
- Gastrointestinal symptoms (nausea, vomiting, abdominal pain)
- Respiratory symptoms (wheezing, dyspnea)
Key clinical trials
- Hemodynamic Monitoring and Fluid Responsiveness in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO) - "HemodynamECMOnitoring-VA Study" (NA)
- Hemodynamic Monitoring and Fluid Responsiveness in Venovenous Extracorporeal Membrane Oxygenation (VV ECMO) - "HemodynamECMOnitoring-VV Study" (NA)
- Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy (NA)
- Geisinger Antibiotic Allergy Pilot Program: Assess and Address (EARLY_PHASE1)
- Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy (NA)
- Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy
- Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge (PHASE3)
- Food Challenge at Home or in Medical Practice - the FoodCHOMP Study (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Direct Oral challenge CI brief — competitive landscape report
- Direct Oral challenge updates RSS · CI watch RSS
- Johns Hopkins University portfolio CI
Frequently asked questions about Direct Oral challenge
What is Direct Oral challenge?
How does Direct Oral challenge work?
What is Direct Oral challenge used for?
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What development phase is Direct Oral challenge in?
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Related
- Manufacturer: Johns Hopkins University — full pipeline
- Therapeutic area: All drugs in Allergy/Immunology
- Indication: Drugs for Confirmation of suspected food allergy
- Indication: Drugs for Confirmation of suspected drug allergy or intolerance
- Indication: Drugs for Assessment of allergic reaction severity
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing