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2023/02/13 | Phase 2 | Withdrawn |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 |
|---|---|---|---|---|---|
| Venlafaxine Hydrochloride Sustained-release Tablets | 国药准字H20243070 | 化学药品 | 片剂 | 1/23/2024 | |
| Venlafaxine Hydrochloride Sustained-release Tablets | 国药准字H20070269 | 化学药品 | 片剂 | 4/8/2022 | |
| Venlafaxine Hydrochloride Sustained-release Tablets | 国药准字H20233245 | 化学药品 | 片剂 | 3/7/2023 | |
| Venlafaxine Hydrochloride Sustained-release Tablets | 国药准字H20203741 | 化学药品 | 片剂 | 12/29/2020 | |
| Venlafaxine Hydrochloride Tablets | 国药准字H20193185 | 化学药品 | 片剂 | 6/19/2024 | |
| Venlafaxine Hydrochloride Tablets | 国药准字H20140089 | 化学药品 | 片剂 | 5/14/2024 | |
| Venlafaxine Hydrochloride Tablets | 国药准字H20193184 | 化学药品 | 片剂 | 6/19/2024 | |
| Venlafaxine Hydrochloride Tablets | 国药准字H20193186 | 化学药品 | 片剂 | 6/19/2024 | |
| Venlafaxine Hydrochloride Tablets | 国药准字H20193183 | 化学药品 | 片剂 | 6/19/2024 | |
| Venlafaxine Hydrochloride Tablets | 国药准字H20110150 | 化学药品 | 片剂 | 12/6/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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