vortioxetine
Trade name: trintellix
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
Earliest trial started Aug 1, 2006 (NCT00839423)
Timeline
2000s
2010s
2020s
- Sep 17, 2021
Zydus Discovery DMCC — Marketing Organization
- Dec 3, 2021
MSN Laboratories — Marketing Organization
- Jul 28, 2022
Prinston Inc — Marketing Organization
- Nov 10, 2025
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Jan 29, 2026
Apotex — Marketing Organization
Indications
Approved for
Studied for
- Aging · Phase 2
- Alcoholism · Phase 2
- Anxiety Disorders · Phase 4
- Attention Deficit Disorder with Hyperactivity · Phase 2
- Binge-Eating Disorder · Phase 2
- Bipolar Disorder · Phase 4
- Brain Injuries, Traumatic · Phase 3
- Breast Neoplasms · Phase 4
- Burning Mouth Syndrome · Phase 3
- Cannabis · Phase 2/Phase 3
- Cardiovascular Diseases · Phase 2
- Cognition Disorders · Phase 4
- Cognitive Dysfunction · Phase 4
- Coronary Artery Disease · Early Phase 1
- COVID-19 · Phase 2
- Dementia · Phase 4
- Depression · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Drug Therapy · Phase 2/Phase 3
- Frontotemporal Dementia · Phase 2
- Frontotemporal Lobar Degeneration · Phase 2
- Gait · Phase 4
- Geriatrics · Phase 2
- Healthy Volunteers · Phase 4
- Hoarding Disorder · Phase 3
- Hot Flashes · Phase 4
- Immune System Diseases · Phase 2
- Liver Diseases · Phase 1
- Major Depressive Disorder · Phase 4
- Menopause · Phase 4
- Motor Activity · Phase 2
- Panic Disorder · Phase 4
- Parkinson Disease · Phase 4
- Pharmacokinetics · Phase 1
- Phobia, Social · Phase 4
- Postoperative Pain · Phase 3
- Pruritus · Phase 1
- Radiation Injuries · Phase 3
- Recurrence · Phase 4
- Schizophrenia · Phase 4
- Sedentary Behavior · Phase 2
- Signs and Symptoms · Phase 2/Phase 3
- Sleep · Phase 4
- Stress Disorders, Post-Traumatic · Phase 4
- Treatment Outcome · Phase 3
- Vasomotor System · Phase 4
Mechanism of action
HTR1A agonist
- Serotonin 3a (5-HT3a) receptorANTAGONIST
HTR3A antagonist
- Serotonin transporterINHIBITOR
SLC6A4 inhibitor
reuptake inhibitor
Approval history
- approvedSep 30, 2013
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL2104993 ↗
- WikipediaVortioxetine ↗
- NCATS3O2K1S3WQV ↗
- ChEMBLCHEMBL2107387 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07266545 | Phase 4 | Dec 31, 2025 | Mayo Clinic |
| NCT07284628 | Phase 2 | Dec 15, 2025 | Cantonal Hospital of St. Gallen, Kantonsspital Aarau, University of Basel, University of Zurich |
| NCT07204314 | Phase 3 | Oct 1, 2025 | Takeda |
| NCT07000734 | Phase 2 | Jul 31, 2025 | Washington University in St. Louis |
| NCT06805266 | Phase 4 | Feb 28, 2025 | University of Salerno |
| NCT06604520 | Phase 2 | Jan 31, 2025 | Johns Hopkins University, National Institute on Aging (NIA) |
| NCT06561438 | Phase 3 | Aug 21, 2024 | Future University in Egypt |
| NCT05866575 | N/A | Jun 1, 2023 | Centre Hospitalier St Anne |
| NCT05814640 | Phase 1/Phase 2 (Phase 2) | Feb 20, 2023 | Central South University, Chongqing Medical University, People's Liberation Army of China |
| NCT06025474 | Phase 3 | Jan 1, 2023 | University of Naples Frederico II |
| NCT05416762 | Phase 1 | Sep 19, 2022 | Cliantha Research Limited, Government of China |
| NCT05416957 | Phase 1 | Sep 18, 2022 | Cliantha Research Limited, Government of China |
| NCT05417087 | Phase 1 | Jun 27, 2022 | Cliantha Research Limited, Government of China |
| NCT05481957 | Phase 4 | Mar 1, 2022 | Zhejiang University |
| NCT05104918 | Phase 3 | Feb 28, 2022 | Rawalpindi Medical College, Pakistan, Scotmann Pharmaceuticals |
| NCT04895488 | Phase 2/Phase 3 (Phase 3) | Nov 15, 2021 | Fundación Pública Andaluza |
| NCT05047952 | Phase 2 | Sep 16, 2021 | Brain and Cognition Discovery Foundation |
| NCT05014919 | Phase 3 | Aug 10, 2021 | Lundbeck |
| NCT04818099 | Phase 3 | Oct 10, 2020 | Guangzhou Medical University, Sun Yat-Sen University |
| NCT04456777 | Early Phase 1 (Phase 1) | Jul 1, 2020 | Klinički Bolnički Centar Zagreb, University of Zagreb |
Organizations
Research & Development (54)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Lundbeck | For profit | 45 | 36 | 4 | 2006 |
| Takeda | For profit | 39 | 26 | 4 | 2008 |
| Cliantha Research Limited | For profit | 3 | 0 | 1 | 2022 |
| Government of China | Government | 3 | 3 | 1 | 2022 |
| Brain and Cognition Discovery Foundation | Academic/Hospital | 2 | 2 | 2 | 2017 |
| Central South University | Academic/Hospital | 2 | 1 | 2 | 2019 |
| Harvard University | Academic/Hospital | 2 | 2 | 1 | 2015 |
| Johns Hopkins University | Academic/Hospital | 2 | 2 | 2 | 2016 |
| University of Miami | Academic/Hospital | 2 | 2 | 1 | 2016 |
| Washington University in St. Louis | Academic/Hospital | 2 | 2 | 2 | 2016 |
| Zhejiang University | Academic/Hospital | 2 | 2 | 2 | 2020 |
| Allergan | For profit | 1 | 1 | 1 | 2019 |
| Cantonal Hospital of St. Gallen | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Centre Hospitalier St Anne | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Chokka Center for Integrative Health | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Chongqing Medical University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| ElMindA Ltd | For profit | 1 | 0 | 1 | 2016 |
| Emory University | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Fundación Pública Andaluza | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Future University in Egypt | Academic/Hospital | 1 | 1 | 1 | 2024 |
Marketing (9)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alkem Labs Ltd | For profit | MKTG | Aug 21, 2019 |
| Apotex | For profit | MKTG | Jan 29, 2026 |
| Cipla | For profit | MKTG | Aug 23, 2019 |
| MSN Laboratories | For profit | MKTG | Dec 3, 2021 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Nov 10, 2025 |
| Prinston Inc | For profit | MKTG | Jul 28, 2022 |
| Takeda | For profit | IND | Jun 12, 2007 |
| Takeda | For profit | NDA | Sep 30, 2013 |
| Zydus Discovery DMCC | For profit | MKTG | Sep 17, 2021 |