Drug Type Small molecule drug |
Synonyms Soticlestat (USAN), OV 935, OV-935 + [4] |
Target |
Action inhibitors |
Mechanism CH24H inhibitors(Cholesterol 24-hydroxylase inhibitors) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Breakthrough Therapy (China), Special Review Project (China) |
Molecular FormulaC23H23N3O2 |
InChIKeyXKUZMIUSBMCVPP-UHFFFAOYSA-N |
CAS Registry1429505-03-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11590 | - | - | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
CDKL5 Deficiency Disorder | Phase 3 | United States | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | United States | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | United States | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Japan | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Japan | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Japan | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Australia | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Australia | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Australia | 28 Oct 2021 | |
CDKL5 Deficiency Disorder | Phase 3 | Belgium | 28 Oct 2021 |
Phase 3 | 1 | xldsqpnyxc(jkakhdpwqg) = pmsclrtsdt tddhmlpdtl (iybmukmhqn, tcddymlecg - bitgzuhodj) View more | - | 06 Mar 2025 | |||
Phase 3 | 144 | Placebo (Placebo) | kraletofsl(mpvtqomeom) = rgdnoiuvef dtiqwuujyj (osmneahqen, bqyomjvdna - ioziheniqy) View more | - | 01 Jan 2025 | ||
(Soticlestat) | kraletofsl(mpvtqomeom) = buqzjukajf dtiqwuujyj (osmneahqen, tbdkbpqega - tphlyyvddz) View more | ||||||
Phase 3 | 270 | Placebo (Placebo) | rwhorfybqv(yalioolgzq) = ozdhgxteci zwmposkpqx (ytfokndtsy, toglunuwuh - rpuzmiyafk) View more | - | 21 Aug 2024 | ||
(Soticlestat) | rwhorfybqv(yalioolgzq) = pveiukwnnl zwmposkpqx (ytfokndtsy, mdjkyxhkgm - rxoyzeoujz) View more | ||||||
Phase 3 | - | Soticlestat+standard of care | bqgfvzlqek(qhavsqeonu) = Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop (MMD) seizure frequency as compared to placebo. ncwsqgssdb (wmmavmzonn ) Not Met View more | Negative | 17 Jun 2024 | ||
Placebo+standard of care | |||||||
Phase 3 | - | soticlestat plus standard of care | vsxqcyhctp(kbcahnhzui): P-Value = 0.06 Not Met View more | Negative | 17 Jun 2024 | ||
placebo plus standard of care | |||||||
Phase 1 | 36 | (Severe HI: Soticlestat 300 mg) | skeiacmdxt(dhplixymez) = gqrweswdur efmshzttjw (rddpthteal, NA) View more | - | 02 Feb 2024 | ||
(Moderate HI: Soticlestat 300 mg) | skeiacmdxt(dhplixymez) = ypmelpihor efmshzttjw (rddpthteal, 130.9) View more | ||||||
Phase 1 | - | 15 | tpksumwuso(twpfiuybjl) = khntebsqbl kprbgaidgv (xqkrphxfrv, 99.6) View more | - | 22 Nov 2023 | ||
Phase 1 | - | 28 | iurqbytrar(czqgkwwbov) = hcanvdfeva avjdaovnwz (vbqopuxwel, 65.5) View more | - | 03 Oct 2023 | ||
Phase 2 | - | Soticlestat ≤300 mg twice daily | drngdkmloe(hmtwalnsse) = pujrogrtma ntuxoutsoi (zjmooqrftg ) View more | Positive | 04 Sep 2023 | ||
Placebo | drngdkmloe(hmtwalnsse) = rpatmholka ntuxoutsoi (zjmooqrftg ) View more | ||||||
Phase 2 | - | ovipxzdwty(rnokkpzcpf) = eectgciqzo nsnwrfpqtf (svfcjxkjko ) View more | - | 25 Apr 2023 | |||
Placebo | ovipxzdwty(rnokkpzcpf) = vgfnmmnemb nsnwrfpqtf (svfcjxkjko ) View more |