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vilazodone

Trade name: viibryd

Small moleculeapproved

Approved

Jan 21, 2011

Vilazodone is a serotonergic antidepressant. The mechanism of the antidepressant effect of vilazodone is not fully understood but is thought to be related to its inhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown. The side effects include activation of mania/hypomania in patients with bipolar disorder, seizures can occur with treatment in patients with a seizure disorder. — NCATS

Clinical trial activity

27 trials · 25 clinical orgs · 10 marketing orgs

Phase 1
1
Phase 2
16
Phase 3
10
Phase 4
8

Earliest trial started Feb 1, 2006 (NCT00285376)

Timeline

1990s

  1. Nov 21, 1997

    Merck KGaA — IND Organization

  2. Nov 21, 1997

    Merck KGaA — IND Organization

2000s

  1. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 21, 2011

    Clinical Data, Inc. — Earliest FDA Approval

  2. Jan 21, 2011

    Allergan — Marketing Organization

  3. Jan 21, 2011

    Allergan — NDA Secondary Org

  4. Jan 21, 2011

    Clinical Data, Inc. — NDA Organization

  5. Jan 21, 2011

    AbbVie — Marketing Organization

  6. Jan 21, 2011

    AbbVie — NDA Secondary Org

  7. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  8. Jul 11, 2016

    Teva — Marketing Organization

  9. Apr 14, 2017

    Alembic — Marketing Organization

2020s

  1. Apr 7, 2021

    Invagen Pharms — Marketing Organization

  2. Apr 7, 2021

    Cipla — Marketing Organization

  3. Apr 27, 2021

    Accord Research — Marketing Organization

  4. Jul 7, 2023

    Apotex — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 21, 2011

Chemistry & pharmacology

Loading structure…

SMILES

N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Mol. weight
441.54 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • emd-515259
  • emd-515259
  • emd-68-843
  • emd-68-843
  • sb-659746-a
  • sb-659746-a
  • viibryd
  • viibryd
  • viibryd
  • viibryd
  • viibryd
  • vilazodona
  • vilazodona
  • vilazodone
  • vilazodone
  • vilazodone
  • vilazodone
  • vilazodone
  • vilazodone
  • vilazodone
  • vilazodone
  • vilazodone
  • vilazodone
  • vilazodone hcl
  • vilazodone hcl
  • vilazodone hcl
  • vilazodone hydrochloride
  • vilazodone hydrochloride
  • vilazodone hydrochloride
  • vilazodone hydrochloride
  • vilazodonum
  • vilazodonum
  • vilbryd

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05948579Phase 2Aug 31, 2023Berry Consultants, Cambridge Cognition Ltd, Citeline, Idorsia Pharmaceuticals Ltd., PPD, United States Army
NCT05422612Phase 2Feb 28, 2023PPD, United States Army
NCT02436239Phase 3May 1, 2015Allergan, Forest Laboratories
NCT02372799Phase 3Feb 1, 2015Allergan, Forest Laboratories
NCT02097147Phase 1Mar 1, 2014Forest Laboratories
NCT01999920Phase 4Dec 1, 2013Columbia University, Forest Laboratories
NCT01878292Phase 3Jul 1, 2013Allergan, Forest Laboratories
NCT01742832Phase 2May 1, 2013University of Chicago
NCT02028026Phase 4Apr 1, 2013Harvard University
NCT01844115Phase 3Apr 1, 2013Actavis, Forest Laboratories
NCT01766401Phase 3Jan 1, 2013Forest Laboratories
NCT01856127Phase 4Jan 1, 2013Forest Laboratories, Thomas Jefferson University, University of Pennsylvania, University of Virginia
NCT02015546Phase 3Dec 1, 2012Duke University
NCT01828515Phase 2Dec 1, 2012Forest Laboratories, The University of Texas, Dallas
NCT01680900N/ANov 1, 2012Forest Laboratories, University of Pennsylvania
NCT01715519Phase 4Oct 1, 2012Department of Veteran Affairs, Forest Laboratories
NCT01712321N/AOct 1, 2012Forest Laboratories, The Medical Research Network, LLC
NCT01574183Phase 2Aug 1, 2012Medical University of South Carolina, National Institute on Drug Abuse (NIDA), University of South Carolina
NCT01608295Phase 4Jul 1, 2012Forest Laboratories, University of California, Los Angeles
NCT01629966Phase 3Jun 1, 2012Forest Laboratories
Showing 20 of 27 trials
Page 1 / 2

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Forest LaboratoriesFor profit191252007
AllerganFor profit3012013
ActavisFor profit2022012
PPDFor profit2012023
United States ArmyGovernment2212023
University of PennsylvaniaAcademic/Hospital2122012
Berry ConsultantsFor profit1012023
Cambridge Cognition LtdFor profit1012023
CitelineFor profit1012023
Columbia UniversityAcademic/Hospital1112013
Department of Veteran AffairsGovernment1112012
Duke UniversityAcademic/Hospital1112012
GenaissanceFor profit1112006
Harvard UniversityAcademic/Hospital1112013
Idorsia Pharmaceuticals Ltd.For profit1012023
Medical University of South CarolinaAcademic/Hospital1012012
National Institute on Drug Abuse (NIDA)Government1012012
Pharmacology Research InstituteFor profit1112006
The Medical Research Network, LLCAcademic/Hospital1112012
The University of Texas, DallasAcademic/Hospital1112012
25 organizations
Page 1 / 2

Marketing (13)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJan 21, 2011
AbbVieFor profitNDA2Jan 21, 2011
Accord ResearchFor profitMKTGApr 27, 2021
AlembicFor profitMKTGApr 14, 2017
AlembicFor profitSYNJan 10, 2020
AllerganFor profitMKTGJan 21, 2011
AllerganFor profitNDA2Jan 21, 2011
ApotexFor profitMKTGJul 7, 2023
CiplaFor profitMKTGApr 7, 2021
Clinical Data, Inc.For profitNDAJan 21, 2011
Invagen PharmsFor profitMKTGApr 7, 2021
Merck KGaAFor profitINDNov 21, 1997
TevaFor profitMKTGJul 11, 2016