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Trintellix (vortioxetine)
Vortioxetine enhances serotonergic activity through serotonin reuptake inhibition with additional 5-HT3 antagonism and 5-HT1A agonism.
Vortioxetine (TRINTELLIX) is an SSRI-like serotonin modulator indicated for major depressive disorder in adults, working through serotonin reuptake inhibition with additional 5-HT3 antagonism and 5-HT1A agonism. The drug has favorable pharmacokinetics with 75% bioavailability, 66-hour half-life, and linear dose-proportional kinetics across 2.5-60 mg doses. Major risks include serotonin syndrome with MAOIs and other serotonergic agents, requiring careful drug interaction monitoring and dose adjustments with CYP2D6 inhibitors. Clinical utility is supported by established efficacy in MDD with manageable safety profile when drug interactions are appropriately controlled.
At a glance
| Generic name | vortioxetine |
|---|---|
| Sponsor | Takeda |
| Drug class | Serotonin modulator and stimulator (SMS); SSRI-like agent |
| Target | Serotonin transporter (SERT); 5-HT3 receptor; 5-HT1A receptor |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2013 |
| Annual revenue | 800 |
Mechanism of action
Vortioxetine's antidepressant effect is thought to be related to enhancement of serotonergic activity in the central nervous system through inhibition of serotonin reuptake. The drug exhibits multiple receptor activities beyond reuptake inhibition, including antagonism at the 5-HT3 receptor and agonism at the 5-HT1A receptor. However, the specific contribution of these additional activities to the overall antidepressant effect has not been established.
Approved indications
- Major Depressive Disorder (MDD)
Boxed warnings
- WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . TRINTELLIX is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). TRINTELLIX is not approved for use in pediatric patients ( 8.4 ).
Common side effects
- Nausea
- Headache
- Dry mouth
- Nasopharyngitis
- Upper respiratory tract infection
- Weight increased
- Back pain
Drug interactions
- Monoamine Oxidase Inhibitors (MAOIs)
- Other Serotonergic Drugs (SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, St. John's Wort)
- Strong CYP2D6 Inhibitors
- Strong CYP Inducers
Key clinical trials
- A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder (PHASE3)
- Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia (PHASE2)
- RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) (PHASE4)
- Discontination of Antidepressants in Remitted Depression (PHASE4)
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) (PHASE1,PHASE2)
- Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study (PHASE2)
- Vortioxetine for Newly Diagnosed Glioblastoma (PHASE2)
- Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trintellix CI brief — competitive landscape report
- Trintellix updates RSS · CI watch RSS
- Takeda portfolio CI