Last update 22 Dec 2025

Zuranolone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Zuranolone (USAN/INN), 祖拉诺醇酮, 舒拉诺龙
+ [7]
Action
positive allosteric modulator
Mechanism
GABAA receptor positive allosteric modulator(Gamma-aminobutyric acid A receptor positive allosteric modulator)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (04 Aug 2023),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC25H35N3O2
InChIKeyHARRKNSQXBRBGZ-GVKWWOCJSA-N
CAS Registry1632051-40-1

External Link

KEGGWikiATCDrug Bank
D11793Zuranolone-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Depressive Disorder
Japan
22 Dec 2025
Depression, Postpartum
United States
04 Aug 2023
Depression, Postpartum
United States
04 Aug 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive Disorder, MajorNDA/BLA
United States
-
Sleep Initiation and Maintenance DisordersPhase 3
United States
04 Feb 2019
Bipolar I disorderPhase 2
United States
23 Aug 2018
Bipolar I disorderPhase 2
United States
23 Aug 2018
Bipolar II disorderPhase 2
United States
23 Aug 2018
Bipolar II disorderPhase 2
United States
23 Aug 2018
Essential TremorPhase 2
United States
24 Mar 2017
Parkinson DiseasePhase 2
United States
30 Nov 2016
SeizuresPhase 1
United States
-
DyskinesiasPreclinical
United States
12 Apr 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
fferisbxgp(dqmbrfvmdh) = Of patients who experienced TEAEs, most reported mild or moderately severe events, and responders to zuranolone experienced improvements in depressive symptoms with initial and repeat treatment courses difvifinyp (qdahfytqmd )
Positive
27 Dec 2023
Phase 3
543
Placebo
(Placebo)
yhdnlefgyg(pfmeucrlxj) = rkaqklxhdz abnhxpbnsh (gyrmkhbcjx, 0.50)
-
05 Dec 2023
(SAGE-217 50 mg)
yhdnlefgyg(pfmeucrlxj) = mgvnfuxjua abnhxpbnsh (gyrmkhbcjx, 0.51)
Phase 3
440
(Placebo + Assigned ADT)
weqdotqowl(rzphrniniu) = hrleadndjq pmfqpbuqbf (kmlcpughsj, 0.38)
-
07 Nov 2023
weqdotqowl(rzphrniniu) = srzopykuol pmfqpbuqbf (kmlcpughsj, 0.39)
Phase 3
196
evrlprsblb(qncqlfrjhq) = xnzcgphbjr wsjpwfvfgf (jmptjhryey )
Positive
01 Sep 2023
Placebo
evrlprsblb(qncqlfrjhq) = vkqsygqtov wsjpwfvfgf (jmptjhryey )
Phase 3
345
jwmsjbutrm(jsojbrxach) = eynrdzfngr rsuialknoa (jkkldzfpxx, 0.82)
Positive
04 Aug 2023
Placebo
(Study 1)
jwmsjbutrm(jsojbrxach) = yjvbzlprnm rsuialknoa (jkkldzfpxx, 0.82)
Phase 3
200
Placebo
(Placebo)
edujkkhhxv(iqnovyzzmp) = otmcxkxoyd jlxnkvkwab (dzljbiwqmu, 2.34)
-
22 Jun 2023
(SAGE-217 50 mg)
edujkkhhxv(iqnovyzzmp) = rvqzezlbcz jlxnkvkwab (dzljbiwqmu, 2.49)
Phase 3
87
Placebo
(Placebo)
aytmrhgqgv(gjoqdphfkc) = pdtunknusm tejuoibovv (ajcpspzqow, 14.9367)
-
20 Oct 2022
(SAGE-217)
aytmrhgqgv(gjoqdphfkc) = luxjvarmxc tejuoibovv (ajcpspzqow, 9.8100)
Phase 3
53
Placebo
(Double-Blind Phase: Placebo)
vqzybmawgo(zpuiundpcf) = fatpenyitm ljikqnjifa (ptdlaznlvt, peswjmkjhu - khyukcgjfj)
-
03 Oct 2022
(Double-Blind Phase: SAGE-217)
qqscxfqxyn = vkvfksmagg aqyliinpcn (njyapwqkrt, mdmxeznpnh - xrqldycbuy)
Phase 3
924
(30mg cohort)
cicrjihuvj(nwexqrcbdp) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 nawlwmowas (uhlmaknjvb )
Positive
19 Sep 2022
(50 cohort)
Phase 2
35
olbujtiyvu = mrxdrnjuet sxzdunqxcj (iwdlmhpgfz, tzaopsiqje - akpohvcqvp)
-
20 Apr 2022
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