Last reviewed · How we verify
sublingual allergen extract
sublingual allergen extract is a Sublingual immunotherapy (SLIT) Biologic drug developed by Medical University of Lodz. It is currently FDA-approved for Allergic rhinitis, Allergic asthma. Also known as: Staloral 300 IR, Stallergenes, France.
Sublingual allergen extract desensitizes the immune system by gradually exposing it to increasing doses of allergen under the tongue, promoting immune tolerance.
Sublingual allergen extract desensitizes the immune system by gradually exposing it to increasing doses of allergen under the tongue, promoting immune tolerance. Used for Allergic rhinitis, Allergic asthma.
At a glance
| Generic name | sublingual allergen extract |
|---|---|
| Also known as | Staloral 300 IR, Stallergenes, France |
| Sponsor | Medical University of Lodz |
| Drug class | Sublingual immunotherapy (SLIT) |
| Modality | Biologic |
| Therapeutic area | Immunology / Allergy |
| Phase | FDA-approved |
Mechanism of action
This immunotherapy works through sublingual immunological tolerance induction, where allergen is placed under the tongue where specialized immune cells (Langerhans cells and dendritic cells) process the antigen and promote regulatory T cell (Treg) development. Over time, repeated exposure leads to a shift from Th2-mediated allergic responses to Th1/Treg-mediated tolerance, reducing allergic symptoms and medication dependence.
Approved indications
- Allergic rhinitis
- Allergic asthma
Common side effects
- Oral pruritus
- Throat irritation
- Local edema
- Gastrointestinal symptoms
Key clinical trials
- Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df (PHASE3)
- Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction (PHASE2)
- Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children (PHASE3)
- Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model (PHASE2)
- Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents (PHASE1)
- Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy (PHASE2)
- Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis
- Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract (PHASE2, 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:
- sublingual allergen extract CI brief — competitive landscape report
- sublingual allergen extract updates RSS · CI watch RSS
- Medical University of Lodz portfolio CI
Frequently asked questions about sublingual allergen extract
What is sublingual allergen extract?
How does sublingual allergen extract work?
What is sublingual allergen extract used for?
Who makes sublingual allergen extract?
Is sublingual allergen extract also known as anything else?
What drug class is sublingual allergen extract in?
What development phase is sublingual allergen extract in?
What are the side effects of sublingual allergen extract?
Related
- Drug class: All Sublingual immunotherapy (SLIT) drugs
- Manufacturer: Medical University of Lodz — full pipeline
- Therapeutic area: All drugs in Immunology / Allergy
- Indication: Drugs for Allergic rhinitis
- Indication: Drugs for Allergic asthma
- Also known as: Staloral 300 IR, Stallergenes, France
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing