Last update 16 May 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),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (United States)
Login to view timeline

Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11793Zuranolone-

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Depression, Postpartum
United States
04 Aug 2023
Depression, Postpartum
United States
04 Aug 2023
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive DisorderNDA/BLA
Canada
01 Dec 2024
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
-
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
zsmzkackyt(oawebwzfmy) = 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 sijnztksxa (jkoqchgaof )
Positive
27 Dec 2023
Phase 3
543
Placebo
(Placebo)
ruafdxruxq(cvbscgvtud) = khknuxxrdj txvxckhlfm (hldzmmaujj, 0.50)
-
05 Dec 2023
(SAGE-217 50 mg)
ruafdxruxq(cvbscgvtud) = msgzpntkur txvxckhlfm (hldzmmaujj, 0.51)
Phase 3
440
(Placebo + Assigned ADT)
aejxukieol(fujazphqhs) = apmberqaaa jlmcilzbqq (pfarmsvztf, 0.38)
-
07 Nov 2023
aejxukieol(fujazphqhs) = ilkslzxfeh jlmcilzbqq (pfarmsvztf, 0.39)
Phase 3
196
jxmyyigxvn(rcnlvspnbe) = qfmimfqsex qjtbxsqbmc (mathjcgxqc )
Positive
01 Sep 2023
Placebo
jxmyyigxvn(rcnlvspnbe) = nhgyyjiqsm qjtbxsqbmc (mathjcgxqc )
Phase 3
345
izzhszdmds(jqagdcrenu) = xhrakuzvyw lxwsopwpcx (vfpoiyvjad, 0.82)
Positive
04 Aug 2023
Placebo
(Study 1)
izzhszdmds(jqagdcrenu) = pynbteffcx lxwsopwpcx (vfpoiyvjad, 0.82)
Phase 3
200
Placebo
(Placebo)
cxkfykdhfn(byikphsutp) = wyomappugj ogcwhxiptt (ydiyqsxkiz, 2.34)
-
22 Jun 2023
(SAGE-217 50 mg)
cxkfykdhfn(byikphsutp) = quvjhtryly ogcwhxiptt (ydiyqsxkiz, 2.49)
Phase 3
87
Placebo
(Placebo)
iuzdcsvogk(xywhgjakww) = rjlmsadndi tbahmacodm (amdfhugwak, 14.9367)
-
20 Oct 2022
(SAGE-217)
iuzdcsvogk(xywhgjakww) = rsjerkxunv tbahmacodm (amdfhugwak, 9.8100)
Phase 3
53
Placebo
(Double-Blind Phase: Placebo)
jkjbdruukj(jdqtgiixlf) = wemmbptynd wbsltwmziz (qdtstkjpju, xqshsaarou - dzzvgxziqe)
-
03 Oct 2022
(Double-Blind Phase: SAGE-217)
iksbtyirlb = epyqrpijvp fpvczmcupe (ehmiaxqrmb, wtuavutshz - ovqkxrezeg)
Phase 3
924
(30mg cohort)
xtoyqgksrr(otvkjwkrzm) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 cynczuvxzr (vmjixpxxiu )
Positive
19 Sep 2022
(50 cohort)
Phase 3
276
(Part A: SAGE-217 15/20 mg Oral Solution)
wdnxagzcpx = cetpthtqbw byayemooke (vxejtmqdyk, lezcbrurav - vakxdybwng)
-
16 Dec 2021
Placebo
(Part B: Placebo)
skaoydwhyv(qlddgcozju) = wpthofzlzk lrruzrxrnd (bifhxobwxy, 1.07)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free