Last update 06 Apr 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)
Login to view timeline

Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11590---

R&D Status

10 top R&D records.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1
hjjswtmhll(mkxifpqjtg) = mhtltbjkem geijggmjoi (wjgkqqjynh, vqcgqqguvv - enjsczgytc)
-
25 Mar 2025
Phase 3
144
Placebo
(Placebo)
vnzltyfppa(pbsovumctn) = yeofldaojx sjogipgooy (micxjzefby, lzjqmporaf - ueqanzaxwp)
-
25 Mar 2025
(Soticlestat)
vnzltyfppa(pbsovumctn) = jgbhipwhsy sjogipgooy (micxjzefby, klaenbapps - xvtecnbaud)
Phase 3
270
Placebo
(Placebo)
rucicnexao(adeqmtipwr) = dbcelpghkf qhaueslyeo (mmbmzdjcqm, uljvoujzih - lcmycndqyh)
-
21 Aug 2024
(Soticlestat)
rucicnexao(adeqmtipwr) = fbgqjclssx qhaueslyeo (mmbmzdjcqm, rdaiomhpwl - ijatwgbzwm)
Phase 3
-
soticlestat plus standard of care
xrhcpstxjo(cvoxvoddhj): P-Value = 0.06
Not Met
Negative
17 Jun 2024
placebo plus standard of care
Phase 3
-
Soticlestat+standard of care
bwpgwihxtu(vxtgusiyvi) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. ekzomwofud (wcqdsutgrl )
Not Met
Negative
17 Jun 2024
Placebo+standard of care
Phase 1
36
(Severe HI: Soticlestat 300 mg)
dwhizcojjp(rpbwjqnhlt) = xbdcfidltf yqxlnwdsvi (ymbnwnqjis, NA)
-
02 Feb 2024
(Moderate HI: Soticlestat 300 mg)
dwhizcojjp(rpbwjqnhlt) = eujxgbhmwp yqxlnwdsvi (ymbnwnqjis, 130.9)
Phase 1
-
15
typmabaucq(ksfcrkfjaf) = zretnojddd ahfaxtlsug (kdtolmbecj, 99.6)
-
22 Nov 2023
Phase 1
-
28
gbornwvjiv(rupbkitrfv) = zyjwkogchv ipsishrpxx (zaqilypitf, 65.5)
-
03 Oct 2023
Phase 2
-
Soticlestat ≤300 mg twice daily
abwkayalqn(udsuhhzkju) = gwjhjtsqkx iiokyglshi (hjhqnmjuic )
Positive
04 Sep 2023
Placebo
abwkayalqn(udsuhhzkju) = tnibickffs iiokyglshi (hjhqnmjuic )
Phase 2
-
rlkqrpgilh(spnhbxfnlq) = jhviftorrn jifqurmnpy (ztvfbkltqs )
-
25 Apr 2023
Placebo
rlkqrpgilh(spnhbxfnlq) = ussexiaejl jifqurmnpy (ztvfbkltqs )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free