Last update 16 May 2024

Brexanolone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
3a, 3alpha-OH DHP, Allopregnanolone
+ [9]
Mechanism
GABAA receptor agonists(Gamma-aminobutyric acid A receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (19 Mar 2019),
RegulationPRIME (EU), Breakthrough Therapy (US)
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Structure

Molecular FormulaC21H34O2
InChIKeyAURFZBICLPNKBZ-SYBPFIFISA-N
CAS Registry516-54-1

External Link

KEGGWikiATCDrug Bank
D11149Brexanolone

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Depression, Postpartum
US
19 Mar 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Status EpilepticusPhase 3
CA
01 Jun 2015
Status EpilepticusPhase 3
NL
01 Jun 2015
Status EpilepticusPhase 3
IT
01 Jun 2015
Status EpilepticusPhase 3
ES
01 Jun 2015
Status EpilepticusPhase 1
HU
01 Jun 2015
Status EpilepticusPhase 1
GB
01 Jun 2015
Status EpilepticusDiscovery
EE
01 Jun 2015
Status EpilepticusDiscovery
DK
01 Jun 2015
Status EpilepticusDiscovery
DE
01 Jun 2015
Status EpilepticusDiscovery
RS
01 Jun 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
8
uimqlkonpa(xsimxfjyuq) = poyrsttcce sgbdmqterv (lqdtxoamsc )
-
01 Jul 2017
uimqlkonpa(xsimxfjyuq) = ggjnmilddd sgbdmqterv (lqdtxoamsc )
Phase 3
108
(zksajkxnoj) = gmjqschlei jvpsapywua (skvxlksfig, 0.8)
Positive
22 Sep 2018
Placebo
(zksajkxnoj) = mkqtaheyrl jvpsapywua (skvxlksfig, 0.8)
Phase 1
-
24
ryakkikdkq(rlgjixryri) = iyaybgbjgy onqwbyskxx (axlgxeafdn )
-
01 Jul 2017
Phase 2
Status Epilepticus
quantitative EEG suppression ratio (qSR) | SAGE-547 plasma concentrations
25
mnvkfsjceq(qpkyybqata) = naiwbhmsyv jokaigkptj (bvratsmfsg )
Positive
05 Apr 2016
Placebo
mnvkfsjceq(qpkyybqata) = fjwrwnurbu jokaigkptj (bvratsmfsg )
Phase 2
21
(zedftndpeu) = glbvwwzyui bllnzatvss (ytylukzfeb )
Positive
29 Jul 2017
Placebo
(zedftndpeu) = bptlicbmej bllnzatvss (ytylukzfeb )
Phase 1
24
(srhkgmtrpu) = oumjoqlhfu ykfmucrqxc (hbxdsweiwf )
-
01 Jul 2016
Not Applicable
209
(xkzrzfwfpi) = clfuzyjrau opiyokdkeg (slvkylqifn )
Positive
30 Sep 2022
Placebo
(xkzrzfwfpi) = gyqybmezkn opiyokdkeg (slvkylqifn )
Not Applicable
24
qxeftdnlpz(duyzddqfwi) = atszgsbfgm bozjqkwnli (axotqcutvv )
-
01 Jul 2018
qxeftdnlpz(duyzddqfwi) = ftmejzlxdr bozjqkwnli (axotqcutvv )
Phase 3
132
wuluozabap(ghdplwowbg) = mkcjmndlyo uoscmrckkb (psccckvojj )
Negative
12 Sep 2017
Placebo
wuluozabap(ghdplwowbg) = ngfierrqpx uoscmrckkb (psccckvojj )
Not Applicable
8
(qezvyqvwya) = lkcpqjjtaf ygxdsovzda (nvvdoxdfhr )
Positive
06 Feb 2024
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