CLINICAL TRIALS PROFILE FOR CONIVAPTAN HYDROCHLORIDE

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
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
NCT00592475 ↗	A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients	Completed	Cumberland Pharmaceuticals	Phase 2	2007-12-01	To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.
NCT00684164 ↗	Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients	Withdrawn	Astellas Pharma Inc	Phase 3	2008-05-01	Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with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.

Clinical Trial Conditions for conivaptan hydrochloride

Condition Name

Condition Name for conivaptan hydrochloride
Intervention	Trials
Hyponatremia	9
Heart Failure	3
Cerebral Edema	2
Liver Disease	2

Condition MeSH

Condition MeSH for conivaptan hydrochloride
Intervention	Trials
Hyponatremia	9
Heart Failure	6
Liver Diseases	2
Edema	2

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

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

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

Clinical Trial Status

Clinical Trial Status for conivaptan hydrochloride
Clinical Trial Phase	Trials
Completed	11
Withdrawn	4
Terminated	3

Clinical Trial Sponsors for conivaptan hydrochloride

Sponsor Name

Sponsor Name for conivaptan hydrochloride
Sponsor	Trials
Cumberland Pharmaceuticals	10
Astellas Pharma Inc	3
Canadian Dermatology Foundation	1

Sponsor Type

Sponsor Type for conivaptan hydrochloride
Sponsor	Trials
Other	17
Industry	14
U.S. Fed	1

Conivaptan Hydrochloride: Clinical Trials Update, Market Analysis and 5-Year Projection

Last updated: May 4, 2026

What is conivaptan and what is its current clinical status?

Conivaptan hydrochloride is a vasopressin receptor antagonist (V1a/V2 inhibitor) used in the treatment of euvolemic and hypervolemic hyponatremia. The clinical development picture for conivaptan is largely historical, with the latest pivotal program details anchored around the approved indications, and no widely documented late-stage expansions in major registries.

Clinical trial visibility (high level)

• The pivotal evidence base supporting approval centered on correction of hyponatremia (including normalization and improved serum sodium response endpoints) in hospital settings.
• Post-approval, conivaptan’s clinical footprint narrowed, with substantially fewer globally prominent late-stage trials than newer vasopressin antagonists and alternatives used in hyponatremia management.

Current operational implication

• For investors and R&D planners, the practical question is not whether additional phase work is expected to be generated by current sponsors, but whether the remaining clinical activity is limited to incremental studies, label maintenance, pharmacovigilance, or investigator-initiated work rather than a new global Phase 3 expansion.

What does the regulatory and evidence set imply for market adoption?

Conivaptan is positioned in a targeted inpatient niche: hyponatremia management in euvolemic and hypervolemic settings. Adoption depends on:

• Hospital prescribing norms for hyponatremia pathways (fluid restriction vs hypertonic saline vs vasopressin antagonists)
• Safety and monitoring workflows (serum sodium correction rate and overcorrection risk controls)
• Competitive access and pricing relative to other V2 antagonists used for the same clinical problem

Mechanism-driven constraints

• Vasopressin antagonists are used when clinicians want aquaresis without worsening volume status.
• Outcome-driven adoption depends on whether payers and clinical protocols prefer conivaptan versus alternative agents, and whether formulary access is stable.

Which market segments matter most for conivaptan?

The market for conivaptan is best understood as a subset of the hyponatremia drug market:

1) Indication-driven segments

• Euvolemic hyponatremia (commonly SIADH-like presentations)
• Hypervolemic hyponatremia (e.g., heart failure, cirrhosis-associated cases)

2) Setting-driven segments

• Inpatient hospitals and acute-care units where sodium correction decisions happen quickly and where IV therapies and monitoring are routine.

3) Access-driven segments

• Hospital formularies and pharmacy benefit arrangements that decide who gets used when.
• Regions where competing V2 antagonists are already entrenched via contract pricing or guideline adoption.

What are the competitive dynamics versus other hyponatremia therapies?

Conivaptan competes in the “vaptans” category but faces a persistent structural headwind: clinician and formulary preference tends to consolidate around fewer SKUs that fit protocols, pricing, and switching behavior.

Key competitive drivers:

• Line-of-therapy placement: how quickly clinicians escalate from conservative measures to pharmacologic aquaresis.
• Protocol standardization: order sets and clinical pathways often lock in a specific agent.
• Monitoring feasibility: nursing and lab turnaround affect which IV therapy is operationally simplest.

What do the pricing and uptake patterns typically look like in this niche?

In hospital inpatient niches, commercial uptake usually follows a pattern:

• Initial adoption via guideline-informed prescribing and early formulary inclusion
• Subsequent share consolidation driven by contracting, relative cost per corrected sodium response, and internal pharmacy experience

For conivaptan, the commercial reality is that ongoing growth depends on repeated formulary wins rather than broad outpatient expansion.

How should investors model demand in the absence of active late-stage expansion?

A robust projection model should treat conivaptan as:

• A mature, protocol-driven inpatient product
• With demand tied to hyponatremia case volumes plus market share stability or change rather than major new indications

Key demand levers

1. Hyponatremia hospitalization volumes (euvolemic and hypervolemic)
2. Vaptan penetration (share of eligible cases treated with any vasopressin antagonist)
3. Conivaptan share within the vaptan subset
4. Formulary and contract shifts over time (replacement risk by competing therapies)
5. Drug supply stability and procurement pricing

Market sizing and 5-year projection: how the numbers translate

The following projection framework converts the above levers into a business forecast.

Projection method (scenario-based, inpatient drug sales)

• Step 1: Estimate annual eligible patient encounters (euvolemic + hypervolemic hyponatremia in inpatient care)
• Step 2: Apply vaptan penetration (any vaptan)
• Step 3: Apply conivaptan share within the vaptan class
• Step 4: Convert treated cases into unit demand (dosing course assumptions aligned to label practice)
• Step 5: Apply net price adjustments based on competitive contracting and channel behavior

Important note for decision-grade modeling

• Conivaptan’s forecast should not assume rapid category expansion. The model should assume a mature niche with modest share changes unless a major access breakthrough occurs.

Base case 5-year projection (global, inpatient-driven)

Because no specific, source-backed epidemiology counts and net pricing for conivaptan were provided in the prompt, this projection is expressed in indexed growth terms rather than unsupported absolute sales figures.

Forecast year	Indexed revenue (Base case)	YoY change	Share dynamics assumption
Year 1	100	-	Starting mature level
Year 2	97	-3%	Slight share pressure from alternatives
Year 3	95	-2%	Stable contracting with minor erosion
Year 4	96	+1%	Occasional formulary stabilization
Year 5	94	-2%	Ongoing consolidation in the class

Base case conclusion

• A reasonable commercial expectation is flat-to-low single digit decline over five years unless conivaptan gains new access or competitive advantage.

What could change the trajectory (upside and downside)?

Upside drivers

• Formulary re-entry or expansion via health system systemwide contracts
• Protocol changes favoring conivaptan for certain inpatient pathways (IV workflow or lab monitoring preferences)
• Companion procurement advantages (net price improvements or supply stability enabling competitive placement)

Downside drivers

• Switching to entrenched alternatives in the vaptan class
• Reduced inpatient use due to protocol shifts toward hypertonic saline optimization or other pharmacologic options
• Contracting pressure leading to unfavorable net pricing

Clinical trial update: what to monitor next

Even without prominent new Phase 3 milestones, conivaptan should be monitored for:

• Label safety updates tied to post-marketing surveillance
• Investigator-initiated or registry studies that report outcomes tied to sodium correction speed and adverse event profiles
• Any new clinical protocol publication that changes hospital ordering behavior

For a drug with a mature role, these are the signals that affect procurement and formularies more than trial readouts.

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Key Takeaways

• Conivaptan is a mature, protocol-driven inpatient therapy for euvolemic and hypervolemic hyponatremia, with clinical development activity largely historical and market uptake tied to hospital formulary decisions.
• Forecasting should model demand through eligible inpatient volumes, vaptan penetration, and conivaptan share within the class, not through broad category growth assumptions.
• A decision-grade base case projection is flat-to-low single digit decline over five years due to ongoing competitive consolidation in the vasopressin antagonist niche.
• The dominant levers are access and contracting, not new pivotal efficacy trials.

FAQs

1. Is conivaptan still used for SIADH-related hyponatremia?
   Yes, it is used in euvolemic hyponatremia contexts consistent with SIADH-like clinical presentations in inpatient care, subject to formulary access and protocol choice.

2. What endpoints drive conivaptan adoption in hospitals?
   Serum sodium correction response and safety around correction rate and overcorrection risk drive clinician confidence and protocol placement.

3. Why does competitive pressure matter so much for conivaptan?
   In hospital markets, procurement contracts and standardized order sets often lock in a specific vasopressin antagonist, reducing switching and limiting category share expansion.

4. What is the most realistic growth path for conivaptan?
   Growth comes from formulary wins and net price improvements rather than new indication-driven expansion.

5. What should be the investor’s primary monitoring signal?
   Track formulary status, contract pricing behavior, and any published hospital protocol shifts that change vaptan agent selection.

References

[1] FDA. Conivaptan hydrochloride approval and labeling history (drug label and regulatory materials).
[2] EMA. Assessment history and any available public regulatory documentation for conivaptan (if applicable).
[3] ClinicalTrials.gov. Conivaptan hydrochloride registry entries and study status.
[4] PubMed. Peer-reviewed clinical studies reporting conivaptan efficacy and safety in hyponatremia.