CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

zuranolone

Trade name: ZURZUVAE

Small moleculeapprovedFast Track FDA

Approved

Aug 4, 2023

Clinical trial activity

14 trials · 1 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
12
Phase 3
7
Phase 4
0

Earliest trial started Dec 1, 2016 (NCT03000530)

Timeline

2010s

  1. Jan 1, 2016

    Sage Therapeutics — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2017

    Sage Therapeutics — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2018

    Sage Therapeutics — Earliest Phase 3 Sponsor(trial)

2020s

  1. Aug 4, 2023

    Sage Therapeutics — Earliest FDA Approval

  2. Aug 4, 2023

    Sage Therapeutics — Marketing Organization

  3. Aug 4, 2023

    Sage Therapeutics — NDA Secondary Org

  4. Aug 4, 2023

    Biogen — Marketing Organization

  5. Aug 4, 2023

    Sage Therapeutics — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackAug 4, 2023

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@]1(O)CC[C@H]2[C@H](CC[C@@H]3[C@@H]2CC[C@]2(C)[C@@H](C(=O)Cn4cc(C#N)cn4)CC[C@@H]32)C1
Mol. weight
409.57 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • sage-217

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05655507Phase 1Jan 31, 2023Sage Therapeutics
NCT04476030Phase 3Nov 16, 2020Sage Therapeutics
NCT04442503Phase 3Jun 22, 2020Sage Therapeutics
NCT04442490Phase 3May 7, 2020Sage Therapeutics
NCT04007367Phase 3Aug 31, 2019Sage Therapeutics
NCT03864614Phase 3Feb 27, 2019Sage Therapeutics
NCT03771664Phase 3Feb 20, 2019Sage Therapeutics
NCT03672175Phase 3Sep 30, 2018Sage Therapeutics
NCT03692910Phase 2Aug 19, 2018Sage Therapeutics
NCT03284931Phase 1Sep 14, 2017Sage Therapeutics
NCT02978326Phase 2Dec 1, 2016Sage Therapeutics
NCT03000569Phase 2Dec 1, 2016Sage Therapeutics
NCT03000530Phase 2Dec 1, 2016Sage Therapeutics
NCT02978781Phase 2Dec 1, 2016Sage Therapeutics
Showing 14 of 14 trials
Page 1 / 1

Organizations

Research & Development (1)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Sage TherapeuticsFor profit141432016
1 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
BiogenFor profitMKTGAug 4, 2023
BiogenFor profitSYNAug 4, 2023
Sage TherapeuticsFor profitMKTGAug 4, 2023
Sage TherapeuticsFor profitNDA2Aug 4, 2023
Sage TherapeuticsFor profitNDAAug 4, 2023