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immunotherapy Staloral
immunotherapy Staloral is a Sublingual immunotherapy (SLIT) Small molecule drug developed by Medical University of Silesia. It is currently FDA-approved for Allergic rhinitis and/or allergic asthma caused by grass pollen allergens, Allergic rhinitis and/or allergic asthma caused by tree pollen allergens.
Staloral is a sublingual immunotherapy that desensitizes the immune system to allergens by inducing immune tolerance through repeated exposure to gradually increasing allergen doses.
Staloral is a sublingual immunotherapy that desensitizes the immune system to allergens by inducing immune tolerance through repeated exposure to gradually increasing allergen doses. Used for Allergic rhinitis and/or allergic asthma caused by grass pollen allergens, Allergic rhinitis and/or allergic asthma caused by tree pollen allergens.
At a glance
| Generic name | immunotherapy Staloral |
|---|---|
| Sponsor | Medical University of Silesia |
| Drug class | Sublingual immunotherapy (SLIT) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy |
| Phase | FDA-approved |
Mechanism of action
Staloral works by administering small, increasing doses of allergen extract under the tongue, which promotes a shift from Th2-mediated allergic responses to Th1/Treg-mediated tolerance. This sublingual immunotherapy (SLIT) approach allows for gradual immune system adaptation to the allergen, reducing allergic symptoms and the need for symptomatic medications over time.
Approved indications
- Allergic rhinitis and/or allergic asthma caused by grass pollen allergens
- Allergic rhinitis and/or allergic asthma caused by tree pollen allergens
Common side effects
- Oral pruritus
- Throat irritation
- Mouth edema
- Ear pruritus
- Gastrointestinal symptoms
Key clinical trials
- 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)
- 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:
- immunotherapy Staloral CI brief — competitive landscape report
- immunotherapy Staloral updates RSS · CI watch RSS
- Medical University of Silesia portfolio CI
Frequently asked questions about immunotherapy Staloral
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Related
- Drug class: All Sublingual immunotherapy (SLIT) drugs
- Manufacturer: Medical University of Silesia — full pipeline
- Therapeutic area: All drugs in Immunology / Allergy
- Indication: Drugs for Allergic rhinitis and/or allergic asthma caused by grass pollen allergens
- Indication: Drugs for Allergic rhinitis and/or allergic asthma caused by tree pollen allergens
- Compare: immunotherapy Staloral vs similar drugs
- Pricing: immunotherapy Staloral cost, discount & access