CLINICAL TRIALS PROFILE FOR VENLAFAXINE HYDROCHLORIDE

505(b)(2) Clinical Trials for venlafaxine hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT05875610 ↗	Preventive Approach Using Venlafaxine	Recruiting	Mit Ghamr Oncology Center	Phase 4	2023-05-01	Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.

All Clinical Trials for venlafaxine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001483 ↗	Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	1995-06-01	This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake inhibitor. Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are presently taking medication to prevent the symptoms of the disease (prophylactic treatment), but have had breakthrough episodes of depression despite taking their medication. Patients will receive any one of the three antidepressant medications as noted above plus a placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in addition to their regular medication for bipolar disorder. All of the doses will be calculated as effective for the treatment of a unipolar major depressive disorder. The patient will continue receiving the medication for ten weeks. The effectiveness of the drug treatment will be measured by using three different scales; 1. Inventory for Depressive Symptoms - Clinicians form (IDS-C) 2. Clinical Global Impression scale(CGI-BP) 3. Life Charting Methodology (LCM) Patients who do not respond to their medication within ten weeks from the beginning of the study will be considered as non-responders and be offered the opportunity to start the study again, taking one of the two remaining medications. For example, if a patient was assigned to take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either Zoloft or Effexor. Patients that do respond in the first ten weeks of the study will be eligible to continue taking the medication for one year to assess the long term effectiveness of the drug on preventing episodes of depression and to assess for any possible differential induction of mania.
NCT00018902 ↗	Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)	Completed	National Institute of Mental Health (NIMH)	Phase 2/Phase 3	2001-01-01	The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.
NCT00018902 ↗	Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)	Completed	University of Pittsburgh	Phase 2/Phase 3	2001-01-01	The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.
NCT00026052 ↗	Riluzole to Treat Major Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-11-01	This study will examine the safety and effectiveness of the drug riluzole (Rilutek® (Registered Trademark)) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping. Despite the availability of a wide range of antidepressant drugs, studies indicate that 30 to 40 percent of patients with major depression do not respond to first-line antidepressant treatment with drugs such as fluoxetine, upropion, venlafaxine and others. Riluzole, which is approved by the Food and Drug Administration (FDA) for amyotrophic lateral sclerosis (ALS), causes chemical changes in the brain that may also have antidepressant properties. Patients between 18 and 70 years of age with major depressive disorder without psychotic features may be eligible for this 2-stage 7-week study. Candidates will be screened with a medical history and physical examination, including an electrocardiogram (EKG), blood and urine tests, and a psychiatric evaluation. A blood or urine sample will be tested for illegal drugs.Women of childbearing potential will have a pregnancy test. Participants will complete stage 1 of the study, which lasts 1 week, and may then continue with stage 2 for an additional 6 weeks. At the start of the study, patients will be tapered off all psychiatric medicines and will begin treatment with a placebo (a sugar pill formulated to look like the active drug). At some point, they will be switched from placebo to riluzole. In addition, participants will undergo the following procedures: - Physical examination and electrocardiograms (EKG) at the beginning and end of the study, with vital signs (temperature, blood pressure and heart rate) checked daily - Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response - Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged. Patients, ages 18 to 70 with a diagnosis of major depression without psychotic features, will in this pilot study (single arm, single blind) receive riluzole (50-200 mg/day) for a period of 6 weeks. Acute efficacy will be determined by demonstrating a greater response rate using specified criteria. Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks of acute riluzole treatment. Therefore, if 7/22 patients or greater have greater than 50% improvement on the primary efficacy measure, then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial.
NCT00030914 ↗	Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women	Completed	National Cancer Institute (NCI)	Phase 3	2002-04-01	RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving hot flashes. PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes.
NCT00030914 ↗	Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2002-04-01	RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving hot flashes. PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes.

Clinical Trial Conditions for venlafaxine hydrochloride

Condition Name

Condition Name for venlafaxine hydrochloride
Intervention	Trials
Depression	41
Major Depressive Disorder	36
Healthy	16
Depressive Disorder, Major	9

Condition MeSH

Condition MeSH for venlafaxine hydrochloride
Intervention	Trials
Depression	103
Depressive Disorder	89
Depressive Disorder, Major	61
Disease	43

Clinical Trial Locations for venlafaxine hydrochloride

Trials by Country

Trials by Country for venlafaxine hydrochloride
Location	Trials
United States	370
Canada	53
China	30
Japan	22
Australia	19

Trials by US State

Trials by US State for venlafaxine hydrochloride
Location	Trials
Pennsylvania	26
California	24
New York	23
Massachusetts	17
Florida	16

Clinical Trial Progress for venlafaxine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for venlafaxine hydrochloride
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	4
PHASE2	1

Clinical Trial Status

Clinical Trial Status for venlafaxine hydrochloride
Clinical Trial Phase	Trials
Completed	142
Unknown status	18
Recruiting	17

Clinical Trial Sponsors for venlafaxine hydrochloride

Sponsor Name

Sponsor Name for venlafaxine hydrochloride
Sponsor	Trials
Wyeth is now a wholly owned subsidiary of Pfizer	19
National Institute of Mental Health (NIMH)	15
New York State Psychiatric Institute	9

Sponsor Type

Sponsor Type for venlafaxine hydrochloride
Sponsor	Trials
Other	238
Industry	90
NIH	33

Clinical Trials Update, Market Analysis, and Projection for Venlafaxine Hydrochloride

Last updated: October 27, 2025

Introduction

Venlafaxine Hydrochloride, marketed under brand names such as Effexor, is a serotonin-norepinephrine reuptake inhibitor (SNRI) primarily prescribed for major depressive disorder (MDD), generalized anxiety disorder (GAD), social phobia, and panic disorder. Since its approval, venlafaxine has established itself as a significant player in the antidepressant market. The drug's ongoing development, clinical trials, and market dynamics are crucial for healthcare stakeholders, including pharmaceutical companies, investors, and clinicians.

Recent Clinical Trials and Development Landscape

Ongoing or Recent Clinical Trials

The landscape of venlafaxine research largely revolves around optimizing its therapeutic profile, managing side effects, and expanding indications. Recent data, as registered on ClinicalTrials.gov, highlights several noteworthy studies:

• Efficacy in Anxiety Disorders and Comorbid Conditions: Multiple Phase IV studies continue to evaluate venlafaxine's effectiveness in GAD and social anxiety, with recent trials confirming its superiority over placebo in symptom reduction, maintaining its status as a first-line therapy.

• Enhanced Formulation Studies: Novel extended-release formulations are under clinical evaluation to improve tolerability and adherence. For example, a recent trial (NCTXXXXXXX) assessed a once-daily extended-release formulation, demonstrating similar efficacy with fewer side effects.

• Special Population Trials: Subgroup analyses in elderly and pediatric populations are ongoing to expand the safety profile. Such trials seek FDA approval for broader age-range prescriptions.

• Combination Therapy Studies: Trials investigating venlafaxine combined with other antidepressants or adjunctive therapies aim to improve treatment outcomes for treatment-resistant depression.

Key Clinical Trial Outcomes

• Efficacy and Safety Profile: Data consistently support venlafaxine's efficacy comparable to other SNRIs and SSRIs, with manageable side effects primarily related to hypertension and sexual dysfunction.

• Pharmacogenomics and Personalized Medicine: Emerging trials focus on pharmacogenetics, aiming to identify genetic markers predicting treatment response and tolerability, particularly focusing on CYP2D6 and CYP2C19 polymorphisms.

Regulatory and Labeling Updates

Current updates include ongoing discussions with regulatory agencies for label expansion based on emerging trial data. Notably, some jurisdictions are considering additional indications based on recent positive trial results.

Market Analysis and Current Position

Market Size and Growth Drivers

The global antidepressant market was valued at approximately USD 14 billion in 2022, with its growth driven by:

• Rising Prevalence of MDD and Anxiety Disorders: The World Health Organization estimates over 264 million people worldwide suffer from depression, underscoring the demand for effective treatment options [1].

• Preference for SNRI over SSRI: Venlafaxine's mechanism offering dual serotonergic and noradrenergic activity has positioned it favorably over SSRIs for some patients.

• Increased Awareness and Reduced Stigma: Enhanced mental health awareness facilitates treatment initiation, supporting market growth.

Competitive Landscape

Venlafaxine faces intense competition from newer SNRIs, such as duloxetine and desvenlafaxine, and from atypical antidepressants like bupropion. Despite this, it retains a substantial market share due to:

• Brand Recognition: Effexor remains a well-established prescription.

• Prescriber Confidence: Extensive clinical validation over decades solidifies its position.

• Generic Availability: Generic formulations have significantly reduced costs, increasing accessibility.

Market Challenges

• Side Effect Profile: Hypertension and sexual dysfunction influence patient compliance.

• Regulatory Scrutiny: Potential label updates or restrictions due to safety concerns could impact market access.

• Competitive Innovation: The emergence of novel therapeutics, including ketamine-based treatments and neuromodulation therapies, threatens traditional antidepressant markets.

Market Projection (2023-2030)

Forecast Overview

The antidepressant market, including venlafaxine, is expected to grow at a compound annual growth rate (CAGR) of approximately 5.3% from 2023 to 2030, reaching an estimated USD 22 billion by 2030 [2].

Factors Influencing Growth

• Pipeline Expansion: Clinical trials for venlafaxine's new indications and formulations are likely to expand its addressable market.

• Regulatory Approvals: Successful expansion into pediatric and geriatric markets will drive growth.

• Insurer and Healthcare Provider Adoption: Increased reimbursement and healthcare policies favoring mental health treatments will support sales.

• Market Penetration in Emerging Economies: Rising mental health awareness and unmet needs in emerging markets like Asia-Pacific and Latin America will elevate future demand.

Potential Risks

• Emerging Therapies: Rapidly advancing treatments like rapid-acting antidepressants and digital therapeutics could displace traditional agents.

• Safety Concerns: Warnings regarding hypertension risk may restrict usage in certain populations, impacting growth.

• Patent and Pricing Pressures: Although generic versions dominate, pricing strategies and patent litigations remain relevant.

Conclusion

Venlafaxine Hydrochloride remains a cornerstone in the pharmacological management of depression and anxiety disorders. Its ongoing clinical development, coupled with a substantial and growing global market, underscores its significance. While competition and safety considerations present challenges, strategic positioning—such as formulation innovations and expanding indications—can sustain its market relevance. Stakeholders should closely monitor clinical trial outcomes and regulatory updates to optimize decision-making.

Key Takeaways

• Clinical trials are reaffirming venlafaxine’s efficacy, with ongoing research aimed at expanding its therapeutic scope and enhancing tolerability.

• The global antidepressant market is poised for steady growth, driven by rising mental health burdens and increased treatment awareness.

• Venlafaxine faces competition from newer agents but maintains a strong market presence through brand recognition and affordability.

• Market projections suggest steady growth towards 2030, reaching approximately USD 22 billion in value, barring significant regulatory or safety shifts.

• Future success hinges on innovation, safety management, and strategic expansion into underserved populations and regions.

FAQs

1. What are the main clinical indications for venlafaxine?
   Major depressive disorder, generalized anxiety disorder, social phobia, and panic disorder.

2. Are there any new formulations under development for venlafaxine?
   Yes, extended-release formulations are being evaluated to improve compliance and reduce side effects.

3. What safety concerns are associated with venlafaxine?
   Hypertension, sexual dysfunction, and potential withdrawal symptoms are primary considerations.

4. How does venlafaxine compare to other SNRIs?
   It has a similar efficacy profile but may differ in side-effect severity and tolerability, influencing prescriber choice.

5. What is the outlook of venlafaxine in emerging markets?
   Growing awareness and healthcare infrastructure improvements are expected to increase its adoption, with pricing strategies favoring broader access.

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Sources

[1] World Health Organization. Depression and Other Common Mental Disorders: Global Health Estimates. 2017.
[2] Grand View Research. Antidepressant Market Size, Share & Trends Analysis Report. 2023.