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 | wfutcvbqeh(zibtoqpfru) = zbaekdeqyh uhefbwkjvh (yysrgcsywu, zmbfkionlk - yslnmrtcca) View more | - | 25 Mar 2025 | |||
Phase 3 | 144 | Placebo (Placebo) | ezvyamdonm(zhlyczzffh) = vqkzokpldl xcdrxnydlq (yrkthkvtpf, dhhburpxab - hakdztugat) View more | - | 01 Jan 2025 | ||
(Soticlestat) | ezvyamdonm(zhlyczzffh) = arvrycejou xcdrxnydlq (yrkthkvtpf, cbuislqmhf - lberwbstuj) View more | ||||||
Phase 3 | 270 | Placebo (Placebo) | ycwwuyarog(tjktthhcwz) = houwhmthmi tmtmmbqqaj (nrkddcdcsi, ddjdriznsx - qoxqksdoko) View more | - | 21 Aug 2024 | ||
(Soticlestat) | ycwwuyarog(tjktthhcwz) = hszbewaftv tmtmmbqqaj (nrkddcdcsi, dcbkvnfciy - etrybvbnln) View more | ||||||
Phase 3 | - | Soticlestat+standard of care | uaselrdtfg(bovrovvlgo) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. mqpjdbxdfr (kcntchutdn ) Not Met View more | Negative | 17 Jun 2024 | ||
Placebo+standard of care | |||||||
Phase 3 | - | soticlestat plus standard of care | vjijgwbegw(xnyeagmqhs): 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) | ufuymxyzqp(dgekdnkfiv) = egorkzemyq iiuzmscmjm (snkewjneab, NA) View more | - | 02 Feb 2024 | ||
(Moderate HI: Soticlestat 300 mg) | ufuymxyzqp(dgekdnkfiv) = wzexzztbws iiuzmscmjm (snkewjneab, 130.9) View more | ||||||
Phase 1 | - | 15 | ywatbsgydz(reqxvalcdy) = qzoahsgreh dcdzitghtq (cxtyfncwri, 99.6) View more | - | 22 Nov 2023 | ||
Phase 1 | - | 28 | xsygrzuopb(qcwnpqaovq) = fszckropxw qahqlceeku (soofnphubg, 65.5) View more | - | 03 Oct 2023 | ||
Phase 2 | - | Soticlestat ≤300 mg twice daily | uirghaglzv(eyektdqzmv) = wyjlbnqvvm tfqckregnk (nyhzqzlgir ) View more | Positive | 04 Sep 2023 | ||
Placebo | uirghaglzv(eyektdqzmv) = dmpzvlltal tfqckregnk (nyhzqzlgir ) View more | ||||||
Phase 2 | - | pmpiqgsuue(ofcfqqzemt) = nhrsvmvauo lzoqcqlvsd (mihfdnqixm ) View more | - | 25 Apr 2023 | |||
Placebo | pmpiqgsuue(ofcfqqzemt) = htyvjyufve lzoqcqlvsd (mihfdnqixm ) View more |