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
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.
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.
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.
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.

Clinical Trial Conditions for VENLAFAXINE HYDROCHLORIDE

Condition Name

Condition Name for VENLAFAXINE HYDROCHLORIDE
Intervention	Trials
Depression	41
Major Depressive Disorder	36
Healthy	16
Bipolar Disorder	9

Condition MeSH

Condition MeSH for VENLAFAXINE HYDROCHLORIDE
Intervention	Trials
Depression	101
Depressive Disorder	89
Depressive Disorder, Major	61
Disease	43

Clinical Trial Locations for VENLAFAXINE HYDROCHLORIDE

Trials by Country

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Trials by Country for VENLAFAXINE HYDROCHLORIDE
Location	Trials
United States	370
Canada	51
China	27
Japan	22
Australia	18

Trials by US State

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−

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
Phase 4	71
Phase 3	40
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for VENLAFAXINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	141
Unknown status	18
Not yet recruiting	16

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	222
Industry	90
NIH	33

Venlafaxine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Venlafaxine Hydrochloride

Venlafaxine hydrochloride is a widely used antidepressant medication that belongs to the class of serotonin-norepinephrine reuptake inhibitors (SNRIs). It is primarily used to treat major depressive disorders, generalized anxiety disorders, panic disorder, social phobia, and other conditions such as diabetic neuropathy and migraine.

Clinical Trials Update

Recent Clinical Trial on Meniere Disease

A recent randomized, double-blind, placebo-controlled, crossover pilot study investigated the efficacy of venlafaxine in patients with Meniere disease. The trial, conducted at a single-center tertiary referral center in Charleston, South Carolina, involved 40 participants who received either venlafaxine (37.5 mg daily) or a placebo for 8 weeks in each phase of the trial.

• Key Findings: The study failed to identify a significant difference between the venlafaxine and placebo groups in terms of the number of episodes and quality-of-life metrics. The mean number of episodes per phase was similar in both the venlafaxine and placebo phases, indicating no significant benefit of venlafaxine over placebo for Meniere disease[1].

Ongoing and Future Trials

Several clinical trials associated with venlafaxine hydrochloride are ongoing or scheduled for future completion. For instance, a Phase 3 study with results scheduled to be delivered in 2025 is listed, although specific details about the study's objectives and outcomes are not yet available[4].

Market Analysis

Global Market Size and Growth

The global venlafaxine hydrochloride market has been experiencing steady growth driven by increasing prevalence of depression, anxiety disorders, and other conditions for which venlafaxine is prescribed.

• Historical and Forecast Data: In 2017, the venlafaxine hydrochloride market was valued at a significant amount and is forecast to reach a higher value by 2027, growing at a compound annual growth rate (CAGR)[2][5].

Market Segmentation

The market is segmented based on product type, application type, and geographic regions.

• Product Type: The market is segmented into less than 98% and more than 98% purity levels of venlafaxine hydrochloride[5].
• Application Type: Venlafaxine hydrochloride is available in various forms such as tablets, capsules, and others[5].
• Geographic Regions: The market is analyzed across key regions including North America, Asia Pacific, Europe, Latin America, and the Middle East & Africa. The Asia Pacific region is expected to register a higher growth rate due to increasing research activities in countries like China, India, and Japan[2][5].

Key Drivers and Challenges

• Drivers: The key drivers of the market include the rapidly growing prevalence of depression, generalized anxiety disorder, social phobia, panic disorder, and an increase in migraine and diabetic patients worldwide[2][5].
• Challenges: The market faces challenges such as side effects associated with venlafaxine intake, including suicidal symptoms, bipolar disorder, and discontinuation syndrome[2][5].

Market Projections

Forecast Period

The market forecasts extend from 2020 to 2027, with some reports providing projections up to 2031.

• Growth Prospects: The market is expected to grow significantly, driven by increasing demand for antidepressant medications and the expanding patient population. The Asia Pacific region is anticipated to contribute substantially to this growth due to rising healthcare expenditures and increasing awareness about mental health[2][3][5].

Competitive Landscape

The market is competitive, with several key players striving to maintain their market position.

• Key Players: Companies such as Pfizer, Mesha Pharma, Sun Pharmaceutical Industries, Taj API, and Synergy Pharmaceutical are prominent in the venlafaxine hydrochloride market. These companies are focusing on strategies like mergers and acquisitions, new product launches, and partnerships to expand their market share[5].

Regional Analysis

Global and Regional Insights

The venlafaxine hydrochloride market is analyzed globally and regionally to understand the market dynamics and growth opportunities.

• Regional Growth: The Asia Pacific region is expected to register a higher growth rate due to the increasing number of research activities and growing healthcare infrastructure in countries like China, India, and Japan[2][5].

Technological and Regulatory Trends

Innovations and Developments

The market is driven by continuous innovations and technological advancements in drug delivery systems and manufacturing processes.

• Extended Release Capsules: The development of venlafaxine hydrochloride extended release capsules is a significant innovation, offering improved patient compliance and therapeutic efficacy[3].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market. Regulatory approvals and compliance with safety standards are essential for market growth.

• SWOT and Porter’s Five Forces Analysis: These analyses provide insights into the strengths, weaknesses, opportunities, and threats of the market, as well as the competitive forces that influence market dynamics[3][5].

Consumer Behavior and COVID-19 Impact

Consumer Behavior

Consumer behavior analysis reveals that there is an increasing awareness about mental health and a growing willingness to seek medical treatment for mental health disorders.

• Demand for Antidepressants: The demand for antidepressant medications like venlafaxine hydrochloride has increased due to the rising prevalence of mental health disorders and the COVID-19 pandemic's impact on mental health[5].

COVID-19 Impact

The COVID-19 pandemic has had a significant impact on the market, with changes in market dynamics and consumer behavior.

• Market Dynamics: The pandemic has accelerated the growth of the venlafaxine hydrochloride market due to increased stress and anxiety levels among the population. However, it has also posed challenges such as supply chain disruptions and delays in clinical trials[5].

Key Takeaways

• Clinical Trials: Recent trials have shown mixed results, with no significant benefit of venlafaxine over placebo for Meniere disease, but ongoing trials may provide new insights.
• Market Growth: The global venlafaxine hydrochloride market is expected to grow significantly, driven by increasing demand for antidepressant medications.
• Regional Insights: The Asia Pacific region is anticipated to contribute substantially to market growth.
• Competitive Landscape: Key players are focusing on strategies like mergers and acquisitions, new product launches, and partnerships to expand their market share.
• Technological Trends: Innovations such as extended release capsules are improving patient compliance and therapeutic efficacy.

FAQs

What is Venlafaxine Hydrochloride used for?

Venlafaxine hydrochloride is used to treat major depressive disorders, generalized anxiety disorders, panic disorder, social phobia, and other conditions such as diabetic neuropathy and migraine[2].

What are the common side effects of Venlafaxine Hydrochloride?

Common side effects include loss of appetite, dry mouth, constipation, dizziness, and sweating. Serious side effects can include suicidal symptoms, bipolar disorder, and discontinuation syndrome[2].

What is the current market size of Venlafaxine Hydrochloride?

The current market size is significant, and it is forecast to grow further by 2027, driven by increasing demand for antidepressant medications[2][5].

Which regions are expected to drive the growth of the Venlafaxine Hydrochloride market?

The Asia Pacific region is expected to register a higher growth rate due to increasing research activities and growing healthcare infrastructure in countries like China, India, and Japan[2][5].

How has the COVID-19 pandemic impacted the Venlafaxine Hydrochloride market?

The pandemic has accelerated the growth of the market due to increased stress and anxiety levels among the population, but it has also posed challenges such as supply chain disruptions and delays in clinical trials[5].

Sources

1. Efficacy of a Serotonin-Norepinephrine Reuptake Inhibitor as a Treatment for Meniere Disease: A Randomized Clinical Trial. PubMed, 2024.
2. Venlafaxine Hydrochloride Market Share & Analysis, 2020-2027. Reports and Data.
3. Global Venlafaxine Hydrochloride Extended Release Capsule Market Report. Cognitive Market Research.
4. Venlafaxine Hydrochloride - Drug Targets, Indications, Patents. Synapse by Patsnap.
5. Venlafaxine Hydrochloride Market Size, Share, Industry Growth, Trend, Business Opportunities, Challenges, Drivers, and Restraint Research Report by 2027. BioSpace.