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SUBLIVAC FIX Birch
SUBLIVAC FIX Birch is a sublingual immunotherapy that desensitizes the immune system to birch pollen allergens through gradual exposure under the tongue.
SUBLIVAC FIX Birch is a sublingual immunotherapy that desensitizes the immune system to birch pollen allergens through gradual exposure under the tongue. Used for Birch pollen-induced allergic rhinitis and/or allergic asthma.
At a glance
| Generic name | SUBLIVAC FIX Birch |
|---|---|
| Sponsor | HAL Allergy |
| Drug class | Sublingual immunotherapy (SLIT) |
| Target | Birch pollen allergens (Bet v 1 and related epitopes) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy |
| Phase | Phase 3 |
Mechanism of action
This is an allergen immunotherapy product administered sublingually (under the tongue) containing birch pollen extract. It works by inducing immune tolerance to birch allergens through repeated low-dose exposure, shifting the immune response from allergic (Th2-mediated) to tolerant (Treg-mediated), thereby reducing allergic symptoms upon natural exposure to birch pollen.
Approved indications
- Birch pollen-induced allergic rhinitis and/or allergic asthma
Common side effects
- Oral pruritus (itching in mouth)
- Throat irritation
- Edema of mouth/lips
- Local allergic reactions at administration site
Key clinical trials
- SUBLIVAC FIX Birch Phase III Short-term Efficacy (PHASE3)
- SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding (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 |