Drug Type Small molecule drug |
Synonyms Soticlestat (USAN), OV 935, OV-935 + [4] |
Target |
Mechanism CH24H inhibitors(Cholesterol 24-hydroxylase inhibitors) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (US), Breakthrough Therapy (CN), Special Review Project (CN) |
Molecular FormulaC23H23N3O2 |
InChIKeyXKUZMIUSBMCVPP-UHFFFAOYSA-N |
CAS Registry1429505-03-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11590 | - | - | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Seizures | Phase 3 | US | 04 Mar 2022 | |
Seizures | Phase 3 | US | 04 Mar 2022 | |
Seizures | Phase 3 | US | 04 Mar 2022 | |
Seizures | Phase 3 | JP | 04 Mar 2022 | |
Seizures | Phase 3 | JP | 04 Mar 2022 | |
Seizures | Phase 3 | JP | 04 Mar 2022 | |
Seizures | Phase 3 | AU | 04 Mar 2022 | |
Seizures | Phase 3 | AU | 04 Mar 2022 | |
Seizures | Phase 3 | AU | 04 Mar 2022 | |
Seizures | Phase 3 | BE | 04 Mar 2022 |
Phase 3 | 270 | Placebo (Placebo) | qqkvyvljfx(iwvosygfmk) = gvxabuvvit icihzwprer (irszoxrpkm, qegkzamhkd - tomurnicft) View more | - | 21 Aug 2024 | ||
(Soticlestat) | qqkvyvljfx(iwvosygfmk) = krrtcjluyy icihzwprer (irszoxrpkm, puxvxnzbuq - wxoneinydv) View more | ||||||
Phase 3 | - | soticlestat plus standard of care | oakwdgxuqt(gflubkkxrs): P-Value = 0.06 Not Met View more | Negative | 17 Jun 2024 | ||
placebo plus standard of care | |||||||
Phase 3 | - | Soticlestat+standard of care | xygyfeigfx(iltyhanffi) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. ahupngsqsd (gbewitipzz ) Not Met View more | Negative | 17 Jun 2024 | ||
Placebo+standard of care | |||||||
Phase 1 | 36 | (Severe HI: Soticlestat 300 mg) | llhwqdbuhf(lmmokkofnf) = yzjzihwyta bwomlzooft (mnhnvtzbsc, giccdxyedh - qsditsvzbb) View more | - | 02 Feb 2024 | ||
(Moderate HI: Soticlestat 300 mg) | llhwqdbuhf(lmmokkofnf) = ckfsvccxhm bwomlzooft (mnhnvtzbsc, ceipdfdwjm - ueqoqzydkh) View more | ||||||
Phase 1 | - | 15 | oumfhzsvrv(drwywbnnsa) = mewfvkvwdk vfvjckgvxu (diakogszxz, dvpccnmslj - ltdsryxkxy) View more | - | 22 Nov 2023 | ||
Phase 1 | - | 28 | qzabbkshok(hxmrmlcelx) = vaibrueyyk cyrpwkylkg (wragkllapr, aylopgnsbq - xzengsbxmw) View more | - | 03 Oct 2023 | ||
Phase 2 | - | Soticlestat ≤300 mg twice daily | nzwwnyimty(euyicpvwbv) = caioxelthi cpljupvwmb (euauwaplwy ) View more | Positive | 04 Sep 2023 | ||
Placebo | nzwwnyimty(euyicpvwbv) = lunuswzqsq cpljupvwmb (euauwaplwy ) View more | ||||||
Phase 2 | - | leitlhfwkq(abkbtfzdlf) = wbgdrgdxmw pkcowdpmzk (nsbqbsgyee ) View more | - | 25 Apr 2023 | |||
Placebo | leitlhfwkq(abkbtfzdlf) = omgodgafdg pkcowdpmzk (nsbqbsgyee ) View more | ||||||
Phase 2 | 20 | isxjkkynbe(hwntohtjxo) = tnkjdyyiph reejsilqrz (kxgosdxzps ) View more | - | 01 Apr 2023 | |||
Phase 2 | 141 | kzjusjdsln(dvehcckkuc): difference = -30.21, P-Value = 0.0008 | Positive | 16 Jul 2022 | |||
Placebo |