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Timothy, Phleum pretense
Timothy, Phleum pretense is a Biologic drug developed by Turku University Hospital. It is currently in Phase 3 development for Allergic rhinitis.
Timothy, Phleum pretense is a plant-based treatment that has been studied for its potential effects on the immune system.
Timothy, Phleum pretense, is a substance used in a grass sublingual immunotherapy (SLIT) treatment, specifically Grastek. This treatment is studied for its effects on allergic rhinoconjunctivitis, including allergic rhinitis induced by birch pollen.
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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 | Timothy, Phleum pretense |
|---|---|
| Sponsor | Turku University Hospital |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
While the exact mechanism of action is not well understood, Timothy, Phleum pretense has been investigated for its potential anti-inflammatory properties and its ability to modulate the immune response.
Approved indications
- Allergic rhinitis
Common side effects
- Gastrointestinal upset
Key clinical trials
- The Impact of Grass SLIT Treatment on Birch Pollen Induced Allergic Rhinitis - a Pilot Evaluation (PHASE4)
- Tonsillar Cytokine Expression After Allergen and/or Virus Intervention (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:
- Timothy, Phleum pretense CI brief — competitive landscape report
- Timothy, Phleum pretense updates RSS · CI watch RSS
- Turku University Hospital portfolio CI
Frequently asked questions about Timothy, Phleum pretense
What is Timothy, Phleum pretense?
How does Timothy, Phleum pretense work?
What is Timothy, Phleum pretense used for?
Who makes Timothy, Phleum pretense?
What development phase is Timothy, Phleum pretense in?
What are the side effects of Timothy, Phleum pretense?
Related
- Manufacturer: Turku University Hospital — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Allergic rhinitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing