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Allergen Immunotherapy Extract
Allergen Immunotherapy Extract is a Allergen immunotherapy Small molecule drug developed by Johns Hopkins University. It is currently in Phase 3 development for Allergic rhinitis, Allergic asthma, Atopic dermatitis. Also known as: ORALTEK®.
Allergen immunotherapy extract desensitizes the immune system to specific allergens by gradually exposing patients to increasing doses, promoting immune tolerance and reducing allergic responses.
Allergen immunotherapy extract desensitizes the immune system to specific allergens by gradually exposing patients to increasing doses, promoting immune tolerance and reducing allergic responses. Used for Allergic rhinitis, Allergic asthma, Atopic dermatitis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Allergen Immunotherapy Extract |
|---|---|
| Also known as | ORALTEK® |
| Sponsor | Johns Hopkins University |
| Drug class | Allergen immunotherapy |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
The extract contains standardized allergen proteins that are administered in gradually increasing doses to shift the immune response from IgE-mediated (allergic) to IgG-mediated (tolerant) pathways. This process induces regulatory T cells and reduces mast cell and basophil reactivity to the allergen, thereby decreasing symptoms upon natural allergen exposure.
Approved indications
- Allergic rhinitis
- Allergic asthma
- Atopic dermatitis
Common side effects
- Local injection site reactions (erythema, swelling, pruritus)
- Systemic allergic reactions
- Anaphylaxis
- Oral pruritus
Key clinical trials
- Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df (PHASE3)
- Dietary Supplement (Beta-Glucans) in Allergic Patients Undergoing Subcutaneous Immunotherapy. (PHASE4)
- Documentation of Efficacy of Intralymphatic Allergen Immunotherapy (PHASE3)
- Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction (PHASE2)
- Long Term Effect of AIT in Children
- Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study (EARLY_PHASE1)
- Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract (PHASE1, PHASE2)
- Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses. (PHASE3)
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:
- Allergen Immunotherapy Extract CI brief — competitive landscape report
- Allergen Immunotherapy Extract updates RSS · CI watch RSS
- Johns Hopkins University portfolio CI
Frequently asked questions about Allergen Immunotherapy Extract
What is Allergen Immunotherapy Extract?
How does Allergen Immunotherapy Extract work?
What is Allergen Immunotherapy Extract used for?
Who makes Allergen Immunotherapy Extract?
Is Allergen Immunotherapy Extract also known as anything else?
What drug class is Allergen Immunotherapy Extract in?
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Related
- Drug class: All Allergen immunotherapy drugs
- Manufacturer: Johns Hopkins University — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Allergic rhinitis
- Indication: Drugs for Allergic asthma
- Indication: Drugs for Atopic dermatitis
- Also known as: ORALTEK®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing