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A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath ENLIVEN

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Trial Profile

A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath ENLIVEN

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jul 2025

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At a glance

  • Drugs Pexidartinib (Primary)
  • Indications Giant cell tumour of tendon sheath; Pigmented villonodular synovitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ENLIVEN; PLX108-10
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 09 Jul 2025 According to a Daiichi Sankyo media release, Long-term efficacy and safety of pexidartinib in patients with tenosynovial giant cell tumor: final results of the ENLIVEN study were published were published in The Oncologist.
  • 09 Jul 2025 According to a Daiichi Sankyo media release, U.S FDA approved TURALIO is the first oral systemic therapy approved in the U.S. for adult patients with TGCT and approval of TURALIO was based on results from the first part of the ENLIVEN phase 3 trial.
  • 09 Jul 2025 Results presented in the Daiichi Sankyo Media Release.

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