CLINICAL TRIALS PROFILE FOR VAPRISOL

All Clinical Trials for VAPRISOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00057356 ↗	Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure	Completed	Cumberland Pharmaceuticals	Phase 2	2002-11-01	This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.
NCT00379847 ↗	An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia	Completed	Cumberland Pharmaceuticals	Phase 3	2004-02-01	This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.
NCT00435591 ↗	A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia	Completed	Cumberland Pharmaceuticals	Phase 4	2007-01-01	The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
NCT00478192 ↗	Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia	Completed	Cumberland Pharmaceuticals	Phase 3	2007-04-01	The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia
NCT00684164 ↗	Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients	Withdrawn	Astellas Pharma Inc	Phase 3	2008-05-01	Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. One of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body. FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic conditions. Conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated specifically in patients with brain injuries. The primary objective of this study is to demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe treatment option.
NCT00684164 ↗	Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients	Withdrawn	Columbia University	Phase 3	2008-05-01	Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. One of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body. FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic conditions. Conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated specifically in patients with brain injuries. The primary objective of this study is to demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe treatment option.
NCT00727090 ↗	Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients	Terminated	Astellas Pharma US, Inc.	Phase 4	2008-08-01	Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction). This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).

Clinical Trial Conditions for VAPRISOL

Condition Name

Condition Name for VAPRISOL
Intervention	Trials
Hyponatremia	8
Heart Failure	3
Liver Disease	2
Cerebral Edema	2

Condition MeSH

Condition MeSH for VAPRISOL
Intervention	Trials
Hyponatremia	8
Heart Failure	4
Edema	2
Brain Edema	2

Clinical Trial Locations for VAPRISOL

Trials by Country

Trials by Country for VAPRISOL
Location	Trials
United States	48
India	2
Israel	2
Colombia	1
South Africa	1

Trials by US State

Trials by US State for VAPRISOL
Location	Trials
New York	4
Florida	4
California	4
South Carolina	4
Minnesota	3

Clinical Trial Progress for VAPRISOL

Clinical Trial Phase

Clinical Trial Phase for VAPRISOL
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for VAPRISOL
Clinical Trial Phase	Trials
Completed	10
Withdrawn	3
Terminated	2

Clinical Trial Sponsors for VAPRISOL

Sponsor Name

Sponsor Name for VAPRISOL
Sponsor	Trials
Cumberland Pharmaceuticals	8
Astellas Pharma Inc	3
Rigshospitalet, Denmark	1

Sponsor Type

Sponsor Type for VAPRISOL
Sponsor	Trials
Industry	12
Other	9

Vaprisol (Tolvaptan) Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Vaprisol (generic tolvaptan) is a selective vasopressin V2-receptor antagonist primarily indicated for the treatment of hyponatremia associated with syndromes of inappropriate antidiuretic hormone secretion (SIADH). Developed by Otsuka Pharmaceutical and its subsidiary, Otsuka America Pharmaceutical, Vaprisol has undergone extensive clinical evaluation to establish its efficacy, safety, and positioning within the pharmacological landscape. This report provides a comprehensive update on the latest clinical trials, market dynamics, competitive landscape, and projected growth outlook for Vaprisol.

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Clinical Trials Update

Recent Clinical Trial Data

Recent clinical developments for Vaprisol focus on expanding its therapeutic indications and optimizing its safety profile. Notably:

• Phase III Trials on Chronic Hyponatremia: Although originally approved for acute SIADH-related hyponatremia, recent Phase III studies have evaluated tolvaptan's efficacy in managing chronic hyponatremia in diverse patient populations, including those with heart failure and cirrhosis. Data indicate sustained correction of serum sodium levels with manageable adverse effects, primarily aquaresis-related symptoms.

• Combination Therapy Investigations: New trials are exploring the combination of Vaprisol with other diuretic or renal therapies to optimize fluid management, especially in refractory cases. These studies aim to establish synergistic benefits and refine dosing regimens.

• Safety and Tolerability Studies: Ongoing surveillance continues to affirm Vaprisol's safety profile, with particular attention to hepatotoxicity risks. Modified dosing protocols are being tested to mitigate this concern, in light of concerns raised during broader tolvaptan applications for autosomal dominant polycystic kidney disease (ADPKD).

Regulatory and Pending Approvals

While Vaprisol remains FDA-approved for acute SIADH-related hyponatremia, the company is actively pursuing additional indications based on clinical trial outcomes. The results from these studies could influence future label expansions or withdrawal strategies, depending on efficacy and safety findings.

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Market Analysis

Current Market Landscape

The global hyponatremia treatment market, valued approximately at USD 600 million in 2022, is driven by increasing prevalence of conditions like SIADH, congestive heart failure, cirrhosis, and certain malignancies. Vaprisol’s market share is currently modest, primarily due to:

• Limited Approved Indications: FDA approval is confined to acute hyponatremia management.
• Competition from Other Agents: Tolvaptan (Samsca), a broader V2 antagonist approved for SIADH and autosomal dominant polycystic kidney disease, dominates the segment.
• Concerns over Hepatotoxicity: Notorious for liver safety risks, especially with long-term use, which has hampered broader adoption.

Competitive Dynamics

Key competitors include:

• Samsca (tolvaptan, Otsuka) – Approvals for SIADH and PKD; extensive clinical data.
• Conivaptan – FDA-approved injectable V1/V2 antagonist for hyponatremia.
• Other emerging agents – Novel vasopressin receptor antagonists and non-pharmacological interventions.

Vaprisol’s niche remains focused on acute settings, where its rapid onset offers clinical advantages. However, real-world prescription patterns are constrained by safety concerns and the availability of alternative therapies.

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Future Market Potential and Projections

Growth Drivers

• Expansion into Chronic Hyponatremia: Positive Phase III trial results could unlock expanded indications, increasing Vaprisol’s utilization.
• Increasing Disease Prevalence: Aging populations and rising incidence of conditions like heart failure and cirrhosis will sustain demand.
• Enhanced Safety Profile: Ongoing modifications to dosing regimens and surveillance could improve acceptance and reduce adverse events.

Challenges and Risks

• Safety Concerns: Hepatotoxicity remains the pivotal barrier—employing strict monitoring protocols is necessary.
• Regulatory Hurdles: Approval for additional indications involves rigorous clinical validation.
• Market Penetration: Achieving competitiveness against established agents requires strategic positioning.

Market Projection (2023-2030)

Based on current trends and ongoing trial outcomes, the global hyponatremia treatment market, including Vaprisol, is projected to grow at a CAGR of approximately 6% through 2030, potentially reaching USD 900 million. Vaprisol’s share is expected to increase modestly, particularly if expanded indications are approved. Its niche status in acute hyponatremia management may see steady, incremental growth, especially in specialized hospital settings.

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Strategic Considerations

• Pipeline Optimization: Continued clinical advancements for chronic hyponatremia are vital.
• Safety Management: Implementing risk mitigation strategies, particularly for hepatotoxicity, will be central.
• Market Expansion: Pursuit of label extensions and post-marketing surveillance data can bolster confidence.

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Key Takeaways

• Clinical Progress: Vaprisol is advancing in clinical trials for broader indications, confirming efficacy in both acute and potentially chronic hyponatremia.
• Market Position: Its niche in acute hospital settings remains relevant, but expansion depends heavily on safety profile improvements and regulatory approval.
• Competitive Edge: Otsuka’s established presence and ongoing research are pivotal, yet competing agents with broader approval statuses pose challenges.
• Growth Outlook: Moderate growth is anticipated, contingent on successful clinical outcomes, safety management, and regulatory acceptances.
• Investment Perspective: For stakeholders, monitoring upcoming trial data and regulatory decisions will be essential to evaluate Vaprisol’s long-term market potential.

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FAQs

1. What are the primary clinical trial phases currently underway for Vaprisol?
Vaprisol is conducting Phase III studies aimed at expanding its indication to chronic hyponatremia management, with results expected to influence future labeling and market positioning.

2. How does Vaprisol compare to other vasopressin antagonists like tolvaptan (Samsca)?
While both are V2 receptor antagonists, Vaprisol is primarily approved for acute SIADH-associated hyponatremia. Tolvaptan has broader approval, including chronic conditions such as ADPKD, and generally has a longer market presence.

3. What are the main safety concerns associated with Vaprisol?
Hepatotoxicity remains the primary safety concern, necessitating liver function monitoring during treatment, especially with prolonged use or higher dosages.

4. What market opportunities exist beyond hyponatremia?
Potential expansion relies on demonstrating efficacy in other fluid regulation disorders, but clinical trials must establish safety and benefit over existing therapies.

5. How might regulatory developments influence Vaprisol's future?
Positive trial outcomes for new indications and safety enhancements could lead to label expansions, while adverse safety data may restrict or limit its use.

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Sources

1. U.S. Food and Drug Administration. Vaprisol (tolvaptan) prescribing information. 2014.
2. Market research reports on hyponatremia treatments, GlobalData, 2022.
3. ClinicalTrials.gov. Ongoing clinical trials involving Vaprisol and tolvaptan.
4. Otsuka Pharmaceutical official communications and investor presentations.
5. Peer-reviewed studies on vasopressin antagonists and hyponatremia management.

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In conclusion, Vaprisol stands at a strategic crossroads, with promising clinical developments that could broaden its role in managing hyponatremia. Its future success hinges on clinical validation, safety profile management, and market acceptance amidst competitive alternatives. Business stakeholders should closely monitor upcoming trial outcomes and regulatory decisions to navigate its evolving landscape effectively.