Vaprisol

(Conivaptan)

Phase 3Small molecule

CCumberland Pharmaceuticals

Vaprisol is one of 170 small molecule programs targeting Stroke. It is currently in Phase 3.

Indications

Total Trials

Active Trials

169

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

StrokeActive, not recruiting

Brain InjuryActive, not recruiting

Congestive Heart FailureActive, not recruiting

Intracerebral HemorrhageActive, not recruiting

Heart FailureActive, not recruiting

HyponatremiaActive, not recruiting

StrokePhase 2

Active, not recruiting

Brain InjuryPhase 1

Active, not recruiting

Congestive Heart FailurePreclinical

Active, not recruiting

Intracerebral HemorrhagePhase 1

Active, not recruiting

Heart FailurePhase 3

Active, not recruiting

HyponatremiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

687 competitors in Heart Failure

#DrugCompanyPhaseTrials

Vaprisol

CCumberland Pharmaceuticals

Phase 3

3 2

Amidate

Pfizer

Preclinical

1 3

Savaysa

Daiichi Sankyo

Preclinical

—4

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

4 5

Xifaxan

SSalix

Preclinical

2 6

Zoloft

VViatris Specialty LLC

Preclinical

2 7

Coumadin

AAbbott

Preclinical

1 8

Tamiflu

CConrado Roberto Hoffmann Filho

Preclinical

1 9

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 10

DPP-4 Inhibitors

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Hyponatremia4 trials

An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

Completed·CCumberland Pharmaceuticals·Phase 3·NCT00379847·251 enrolled

A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Completed·CCumberland Pharmaceuticals·Phase 4·NCT00435591·121 enrolled

Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients

Withdrawn·—·Phase 3·NCT00684164

Show 1 more trial

Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Completed·CCumberland Pharmaceuticals·Phase 3·NCT00478192·50 enrolled

Heart Failure3 trials

Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)

Terminated·CCumberland Pharmaceuticals·Phase 3·NCT00843986·9 enrolled

Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure Patients

Completed·FFinn Gustafsson·Phase 4·NCT01752543·20 enrolled

Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure

Completed·CCumberland Pharmaceuticals·Phase 2·NCT00057356·170 enrolled

Congestive Heart Failure1 trial

Comparing the Effects of Conivaptan and Diuretics on Plasma Neurohormones and Renal Blood Flow in Patients With Chronic Congestive Heart Failure

Unknown status·HHennepin County Medical Center, Minneapolis·N/A·NCT00924014·8 enrolled

Stroke1 trial

Study of Stroke Related Edema Treatments

Withdrawn·UUniversity of Florida·Phase 2·NCT01954290

Intracerebral Hemorrhage1 trial

Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study

Completed·JJesse Corry·Phase 1·NCT03000283·7 enrolled

4 more indications

Hemodynamic Response1 trial

A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients

Completed·CCumberland Pharmaceuticals·Phase 2·NCT00592475·20 enrolled

Infusion1 trial

Diuretic and Renal Effects of Vaprisol When Administered Along With Furosemide and Nesiritide Continuous Infusion

Withdrawn·AAlbert Einstein Healthcare Network·Phase 4·NCT00806910

Brain Injury1 trial

Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury

Completed·UUniversity of Washington·Phase 1·NCT00930202·10 enrolled

Unspecified1 trial

Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Terminated·NNorthwestern University·Phase 4·NCT00727090·6 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 29, 2005

VAPRISOL

NDA NDA021697

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Conivaptan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Conivaptan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Conivaptan. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021697). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cumberland Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: CCumberland Pharmaceuticals

Vaprisol

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Hyponatremia4 trials

Heart Failure3 trials

Congestive Heart Failure1 trial

Stroke1 trial

Intracerebral Hemorrhage1 trial

Hemodynamic Response1 trial

Infusion1 trial

Brain Injury1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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