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.
Background
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 | Not yet 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 |
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 |
|---|---|---|---|---|---|
| Vortioxetine Hydrobromide Tablets | 国药准字H20253153 | 化学药品 | 片剂 | 1/14/2025 | |
| Vortioxetine Hydrobromide Tablets | 国药准字H20253161 | 化学药品 | 片剂 | 1/14/2025 | |
| Vortioxetine Hydrobromide Tablets | 国药准字H20243148 | 化学药品 | 片剂 | 2/6/2024 | |
| Vortioxetine Hydrobromide Tablets | 国药准字H20253190 | 化学药品 | 片剂 | 1/14/2025 | |
| Vortioxetine Hydrobromide Tablets | 国药准字H20249358 | 化学药品 | 片剂 | 11/15/2024 | |
| Vortioxetine Hydrobromide Tablets | 国药准字H20253149 | 化学药品 | 片剂 | 1/14/2025 | |
| Vortioxetine Hydrobromide Tablets | 国药准字H20253191 | 化学药品 | 片剂 | 1/14/2025 | |
| Vortioxetine Hydrobromide Tablets | 国药准字H20233155 | 化学药品 | 片剂 | 2/14/2023 | |
| Vortioxetine Hydrobromide Tablets | 国药准字HJ20170382 | 化学药品 | 片剂 | 7/29/2022 | |
| Vortioxetine Hydrobromide Tablets | 国药准字H20243891 | 化学药品 | 片剂 | 6/4/2024 |
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 |