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A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

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Trial Profile

A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2024

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At a glance

  • Drugs Momelotinib (Primary) ; Ruxolitinib
  • Indications Myelofibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms Simplify 1
  • Sponsors Gilead Sciences; Sierra Oncology

Most Recent Events

  • 12 Nov 2024 According to a GSK media release, Health Canada has approved Ojjaara (momelotinib) for the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk primary myelofibrosis (MF), post polycythemia vera MF or post essential thrombocythemia MF who have moderate to severe anemia.
  • 01 Sep 2024 Results of sub group analysis(n=15) assessing efficacy and safety of Momelotinib vs. Ruxolitinib in Japanese patients published in the International Journal of Hematology.
  • 24 Jun 2024 According to a GSK Plc media release, based on data from phase 3 MOMENTUM trial (NCT04173494) and phase 3 SIMPLIFY-1 trial (NCT01969838) , Momelotinib has been approved by Japan's Ministry of Health, Labour and Welfare (MHLW) in use for patients with myelofibrosis and anemia.

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