Drugs / Vilazodone

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) VIIBRYD 2015-03-16 – 2020-01-31 fda.gov
Approved US (FDA) VIIBRYD 2011-01-21 fda.gov

Trials 27 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02097147 Mar → Sep 2014 Forest Laboratories Completed No outcome recorded
Phase 25 trials
Phase 2 NCT05948579 Aug 2027 → May 2028 expected post-traumatic stress disorder Global Coalition for Adaptive Research Not yet recruiting No outcome recorded
Phase 2 NCT05422612 Nov 2023 → Jul 2028 post-traumatic stress disorder Global Coalition for Adaptive Research Suspended No outcome recorded
Phase 2 NCT01828515 Dec 2012 → Apr 2014 cognitive disorder University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 2 NCT01574183 Aug 2012 → Aug 2015 cannabis dependence Medical University of South Carolina Completed No outcome recorded
Phase 2 NCT00290914 major depressive disorder Pharmacology Research Institute Completed No outcome recorded
Phase 310 trials
Phase 3 NCT02436239 May 2015 → Jul 2018 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT02372799 Feb 2015 → Sep 2018 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT01878292 Jul 2013 → Mar 2016 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT01844115 Apr 2013 → Mar 2014 generalized anxiety disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT01766401 Jan 2013 → Jan 2014 generalized anxiety disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT02015546 Dec 2012 → Dec 2013 major depressive disorder Duke University Completed No outcome recorded
Phase 3 NCT01629966 Jun 2012 → Feb 2014 generalized anxiety disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT00683592 Mar 2008 → Feb 2009 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT00644358 Dec 2007 → May 2009 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT00285376 Feb 2006 → May 2007 major depressive disorder Genaissance Pharmaceuticals Completed No outcome recorded
Phase 49 trials
Phase 4 NCT01999920 Dec 2013 → Mar 2017 separation anxiety disorder New York State Psychiatric Institute Completed No outcome recorded
Phase 4 NCT01916824 Aug 2013 → Dec 2015 major depressive disorder Emory University Completed No outcome recorded
Phase 4 NCT02028026 Apr 2013 → Feb 2015 anxiety, major depressive disorder Massachusetts General Hospital Withdrawn No outcome recorded
Phase 4 NCT01856127 Jan 2013 → Jun 2016 major depressive disorder, sexual disorder Thomas Jefferson University Terminated No outcome recorded
Phase 4 NCT01715519 Oct 2012 → Dec 2015 depressive disorder, post-traumatic stress disorder Southern California Institute for Research and Education Completed No outcome recorded
Phase 4 NCT01608295 Jul 2012 → Sep 2015 major depressive disorder University of California, Los Angeles Completed No outcome recorded
Phase 4 NCT01573598 Apr 2012 → Oct 2014 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase 4 NCT01473381 Dec 2011 → Jun 2013 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase 4 NCT01473394 Dec 2011 → Feb 2013 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase not applicable2 trials
NCT01680900 Nov 2012 → Aug 2013 University of Pennsylvania Completed No outcome recorded
NCT01712321 Oct 2012 → Mar 2014 social phobia The Medical Research Network Unknown No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT03321526 Background Dec 2017 → Jun 2019 major depressive disorder Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT01742832 Comparator May 2013 → Mar 2016 major depressive disorder University of Chicago Completed No outcome recorded
Phase 32 trials
Phase 3 NCT01838876 Background Apr 2013 → Jul 2015 major depressive disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT01715805 Background Nov 2012 → Jun 2016 major depressive disorder Forest Laboratories Completed No outcome recorded

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 34 sources stand behind the page.

FieldValueCited text
Known as Vilazodone “ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its...” NCT01838876
30

“Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of...” NCT03321526

Vilazodone is a selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist that is approved for treatment of major depressive disorder in adults in the USA and Mexico.” PMID 26291335 Nov 2015

“ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.” NCT01715805

“A Double-Blind, Placebo-Controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder and Comorbid Depression.” PMID 28858440 Aug 2017

Vilazodone, Viibryd” NCT01916824

NCT00290914

NCT01608295

NCT01574183

NCT01712321

NCT01573598

NCT01680900

NCT05948579

NCT05422612

NCT01878292

NCT02028026

NCT01828515

NCT01856127

NCT00644358

NCT00683592

NCT02015546

NCT01629966

NCT02097147

NCT01844115

NCT00285376

NCT02372799

NCT01742832

NCT01999920

NCT01473394

NCT02436239

NCT01473381

Known as EMD 515259 ChEMBL registry synonym — accepted as the source's own label CHEMBL439849
Known as EMD 68 843 ChEMBL registry synonym — accepted as the source's own label CHEMBL439849
Known as EMD 68843 BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL439849
Known as SB-659746-A ChEMBL registry synonym — accepted as the source's own label CHEMBL439849
Known as Viibryd ChEMBL registry synonym — accepted as the source's own label CHEMBL439849
Known as Vilazodona ChEMBL registry synonym — accepted as the source's own label CHEMBL439849
Known as Vilazodone HCl Vilazodone HCl will be administered at 10 mg once daily for 7 days, followed by 20 mg for 7 days, followed by 40 mg for the remainder of the trial.” NCT05422612
1

Vilazodone HCl will be administered at 10 mg once daily for 7 days, followed by 20 mg for 7 days, followed by 40 mg for the remainder of the trial.” NCT05948579

Known as VILAZODONE HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL439849
Known as Vilazodone Hydrochloride (HCl) “Intervention B Vilazodone Hydrochloride (HCl)NCT05948579
1

“Intervention B Vilazodone Hydrochloride (HCl)NCT05422612

Known as Vilazodone, Viibryd Vilazodone, ViibrydNCT01916824
Action Activate “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL439849
Action Inhibit “Vilazodone, a novel serotonin (5-HT) reuptake inhibitor and 5-HT1A partial agonist approved for MDD, exerts its effects at the 5-HT transporter and at both presynaptic and...” PMID 23216998 Dec 2012
1

“Serotonin transporter inhibitor” CHEMBL439849

Modality Small molecule CHEMBL439849
Route Oral “OBJECTIVE: To evaluate the efficacy, and further establish the safety profile, of oral once-daily vilazodone, a potent and selective serotonin 1A receptor partial agonist and...” PMID 21527122 Apr 2011
Target HTR1A “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL439849
Target SLC6A4 “Serotonin transporter inhibitor” CHEMBL439849