vortioxetine

Trade name: trintellix

Small moleculeapproved

Approved

Sep 30, 2013

Vortioxetine is an antidepressant for the treatment of major depressive disorder. Vortioxetine’s mechanism of action is not fully understood. Vortioxetine binds with high affinity to the serotonin transporter and its antidepressant actions are believed to be secondary to enhancing serotonin in the central nervous system through inhibition of reuptake. Vortioxetine also displays binding affinities to other serotonin (5-HT) receptors, including 5-HT3, 5-HT1A, and 5-HT7. Due to multimodal neurotransmitter enhancer profile, it has been suggested that it might need lesser receptor occupancy rate for clinical trials than other selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors. Since vortioxetine is an agonist and antagonist of multiple serotonin receptors, potential interactions may occur with other medications that alter the serotonergic pathways. There is an increased risk of serotonin syndrome when vortioxetine is used in combination with other serotonergic agents. — NCATS

Clinical trial activity

104 trials · 54 clinical orgs · 8 marketing orgs

Phase 1
16
Phase 2
57
Phase 3
46
Phase 4
27

Earliest trial started Aug 1, 2006 (NCT00839423)

Timeline

2000s

  1. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

  3. Jun 12, 2007

    Takeda — IND Organization

  4. Jun 12, 2007

    Takeda — IND Organization

2010s

  1. Jan 1, 2011

    Takeda — Earliest Phase 1 Sponsor(trial)

  2. Sep 30, 2013

    Takeda — Earliest FDA Approval

  3. Sep 30, 2013

    Takeda — NDA Organization

  4. Aug 21, 2019

    Alkem Labs Ltd — Marketing Organization

  5. Aug 23, 2019

    Cipla — Marketing Organization

2020s

  1. Sep 17, 2021

    Zydus Discovery DMCC — Marketing Organization

  2. Dec 3, 2021

    MSN Laboratories — Marketing Organization

  3. Jul 28, 2022

    Prinston Inc — Marketing Organization

  4. Nov 10, 2025

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  5. Jan 29, 2026

    Apotex — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedSep 30, 2013

Chemistry & pharmacology

Loading structure…

SMILES

Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Mol. weight
298.46 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 warningFirst in class

Sources

Also known as

  • 1-(2-(2,4-dimethylphenylsulfanyl)phenyl)piperazine
  • 4-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazin-1-ium
  • 4-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazin-1-ium
  • brintellix
  • brintellix
  • brintellix
  • brintellix
  • brintellix
  • luaa21004
  • lu aa21004
  • lu aa21004
  • lu aa21004
  • lu aa21004
  • lu-aa21004
  • lu-aa21004-(hbr)
  • lu-aa21004-(hbr)
  • vortioxetine
  • vortioxetine
  • vortioxetine
  • vortioxetine
  • vortioxetine
  • vortioxetine
  • vortioxetine
  • vortioxetine
  • vortioxetine
  • vortioxetine
  • vortioxetine cation
  • vortioxetine cation
  • vortioxetine dl-lactate
  • vortioxetine-dl-lactate
  • vortioxetine-dl-lactate
  • vortioxetine-dl-lactate
  • vortioxetine-dl-lactate
  • vortioxetine-dl-lactate
  • vortioxetine hydrobromide
  • vortioxetine hydrobromide
  • vortioxetine hydrobromide
  • vortioxetine hydrobromide
  • vortioxetine hydrobromide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07266545Phase 4Dec 31, 2025Mayo Clinic
NCT07284628Phase 2Dec 15, 2025Cantonal Hospital of St. Gallen, Kantonsspital Aarau, University of Basel, University of Zurich
NCT07204314Phase 3Oct 1, 2025Takeda
NCT07000734Phase 2Jul 31, 2025Washington University in St. Louis
NCT06805266Phase 4Feb 28, 2025University of Salerno
NCT06604520Phase 2Jan 31, 2025Johns Hopkins University, National Institute on Aging (NIA)
NCT06561438Phase 3Aug 21, 2024Future University in Egypt
NCT05866575N/AJun 1, 2023Centre Hospitalier St Anne
NCT05814640Phase 1/Phase 2 (Phase 2)Feb 20, 2023Central South University, Chongqing Medical University, People's Liberation Army of China
NCT06025474Phase 3Jan 1, 2023University of Naples Frederico II
NCT05416762Phase 1Sep 19, 2022Cliantha Research Limited, Government of China
NCT05416957Phase 1Sep 18, 2022Cliantha Research Limited, Government of China
NCT05417087Phase 1Jun 27, 2022Cliantha Research Limited, Government of China
NCT05481957Phase 4Mar 1, 2022Zhejiang University
NCT05104918Phase 3Feb 28, 2022Rawalpindi Medical College, Pakistan, Scotmann Pharmaceuticals
NCT04895488Phase 2/Phase 3 (Phase 3)Nov 15, 2021Fundación Pública Andaluza
NCT05047952Phase 2Sep 16, 2021Brain and Cognition Discovery Foundation
NCT05014919Phase 3Aug 10, 2021Lundbeck
NCT04818099Phase 3Oct 10, 2020Guangzhou Medical University, Sun Yat-Sen University
NCT04456777Early Phase 1 (Phase 1)Jul 1, 2020Klinički Bolnički Centar Zagreb, University of Zagreb
Showing 20 of 104 trials
Page 1 / 6

Organizations

Research & Development (54)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
LundbeckFor profit453642006
TakedaFor profit392642008
Cliantha Research LimitedFor profit3012022
Government of ChinaGovernment3312022
Brain and Cognition Discovery FoundationAcademic/Hospital2222017
Central South UniversityAcademic/Hospital2122019
Harvard UniversityAcademic/Hospital2212015
Johns Hopkins UniversityAcademic/Hospital2222016
University of MiamiAcademic/Hospital2212016
Washington University in St. LouisAcademic/Hospital2222016
Zhejiang UniversityAcademic/Hospital2222020
AllerganFor profit1112019
Cantonal Hospital of St. GallenAcademic/Hospital1012025
Centre Hospitalier St AnneAcademic/Hospital1112023
Chokka Center for Integrative HealthAcademic/Hospital1012015
Chongqing Medical UniversityAcademic/Hospital1112023
ElMindA LtdFor profit1012016
Emory UniversityAcademic/Hospital1012016
Fundación Pública AndaluzaAcademic/Hospital1112021
Future University in EgyptAcademic/Hospital1112024
54 organizations
Page 1 / 3

Marketing (9)

OrganizationOrg typeRelationshipDate
Alkem Labs LtdFor profitMKTGAug 21, 2019
ApotexFor profitMKTGJan 29, 2026
CiplaFor profitMKTGAug 23, 2019
MSN LaboratoriesFor profitMKTGDec 3, 2021
Macleods Pharmaceuticals, LtdFor profitMKTGNov 10, 2025
Prinston IncFor profitMKTGJul 28, 2022
TakedaFor profitINDJun 12, 2007
TakedaFor profitNDASep 30, 2013
Zydus Discovery DMCCFor profitMKTGSep 17, 2021