Overview
Venlafaxine is an antidepressant and a serotonin and norepinephrine reuptake inhibitor (SNRI). Its active metabolite, desvenlafaxine, works by blocking the reuptake of serotonin and norepinephrine, which are key neurotransmitters in mood regulation. Venlafaxine is officially approved to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder, and panic disorder in adults. The immediate formulation of the drug, marketed as Effexor, was first approved by the FDA in 1993 and the extended-release formulation, Effexor XR, was later introduced in 1997. Venlafaxine has been used as a first-line treatment for MDD, GAD, social anxiety disorder, and panic disorder in Canada for many years. It was also considered a second-line treatment for obsessive-compulsive disorder (OCD). Venlafaxine was also investigated in off-label uses for the prophylaxis of migraine headaches, for reduction of vasomotor symptoms associated with menopause, and for the management of neuropathic pain (although there is only minimal evidence of efficacy for this condition).
Background
Venlafaxine is an antidepressant and a serotonin and norepinephrine reuptake inhibitor (SNRI). Its active metabolite, desvenlafaxine, works by blocking the reuptake of serotonin and norepinephrine, which are key neurotransmitters in mood regulation. Venlafaxine is officially approved to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder, and panic disorder in adults. The immediate formulation of the drug, marketed as Effexor, was first approved by the FDA in 1993 and the extended-release formulation, Effexor XR, was later introduced in 1997. Venlafaxine has been used as a first-line treatment for MDD, GAD, social anxiety disorder, and panic disorder in Canada for many years. It was also considered a second-line treatment for obsessive-compulsive disorder (OCD). Venlafaxine was also investigated in off-label uses for the prophylaxis of migraine headaches, for reduction of vasomotor symptoms associated with menopause, and for the management of neuropathic pain (although there is only minimal evidence of efficacy for this condition).
Indication
Venlafaxine is indicated for the management of major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder (SAD), and panic disorder.
Associated Conditions
- Generalized Anxiety Disorder
- Major Depressive Disorder (MDD)
- Migraine
- Neuropathic Pain
- Panic Disorder
- Social Anxiety Disorder (SAD)
- Vasomotor Symptoms Associated With Menopause
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/06/24 | N/A | Completed | |||
2020/01/18 | Not Applicable | UNKNOWN | Beijing Tongren Hospital | ||
2020/01/06 | Phase 2 | Completed | |||
2019/12/20 | Phase 4 | UNKNOWN | Xijing Hospital | ||
2018/07/17 | Not Applicable | Completed | Guangzhou General Hospital of Guangzhou Military Command | ||
2018/07/02 | Not Applicable | Completed | |||
2018/05/22 | N/A | Recruiting | |||
2018/04/27 | N/A | Recruiting | |||
2018/02/15 | Phase 3 | Completed | |||
2017/09/07 | Phase 1 | Terminated |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 65841-752 | ORAL | 75 mg in 1 1 | 9/28/2023 | |
| Bryant Ranch Prepack | 71335-1338 | ORAL | 75 mg in 1 1 | 1/7/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-690 | ORAL | 75 mg in 1 1 | 5/9/2014 | |
| A-S Medication Solutions | 50090-6301 | ORAL | 37.5 mg in 1 1 | 10/21/2022 | |
| A-S Medication Solutions | 50090-5145 | ORAL | 75 mg in 1 1 | 11/6/2020 | |
| Bryant Ranch Prepack | 71335-1864 | ORAL | 37.5 mg in 1 1 | 1/13/2022 | |
| Northstar Rx LLC | 16714-659 | ORAL | 100 mg in 1 1 | 10/30/2023 | |
| XLCare Pharmaceuticals, Inc. | 72865-198 | ORAL | 75 mg in 1 1 | 10/29/2021 | |
| Proficient Rx LP | 63187-414 | ORAL | 75 mg in 1 1 | 1/1/2021 | |
| AvPAK | 50268-817 | ORAL | 37.5 mg in 1 1 | 1/8/2024 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Venlafaxine Hydrochloride Capsules | 国药准字H20067435 | 化学药品 | 胶囊剂 | 6/23/2021 | |
| Venlafaxine Hydrochloride Capsules | 国药准字H19980051 | 化学药品 | 胶囊剂 | 4/24/2024 | |
| Venlafaxine Hydrochloride Capsules | 国药准字H20066157 | 化学药品 | 胶囊剂 | 6/23/2021 | |
| Venlafaxine Hydrochloride Sustained-Release Capsules | 国药准字H20213455 | 化学药品 | 胶囊剂 | 6/8/2021 | |
| Venlafaxine Hydrochloride Sustained-Release Capsules | 国药准字H20243693 | 化学药品 | 胶囊剂 | 5/15/2024 | |
| Venlafaxine Hydrochloride Sustained-Release Capsules | 国药准字H20223035 | 化学药品 | 胶囊剂 | 1/30/2022 | |
| Venlafaxine Hydrochloride Sustained-Release Capsules | 国药准字H20223276 | 化学药品 | 胶囊剂 | 4/29/2022 | |
| Venlafaxine Hydrochloride Sustained-Release Capsules | 国药准字H20234024 | 化学药品 | 胶囊剂 | 8/8/2023 | |
| Venlafaxine Hydrochloride Sustained-Release Capsules | 国药准字HJ20160384 | 化学药品 | 胶囊剂 | 7/22/2021 | |
| Venlafaxine Hydrochloride Sustained-Release Capsules | 国药准字H20223057 | 化学药品 | 胶囊剂 | 1/30/2022 |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.