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Soticlestat - Takeda

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Drug Profile

Soticlestat - Takeda

Alternative Names: OV-935; TAK 935

Latest Information Update: 14 Oct 2025

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At a glance

  • Originator Takeda
  • Class Analgesics; Antiepileptic drugs; Heterocyclic compounds; Piperidines; Pyridines; Small molecules
  • Mechanism of Action Cholesterol 24-hydroxylase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Lennox-Gastaut syndrome; Dravet syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Discontinued Complex regional pain syndromes; Dravet syndrome; Lennox-Gastaut syndrome

Most Recent Events

  • 14 Oct 2025 CTP Push 297820: updated trial termination info in KDM and HE added
  • 30 Jul 2025 Takeda terminates the Phase-II clinical trials in Myoclonic epilepsies, Lennox-Gastaut syndrome and Dravet syndrome (Adjunctive treatment, In adolescents, In adults, In children) in USA, Australia, Canada, China, Israel, Portugal, Poland, Spain due to negative results from the phase III trials and unrelated to patient safety it has been determined that supplementary data from the study is no longer necessary (PO) (NCT03635073)
  • 10 Feb 2025 Discontinued - Phase-II for Complex regional pain syndromes (Adjunctive treatment) in United Kingdom (PO) prior to February 2025 (Takeda Pipeline, February 2025)

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