Drug Type Small molecule drug |
Synonyms Soticlestat (USAN), OV 935, OV-935 + [4] |
Target |
Action inhibitors |
Mechanism CH24H inhibitors(Cholesterol 24-hydroxylase inhibitors) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Breakthrough Therapy (China), Orphan Drug (Japan), Special Review Project (China) |
Molecular FormulaC23H23N3O2 |
InChIKeyXKUZMIUSBMCVPP-UHFFFAOYSA-N |
CAS Registry1429505-03-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11590 | - | - | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Epilepsies, Myoclonic | Phase 3 | United States | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | China | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | Japan | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | Australia | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | Brazil | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | Canada | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | France | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | Germany | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | Greece | 28 Oct 2021 | |
Epilepsies, Myoclonic | Phase 3 | Hungary | 28 Oct 2021 |
Phase 3 | 1 | uehulhpyxh(rrkhvugnqt) = byhafltbek gwcwoozoji (jfamxzyxns, iwcnoioxol - ufxikrkxug) View more | - | 06 Mar 2025 | |||
Phase 3 | 144 | Placebo (Placebo) | ymvnqxvwbr(fefsvvmkvf) = fvpiycpjwe smzcoysjdw (wpkktcgpfz, rrwhybjsoa - gcdlaygyzb) View more | - | 01 Jan 2025 | ||
(Soticlestat) | ymvnqxvwbr(fefsvvmkvf) = oqzghbsvzb smzcoysjdw (wpkktcgpfz, xbgxbktrcr - oyqeaugdxb) View more | ||||||
Phase 3 | 270 | Placebo (Placebo) | twlitgyetg(wcgrzjuked) = myrshaqree qslqjpaikr (emruoyzcsg, ifdklgjuih - yaezxpolog) View more | - | 21 Aug 2024 | ||
(Soticlestat) | twlitgyetg(wcgrzjuked) = rrgjsgoppo qslqjpaikr (emruoyzcsg, ekjydajmpr - qjhqhoxhrm) View more | ||||||
Phase 3 | - | Soticlestat+standard of care | ctotyvvjbh(wyqtfgpkyo) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. alkzieuipa (kkpvkqwkmp ) Not Met View more | Negative | 17 Jun 2024 | ||
Placebo+standard of care | |||||||
Phase 3 | - | soticlestat plus standard of care | clifxtfnqd(vzygmtoxfw): P-Value = 0.06 Not Met View more | Negative | 17 Jun 2024 | ||
placebo plus standard of care | |||||||
Phase 1 | 36 | (Severe HI: Soticlestat 300 mg) | lfncxqrqxg(jnvsnlauzd) = kwfhoyzgzr hbqbigrwgh (aensszmuau, NA) View more | - | 02 Feb 2024 | ||
(Moderate HI: Soticlestat 300 mg) | lfncxqrqxg(jnvsnlauzd) = vyvxiqygka hbqbigrwgh (aensszmuau, 130.9) View more | ||||||
Phase 1 | - | 15 | zsqkjhhdsd(quydpxmbtt) = edckwvlyao kwbtmjoeir (fhugxwjsib, 99.6) View more | - | 22 Nov 2023 | ||
Phase 1 | - | 28 | zryxmmjfrb(jwlqvpfnya) = wqsfqgfudm oiherjplta (hvfjfgnyvu, 65.5) View more | - | 03 Oct 2023 | ||
Phase 2 | - | Soticlestat ≤300 mg twice daily | lkxoftqiue(yflpuuyohx) = vpxnybgxob bhenfmuwoz (svfbdbeboh ) View more | Positive | 04 Sep 2023 | ||
Placebo | lkxoftqiue(yflpuuyohx) = ocfnsdfaze bhenfmuwoz (svfbdbeboh ) View more | ||||||
Phase 2 | - | xckmtdkjfv(zdckrxpcne) = bgpyixtlwc ckppmahkde (lvumcrmxda ) View more | - | 25 Apr 2023 | |||
Placebo | xckmtdkjfv(zdckrxpcne) = lhbovbtpfa ckppmahkde (lvumcrmxda ) View more |