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Staloral 300
Staloral 300 is an allergen immunotherapy that desensitizes the immune system to grass pollen allergens through sublingual administration.
Staloral 300 is an allergen immunotherapy that desensitizes the immune system to grass pollen allergens through sublingual administration. Used for Grass pollen-induced allergic rhinitis, Grass pollen-induced allergic asthma.
At a glance
| Generic name | Staloral 300 |
|---|---|
| Sponsor | Medical University of Lodz |
| Drug class | Allergen immunotherapy (sublingual tablet) |
| Target | Grass pollen allergens (Phleum pratense and related species) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy |
| Phase | FDA-approved |
Mechanism of action
Staloral is a sublingual immunotherapy (SLIT) tablet containing standardized grass pollen allergen extract. It works by gradually exposing the immune system to increasing doses of the allergen, promoting immune tolerance through induction of regulatory T cells and shift toward Th1/Treg responses. This reduces allergic symptoms and the need for symptomatic medications in patients with grass pollen-induced allergic rhinitis and asthma.
Approved indications
- Grass pollen-induced allergic rhinitis
- Grass pollen-induced allergic asthma
Common side effects
- Oral pruritus
- Throat irritation
- Ear pruritus
- Mouth edema
- Gastrointestinal symptoms
Key clinical trials
- Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma (PHASE3)
- 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)
- A Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Asthmatic Patients Allergic to House-dust Mites (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:
- Staloral 300 CI brief — competitive landscape report
- Staloral 300 updates RSS · CI watch RSS
- Medical University of Lodz portfolio CI