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Epicutaneous Immunotherapy

Assistance Publique - Hôpitaux de Paris · Phase 2 active Biologic

Epicutaneous Immunotherapy is a Immunotherapy Biologic drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 2 development for Allergic rhinitis, Atopic dermatitis.

Allergen exposure to induce immune tolerance

Allergen exposure to induce immune tolerance Used for Allergic rhinitis, Atopic dermatitis.

Likelihood of approval
16.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameEpicutaneous Immunotherapy
SponsorAssistance Publique - Hôpitaux de Paris
Drug classImmunotherapy
ModalityBiologic
Therapeutic areaImmunology
PhasePhase 2

Mechanism of action

Epicutaneous immunotherapy involves applying small amounts of allergens to the skin to stimulate an immune response, leading to increased tolerance and reduced symptoms in individuals with allergies.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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Frequently asked questions about Epicutaneous Immunotherapy

What is Epicutaneous Immunotherapy?

Epicutaneous Immunotherapy is a Immunotherapy drug developed by Assistance Publique - Hôpitaux de Paris, indicated for Allergic rhinitis, Atopic dermatitis.

How does Epicutaneous Immunotherapy work?

Allergen exposure to induce immune tolerance

What is Epicutaneous Immunotherapy used for?

Epicutaneous Immunotherapy is indicated for Allergic rhinitis, Atopic dermatitis.

Who makes Epicutaneous Immunotherapy?

Epicutaneous Immunotherapy is developed by Assistance Publique - Hôpitaux de Paris (see full Assistance Publique - Hôpitaux de Paris pipeline at /company/assistance-publique-h-pitaux-de-paris).

What drug class is Epicutaneous Immunotherapy in?

Epicutaneous Immunotherapy belongs to the Immunotherapy class. See all Immunotherapy drugs at /class/immunotherapy.

What development phase is Epicutaneous Immunotherapy in?

Epicutaneous Immunotherapy is in Phase 2.

What are the side effects of Epicutaneous Immunotherapy?

Common side effects of Epicutaneous Immunotherapy include Local skin reaction, Systemic allergic reaction.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing