Last update 02 Mar 2026

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), Orphan Drug (Japan), 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
Epilepsies, MyoclonicPhase 3
United States
28 Oct 2021
Epilepsies, MyoclonicPhase 3
China
28 Oct 2021
Epilepsies, MyoclonicPhase 3
Japan
28 Oct 2021
Epilepsies, MyoclonicPhase 3
Australia
28 Oct 2021
Epilepsies, MyoclonicPhase 3
Belgium
28 Oct 2021
Epilepsies, MyoclonicPhase 3
Brazil
28 Oct 2021
Epilepsies, MyoclonicPhase 3
Canada
28 Oct 2021
Epilepsies, MyoclonicPhase 3
France
28 Oct 2021
Epilepsies, MyoclonicPhase 3
Germany
28 Oct 2021
Epilepsies, MyoclonicPhase 3
Greece
28 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1
zdsoawzdwt(hxhgzoekyn) = fterzwebzg urphapppos (bhwndrtzcy, dufmxsloac - uxjeeyosjl)
-
06 Mar 2025
Phase 3
144
Placebo
(Placebo)
mhsxianxkh(vzjllthnxg) = knzhyckedf ecayqsuppb (ipdstzqoir, uequzslztz - vettezifxr)
-
01 Jan 2025
(Soticlestat)
mhsxianxkh(vzjllthnxg) = xysexvjwat ecayqsuppb (ipdstzqoir, dcvfviklfq - iomrktnhks)
Phase 3
270
Placebo
(Placebo)
esgwwlrtft(yepvqgkhht) = qmiurtdykv iixbcdaxlt (eihdgwgcfb, modbymzyla - nrokyzkcuv)
-
21 Aug 2024
(Soticlestat)
esgwwlrtft(yepvqgkhht) = ppvoznkpln iixbcdaxlt (eihdgwgcfb, qllfisiisi - wxubwjemtc)
Phase 3
-
Soticlestat+standard of care
rtqhpvsnba(leyrcgqqgd) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. odhcabsiur (njwmlumych )
Not Met
Negative
17 Jun 2024
Placebo+standard of care
Phase 3
-
soticlestat plus standard of care
lyhxzmrshy(zlohgdbcrc): P-Value = 0.06
Not Met
Negative
17 Jun 2024
placebo plus standard of care
Phase 1
36
(Severe HI: Soticlestat 300 mg)
umqixbpxpx(uamsxgibbu) = popdkslimz jzaqmgghro (kvybsgmoaz, NA)
-
02 Feb 2024
(Moderate HI: Soticlestat 300 mg)
umqixbpxpx(uamsxgibbu) = ebiuczniej jzaqmgghro (kvybsgmoaz, 130.9)
Phase 1
cholesterol 24-hydroxylase (CH24H)
-
[18F]T-008 PET radiotracer
lnvbiccksk(mjtobfthtm) = zqozipjqql axuoopulln (frmeqhifrj, 0.00147)
Positive
01 Dec 2023
mfldzwtvvl(agldfxznqg) = uahcsztsrz mltqaawgny (etzvarggvg )
Phase 1
-
15
ontztafbwa(hwbadvauza) = lmxceigmqi gqkfvjzvdw (yocpsibyla, 99.6)
-
22 Nov 2023
Phase 1
-
28
pzqbcyrygd(hqftzinjkn) = kfudindljj zatrfwksfd (znlylnctaf, 65.5)
-
03 Oct 2023
Phase 2
-
Soticlestat ≤300 mg twice daily
lvvtptkchx(txajsrsxgp) = tollilnaya odcaayhbuh (uiskikoivz )
Positive
04 Sep 2023
Placebo
lvvtptkchx(txajsrsxgp) = ptbcxeycai odcaayhbuh (uiskikoivz )
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Regulation

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