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Purethal Mites
Purethal Mites is a Allergen immunotherapy Biologic drug developed by Medical University of Silesia. It is currently in Phase 3 development for Allergic rhinitis and/or asthma induced by dust mite allergens.
Purethal Mites is an allergen immunotherapy product designed to desensitize patients to dust mite allergens through controlled exposure.
Purethal Mites is an allergen immunotherapy product designed to desensitize patients to dust mite allergens through controlled exposure. Used for Allergic rhinitis and/or asthma induced by dust mite allergens.
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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 | Purethal Mites |
|---|---|
| Sponsor | Medical University of Silesia |
| Drug class | Allergen immunotherapy |
| Target | Dust mite allergen proteins (Der p 1, Der p 2, and related epitopes) |
| Modality | Biologic |
| Therapeutic area | Immunology / Allergy |
| Phase | Phase 3 |
Mechanism of action
This is an allergen extract-based immunotherapy that works by gradually exposing patients to standardized dust mite allergen components, promoting immune tolerance and reducing allergic responses. The mechanism involves shifting the immune response from Th2-mediated (allergic) to Th1-mediated (tolerant) pathways, potentially involving regulatory T cell induction and IgG blocking antibody production.
Approved indications
- Allergic rhinitis and/or asthma induced by dust mite allergens
Common side effects
- Local injection site reactions (itching, swelling, erythema)
- Oral pruritus or throat irritation
- Systemic allergic reactions
- Rhinitis or asthma exacerbation
Key clinical trials
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy of PURETHAL Mites Mixture 50,000 AUeq/mL Subcutaneous Immunotherapy in Adult Subjects With Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma Induced by House Dust Mite (HDM) (PHASE3)
- House Dust Mite Injection Immunotherapy in Elderly Patients. (PHASE3)
- PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis (PHASE2)
- Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients (PHASE2)
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:
- Purethal Mites CI brief — competitive landscape report
- Purethal Mites updates RSS · CI watch RSS
- Medical University of Silesia portfolio CI
Frequently asked questions about Purethal Mites
What is Purethal Mites?
How does Purethal Mites work?
What is Purethal Mites used for?
Who makes Purethal Mites?
What drug class is Purethal Mites in?
What development phase is Purethal Mites in?
What are the side effects of Purethal Mites?
What does Purethal Mites target?
Related
- Drug class: All Allergen immunotherapy drugs
- Target: All drugs targeting Dust mite allergen proteins (Der p 1, Der p 2, and related epitopes)
- Manufacturer: Medical University of Silesia — full pipeline
- Therapeutic area: All drugs in Immunology / Allergy
- Indication: Drugs for Allergic rhinitis and/or asthma induced by dust mite allergens
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing