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Staloral
Staloral is a Small molecule drug developed by Stallergenes Greer. It is currently in Phase 3 development.
Staloral is a sublingual immunotherapy used to treat conditions such as allergy, bronchial asthma, and allergic rhinitis, specifically in patients allergic to house-dust mites. It is administered via a sublingual applicator, either as Staloral itself or a placebo, in a randomized, double-blind, placebo-controlled study.
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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).
| 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 | Staloral |
|---|---|
| Sponsor | Stallergenes Greer |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma (PHASE3)
- 4"S" - Seasonal Symptoms Suppression Study (PHASE4)
- A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy (PHASE4)
- Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites (PHASE4)
- POLlinosis and Exhaled Breath Temperature (PHASE4)
- Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis (PHASE3)
- House Dust Mite SLIT in Elderly Patients (PHASE4)
- SUBLIVAC® Birch PROBE Study (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:
- Staloral CI brief — competitive landscape report
- Staloral updates RSS · CI watch RSS
- Stallergenes Greer portfolio CI
Frequently asked questions about Staloral
What is Staloral?
Who makes Staloral?
What development phase is Staloral in?
Related
- Manufacturer: Stallergenes Greer — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing