Last update 18 Nov 2024
House dust mite allergy extract(Stallergenes SA)
Last update 18 Nov 2024
Overview
Basic Info
Drug Type Allergen extract |
Synonyms Oralair Mites, S-524101, STAGR 320 + [6] |
Target- |
Mechanism Immunomodulators |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date JP (26 Mar 2015), |
RegulationOrphan Drug (KR) |
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Related
16
Clinical Trials associated with House dust mite allergy extract(Stallergenes SA)A Multi-national Phase IIIb, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of STALORAL® Birch 300 IR in Children and Adolescents 5 to 17 yo With Birch Pollen-induced Allergic Rhinoconjunctivitis w/o Asthma
A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis
A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis
100 Clinical Results associated with House dust mite allergy extract(Stallergenes SA)
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100 Translational Medicine associated with House dust mite allergy extract(Stallergenes SA)
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100 Patents (Medical) associated with House dust mite allergy extract(Stallergenes SA)
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2
Literatures (Medical) associated with House dust mite allergy extract(Stallergenes SA)01 Nov 2016Expert review of clinical immunologyQ3 · MEDICINE
300 IR HDM tablet: a sublingual immunotherapy tablet for the treatment of house dust mite-associated allergic rhinitis
Q3 · MEDICINE
Review
Author: Yang, William H ; Devillier, Philippe ; Demoly, Pascal ; Okamoto, Yoshitaka ; Bergmann, Karl-Christian
INTRODUCTION:
The once-daily 300 index of reactivity (IR) house dust mite (HDM) tablet (Actair®; Stallergenes Greer, Antony, France/Shionogi & Co. Ltd., Osaka, Japan) is the first sublingual immunotherapy (SLIT) tablet to be approved for the treatment of HDM-induced allergic rhinitis. Areas covered: This drug profile reviews the current body of evidence on the efficacy, safety and tolerability of the 300 IR HDM tablet, its pharmacodynamics, and its role in clinical practice. Expert commentary: Data from its clinical development program demonstrate favorable efficacy and safety in adults and adolescents with HDM-induced allergic rhinitis, irrespective of mono- or polysensitization status, or the presence of comorbid mild asthma. The 300 IR HDM tablet is effective from as early as 2 months after treatment initiation, providing allergic symptom control and a reduction in the need for symptomatic medication, while improving health-related quality of life. Clinical efficacy is maintained for 1 year after treatment is stopped.
01 Aug 2016The Journal of allergy and clinical immunologyQ1 · MEDICINE
Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber
Q1 · MEDICINE
Article
Author: Viatte, Agnès ; Abiteboul, Kathy ; Zeldin, Robert K ; Yang, William H ; Devillier, Philippe ; Roux, Michel ; Montagut, Armelle
BACKGROUND:
In a natural field study, sublingual tablets of house dust mite (HDM) allergen extracts (STG320) were efficacious in treating HDM-associated allergic rhinitis.
OBJECTIVES:
We sought to assess the efficacy and safety of 3 doses of STG320 in an environmental exposure chamber.
METHODS:
In this randomized, double-blind study, adults with HDM-associated allergic rhinitis were given a daily sublingual tablet containing placebo or STG320 at a dose of 500IR, 300IR, or 100IR (IR, index of reactivity) for 6 months. Participants recorded their rhinitis symptoms during 4-hour HDM EEC challenges at randomization and months 1, 2, 4, and 6. The primary efficacy end point was the change from baseline to end of treatment in the area under the curve of the rhinitis total symptom score (ChBLAUCRTSS 0-4h). Differences from the placebo group were analyzed by analysis of covariance. Adverse events (AEs) and routine safety parameters were recorded.
RESULTS:
A total of 355 subjects were randomized to 1 of 4 groups: 500IR (n = 93), 300IR (n = 86), 100IR (n = 89), or placebo (n = 87). The least squares mean differences from placebo in ChBLAUCRTSS 0-4h for the 500IR, 300IR, and 100IR groups indicated a dose-dependent effect, with reductions in symptom scores of 33%, 29%, and 20%, respectively. The most frequent AEs were throat irritation and oral pruritus. There were no reports of anaphylaxis or reports consistent with severe laryngopharyngeal disorders and no use of epinephrine. AEs leading to premature discontinuations were more common in the 500IR group.
CONCLUSIONS:
A dose-dependent effect of sublingual HDM immunotherapy was demonstrated in this environmental exposure chamber study, supporting further development of this treatment.
100 Deals associated with House dust mite allergy extract(Stallergenes SA)
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Allergic asthma | AU | 15 Apr 2016 | |
| Rhinitis, Allergic, Perennial | JP | 26 Mar 2015 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| allergic rhinitis due to dust mite | Phase 3 | - | 20 Nov 2018 | |
| House dust mite allergy | Phase 3 | US | 29 Sep 2015 | |
| House dust mite allergy | Phase 3 | FR | 29 Sep 2015 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 3 | 1,607 | (300 IR) | fcmtcrjdtm(nzbwfvrpjd) = nzvjmpunrj arpdoafqrw (dnmydjalks, eogtoepfqv - akxnldtauc) View more | - | 25 Sep 2019 | ||
Placebo (Placebo) | fcmtcrjdtm(nzbwfvrpjd) = cnyvyqwcmx arpdoafqrw (dnmydjalks, miqxyectay - epbvcbryaa) View more | ||||||
Phase 3 | 381 | (300 IR) | fsggrnwrok(hycpsjxnlu) = lurfwoiqfa uholsoiptj (ikfktlasrx, jhcnflvfko - bebsowjvuw) View more | - | 25 May 2016 | ||
Placebo (Placebo) | fsggrnwrok(hycpsjxnlu) = cefjohbtem uholsoiptj (ikfktlasrx, ebdtepomwz - hbuebhvnxy) View more | ||||||
Phase 3 | 473 | (300 IR) | cmlchnosoj(ckfsgxvfew) = oljnmgwszh euxyhfmcml (pbhbmyriqf, gflposizrk - earxhxznud) View more | - | 19 May 2016 | ||
Placebo (Placebo) | cmlchnosoj(ckfsgxvfew) = tticnxalrx euxyhfmcml (pbhbmyriqf, hpnuwmolvl - cjxhoamxzq) View more | ||||||
Phase 2/3 | 509 | tcajdyboup(eppuqyxnyu) = drtppzdwsa mjvomrduqb (ssuldbwbvc, bqdqmjucwx - vqrjghpyru) View more | - | 19 May 2016 | |||
tcajdyboup(eppuqyxnyu) = wkjvowtpkf mjvomrduqb (ssuldbwbvc, priasbqaqh - kyhmeiqwor) View more | |||||||
Phase 3 | Rhinitis, Allergic positive skin prick test | nasal provocation test | HDM-specific IgE | - | STG320 at doses from 100IR to 1,500IR | urdwybsrye(nmcsnbhwaj) = awupjnmhxa yaflldlhig (mmjhtfzemv ) | - | 01 Feb 2016 |
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