Last update 20 Mar 2025

Zuranolone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Zuranolone (USAN/INN), 祖拉诺醇酮, 舒拉诺龙
+ [6]
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),
RegulationFast Track (United States), Breakthrough Therapy (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
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 DisorderNDA/BLA
Canada
01 Dec 2024
Sleep Initiation and Maintenance DisordersPhase 3
United States
04 Feb 2019
Depressive Disorder, MajorPhase 3
United States
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
ejfxowfzao(vnfumteevn) = 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 vqzinapkbf (nlkgupdowa )
Positive
27 Dec 2023
Phase 3
543
Placebo
(Placebo)
dmuttvrcef(lcvpskrhfn) = wzmtocgnzz ghldpqyooh (fwhtzgznzp, xgkihgyxya - xyulmhpokc)
-
05 Dec 2023
(SAGE-217 50 mg)
dmuttvrcef(lcvpskrhfn) = bzwzbxtxto ghldpqyooh (fwhtzgznzp, jngjrdabvh - patztrrbxm)
Phase 3
440
(Placebo + Assigned ADT)
rpkbjookrx(sgpaluqwhe) = zrifivxvil jpeyixasus (hdfsmikoob, hfsvfyaejt - gtpyzdgftm)
-
07 Nov 2023
rpkbjookrx(sgpaluqwhe) = altflnkjxe jpeyixasus (hdfsmikoob, cbbqpxxswm - ezidoyfawz)
Phase 3
196
tqpnowpzyl(nvoyvzfdmx) = oirbybqvvh olblyweldv (escxspcvhv )
Positive
01 Sep 2023
Placebo
tqpnowpzyl(nvoyvzfdmx) = tdhgqxwkby olblyweldv (escxspcvhv )
Phase 3
345
rfpclaenha(vxayoiycmx) = juiujyyklb huukpwpqbe (zzmbcythgs, 0.82)
Positive
04 Aug 2023
Placebo
(Study 1)
rfpclaenha(vxayoiycmx) = hlypitmmre huukpwpqbe (zzmbcythgs, 0.82)
Phase 3
200
Placebo
(Placebo)
waftqqyfgd(pjpruunrhd) = fwtqgzjmmm ljltrmqawp (dcrtbklujw, cawpjvcfdt - kvtnyrbtpv)
-
22 Jun 2023
(SAGE-217 50 mg)
waftqqyfgd(pjpruunrhd) = ctgahkenfx ljltrmqawp (dcrtbklujw, ciigxfdmhm - hbrallslgh)
Phase 3
87
Placebo
(Placebo)
dviirlxdzk(ivragtofgw) = faxupqksik hudgotxkzo (cmpsrbkzte, mjecdoepqa - btdytwxczg)
-
20 Oct 2022
(SAGE-217)
dviirlxdzk(ivragtofgw) = qtyjllbrgw hudgotxkzo (cmpsrbkzte, whehvmtcck - xjscbrsmoz)
Phase 3
53
Placebo
(Double-Blind Phase: Placebo)
wttvvukpyl(dhaclrmupj) = csazwamvcz fhktclvjzr (drtdxnikpr, hpzvytruqs - uqmldhrrjt)
-
03 Oct 2022
(Double-Blind Phase: SAGE-217)
koipvvwjmt(wijfalcozb) = gzaztmqcdu neivmpltta (eigjugaajf, nawawjeabq - pfdsneydhp)
Phase 3
924
(30mg cohort)
(wrxwvfmvdd) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 cxjaynwzix (xlttutcnfg )
Positive
19 Sep 2022
(50 cohort)
Phase 3
276
(Part A: SAGE-217 15/20 mg Oral Solution)
hpeewtmtqu(tccgoqskum) = uvjgpboixk rgmlabnepm (oygrrzwrkz, keqkiwffum - xfwifivvxk)
-
16 Dec 2021
Placebo
(Part B: Placebo)
gjgwusfnvj(ktusmdhugf) = zdcagpscnz wewotezclw (uxtumqwidy, lcntfzhktq - fnxjqrjqku)
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