Drugs / Soticlestat
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT05602818 | Nov 2022 → Jun 2023 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05309902 | Oct → Dec 2022 | — | Takeda | Withdrawn | No outcome recorded |
| Phase 1 | NCT05284760 | Mar → May 2022 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05098041 | Nov 2021 → Feb 2022 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05098054 | Oct 2021 → May 2022 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05064449 | Oct → Nov 2021 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04461483 | Aug → Nov 2020 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04992442 | Jul → Aug 2020 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02906813 | Sep → Oct 2016 | — | Takeda | Completed | Mixed |
| Phase 1 | NCT02539134 | Sep 2015 → Apr 2016 | epilepsy | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02497235 | Jul → Dec 2015 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02201056 | Jul 2014 → Jul 2015 | — | Takeda | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03166215 | Aug 2017 → Sep 2018 | developmental and epileptic encephalopathy | Takeda | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03990649 | Jul 2019 → Jun 2020 | complex regional pain syndrome | Millennium Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 2 | NCT03694275 | Sep 2018 → Jul 2020 | CDKL5 disorder, partial duplication of the long arm of chromosome 15 | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT03650452 | Aug 2018 → Jun 2020 | Dravet syndrome, Lennox-Gastaut syndrome | Takeda | Completed | Met primary |
| Phase 2 | NCT03635073 | Jul 2018 → Jul 2025 | Dravet syndrome, Lennox-Gastaut syndrome | Takeda | Terminated | No outcome recorded |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT06422377 | Apr → Aug 2024 | Dravet syndrome, Lennox-Gastaut syndrome | Takeda | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05163314 | Mar 2022 → Sep 2025 | Dravet syndrome, Lennox-Gastaut syndrome | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT04938427 | Nov 2021 → Jan 2024 | Lennox-Gastaut syndrome | Takeda | Completed | Missed primary |
| Phase 3 | NCT04940624 | Oct 2021 → Apr 2024 | Dravet syndrome | Takeda | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-06-17 | Takeda | Results Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome takeda.com ↗
Soticlestat narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo (p-value = 0.06). |
| 2020-08-25 | Takeda | Results Phase 2 ELEKTRA Study of Soticlestat (TAK-935/OV935) Meets Primary Endpoint Reducing Seizure Frequency in Children with Dravet Syndrome or Lennox-Gastaut Syndrome takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) and Ovid Therapeutics Inc. (NASDAQ: OVID) (“Ovid”), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced positive topline results from the randomized Phase 2 ELEKTRA study of soticlestat in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). |
All press releases naming this drug 6 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Soticlestat | “A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet...” PMID 35841234 ↗ Aug 202213“Soticlestat tablets twice daily (BID) orally or via gastrostomy tube (G-tube)/ percutaneous endoscopic gastrostomy (PEG) tube, BID.” NCT03694275 ↗ |
| Known as | OV-935 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298172 ↗ |
| Known as | TAK-935 | “Evaluating the Abuse Potential of Soticlestat (TAK-935) in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System Depressant Experience” NCT05602818 ↗10“The drug being tested in this study is called soticlestat (TAK-935).” NCT05163314 ↗ “The drug being tested in this study is called soticlestat (TAK-935).” NCT05284760 ↗ “The drug being tested in this study is called soticlestat (TAK-935).” NCT04940624 ↗ |
| Action | Inhibit | “Cholesterol 24-hydroxylase inhibitor” CHEMBL4298172 ↗ |
| Modality | Small molecule | — CHEMBL4298172 ↗ |
| Route | Oral | “when administered as a single dose of oral solution” NCT02201056 ↗ |
| Target | CYP46A1 | “Cholesterol 24-hydroxylase inhibitor” CHEMBL4298172 ↗ |