NDAORALTABLET
Approved
Sep 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
31
Data completeness
4/8 — Partial
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRINTELLIX (vortioxetine) is an oral small-molecule antidepressant approved by the FDA on September 30, 2013, developed by Takeda. It is indicated for the treatment of major depressive disorder in adults. The drug functions as a serotonin modulator and stimulator (SMS), working through multiple mechanisms including serotonin transporter inhibition and direct receptor modulation. TRINTELLIX represents a distinct pharmacological approach within the antidepressant class and occupies a position in the SSRI/SNRI treatment landscape.
$0.4BPart D
6.4 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (31)
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Started Oct 2025
180 enrolled
Major Depressive Disorder
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Started Mar 2025
50 enrolled
Fronto-temporal DementiaFronto-temporal Lobar DementiaFrontotemporal Degeneration+3 more
A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression
Started Jun 2024
147,777 enrolled
Major Depressive Disorder
Vortioxetine for Post-COVID-19 Condition
Started Sep 2021
149 enrolled
Post-COVID-19 ConditionPost-COVID-19 SyndromeCognitive Impairment
Vortioxetine to Prevent Return of Symptoms in Children With Depression
Started Aug 2021
35 enrolled
Depression
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.