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A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)

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Trial Profile

A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2024

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At a glance

  • Drugs Condoliase (Primary)
  • Indications Intervertebral disc displacement
  • Focus Registrational; Therapeutic Use
  • Acronyms Discovery 6603
  • Sponsors Seikagaku Corporation

    • Most Recent Events

    • 02 Dec 2024 According to a Ferring Pharmaceuticals media release, Seikagaku Corporation and Ferring Pharmaceuticals announces intention to hold a meeting with the Anesthetic and Analgesic Drug Products Advisory Committee of the US FDA to review data supporting the BLA of condoliase for Intervertebral disc displacement in Jan 2025.
    • 01 Dec 2024 According to Seikagaku Corporation media release, A Biologics License Application (BLA) has been accepted for filing by the U.S. Food and Drug Administration (FDA), which means that SI-6603 is now a step away from release in the U.S. market.
    • 25 Sep 2024 Results published in a Ferring Pharmaceuticals Media Release

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