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).
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/31 | Phase 4 | Recruiting | All India Institute of Medical Sciences, Bhubaneswar | ||
2024/03/06 | Phase 4 | Recruiting | |||
2024/02/26 | Not Applicable | Completed | First Affiliated Hospital of Zhejiang University | ||
2023/11/14 | Phase 4 | Recruiting | |||
2023/10/30 | Phase 3 | Recruiting | Reinier de Graaf Groep | ||
2023/09/22 | N/A | Active, not recruiting | |||
2023/08/03 | Phase 3 | Recruiting | Dr. Inge Winter | ||
2023/06/01 | Phase 1 | Not yet recruiting | |||
2023/05/25 | Phase 4 | Recruiting | Mit Ghamr Oncology Center | ||
2023/02/13 | Phase 2 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| IntelliPharmaCeutics Corp. | 35208-011 | ORAL | 37.5 mg in 1 1 | 6/25/2015 | |
| Preferred Pharmaceuticals Inc. | 68788-7891 | ORAL | 37.5 mg in 1 1 | 10/10/2023 | |
| Direct_Rx | 72189-414 | ORAL | 75 mg in 1 1 | 5/16/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-4876 | ORAL | 75 mg in 1 1 | 2/17/2021 | |
| Zydus Pharmaceuticals USA Inc. | 68382-034 | ORAL | 37.5 mg in 1 1 | 10/21/2022 | |
| American Health Packaging | 68084-844 | ORAL | 37.5 mg in 1 1 | 10/12/2022 | |
| REMEDYREPACK INC. | 70518-3269 | ORAL | 75 mg in 1 1 | 11/17/2021 | |
| Rising Pharma Holdings, Inc. | 57237-176 | ORAL | 100 mg in 1 1 | 8/21/2023 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0296 | ORAL | 75 mg in 1 1 | 4/5/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-3431 | ORAL | 37.5 mg in 1 1 | 7/27/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DEPREVIX MODIFIED RELEASE HARD CAPSULE 150MG | SIN15521P | CAPSULE, DELAYED RELEASE | 150mg | 8/8/2018 | |
| VENLEX FORTE XR CAPSULES 150MG | SIN15039P | CAPSULE, EXTENDED RELEASE | 150 mg | 6/22/2016 | |
| VENLEX XR CAPSULES 75MG | SIN15038P | CAPSULE, EXTENDED RELEASE | 75 mg | 6/22/2016 | |
| EFEXOR XR CAPSULE 75 mg | SIN11435P | CAPSULE | 75 mg | 12/19/2000 | |
| ViePax XR 75mg Tablet | SIN13478P | TABLET, EXTENDED RELEASE | 75 mg | 6/19/2008 | |
| VIEPAX XR TABLET 150MG | SIN15968P | TABLET, EXTENDED RELEASE | 150mg | 6/29/2020 | |
| DEPREVIX MODIFIED RELEASE HARD CAPSULE 75MG | SIN15520P | CAPSULE, DELAYED RELEASE | 75mg | 8/8/2018 |
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
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 |
|---|---|---|---|---|---|
| VENLAFAXINA RETARD PHARMAKERN 75 MG CAPSULAS DURAS DE LIBERACION PROLONGADA EFG | 69817 | CÁPSULA DURA DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| VENLAFAXINA RETARD PHARMAKERN 150 MG CAPSULAS DURAS DE LIBERACION PROLONGADA EFG | 69816 | CÁPSULA DURA DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
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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