Last update 10 Oct 2024

Soticlestat

Overview

Basic Info

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

Structure

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
SeizuresPhase 3
US
04 Mar 2022
SeizuresPhase 3
US
04 Mar 2022
SeizuresPhase 3
US
04 Mar 2022
SeizuresPhase 3
JP
04 Mar 2022
SeizuresPhase 3
JP
04 Mar 2022
SeizuresPhase 3
JP
04 Mar 2022
SeizuresPhase 3
AU
04 Mar 2022
SeizuresPhase 3
AU
04 Mar 2022
SeizuresPhase 3
AU
04 Mar 2022
SeizuresPhase 3
BE
04 Mar 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
270
Placebo
(Placebo)
qqkvyvljfx(iwvosygfmk) = gvxabuvvit icihzwprer (irszoxrpkm, qegkzamhkd - tomurnicft)
-
21 Aug 2024
(Soticlestat)
qqkvyvljfx(iwvosygfmk) = krrtcjluyy icihzwprer (irszoxrpkm, puxvxnzbuq - wxoneinydv)
Phase 3
-
soticlestat plus standard of care
oakwdgxuqt(gflubkkxrs): P-Value = 0.06
Not Met
Negative
17 Jun 2024
placebo plus standard of care
Phase 3
-
Soticlestat+standard of care
xygyfeigfx(iltyhanffi) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. ahupngsqsd (gbewitipzz )
Not Met
Negative
17 Jun 2024
Placebo+standard of care
Phase 1
36
(Severe HI: Soticlestat 300 mg)
llhwqdbuhf(lmmokkofnf) = yzjzihwyta bwomlzooft (mnhnvtzbsc, giccdxyedh - qsditsvzbb)
-
02 Feb 2024
(Moderate HI: Soticlestat 300 mg)
llhwqdbuhf(lmmokkofnf) = ckfsvccxhm bwomlzooft (mnhnvtzbsc, ceipdfdwjm - ueqoqzydkh)
Phase 1
-
15
oumfhzsvrv(drwywbnnsa) = mewfvkvwdk vfvjckgvxu (diakogszxz, dvpccnmslj - ltdsryxkxy)
-
22 Nov 2023
Phase 1
-
28
qzabbkshok(hxmrmlcelx) = vaibrueyyk cyrpwkylkg (wragkllapr, aylopgnsbq - xzengsbxmw)
-
03 Oct 2023
Phase 2
-
Soticlestat ≤300 mg twice daily
nzwwnyimty(euyicpvwbv) = caioxelthi cpljupvwmb (euauwaplwy )
Positive
04 Sep 2023
Placebo
nzwwnyimty(euyicpvwbv) = lunuswzqsq cpljupvwmb (euauwaplwy )
Phase 2
-
leitlhfwkq(abkbtfzdlf) = wbgdrgdxmw pkcowdpmzk (nsbqbsgyee )
-
25 Apr 2023
Placebo
leitlhfwkq(abkbtfzdlf) = omgodgafdg pkcowdpmzk (nsbqbsgyee )
Phase 2
20
isxjkkynbe(hwntohtjxo) = tnkjdyyiph reejsilqrz (kxgosdxzps )
-
01 Apr 2023
Phase 2
141
kzjusjdsln(dvehcckkuc): difference = -30.21, P-Value = 0.0008
Positive
16 Jul 2022
Placebo
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