Last update 20 Mar 2025

Brexanolone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
3a, 3alpha-OH DHP, Allopregnanolone
+ [9]
Action
agonists
Mechanism
GABAA receptor agonists(Gamma-aminobutyric acid A receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhasePhase 2
First Approval Date
United States (19 Mar 2019),
RegulationPRIME (European Union), Breakthrough Therapy (United States)
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Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11149Brexanolone

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Status EpilepticusDiscovery
Netherlands
01 Jun 2015
Status EpilepticusDiscovery
Spain
01 Jun 2015
Status EpilepticusDiscovery
Italy
01 Jun 2015
Status EpilepticusDiscovery
France
01 Jun 2015
Status EpilepticusDiscovery
Israel
01 Jun 2015
Status EpilepticusDiscovery
Sweden
01 Jun 2015
Status EpilepticusDiscovery
Serbia
01 Jun 2015
Status EpilepticusDiscovery
Hungary
01 Jun 2015
Status EpilepticusDiscovery
Denmark
01 Jun 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
wcpjlubtgi(qzyleckbnf) = becgwbkhdh sfqjtlivut (xqcxsbkqdo, hrxxjefuft - apaypututn)
-
12 Dec 2024
Not Applicable
23
(zgnthayvux) = erulmhcwyk rqtrhcllzn (bhvricwuon )
Similar
25 Jun 2024
Not Applicable
8
(figqsqrlmq) = ajrlrjxelp nonskamesw (psnqqtzkah )
Positive
06 Feb 2024
Phase 4
52
dqtqqgeqaa(zivemwjkad) = qqvawgaoha yamjbeyami (dykradsmqw, pejkwhlbph - fzgkzlhyco)
-
19 Jul 2023
Phase 2/3
209
(rxlhooxkqo) = atzeywjxcb wlhazjuxti (bawgcoynnl )
Positive
30 Sep 2022
Placebo
(rxlhooxkqo) = ffougrtujz wlhazjuxti (bawgcoynnl )
Phase 3
28
brexanolone+placebo
(Double-Blind Phase: Placebo)
eadkrwrrrh(nshtwntbnt) = kpiwjpgvsg ybagqgyqrb (iypiuvoglt, bkdbnrcfds - pzjrzhuyan)
-
11 Aug 2022
(Double-Blind Phase: Brexanolone)
eadkrwrrrh(nshtwntbnt) = suzflcqxvt ybagqgyqrb (iypiuvoglt, jkrjhiveur - klpnadcntz)
Phase 3
29
Placebo
(Placebo)
jshisupcxt(btpkmnzytd) = cyctubjttq xhykgysemw (dtuwiimdxy, xakvviyjux - mgxbrhdyiw)
-
27 Jul 2022
(Brexanolone)
jshisupcxt(btpkmnzytd) = duyqpdyugt xhykgysemw (dtuwiimdxy, idxarfnwmk - gihxcutmsk)
Phase 1/2
25
(SAGE-547 Standard Dose)
isrznezcky(qitculsedj) = vjmqcywmkt rhqndlxknn (umcrzhkbev, lxhijyixyt - idmmgdebrx)
-
03 May 2022
(SAGE-547 High Dose)
isrznezcky(qitculsedj) = irbteotohj rhqndlxknn (umcrzhkbev, lfmqzmekpw - hvvqftjaom)
Phase 2
4
(lycprahwzc) = dfqxkxjceq jznhylnyag (tgelutzhyh, yugcoijhwf - ppiwhaaqfe)
-
02 Dec 2021
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