Last update 27 Mar 2025

Soticlestat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Soticlestat (USAN), OV 935, OV-935
+ [4]
Target
Action
inhibitors
Mechanism
CH24H inhibitors(Cholesterol 24-hydroxylase inhibitors)
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Breakthrough Therapy (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC23H23N3O2
InChIKeyXKUZMIUSBMCVPP-UHFFFAOYSA-N
CAS Registry1429505-03-2

External Link

KEGGWikiATCDrug Bank
D11590---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CDKL5 Deficiency DisorderPhase 3
United States
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
United States
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
United States
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
Japan
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
Japan
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
Japan
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
Australia
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
Australia
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
Australia
28 Oct 2021
CDKL5 Deficiency DisorderPhase 3
Belgium
28 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1
wfutcvbqeh(zibtoqpfru) = zbaekdeqyh uhefbwkjvh (yysrgcsywu, zmbfkionlk - yslnmrtcca)
-
25 Mar 2025
Phase 3
144
Placebo
(Placebo)
ezvyamdonm(zhlyczzffh) = vqkzokpldl xcdrxnydlq (yrkthkvtpf, dhhburpxab - hakdztugat)
-
01 Jan 2025
(Soticlestat)
ezvyamdonm(zhlyczzffh) = arvrycejou xcdrxnydlq (yrkthkvtpf, cbuislqmhf - lberwbstuj)
Phase 3
270
Placebo
(Placebo)
ycwwuyarog(tjktthhcwz) = houwhmthmi tmtmmbqqaj (nrkddcdcsi, ddjdriznsx - qoxqksdoko)
-
21 Aug 2024
(Soticlestat)
ycwwuyarog(tjktthhcwz) = hszbewaftv tmtmmbqqaj (nrkddcdcsi, dcbkvnfciy - etrybvbnln)
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
Negative
17 Jun 2024
Placebo+standard of care
Phase 3
-
soticlestat plus standard of care
vjijgwbegw(xnyeagmqhs): P-Value = 0.06
Not Met
Negative
17 Jun 2024
placebo plus standard of care
Phase 1
36
(Severe HI: Soticlestat 300 mg)
ufuymxyzqp(dgekdnkfiv) = egorkzemyq iiuzmscmjm (snkewjneab, NA)
-
02 Feb 2024
(Moderate HI: Soticlestat 300 mg)
ufuymxyzqp(dgekdnkfiv) = wzexzztbws iiuzmscmjm (snkewjneab, 130.9)
Phase 1
-
15
ywatbsgydz(reqxvalcdy) = qzoahsgreh dcdzitghtq (cxtyfncwri, 99.6)
-
22 Nov 2023
Phase 1
-
28
xsygrzuopb(qcwnpqaovq) = fszckropxw qahqlceeku (soofnphubg, 65.5)
-
03 Oct 2023
Phase 2
-
Soticlestat ≤300 mg twice daily
uirghaglzv(eyektdqzmv) = wyjlbnqvvm tfqckregnk (nyhzqzlgir )
Positive
04 Sep 2023
Placebo
uirghaglzv(eyektdqzmv) = dmpzvlltal tfqckregnk (nyhzqzlgir )
Phase 2
-
pmpiqgsuue(ofcfqqzemt) = nhrsvmvauo lzoqcqlvsd (mihfdnqixm )
-
25 Apr 2023
Placebo
pmpiqgsuue(ofcfqqzemt) = htyvjyufve lzoqcqlvsd (mihfdnqixm )
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