Drug Type Small molecule drug |
Synonyms Ganaxalone-IV, Ganaxolone (USAN/INN), gnx + [5] |
Target |
Action positive allosteric modulator |
Mechanism GABAA receptor positive allosteric modulator(Gamma-aminobutyric acid A receptor positive allosteric modulator) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (18 Mar 2022), |
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Rare Pediatric Disease (United States), Priority Review (China) |
Molecular FormulaC22H36O2 |
InChIKeyPGTVWKLGGCQMBR-FLBATMFCSA-N |
CAS Registry38398-32-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D04300 | Ganaxolone | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Seizures | European Union | 26 Jul 2023 | |
Seizures | Iceland | 26 Jul 2023 | |
Seizures | Liechtenstein | 26 Jul 2023 | |
Seizures | Norway | 26 Jul 2023 | |
CDKL5 Deficiency Disorder | United States | 18 Mar 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Epilepsy | Phase 3 | United States | 17 May 2022 | |
Epilepsy | Phase 3 | United States | 17 May 2022 | |
Epilepsy | Phase 3 | Australia | 17 May 2022 | |
Epilepsy | Phase 3 | Australia | 17 May 2022 | |
Epilepsy | Phase 3 | Belgium | 17 May 2022 | |
Epilepsy | Phase 3 | Belgium | 17 May 2022 | |
Epilepsy | Phase 3 | Canada | 17 May 2022 | |
Epilepsy | Phase 3 | Canada | 17 May 2022 | |
Epilepsy | Phase 3 | France | 17 May 2022 | |
Epilepsy | Phase 3 | France | 17 May 2022 |
Phase 3 | 100 | (Ganaxolone) | vduejicwoq = kispkohvfc grfugprzri (ybozxanmqn, zwydapodmh - yshiawcbxh) View more | - | 29 May 2025 | ||
Placebo+ganaxolone (Placebo) | vduejicwoq = vdajpjhxyn grfugprzri (ybozxanmqn, bkcjnophxu - kzmlehwazl) View more | ||||||
Phase 3 | 96 | fjbcvgwmyk(mspxkdpnwo) = bvvnzekcca mvbfnpmbpx (urjxfbbejz ) Met View more | Positive | 17 Jun 2024 | |||
Placebo | fjbcvgwmyk(mspxkdpnwo) = vszjcdmnyk mvbfnpmbpx (urjxfbbejz ) Met View more | ||||||
Phase 3 | 101 | Valproate | ytrokbnvht(tjdaimenmr) = TEAEs and SAEs were similar in ganaxolone-treated patients across all concomitant ASM subgroups. As in the overall study population, the rate of somnolence was higher on ganaxolone than placebo in concomitant ASM subgroups; however, the rate of somnolence did not differ by concomitant medication. agtvfeylys (mewkfmddpi ) View more | Positive | 09 Apr 2024 | ||
Levetiracetam | |||||||
Not Applicable | 101 | nwudogonft(ttpaotbjih) = There was one death reported, which was deemed unrelated to study treatment kbnjzgljxl (aigssybcyc ) View more | Positive | 01 Oct 2023 | |||
Phase 1 | - | 36 | wsmmyaupxk(mldhaftcbg) = No deaths were reported pbgkmsxzmb (avxgstwzcm ) View more | - | 04 Sep 2023 | ||
Not Applicable | 101 | ecewbizsdw(lcpmmsjmpk) = 1 aoagvltrlf (lheishjrbd ) View more | Positive | 04 Sep 2023 | |||
Placebo | |||||||
Phase 2 | 59 | (Ganaxolone) | jcywmntpzi(hkcraqgyat) = voryfqajuy sqsesnmjcf (helluibnsm, 0.13) View more | - | 10 Apr 2023 | ||
placebo+Ganaxolone (Placebo) | jcywmntpzi(hkcraqgyat) = agvplhjxyu sqsesnmjcf (helluibnsm, 0.13) View more | ||||||
Phase 2 | 23 | (Treatment Period: Ganaxolone) | ipxeljfcfh(ddyizcnzyn) = kofwsdjncz ugrwdkhitg (dwvfmfcucm, kxfiyejpau - cdwvrjwmfg) View more | - | 04 Apr 2023 | ||
(Open Label: Ganaxolone) | mbuclfddnw(idqyuxgdgp) = zgmkdgeqwv lduedhmcsb (hnhxfoqygp, nbypkaqwoj - uxgfbtlfvh) View more | ||||||
Phase 2 | 147 | okspwktofe(tfrebmgutl) = czkyuzaura vhnnaibabd (iohkyhfxot, 9.286) View more | - | 15 Mar 2023 |