Viibryd

(Vilazodone)

ApprovedSmall molecule

Vilazodone is used to treat depression by helping to balance chemicals in the brain that affect mood and emotional well-being.[2] Viibryd is currently approved and in use across 7 indications[4].[1]

Viibryd is one of 145 small molecule programs targeting Cannabis Dependence. It is currently in Approved.

Indications

Total Trials

Active Trials

144

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Cannabis DependenceApproved

Social Anxiety DisorderActive, not recruiting

Bipolar DisorderActive, not recruiting

Hot FlashesActive, not recruiting

Major Depressive DisorderCompleted

Sexual DysfunctionTerminated

Separation Anxiety DisorderCompleted

Cannabis DependenceApproved

Approved

Social Anxiety DisorderPreclinical

Active, not recruiting

Bipolar DisorderPreclinical

Active, not recruiting

Hot FlashesPreclinical

Active, not recruiting

Major Depressive DisorderApproved

Completed

Sexual DysfunctionApproved

Terminated

Separation Anxiety DisorderApproved

Completed

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Viibryd

AbbVie

Approved

10 2

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 3

Ketalar

Boehringer Ingelheim

Phase 3

3 4

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 5

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 6

Sunosi

AAxsome Therapeutics, Inc.

Phase 3

1 7

Psilocybin

COMPASS Pathways

Phase 3

11 8

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

2 9

Aticaprant

Johnson & Johnson

Phase 3

4 10

Selective Serotonin Reuptake Inhibitor

Johnson & Johnson

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Major Depressive Disorder10 trials

Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)

Completed·FForest Laboratories·Phase 3·NCT02372799·473 enrolled

Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)

Completed·FForest Laboratories·Phase 3·NCT00683592·481 enrolled

Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

Completed·FForest Laboratories·Phase 4·NCT01473394·518 enrolled

Show 7 more trials

A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)

Completed·FForest Laboratories·Phase 3·NCT00644358·616 enrolled

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Completed·FForest Laboratories·Phase 4·NCT01473381·1,162 enrolled

Safety and Efficacy Study of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder

Completed·PPharmacology Research Institute·Phase 2·NCT00290914

Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT01878292·529 enrolled

Double-Blind Treatment of Major Depressive Disorder With Vilazodone

Completed·UUniversity of Chicago·Phase 2·NCT01742832·79 enrolled

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Completed·FForest Laboratories·Phase 4·NCT01573598·1,219 enrolled

A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

Completed·FForest Laboratories·Phase 3·NCT02436239·330 enrolled

Generalized Anxiety Disorder2 trials

Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

Completed·FForest Laboratories·Phase 3·NCT01629966·680 enrolled

Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder

Completed·FForest Laboratories·Phase 3·NCT01844115·415 enrolled

Treatment1 trial

Vilazodone Treatment for Marijuana Dependence

Completed·MMedical University of South Carolina·Phase 2·NCT01574183·76 enrolled

Hot flashes1 trial

Vilazodone for Menopausal Hot Flashes

Completed·UUniversity of Pennsylvania·N/A·NCT01680900·36 enrolled

Sexual Dysfunction1 trial

Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

Terminated·TThomas Jefferson University·Phase 4·NCT01856127·4 enrolled

8 more indications

Effectiveness1 trial

Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response

Completed·GGenaissance Pharmaceuticals·Phase 3·NCT00285376·410 enrolled

Memory Impairment1 trial

Vilazodone for Corticosteroid-Induced Memory Impairment

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT01828515·24 enrolled

ESS1 trial

The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives

Withdrawn·MMassachusetts General Hospital·Phase 4·NCT02028026

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Elective1 trial

Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone

Completed·—·Phase 3·NCT02015546·70 enrolled

Social Anxiety Disorder1 trial

Study of Vilazodone to Treat Social Anxiety Disorder

Unknown status·TThe Medical Research Network·N/A·NCT01712321·30 enrolled

Sexual Function1 trial

Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo

Completed·FForest Laboratories·Phase 1·NCT02097147·202 enrolled

Separation Anxiety Disorder1 trial

Vilazodone for Separation Anxiety Disorder

Completed·NNew York State Psychiatric Institute·Phase 4·NCT01999920·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 21, 2011

VIIBRYD

NDA NDA022567

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Vilazodone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Viibryd drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Vilazodone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Vilazodone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022567). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin Transporter Inhibitor; Serotonin 1a (5-Ht1a) Receptor Partial Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Viibryd

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Major Depressive Disorder10 trials

Generalized Anxiety Disorder2 trials

Treatment1 trial

Hot flashes1 trial

Sexual Dysfunction1 trial

Effectiveness1 trial

Memory Impairment1 trial

ESS1 trial

Bipolar Disorder1 trial

Elective1 trial

Social Anxiety Disorder1 trial

Sexual Function1 trial

Separation Anxiety Disorder1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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