Venlafaxine

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

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Title	Posted	Study ID	Phase	Status	Sponsor
Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea	2020/06/24	NCT04446039	N/A	Completed	Pfizer
Bioequivalence Study of Venlafaxine Hydrochloride Sustained-Release Capsules in Chinese Healthy Volunteers	2020/01/18	NCT04229602	Not Applicable	UNKNOWN	Beijing Tongren Hospital
Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes	2020/01/06	NCT04218123	Phase 2	Completed	Medical University of South Carolina
Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine	2019/12/20	NCT04207385	Phase 4	UNKNOWN	Xijing Hospital
The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study	2018/07/17	NCT03588572	Not Applicable	Completed	Guangzhou General Hospital of Guangzhou Military Command
Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy	2018/07/02	NCT03574792	Not Applicable	Completed	Roswell Park Cancer Institute
Bariatric Surgery and Pharmacokinetics of Venlafaxine	2018/05/22	NCT03532477	N/A	Recruiting	Norwegian University of Science and Technology
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants	2018/04/27	NCT03511118	N/A	Recruiting	Duke University
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression	2018/02/15	NCT03434041	Phase 3	Completed	Janssen Research & Development, LLC
A Proof of Concept Study of the Prevention of Mild Cognitive Impairment and Eventual Alzheimer's Disease Using F18 Flutemetamol	2017/09/07	NCT03274817	Phase 1	Terminated	NYU Langone Health

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
venlafaxine hydrochloride	Zydus Lifesciences Limited	65841-752	ORAL	75 mg in 1 1	9/28/2023
venlafaxine hydrochloride	Bryant Ranch Prepack	71335-1338	ORAL	75 mg in 1 1	1/7/2022
Venlafaxine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	43353-690	ORAL	75 mg in 1 1	5/9/2014
venlafaxine hydrochloride	A-S Medication Solutions	50090-6301	ORAL	37.5 mg in 1 1	10/21/2022
venlafaxine hydrochloride	A-S Medication Solutions	50090-5145	ORAL	75 mg in 1 1	11/6/2020
Venlafaxine Hydrochloride	Bryant Ranch Prepack	71335-1864	ORAL	37.5 mg in 1 1	1/13/2022
Venlafaxine	Northstar Rx LLC	16714-659	ORAL	100 mg in 1 1	10/30/2023
VENLAFAXINE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	72865-198	ORAL	75 mg in 1 1	10/29/2021
Venlafaxine	Proficient Rx LP	63187-414	ORAL	75 mg in 1 1	1/1/2021
Venlafaxine Hydrochloride	AvPAK	50268-817	ORAL	37.5 mg in 1 1	1/8/2024

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TERRY WHITE CHEMISTS VENLAFAXINE XR venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack	286953	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/23/2017
ELAXINE SR 150 venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack	285316	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/17/2017
APO-VENLAFAXINE XR venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack	286957	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/23/2017
Venlafaxine XR-WGR venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack	285259	GM Pharma International Pty Ltd	Medicine	A	5/17/2017
VENLAFAXINE GENERICHEALTH XR venlafaxine (as hydrochloride) 75mg modified release capsule blister	151884	Generic Health Pty Ltd	Medicine	A	8/6/2009
ELAXINE SR 75 venlafaxine (as hydrochloride) 75 mg modified release capsule blister pack	285315	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/17/2017
ALEMBIC VENLAFAXINE XR venlafaxine (as hydrochloride) 37.5 mg modified release capsule blister pack	285251	Alembic Pharmaceuticals Australia Pty Ltd	Medicine	A	5/17/2017
APO-VENLAFAXINE XR venlafaxine (as hydrochloride) 75 mg modified release capsule blister pack	286958	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/23/2017
Venlafaxine XR-WGR venlafaxine (as hydrochloride) 225 mg modified release capsule	292623	GM Pharma International Pty Ltd	Medicine	A	8/9/2018
EFEXOR-XR venlafaxine (as hydrochloride) 37.5mg modified release capsule blister pack	99802	Viatris Pty Ltd	Medicine	A	10/14/2004

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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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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