Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as conivaptan hydrochloride, Vaprisol, YM087
conivaptan · 9 trials · 5 indications
Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1. Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment. Change is calculated as Hour 48 - Baseline.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
| Arm | Type | Description |
|---|---|---|
| Regimen 1 Conivaptan QD | EXPERIMENTAL | 20 mg conivaptan once a day |
| Regimen 2 Conivaptan BID | EXPERIMENTAL | 20 mg conivaptan two times a day |
| Regimen 3 Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Lower dose |
| 2 | EXPERIMENTAL | Higher dose |
| Regimen 1 Conivaptan 12.5 mg | EXPERIMENTAL | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours |
| Regimen 2 Conivaptan 25 mg | EXPERIMENTAL | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours |
| 3 | EXPERIMENTAL | Middle dose |
| 4 | EXPERIMENTAL | High dose |
| Subjects with severe hepatic impairment | EXPERIMENTAL | - |
| Subjects with normal hepatic function | ACTIVE_COMPARATOR | - |
| 1. Mild Renal Function Impaired Subjects | EXPERIMENTAL | - |
| 2. Moderate Renal Function Impaired Subjects | EXPERIMENTAL | - |
| 3. Subjects with Normal Renal Function | EXPERIMENTAL | - |
| 1. Mildly Hepatic Impaired Subjects | EXPERIMENTAL | - |
| 2. Moderately Hepatic Impaired Subjects | EXPERIMENTAL | - |
| 3. Subjects with Normal Hepatic Function | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Conivaptan | DRUG | premix bag |
| Placebo | DRUG | premix bag |
| YM087 | DRUG | - |
| YM087 oral | DRUG | - |
| conivaptan hydrochloride | DRUG | Intravenous |
Inclusion Criteria: * Euvolemic or hypervolemic (edematous) based on clinical presentation * Serum sodium between 115 and 130mEq/L at baseline Exclusion Criteria: * Clinical presentation of volume depletion or dehydration
Conivaptan is an investigational small molecule studied in chronic heart failure, hyponatremia, kidney diseases, liver cirrhosis, and liver disease. It is being developed by Cumberland Pharmaceuticals Inc. under the ticker CPIX. The program is in Phase 2 development, and the compound is a dual antagonist of the AVPR1A and AVPR2 receptors.
Conivaptan targets AVPR1A and AVPR2, two vasopressin receptors, and acts as an antagonist at both. By blocking these receptors, the small molecule interferes with vasopressin signaling. This dual AVPR1A and AVPR2 antagonism is the basis for its study in cardiovascular and fluid balance related conditions such as hyponatremia and chronic heart failure.
Cumberland Pharmaceuticals Inc., which trades under the ticker CPIX, is developing conivaptan. The company sponsors the clinical program for the drug, including the completed trials in liver and kidney impairment and in cirrhotic patients.
Conivaptan is in Phase 2 development and is investigational. It has not been established as approved for any indication. The program includes completed Phase 1 pharmacokinetic studies and a completed Phase 2 study, with no trials currently active.
Completed conivaptan trials include NCT01370148, a Phase 1 study of intravenous conivaptan in severe hepatic impairment, NCT00887627, a Phase 1 pharmacokinetic comparison in mild and moderate kidney impairment, NCT00851227, a Phase 1 comparison in mild and moderate liver impairment, and NCT00592475, a Phase 2 study of intravenous conivaptan in cirrhotic patients in Spain.
Yes, conivaptan hydrochloride is another name for conivaptan. Both names refer to the same small molecule developed by Cumberland Pharmaceuticals Inc. for conditions including hyponatremia, chronic heart failure, kidney diseases, and liver disease.