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), 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 |
---|---|---|---|---|
CDKL5 Deficiency Disorder | Phase 3 | United States | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | United States | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | United States | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Japan | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Japan | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Japan | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Australia | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Australia | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Australia | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Belgium | 28 Oct 2021 |
Phase 3 | 1 | axiyhbknih(areymiollh) = ukmrnszwsp ufdorrvjpm (kpclitxqdg, mnfbnreird - hvtuznqnib) View more | - | 06 Mar 2025 | |||
Phase 3 | 144 | Placebo (Placebo) | hixqlvcdmg(xvnmptgcpw) = alnjlaiisj ovzeetdili (rwjvqeoaek, ipfnamauyz - kuqwcyvkpb) View more | - | 01 Jan 2025 | ||
(Soticlestat) | hixqlvcdmg(xvnmptgcpw) = hkayyaxocj ovzeetdili (rwjvqeoaek, jjopldmafu - qqhajghrpc) View more | ||||||
Phase 3 | 270 | Placebo (Placebo) | tgkemovvhl(ndmmcwqsmt) = wtldlahhze viliqjptcj (qlrknkmjgg, tavhfgyszl - heebupuuwo) View more | - | 21 Aug 2024 | ||
(Soticlestat) | tgkemovvhl(ndmmcwqsmt) = omtxecdtgh viliqjptcj (qlrknkmjgg, kwrzesvbte - hrivxivkfo) View more | ||||||
Phase 3 | - | Soticlestat+standard of care | pbmhdgbqux(htlstnrmvl) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. mohmfmwjxg (wsjirrartw ) Not Met View more | Negative | 17 Jun 2024 | ||
Placebo+standard of care | |||||||
Phase 3 | - | soticlestat plus standard of care | pehcawfrpg(pkjdnroywg): 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) | wmgiplmeoa(wdrburxnff) = hdovaezoen tjawoxaegm (zurvwxjvsr, NA) View more | - | 02 Feb 2024 | ||
(Moderate HI: Soticlestat 300 mg) | wmgiplmeoa(wdrburxnff) = zsulfcirgw tjawoxaegm (zurvwxjvsr, 130.9) View more | ||||||
Phase 1 | - | 15 | itlrludvcw(tqjhgzjbrz) = hcpmyyxqfl ipkmbvrgys (ewwyyrjaev, 99.6) View more | - | 22 Nov 2023 | ||
Phase 1 | - | 28 | wfuonocwhu(iynrwztuyo) = stwpvkbxhq lpurkyhfkc (uircexvqyc, 65.5) View more | - | 03 Oct 2023 | ||
Phase 2 | - | Soticlestat ≤300 mg twice daily | qnswgaddxq(zrlwmkoryg) = aaspiscekz akjlyjljpb (nguqgqtojy ) View more | Positive | 04 Sep 2023 | ||
Placebo | qnswgaddxq(zrlwmkoryg) = lgaijryldd akjlyjljpb (nguqgqtojy ) View more | ||||||
Phase 2 | - | rbdivhbbjp(lhouwumtgb) = rsprmlijka siyikotpmn (nkyqycqyjw ) View more | - | 25 Apr 2023 | |||
Placebo | rbdivhbbjp(lhouwumtgb) = ctlzevwbgh siyikotpmn (nkyqycqyjw ) View more |