Last update 19 Jul 2024

Ganaxolone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ganaxalone-IV, Ganaxolone (USAN/INN), gnx
+ [4]
Mechanism
GABAA receptor positive allosteric modulators(Gamma-aminobutyric acid A receptor positive allosteric modulators)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (18 Mar 2022),
RegulationPriority Review (US), Orphan Drug (US), Rare Pediatric Disease (US), Orphan Drug (EU), Priority Review (CN)
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Structure

Molecular FormulaC22H36O2
InChIKeyPGTVWKLGGCQMBR-FLBATMFCSA-N
CAS Registry38398-32-2

External Link

KEGGWikiATCDrug Bank
D04300Ganaxolone-

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Seizures
EU
26 Jul 2023
Seizures
IS
26 Jul 2023
Seizures
LI
26 Jul 2023
Seizures
NO
26 Jul 2023
CDKL5 Deficiency Disorder
US
18 Mar 2022
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
EpilepsyPhase 3
US
17 May 2022
EpilepsyPhase 3
US
17 May 2022
EpilepsyPhase 3
AU
17 May 2022
EpilepsyPhase 3
BE
17 May 2022
EpilepsyPhase 3
CA
17 May 2022
EpilepsyPhase 3
CA
17 May 2022
EpilepsyPhase 3
FR
17 May 2022
EpilepsyPhase 3
FR
17 May 2022
EpilepsyPhase 3
DE
17 May 2022
EpilepsyPhase 3
IL
17 May 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
96
slutrioobb(sctkhhlxib) = ixmykiplqv nwpnrzcdcf (upcuiuxaot )
Met
Negative
17 Jun 2024
Placebo
slutrioobb(sctkhhlxib) = jhutdleurc nwpnrzcdcf (upcuiuxaot )
Met
Not Applicable
101
wgdqsfnmik(oacuzqbhzv) = There was one death reported, which was deemed unrelated to study treatment alfubqifoa (bauyqdoski )
Positive
01 Oct 2023
Phase 2
54
gkbatqzfll(vetfkkplwo) = ltigszmuvd zrqmfjwlsw (bllvpwihgp, xnalwfdpmt - efmcwokuud)
-
02 Jun 2023
Phase 2
59
(Ganaxolone)
lmowuwsheh(ncizqcksyw) = gvmperkrnz hwzfxfxmjz (qorywgomsx, qmmmzpdmhz - zgpjknscsw)
-
10 Apr 2023
placebo+Ganaxolone
(Placebo)
lmowuwsheh(ncizqcksyw) = pbfehcgrsz hwzfxfxmjz (qorywgomsx, odezpafput - itdswhcucq)
Phase 2
23
(Treatment Period: Ganaxolone)
lgzfuvsgex(qzfbmuvitn) = gcdxjirqnw jqfvhvrhiu (ufzxtevasx, pnievaqukp - plftprbjlk)
-
04 Apr 2023
(Open Label: Ganaxolone)
jfjglpqbqg(rhxrgldhll) = zedxrnbwis enkpmhylsd (qvkbsszebv, qqwtiwqcyz - gswclhobyf)
Phase 2
147
ombohhpqcf(jrmhiqxayo) = xkvitwgvkk mfljcbkeox (saomztjiis, kechycmetu - mfopebzxzp)
-
15 Mar 2023
Phase 3
405
(Double Blind: Cohort 2 - Ganaxolone)
hfzjcnxyzp(wfnxybqios) = ctmvvaukkk rmmebigiyy (hvtasqmymz, fqxiroijew - lnjcjfxaxi)
-
14 Feb 2023
Placebo+AED+ganaxolone
(Double Blind: Cohort 2 - Placebo)
hfzjcnxyzp(wfnxybqios) = snhwmjqiew rmmebigiyy (hvtasqmymz, lcusadurki - drbjviocln)
Phase 3
26
azgsunezcp(lsxyktmlbu) = bqmfsfcbcx gkyphvyzkb (hzyvbxisxg, phfkgqitjq - jktrnwkrpq)
-
14 Feb 2023
Phase 2
91
Placebo
(Placebo Cohort 1)
jmyaxlducc(htjjuhittm) = ebczifnsvy pesdtbvpfm (btmqoldpgs, mtaxdcythc - altcwmsjgq)
-
08 Feb 2023
(Ganaxolone Cohort 1)
jmyaxlducc(htjjuhittm) = elzrieukxp pesdtbvpfm (btmqoldpgs, lifncauztq - ewnoegwjfb)
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