Drugs / Vilazodone
Vilazodone
also known as
Vilazodone HCl · Vilazodone Hydrochloride (HCl) · EMD 515259 · EMD 68 843 · EMD 68843 BASE · SB-659746-A · Viibryd · Vilazodona · +2 more
Small molecule targets HTR1A, SLC6A4 via activation / inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 5 met primary · 3 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT01878292 | Jul 2013 → Mar 2016 | major depressive disorder | Forest Laboratories | Completed | Missed primary |
| Phase 3 | NCT01844115 | Apr 2013 → Mar 2014 | generalized anxiety disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT01766401 | Jan 2013 → Jan 2014 | generalized anxiety disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT02015546 | Dec 2012 → Dec 2013 | major depressive disorder | Duke University | Completed | Missed primary |
| Phase 3 | NCT01629966 | Jun 2012 → Feb 2014 | generalized anxiety disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT00683592 | Mar 2008 → Feb 2009 | major depressive disorder | Forest Laboratories | Completed | Met primary |
| 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 | Met primary |
| Phase 49 trials · 2 met primary · 2 missed | ||||||
| Phase 4 | NCT01999920 | Dec 2013 → Mar 2017 | separation anxiety disorder | New York State Psychiatric Institute | Completed | Missed primary |
| 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 Stop: Enrollment |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 4 | NCT01473394 | Dec 2011 → Feb 2013 | major depressive disorder | Forest Laboratories | Completed | Met primary |
| Phase not applicable2 trials · 1 met primary · 1 missed | ||||||
| — | NCT01680900 | Nov 2012 → Aug 2013 | — | University of Pennsylvania | Completed | Missed primary |
| — | NCT01712321 | Oct 2012 → Mar 2014 | social phobia | The Medical Research Network | Unknown | Met primary |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT03321526 Background | Dec 2017 → Jun 2019 | major depressive disorder | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT01742832 Comparator | May 2013 → Mar 2016 | major depressive disorder | University of Chicago | Completed | No outcome recorded |
| 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 | Missed primary |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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)” NCT05422612 ↗1“Intervention B Vilazodone Hydrochloride (HCl)” NCT05948579 ↗ |
| Known as | Vilazodone, Viibryd | “Vilazodone, Viibryd” NCT01916824 ↗ |
| 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 20121“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 ↗ |