Drug Profile

Soticlestat - Takeda

Alternative Names: OV-935; TAK 935

Latest Information Update: 24 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

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

03 Oct 2025 Takeda terminates the phase III ENDYMION 2 trial in Dravet syndrome and Lennox-Gastaut Syndrome (Adjunctive treatment, In adolescents, In children, In adults) in USA, Australia, Belgium, China, France, Greece, Hungary, Italy, Japan, Latvia, the Netherlands, Poland, Serbia, Spain, Canada, Russia, Ukraine, Brazil, Germany, and Mexico (PO) since supplementary data from the trial is no longer necessary (NCT05163314) (CTIS-002482-17)
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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