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Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study

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Trial Profile

Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs Budesonide (Primary)
  • Indications Eosinophilic oesophagitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ORBIT1
  • Sponsors Shire; Takeda

    • Most Recent Events

    • 12 Feb 2024 According to a Takeda media release, based on results from study 1(NCT02605837) and study 2(NCT01642212), the FDA has approved EOHILIA (budesonide oral suspension), for people 11 years and older with eosinophilic esophagitis (EoE).
    • 01 Dec 2023 Results of pooled post hoc analysis (n=76 from studies NCT01642212 and NCT02605837) assessing efficacy and safety of budesonide oral suspension (BOS) in adolescents with eosinophilic esophagitis published in the Journal of Pediatric Gastroenterology and Nutrition
    • 20 Sep 2023 According to a Takeda media release, company announced that USFDA that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis and company expects a decision from the FDA during the first half of 2024.
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