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PURETHAL Birch, 20.000 AUM/ml
PURETHAL Birch is an allergen extract that desensitizes the immune system to birch pollen through gradual exposure, reducing allergic responses.
PURETHAL Birch is an allergen extract that desensitizes the immune system to birch pollen through gradual exposure, reducing allergic responses. Used for Birch pollen-induced allergic rhinitis and/or allergic asthma.
At a glance
| Generic name | PURETHAL Birch, 20.000 AUM/ml |
|---|---|
| Sponsor | HAL Allergy |
| Drug class | Allergen immunotherapy extract |
| Target | Birch pollen allergens (Bet v 1 and related proteins) |
| Modality | Biologic |
| Therapeutic area | Immunology / Allergy |
| Phase | FDA-approved |
Mechanism of action
This is an allergen immunotherapy (AIT) product containing standardized birch pollen extract. It works by inducing immune tolerance through repeated subcutaneous administration of increasing doses of the allergen, shifting the immune response from Th2-mediated (allergic) to Th1/Treg-mediated (tolerant) pathways. Over time, this reduces IgE-mediated reactions and increases IgG-blocking antibodies, thereby decreasing symptoms upon natural allergen exposure.
Approved indications
- Birch pollen-induced allergic rhinitis and/or allergic asthma
Common side effects
- Local injection site reactions (erythema, swelling, pruritus)
- Systemic allergic reactions (mild to moderate)
- Anaphylaxis
- Itching or swelling of mouth/throat
Key clinical trials
- PURETHAL Birch RUSH Study (PHASE4)
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 Birch, 20.000 AUM/ml CI brief — competitive landscape report
- PURETHAL Birch, 20.000 AUM/ml updates RSS · CI watch RSS
- HAL Allergy portfolio CI