Drug

Vortioxetine

Approved · EMA

Emerging researchLate-stage development

Also known as Brintellix, Trintellix, Brintellix (vortioxetine), Vortioxetina+1 more

Brintellix, Trintellix, Brintellix (vortioxetine), Vortioxetina, vortioxetinum.

RxNorm1455099 ChEMBLCHEMBL2104993UNII3O2K1S3WQV

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II Drug Repurposing Trial of Vortioxetine for the Treatment of Patients With Newly Diagnosed Glioblastoma

Clinical trial2026-06-29Results expected Q2 2029 · ClinicalTrials.gov

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Clinical trial2026-06-22Results expected Q4 2028 · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once-Daily Oral Administration of Vortioxetine in Japanese Pediatric Patients 12 to 17 Years of Age With Major Depressive Disorder (MDD)

Clinical trial2026-05-22Results expected Q3 2029 · ClinicalTrials.gov

Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study

Clinical trial2026-04-30Completed · ClinicalTrials.gov

Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia

Clinical trial2026-03-09Results expected Q2 2029 · ClinicalTrials.gov

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD): a Pragmatic Clinical Trial

Clinical trial2026-01-27Results expected Q4 2026 · ClinicalTrials.gov

An Open-Label Clinical Trial Evaluating Sensitivity to Change in Cognition Using the THINC-it Following Treatment With Vortioxetine in Major Depressive Disorder

Clinical trial2025-06-08Results posted · ClinicalTrials.gov

Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine

Clinical trial2025-06-07Completed · ClinicalTrials.gov

Approval: Brintellix (EMA)

Regulatory2013-12-18EMA

A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder.

Research2012-09-11The international journal of neuropsychopharmacology

Vortioxetine (Lu AA21004) 5 mg in generalized anxiety disorder: results of an 8-week randomized, double-blind, placebo-controlled clinical trial in the United States.

Research2012-08-15European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Vortioxetine (Lu AA21004) in generalized anxiety disorder: results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial.

Research2012-08-14European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Vortioxetine

Aliases & brands

BrintellixTrintellixBrintellix (vortioxetine)Vortioxetinavortioxetinum

RxNorm CUI

1455099

ChEMBL ID

CHEMBL2104993

UNII

3O2K1S3WQV

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2013-12-18

Latest approval

2013-12-18

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2013-12-18Approval

Approval: Brintellix (EMA)

Indication: Treatment of major depressive episodes in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

90 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 90

Early Phase 12Phase 16Phase 1 / 21Phase 214Phase 2 / 34Phase 336Phase 427

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

RecruitingPH IVMayo Clinicn=1202030

An Open Study to Evaluate the Efficacy of Vortioxetine on Freezing of Gait in Patients Affected by Parkinson Disease with Depressive Symptoms

Not yet recruitingPH IVMarianna Ambonin=402027

Adjunctive Vortioxetine in Schizophrenia

Unknown statusPH IVNorthwell Healthn=882024

Clinical Efficacy and Safety of Vortioxetine Combined With Mood Stabilizer in the Treatment of Bipolar Disorder Type II Depression

CompletedPH IVFirst Affiliated Hospital of Zhejiang Universityn=1312023

Tolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label Study

Unknown statusPH IVIRCCS San Raffaele Roman=202023

Recent completions

Trials that read out recently, adding to the completed evidence base.

Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study

CompletedPH IIWashington University School of Medicinen=232026

Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine

CompletedPH IIIFuture University in Egyptn=862025

Clinical Efficacy and Safety of Vortioxetine Combined With Mood Stabilizer in the Treatment of Bipolar Disorder Type II Depression

CompletedPH IVFirst Affiliated Hospital of Zhejiang Universityn=1312023

Substance Misuse To Psychiatric Disorders for Cannabis (SToP-C)--an Early Assertive Pharmacotherapy Intervention Pilot Study

CompletedPH II/IIIThe University of Hong Kongn=372023

Assessing Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly Patients With Depression: a Pragmatic, Multicenter, Open-label, Parallel-group, Superiority, Randomized Trial

CompletedPH IVAzienda Ospedaliera Universitaria Integrata Veronan=3622023

Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Vortioxetine for Cognitive Deficits in Persons With Post-COVID-19 Condition

CompletedPH IIBrain and Cognition Discovery Foundationn=1492023

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20122013

Most influential

A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder.

The international journal of neuropsychopharmacology · 2013 · 91 cites

Vortioxetine (Lu AA21004) in generalized anxiety disorder: results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2012 · 54 cites

Vortioxetine (Lu AA21004) 5 mg in generalized anxiety disorder: results of an 8-week randomized, double-blind, placebo-controlled clinical trial in the United States.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2012 · 43 cites