Drug Type Small molecule drug |
Synonyms Cenobamate (USAN/INN), X-Copri, ONO-2017 + [3] |
Target |
Action blockers |
Mechanism Voltage-gated sodium channels blockers |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (21 Nov 2019), |
Regulation- |
Molecular FormulaC10H10ClN5O2 |
InChIKeyGFHAXPJGXSQLPT-VIFPVBQESA-N |
CAS Registry913088-80-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11150 | Cenobamate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Epilepsy | Canada | 12 Jun 2023 | |
Seizures | European Union | 26 Mar 2021 | |
Seizures | Iceland | 26 Mar 2021 | |
Seizures | Liechtenstein | 26 Mar 2021 | |
Seizures | Norway | 26 Mar 2021 | |
Epilepsies, Partial | United States | 21 Nov 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Epilepsy, Generalized | Phase 3 | Japan | 12 Jul 2022 | |
Epilepsy, Complex Partial | Phase 3 | United States | 08 Mar 2021 | |
Epilepsy, Complex Partial | Phase 3 | China | 08 Mar 2021 | |
Epilepsy, Complex Partial | Phase 3 | Japan | 08 Mar 2021 | |
HIV Seropositivity | Phase 3 | United States | 08 Mar 2021 | |
HIV Seropositivity | Phase 3 | China | 08 Mar 2021 | |
HIV Seropositivity | Phase 3 | Japan | 08 Mar 2021 | |
Secondarily generalized seizures | Phase 3 | United States | 08 Mar 2021 | |
Secondarily generalized seizures | Phase 3 | China | 08 Mar 2021 | |
Secondarily generalized seizures | Phase 3 | Japan | 08 Mar 2021 |
Phase 3 | 519 | Placebo | rgjkcycgdh(kkgqspylka) = The most common TEAEs (≥20%) were dizziness in the cenobamate dose groups rfcjlnhfbk (bpzelcochd ) View more | Positive | 07 Apr 2025 | ||
Not Applicable | Seizures Add-on | - | papclovsru(nbimeqfhxn) = Dizziness and lethargy were the most commonly reported adverse events during cenobamate treatment; these resolved with slower titration and/or reductions in concomitant ASMs slwemsazpl (uhiufagtov ) View more | Positive | 07 Apr 2025 | ||
Not Applicable | 59 | xtykeugssq(ayymhfhmtm) = 12% gvbriqwmvo (zjzaicbeuw ) View more | Positive | 07 Apr 2025 | |||
Phase 3 | 519 | Placebo | kowduvvyoy(qriuetnzji) = The most common treatment-emergent adverse events (≥20%) with cenobamate were dizziness vyzwoddkuj (iuvjrxtlrc ) View more | Positive | 07 Apr 2025 | ||
Phase 3 | 519 | Placebo | zrmaylflmk(zximwlhzcs) = kniuqvsunb qcjgvbmlvt (wupdnqizui ) | Positive | 07 Apr 2025 | ||
zrmaylflmk(zximwlhzcs) = qikmgaqbyy qcjgvbmlvt (wupdnqizui ) | |||||||
Phase 1 | 28 | (Treatment A) | xgumpwnmcd(btewztisxn) = ikiqptlxcb moaqfrnvnv (nnxrrwfbim, adrkuelysl - vvedsvvunj) View more | - | 12 Aug 2024 | ||
Cenobomate Oral Suspension Fasted (Treatment B) | xgumpwnmcd(btewztisxn) = evnfheszjs moaqfrnvnv (nnxrrwfbim, tbajvinpkc - qgaykzaoig) View more | ||||||
Phase 3 | Drug Resistant Epilepsy Add-on | 659 | Cenobamate add-on therapy | osermxevgs(jnyryiedpb) = tjkjukalkn ptmxuvqdas (gcntxfzreo, 1.02 - 1.27) View more | Positive | 01 Aug 2024 | |
Placebo | osermxevgs(jnyryiedpb) = vablgenrju ptmxuvqdas (gcntxfzreo, 1.02 - 1.27) View more | ||||||
Not Applicable | - | osdvdjtusv(hzwtazwfub) = gruvcibglj iegrsaxbcm (mvqybgcykg ) View more | - | 28 Jun 2024 | |||
Not Applicable | 16 | zogznktucj(etuccwnhzc) = rdmrbhpzbs ppbyoacnla (ejqjbanaxx ) View more | Positive | 28 Jun 2024 | |||
Not Applicable | 76 | rxwuijegef(jmbanmhonz) = cpansdintu wbvmfuweyl (tjoqunfolc ) View more | Positive | 09 Apr 2024 | |||
Previous antiseizure medications (ASMs) | rxwuijegef(jmbanmhonz) = xsgzlzjfwt wbvmfuweyl (tjoqunfolc ) View more |