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Last Updated: June 13, 2025

CLINICAL TRIALS PROFILE FOR CONIVAPTAN HYDROCHLORIDE


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All Clinical Trials for Conivaptan Hydrochloride

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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Conivaptan Hydrochloride

Condition Name

Condition Name for Conivaptan Hydrochloride
Intervention Trials
Hyponatremia 9
Heart Failure 3
Liver Disease 2
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Condition MeSH

Condition MeSH for Conivaptan Hydrochloride
Intervention Trials
Hyponatremia 9
Heart Failure 6
Liver Diseases 2
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Clinical Trial Locations for Conivaptan Hydrochloride

Trials by Country

Trials by Country for Conivaptan Hydrochloride
Location Trials
United States 50
India 3
Israel 2
South Africa 1
Colombia 1
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Trials by US State

Trials by US State for Conivaptan Hydrochloride
Location Trials
Colorado 4
South Carolina 4
New York 4
Florida 4
California 4
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Clinical Trial Progress for Conivaptan Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Conivaptan Hydrochloride
Clinical Trial Phase Trials
Phase 4 5
Phase 3 6
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Conivaptan Hydrochloride
Clinical Trial Phase Trials
Completed 11
Withdrawn 4
Terminated 3
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Clinical Trial Sponsors for Conivaptan Hydrochloride

Sponsor Name

Sponsor Name for Conivaptan Hydrochloride
Sponsor Trials
Cumberland Pharmaceuticals 10
Astellas Pharma Inc 3
Columbia University 1
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Sponsor Type

Sponsor Type for Conivaptan Hydrochloride
Sponsor Trials
Other 17
Industry 14
U.S. Fed 1
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Conivaptan Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Conivaptan hydrochloride, marketed under the brand name Vaprisol, is a nonpeptide antagonist of the vasopressin receptors V1A and V2. It is primarily used to treat euvolemic hyponatremia, a condition characterized by low sodium levels in the blood without significant dehydration or fluid overload. Here, we will delve into the clinical trials, market analysis, and future projections for conivaptan hydrochloride.

Clinical Trials and Efficacy

Conivaptan hydrochloride has undergone extensive clinical trials to evaluate its efficacy and safety. Three double-blind, placebo-controlled, randomized, multicenter studies were conducted in the United States and internationally. These studies demonstrated that conivaptan is effective in increasing serum sodium levels and enhancing water clearance in patients with euvolemic hyponatremia[1][3][5].

Dosage and Administration

The approved dosing regimen for conivaptan hydrochloride involves a 20-mg intravenous (i.v.) loading dose administered over 30 minutes, followed by a continuous infusion of 20 mg over 24 hours. The dosage can be increased to 40 mg/day if necessary to raise serum sodium levels[1][4][5].

Safety and Tolerability

Clinical trials have shown that conivaptan hydrochloride is generally well tolerated, with both oral and i.v. administration. However, the drug is being evaluated for its use in acute and chronic heart failure, and its long-term safety and effects on hemodynamic parameters are still under investigation[1][3][5].

Market Analysis

Current Market Size and Growth

The U.S. vasopressin market, which includes conivaptan hydrochloride, was valued at US$ 894.6 million in 2021. This market is expected to exhibit a compound annual growth rate (CAGR) of 14.7% from 2021 to 2028, reaching a projected value of US$ 2,329.9 million by 2028[2].

Drivers of Market Growth

Several factors are driving the growth of the U.S. vasopressin market, including:

  • High Prevalence of Chronic Diseases: Conditions such as diabetes insipidus, cardiovascular diseases, and septic shock contribute significantly to the demand for vasopressin and its antagonists like conivaptan hydrochloride[2].
  • Increasing Regulatory Approvals: The approval of new treatments and the expansion of indications for existing drugs are expected to boost market growth[2].
  • COVID-19 Pandemic Impact: Despite initial disruptions, key companies have focused on enhancing the availability of vasopressin and its antagonists, such as conivaptan, to treat critical care patients during the pandemic[2].

Market Projections

Future Trends

The market for conivaptan hydrochloride is expected to grow due to several trends:

  • Expanding Indications: Ongoing evaluations for the treatment of acute and chronic heart failure could expand the market for conivaptan hydrochloride if successful[1][3][5].
  • Increasing Demand: The high prevalence of conditions that require vasopressin antagonists, such as hyponatremia and heart failure, will continue to drive demand[2].

Challenges and Opportunities

While the market shows promising growth, there are challenges to consider:

  • Supply Chain Disruptions: The COVID-19 pandemic highlighted vulnerabilities in the supply chain, which could impact the availability of conivaptan hydrochloride in the future[2].
  • Regulatory and Safety Considerations: The long-term safety and efficacy of conivaptan hydrochloride, particularly in new indications, will need to be closely monitored and regulated[1][3][5].

Key Players and Initiatives

Several pharmaceutical companies are involved in the U.S. vasopressin market, including:

  • Cumberland Pharmaceuticals Inc.: Announced initiatives to increase the availability of Vaprisol (conivaptan hydrochloride) during the COVID-19 pandemic[2].
  • Other Key Players: Companies like Par Pharmaceutical, Pfizer Inc., Eagle Pharmaceuticals, Inc., and Astellas Pharma Inc. are also active in this market[2].

Conclusion

Conivaptan hydrochloride has established itself as a valuable treatment for euvolemic hyponatremia, with a unique mechanism of action that results in the excretion of free water. The drug's efficacy and safety profile, as demonstrated in clinical trials, support its continued use and potential expansion into new indications.

Key Takeaways

  • Clinical Efficacy: Conivaptan hydrochloride is effective in increasing serum sodium levels and enhancing water clearance.
  • Market Growth: The U.S. vasopressin market is expected to grow significantly, driven by high prevalence of chronic diseases and increasing regulatory approvals.
  • Future Trends: Expanding indications and increasing demand are expected to drive the market forward.
  • Challenges: Supply chain disruptions and regulatory considerations need to be addressed.

FAQs

What is conivaptan hydrochloride used for?

Conivaptan hydrochloride is used to treat euvolemic hyponatremia, a condition characterized by low sodium levels in the blood without significant dehydration or fluid overload[1][3][5].

How is conivaptan hydrochloride administered?

Conivaptan hydrochloride is administered as an intravenous (i.v.) loading dose of 20 mg over 30 minutes, followed by a continuous infusion of 20 mg over 24 hours. The dosage can be increased to 40 mg/day if necessary[1][4][5].

What are the potential side effects of conivaptan hydrochloride?

Common side effects include hypotension, thirst, and increased urine output. In patients with cirrhosis, it may also cause splanchnic vasodilation leading to variceal bleeding[1][4][5].

Is conivaptan hydrochloride safe for long-term use?

The long-term safety and effects of conivaptan hydrochloride on hemodynamic parameters are still under investigation. Current clinical studies have been short-term[1][3][5].

Which companies are involved in the U.S. vasopressin market?

Key companies include Cumberland Pharmaceuticals Inc., Par Pharmaceutical, Pfizer Inc., Eagle Pharmaceuticals, Inc., and Astellas Pharma Inc.[2].

Sources

  1. DrugBank Online: Conivaptan: new treatment for hyponatremia.
  2. Coherent Market Insights: U.S. Vasopressin Market Size, Trends and Forecast to 2028.
  3. PubMed: Conivaptan: new treatment for hyponatremia.
  4. FDA Label: Vaprisol (conivaptan hydrochloride) injection.
  5. DrugBank: Conivaptan: Uses, Interactions, Mechanism of Action.
Last updated: 2025-01-02

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