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Efficacy and Safety of New Oral Budesonide-MMX (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-Blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol 2400 mg

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Trial Profile

Efficacy and Safety of New Oral Budesonide-MMX (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-Blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol 2400 mg

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2023

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At a glance

  • Drugs Budesonide (Primary) ; Mesalazine
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms CORE-1
  • Sponsors Bausch Health Companies; Salix Pharmaceuticals

Most Recent Events

  • 28 Jun 2023 According to a Cosmo Pharmaceuticals media release, Ferring Pharmaceuticals has received the approval for Cortiment (budesonide 9 mg MMX tablets) in Japan by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
  • 23 Jun 2022 According to a Cosmo Pharmaceuticals media release, the ferring pharmaceuticals has submitted the NDA of Cortiment MMX (budesonide), for Japan on June 23, 2022, and the application has been accepted by PMDA (Pharmaceuticals and Medical Devices Agency). The review is expected to last approximately a year.
  • 16 Oct 2013 Pooled results presented at the 21st United European Gastroenterology Week.

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