Overview
Vortioxetine is an antidepressant medication indicated for the treatment of major depressive disorder (MDD). It is classified as a serotonin modulator and stimulator (SMS) as it has a multimodal mechanism of action towards the serotonin neurotransmitter system whereby it simultaneously modulates one or more serotonin receptors and inhibits the reuptake of serotonin. More specifically, vortioxetine acts via the following biological mechanisms: as a serotonin reuptake inhibitor (SRI) through inhibition of the serotonin transporter, as a partial agonist of the 5-HT1B receptor, an agonist of 5-HT1A, and an antagonist of the 5-HT3, 5-HT1D, and 5-HT7 receptors. SMSs were developed because there are many different subtypes of serotonin receptors, however, not all of these receptors appear to be involved in the antidepressant effects of SRIs. Some serotonin receptors seem to play a relatively neutral or insignificant role in the regulation of mood, but others, such as 5-HT1A autoreceptors and 5-HT7 receptors, appear to play an oppositional role in the efficacy of SRIs in treating depression.
Indication
用于治疗重度抑郁症成人患者。
Associated Conditions
- Major Depressive Disorder (MDD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/03 | Phase 2 | Recruiting | |||
2025/02/03 | Phase 4 | Not yet recruiting | Marianna Amboni | ||
2024/09/19 | Phase 2 | Recruiting | |||
2024/08/20 | Phase 3 | Completed | |||
2023/09/06 | Phase 3 | Recruiting | Federico II University | ||
2023/07/06 | N/A | Completed | |||
2023/05/03 | N/A | Recruiting | Central South University | ||
2023/04/18 | Phase 1 | Recruiting | First Affiliated Hospital of Chongqing Medical University | ||
2022/08/01 | Phase 4 | Completed | First Affiliated Hospital of Zhejiang University | ||
2022/06/14 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cardinal Health 107, LLC | 55154-0256 | ORAL | 10 mg in 1 1 | 12/13/2018 | |
| Takeda Pharmaceuticals America, Inc. | 64764-720 | ORAL | 5 mg in 1 1 | 8/30/2023 | |
| Takeda Pharmaceuticals America, Inc. | 64764-750 | ORAL | 20 mg in 1 1 | 8/30/2023 | |
| Cardinal Health 107, LLC | 55154-0257 | ORAL | 20 mg in 1 1 | 12/13/2018 | |
| Takeda Pharmaceuticals America, Inc. | 64764-730 | ORAL | 10 mg in 1 1 | 8/30/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/18/2013 | ||
Authorised | 12/18/2013 | ||
Authorised | 12/18/2013 | ||
Authorised | 12/18/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BRINTELLIX ORAL DROPS, SOLUTION 20MG/ML | SIN16577P | SOLUTION | 20 mg/mL | 8/22/2022 | |
| BRINTELLIX FILM-COATED TABLETS 10MG | SIN14666P | TABLET, FILM COATED | 10.00mg | 11/17/2014 | |
| VORTIOSON FILM-COATED TABLET 5MG | SIN16557P | TABLET, FILM COATED | 5 mg | 7/20/2022 | |
| BRINTELLIX FILM-COATED TABLETS 5MG | SIN14665P | TABLET, FILM COATED | 5.00mg | 11/17/2014 | |
| VORTIOSON FILM-COATED TABLET 10MG | SIN16556P | TABLET, FILM COATED | 10 mg | 7/20/2022 | |
| BRINTELLIX FILM-COATED TABLETS 20MG | SIN14667P | TABLET, FILM COATED | 20.00mg | 11/17/2014 | |
| VORTIOSON FILM-COATED TABLET 20MG | SIN16555P | TABLET, FILM COATED | 20 mg | 7/20/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BRINTELLIX vortioxetine (as hydrobromide) 10 mg film-coated tablet blister pack | 203955 | Medicine | A | 3/31/2014 | |
| BRINTELLIX vortioxetine (as hydrobromide) 15 mg film-coated tablet blister pack | 203981 | Medicine | A | 3/31/2014 | |
| BRINTELLIX vortioxetine (as hydrobromide) 20 mg film-coated tablet blister pack | 203970 | Medicine | A | 3/31/2014 | |
| BRINTELLIX vortioxetine (as hydrobromide) 5 mg film-coated tablet blister pack | 203986 | Medicine | A | 3/31/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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