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Recombinant birch pollen
Recombinant birch pollen is a Allergen immunotherapy Biologic drug developed by Allergopharma GmbH & Co. KG. It is currently in Phase 3 development for Birch pollen-induced allergic rhinitis and/or allergic asthma.
Recombinant birch pollen allergen extract desensitizes the immune system to birch pollen through repeated controlled exposure, reducing allergic responses.
Recombinant birch pollen is being studied as a potential treatment for various allergic conditions, including seasonal allergic rhinitis and birch pollen-related rhinoconjunctivitis. The recombinant birch pollen, known as GNR-127, is administered in different doses (20 mcg, 40 mcg, and 80 mcg) to evaluate its efficacy, safety, and immunogenicity.
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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 | Recombinant birch pollen |
|---|---|
| Sponsor | Allergopharma GmbH & Co. KG |
| Drug class | Allergen immunotherapy |
| Target | Birch pollen allergens (Bet v 1 and related epitopes) |
| Modality | Biologic |
| Therapeutic area | Immunology / Allergy |
| Phase | Phase 3 |
Mechanism of action
This recombinant allergen immunotherapy product contains engineered birch pollen proteins designed to induce immune tolerance. By administering gradually increasing doses of the recombinant allergen, the therapy shifts the immune response from IgE-mediated (allergic) to regulatory T cell-mediated tolerance, thereby reducing symptoms upon natural birch pollen 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
- Oral allergy syndrome
- Rhinitis symptoms
Key clinical trials
- A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis. (PHASE1, PHASE2)
- Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy (PHASE2)
- Skin Testing With Recombinant Bet v 1 and Hypoallergenic Recombinant Bet v 1 Fragments
- Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal Rhinoconjunctivitis (PHASE2)
- Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative (PHASE2)
- Efficacy and Safety From a Recombinant Folding Variant of Bet v 1 (PHASE3)
- Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1 (PHASE1)
- Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis (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:
- Recombinant birch pollen CI brief — competitive landscape report
- Recombinant birch pollen updates RSS · CI watch RSS
- Allergopharma GmbH & Co. KG portfolio CI
Frequently asked questions about Recombinant birch pollen
What is Recombinant birch pollen?
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What is Recombinant birch pollen used for?
Who makes Recombinant birch pollen?
What drug class is Recombinant birch pollen in?
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What does Recombinant birch pollen target?
Related
- Drug class: All Allergen immunotherapy drugs
- Target: All drugs targeting Birch pollen allergens (Bet v 1 and related epitopes)
- Manufacturer: Allergopharma GmbH & Co. KG — full pipeline
- Therapeutic area: All drugs in Immunology / Allergy
- Indication: Drugs for Birch pollen-induced allergic rhinitis and/or allergic asthma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing