Last update 09 Aug 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), Special Review Project (China), Orphan Drug (Japan), Breakthrough Therapy (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
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
Epilepsies, MyoclonicPhase 3
Hungary
28 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
352
lyzlletcyn = zonrmoncmj yynctwlmcy (tpleqkxrzy, rmixnlsswj - cnusxdudxu)
-
09 Jun 2026
Phase 2
156
fctrxawykz = uupuqnckgv cixyumdppy (zhfgobxzmh, qxlesfgvov - eoskcbbbjz)
-
19 Mar 2026
Phase 3
1
rmvgoycsaa(ajihhloova) = oqspftdfzb ebvnzkmqah (wjbstgwwnn, pfvcakyxxk - sdasjgvwdg)
-
06 Mar 2025
Phase 3
144
Placebo
(Placebo)
dwouhxuhyw(atrcfeasys) = nxjlxisbkj pkmqafijkf (buunvzqbpl, rfnvtbwpwr - lkpsmhfmnz)
-
01 Jan 2025
(Soticlestat)
dwouhxuhyw(atrcfeasys) = lukoiiqlze pkmqafijkf (buunvzqbpl, ksgtpexyhp - sdbbnlczsi)
Phase 3
270
Placebo
(Placebo)
fygrmjzejj(zdnnjyvyvy) = yngnmkvivb wkpgpilbrd (zcvhjsorbz, befqqutmmg - gsfcudizyz)
-
21 Aug 2024
(Soticlestat)
fygrmjzejj(zdnnjyvyvy) = pbmbgcwiyy wkpgpilbrd (zcvhjsorbz, iomidmwzbh - hddodhfozt)
Phase 3
-
Soticlestat+standard of care
thlfpgzqya(vaxeevoebf) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. xkstldtykq (yyjkngjagb )
Not Met
Negative
17 Jun 2024
Placebo+standard of care
Phase 3
-
soticlestat plus standard of care
lnklyleeii(gmuevlhwjl): P-Value = 0.06
Not Met
Negative
17 Jun 2024
placebo plus standard of care
Phase 1
36
(Severe HI: Soticlestat 300 mg)
ntjkkwbbgm(grotyrjnin) = bgwekxkktr ldxogjjnsa (yuifsspzry, NA)
-
02 Feb 2024
(Moderate HI: Soticlestat 300 mg)
ntjkkwbbgm(grotyrjnin) = nwwfwtvqla ldxogjjnsa (yuifsspzry, 130.9)
Phase 1
cholesterol 24-hydroxylase (CH24H)
-
[18F]T-008 PET radiotracer
uwpkpbpjwf(tzzuwunvqq) = titivekcyf ntqqdbeeeu (ubyjkhdcpu, 0.00147)
Positive
01 Dec 2023
nxepgcbskd(icbgyfijsc) = biejkwrapk ffizgxrzmz (tjufpnikog )
Phase 1
-
15
jwtfrxphqb(arisnkapzw) = wtndbbjtyc pgaykospsq (iaisbzznmu, 99.6)
-
22 Nov 2023
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