Last reviewed · How we verify
VORTIOXETINE
At a glance
| Generic name | VORTIOXETINE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2013 |
Approved indications
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
- Dizziness
- Diarrhea
- Dry mouth
- Constipation
- Vomiting
- Pruritis
- Abnormal dreams
- Flatulence
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)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VORTIOXETINE CI brief — competitive landscape report
- VORTIOXETINE updates RSS · CI watch RSS