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A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis

Trial Profile

A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2021

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At a glance

  • Drugs House dust mite allergy immunotherapy (Primary)
  • Indications Perennial allergic rhinitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Shionogi
  • Most Recent Events

    • 16 Feb 2018 According to a Stallergenes Greer media release, based on the data of this study, Shionogi has received an approval for the ACTAIR, an allergy immunotherapy sublingual tablet for the treatment of house dust mite (HDM) induced allergic rhinitis, to treat patients under the age of 12. The drug was already approved for HDM in Japan in patients above the age of 12 years since march 2015.
    • 15 Jan 2018 Status changed from active, no longer recruiting to completed.
    • 28 Mar 2017 According to a Stallergenes Greer plc media release, a New Drug Application (NDA) for ACTAIR, an investigational allergy immunotherapy sublingual tablet, for the treatment of house dust mite (HDM) induced allergic rhinitis in children 5 to 11 years old has been submitted in Japan. The submission is based on data from this trial.
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