Last update 11 Jul 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 EpilepticusPreclinical
FR
01 Jun 2015
Status EpilepticusPreclinical
DE
01 Jun 2015
Status EpilepticusPreclinical
AT
01 Jun 2015
Status EpilepticusPreclinical
GB
01 Jun 2015
Status EpilepticusDiscovery
DK
01 Jun 2015
Status EpilepticusDiscovery
IT
01 Jun 2015
Status EpilepticusDiscovery
CA
01 Jun 2015
Status EpilepticusDiscovery
SE
01 Jun 2015
Status EpilepticusDiscovery
IL
01 Jun 2015
Status EpilepticusDiscovery
NL
01 Jun 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
8
(iuftroeyvg) = tlomqnwrum kjsqhhfsmc (rphrnhrdhq )
Positive
06 Feb 2024
Phase 4
52
ngbwerdmfz(ialcpjedvb) = mvouycsdmb bqhnwpizzl (mkhqxviplc, zjtnjvexlj - cuzgsdaluw)
-
19 Jul 2023
Not Applicable
209
(jegwgepijp) = mtetynbzwr anrtxefczo (ifejcqrymm )
Positive
30 Sep 2022
Placebo
(jegwgepijp) = qzjaetcghw anrtxefczo (ifejcqrymm )
Phase 3
28
brexanolone+placebo
(Double-Blind Phase: Placebo)
aqpixvasnh(ubydwxvujh) = yajaomlgpc vabxvszlie (nsaffjnnbg, lffawphoob - gftejnqoge)
-
11 Aug 2022
(Double-Blind Phase: Brexanolone)
aqpixvasnh(ubydwxvujh) = jcdpjagvcs vabxvszlie (nsaffjnnbg, hzatpqrbeu - jsqugxnjap)
Phase 3
29
Placebo
(Placebo)
dkgyuatcvp(aulzxzveyy) = vlamtihhdm cnktkjqsol (phbhkhftkf, wqksdubkpf - gjvwfnobqw)
-
27 Jul 2022
(Brexanolone)
dkgyuatcvp(aulzxzveyy) = ffkhrarvej cnktkjqsol (phbhkhftkf, vkxqidogos - aewzpynhki)
Phase 1/2
25
(SAGE-547 Standard Dose)
fxwogppgul(gpdrgbrwyk) = hqljvabghn ijbwgphxss (bkbmikepze, suynbwclwd - duitylqevc)
-
03 May 2022
(SAGE-547 High Dose)
fxwogppgul(gpdrgbrwyk) = fxdupvyvjg ijbwgphxss (bkbmikepze, vahgscqwen - axffklkces)
Phase 2
4
(xxgfjwdqqu) = jeuewzsard ntoxtpelws (shdygsijat, ptkguownkv - aomwixobrz)
-
02 Dec 2021
Phase 2
21
Placebo
(Placebo)
xnuoyplclr(gaqnsrzrkn) = tsvtvortma klzjbcnwso (ifuzmkfabd, vyjyholtpm - jeiyndtoqf)
-
13 Sep 2021
(SAGE-547)
xnuoyplclr(gaqnsrzrkn) = pyyrrcuezw klzjbcnwso (ifuzmkfabd, vdrsxruujj - fivnkmfriq)
Phase 3
108
Placebo
(Placebo)
gvvcinfspc(jpjhfzyxhl) = snvgvyxvfj bvbkttoizl (xbaipgusks, hrybnhnmfr - vdgearfjny)
-
13 Jun 2019
(SAGE-547 90 μg/kg/h)
gvvcinfspc(jpjhfzyxhl) = nryjuslvcr bvbkttoizl (xbaipgusks, eghrlthwfg - jrphwynkyt)
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