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A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

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Trial Profile

A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2025

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At a glance

  • Drugs Vimseltinib (Primary)
  • Indications Giant cell tumour of tendon sheath
  • Focus Registrational; Therapeutic Use
  • Acronyms MOTION
  • Sponsors Deciphera Pharmaceuticals

Most Recent Events

  • 28 Jul 2025 According to Deciphera Pharmaceuticals media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of vimseltinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT), European Commission decision is expected in the second quarter of the fiscal year ending March 31, 2026. The positive CHMP opinion is supported by results from this and the phase 1/2 study.
  • 24 Feb 2025 Study design has been amended (Crossover has been implemented ).
  • 14 Feb 2025 According to an Ono Pharmaceutical media release,company announced that the U.S. Food and Drug Administration (FDA) has approved ROMVIMZA (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity based on this trial

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