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 144 small molecule programs targeting Sexual Dysfunction. It is currently in Approved.

Indications

Total Trials

Active Trials

143

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Sexual DysfunctionTerminated

Social Anxiety DisorderActive, not recruiting

Major Depressive DisorderCompleted

Bipolar DisorderActive, not recruiting

Cannabis DependenceApproved

Separation Anxiety DisorderCompleted

Hot FlashesActive, not recruiting

Sexual DysfunctionApproved

Terminated

Social Anxiety DisorderPreclinical

Active, not recruiting

Major Depressive DisorderApproved

Completed

Bipolar DisorderPreclinical

Active, not recruiting

Cannabis DependenceApproved

Approved

Separation Anxiety DisorderApproved

Completed

Hot FlashesPreclinical

Active, not recruiting

Competition

Competitive Landscape

115 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Vraylar

AbbVie

Approved

6 2

Viibryd

AbbVie

Approved

10 3

Tofranil

Sanofi

Approved

—4

Pristiq

PPrism Pharmaceuticals

Approved

4 5

Norpramin

VValidus Pharmaceuticals

Approved

—6

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 7

Ketalar

Boehringer Ingelheim

Phase 3

5 8

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 9

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 10

Psilocybin

COMPASS Pathways

Phase 3

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

Clinical

Trials by Indication[1]

Major Depressive Disorder10 trials

Double-Blind Treatment of Major Depressive Disorder With Vilazodone

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

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

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

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

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

Show 7 more trials

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

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

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

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

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

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

8 more indications

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

Sexual Dysfunction1 trial

Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

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

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

Regulatory

FDA Approval Timeline[5]

Jan 21, 2011

VIIBRYD

NDA NDA022567

Jun 29, 2011

VIIBRYD

NDA NDA022567

Sep 21, 2011

VIIBRYD

NDA NDA022567

Dec 14, 2012

VIIBRYD

NDA NDA022567

Dec 21, 2012

VIIBRYD

NDA NDA022567

Jan 10, 2013

VIIBRYD

NDA NDA022567

Jun 8, 2013

VIIBRYD

NDA NDA022567

Dec 17, 2013

VIIBRYD

NDA NDA022567

Apr 7, 2014

VIIBRYD

NDA NDA022567

Apr 17, 2014

VIIBRYD

NDA NDA022567

Jul 16, 2014

VIIBRYD

NDA NDA022567

Mar 16, 2015

VIIBRYD

NDA NDA022567

Jun 11, 2015

VIIBRYD

NDA NDA022567

Dec 16, 2015

VIIBRYD

NDA NDA022567

Sep 6, 2016

VIIBRYD

NDA NDA022567

Jan 4, 2017

VIIBRYD

NDA NDA022567

Jan 31, 2020

VIIBRYD

NDA NDA022567

Sep 20, 2021

VIIBRYD

NDA NDA022567

Aug 18, 2023

VIIBRYD

NDA NDA022567

Apr 19, 2024

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

Bipolar Disorder1 trial

Treatment1 trial

Hot flashes1 trial

Elective1 trial

Sexual Dysfunction1 trial

Social Anxiety Disorder1 trial

Sexual Function1 trial

Separation Anxiety Disorder1 trial

Effectiveness1 trial

Memory Impairment1 trial

ESS1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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