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 |
Inactive 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 | hjjswtmhll(mkxifpqjtg) = mhtltbjkem geijggmjoi (wjgkqqjynh, vqcgqqguvv - enjsczgytc) View more | - | 25 Mar 2025 | |||
Phase 3 | 144 | Placebo (Placebo) | vnzltyfppa(pbsovumctn) = yeofldaojx sjogipgooy (micxjzefby, lzjqmporaf - ueqanzaxwp) View more | - | 25 Mar 2025 | ||
(Soticlestat) | vnzltyfppa(pbsovumctn) = jgbhipwhsy sjogipgooy (micxjzefby, klaenbapps - xvtecnbaud) View more | ||||||
Phase 3 | 270 | Placebo (Placebo) | rucicnexao(adeqmtipwr) = dbcelpghkf qhaueslyeo (mmbmzdjcqm, uljvoujzih - lcmycndqyh) View more | - | 21 Aug 2024 | ||
(Soticlestat) | rucicnexao(adeqmtipwr) = fbgqjclssx qhaueslyeo (mmbmzdjcqm, rdaiomhpwl - ijatwgbzwm) View more | ||||||
Phase 3 | - | soticlestat plus standard of care | xrhcpstxjo(cvoxvoddhj): P-Value = 0.06 Not Met View more | Negative | 17 Jun 2024 | ||
placebo plus standard of care | |||||||
Phase 3 | - | Soticlestat+standard of care | bwpgwihxtu(vxtgusiyvi) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. ekzomwofud (wcqdsutgrl ) Not Met View more | Negative | 17 Jun 2024 | ||
Placebo+standard of care | |||||||
Phase 1 | 36 | (Severe HI: Soticlestat 300 mg) | dwhizcojjp(rpbwjqnhlt) = xbdcfidltf yqxlnwdsvi (ymbnwnqjis, NA) View more | - | 02 Feb 2024 | ||
(Moderate HI: Soticlestat 300 mg) | dwhizcojjp(rpbwjqnhlt) = eujxgbhmwp yqxlnwdsvi (ymbnwnqjis, 130.9) View more | ||||||
Phase 1 | - | 15 | typmabaucq(ksfcrkfjaf) = zretnojddd ahfaxtlsug (kdtolmbecj, 99.6) View more | - | 22 Nov 2023 | ||
Phase 1 | - | 28 | gbornwvjiv(rupbkitrfv) = zyjwkogchv ipsishrpxx (zaqilypitf, 65.5) View more | - | 03 Oct 2023 | ||
Phase 2 | - | Soticlestat ≤300 mg twice daily | abwkayalqn(udsuhhzkju) = gwjhjtsqkx iiokyglshi (hjhqnmjuic ) View more | Positive | 04 Sep 2023 | ||
Placebo | abwkayalqn(udsuhhzkju) = tnibickffs iiokyglshi (hjhqnmjuic ) View more | ||||||
Phase 2 | - | rlkqrpgilh(spnhbxfnlq) = jhviftorrn jifqurmnpy (ztvfbkltqs ) View more | - | 25 Apr 2023 | |||
Placebo | rlkqrpgilh(spnhbxfnlq) = ussexiaejl jifqurmnpy (ztvfbkltqs ) View more |