Skip to content

Tolvaptan

FDA-approved product (tablet, oral), marketed as Jynarque, Samsca, Tolvaptan.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Tolvaptan
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Autosomal dominant polycystic kidney disease
  • Cardiovascular disease
  • Congestive heart failure
  • Heart failure
  • Hyponatremia
  • Inappropriate ADH syndrome
  • Polycystic Kidney Disease

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Vasopressin antagonists
FDA pharmacologic class
Vasopressin V2 Receptor Antagonist FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA, E. coli and M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA60.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli44.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae19.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis70.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-6.4 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-6.1 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.0 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.2 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Tolvaptan with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

    NCT01451827 · start 2011-10

    Registered record
    Registry ID
    NCT01451827
    Conditions
    Autosomal Dominant Polycystic Kidney Disease
    Interventions
    Tolvaptan MR; Tolvaptan IR; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2011-10
    Completion
    2013-07
    Enrolment
    178

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAutosomal Dominant Polycystic Kidney Disease
    InterventionTolvaptan MR; Tolvaptan IR; Placebo
    PhasePhase 2
    Registry statusCompleted
  • Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Male

    NCT07166887 · start 2011-06-07

    Registered record
    Registry ID
    NCT07166887
    Conditions
    Healthy Subjects
    Interventions
    Tolvaptan
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-06-07
    Completion
    2011-07-27
    Enrolment
    12

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Subjects
    InterventionTolvaptan
    PhasePhase 1
    Registry statusCompleted
  • Tolvaptan for In-hospital Hyponatremia

    NCT01386372 · start 2011-06

    Registered record
    Registry ID
    NCT01386372
    Conditions
    Hyponatremia
    Interventions
    Tolvaptan; Standard therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2011-06
    Completion
    2012-11
    Enrolment
    3

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHyponatremia
    InterventionTolvaptan; Standard therapy
    PhasePhase 2
    Registry statusTerminated
  • A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

    NCT01280721 · start 2010-11

    Registered record
    Registry ID
    NCT01280721
    Conditions
    Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Interventions
    tolvaptan
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2010-11
    Completion
    2014-08
    Enrolment
    135

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAutosomal Dominant Polycystic Kidney Disease (ADPKD)
    Interventiontolvaptan
    PhasePhase 3
    Registry statusCompleted
  • Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice

    NCT01228682 · start 2010-10

    Registered record
    Registry ID
    NCT01228682
    Conditions
    SIADH; Non-SIADH Hyponatremia; Non-Hyponatremia
    Interventions
    Tolvaptan
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2010-10
    Completion
    2014-04
    Enrolment
    200

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSIADH; Non-SIADH Hyponatremia; Non-Hyponatremia
    InterventionTolvaptan
    PhaseNot recorded
    Registry statusUnknown
  • Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

    NCT01336972 · start 2010-10

    Registered record
    Registry ID
    NCT01336972
    Conditions
    Autosomal Dominant Polycystic Kidney Disease
    Interventions
    Tolvaptan
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2010-10
    Completion
    2011-11
    Enrolment
    29

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAutosomal Dominant Polycystic Kidney Disease
    InterventionTolvaptan
    PhasePhase 2
    Registry statusCompleted
  • Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites

    NCT01349348 · start 2010-10

    Registered record
    Registry ID
    NCT01349348
    Conditions
    Ascites; Hepatic Cirrhosis
    Interventions
    Tolvaptan; Tolvaptan; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2010-10
    Completion
    2012-07
    Enrolment
    535

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAscites; Hepatic Cirrhosis
    InterventionTolvaptan; Tolvaptan; placebo
    PhasePhase 3
    Registry statusCompleted
  • Tolvaptan Extension Study in Participants With ADPKD

    NCT01214421 · start 2010-05-26

    Registered record
    Registry ID
    NCT01214421
    Conditions
    Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Interventions
    Tolvaptan
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2010-05-26
    Completion
    2016-02-29
    Enrolment
    1,083

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAutosomal Dominant Polycystic Kidney Disease (ADPKD)
    InterventionTolvaptan
    PhasePhase 3
    Registry statusCompleted
  • A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg

    NCT01048788 · start 2009-12

    Registered record
    Registry ID
    NCT01048788
    Conditions
    Cirrhosis
    Interventions
    OPC-41061
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2009-12
    Completion
    2011-08
    Enrolment
    51

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCirrhosis
    InterventionOPC-41061
    PhasePhase 3
    Registry statusCompleted
  • A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema

    NCT01050530 · start 2009-12

    Registered record
    Registry ID
    NCT01050530
    Conditions
    Cirrhosis
    Interventions
    OPC-41061; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2009-12
    Completion
    2012-02
    Enrolment
    162

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCirrhosis
    InterventionOPC-41061; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Tolvaptan Versus Fluid Restriction in SIADH

    NCT04119206 · start 2009-01-01

    Registered record
    Registry ID
    NCT04119206
    Conditions
    Hyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion; Pituitary
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2009-01-01
    Completion
    2013-12-31
    Enrolment
    334

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion; Pituitary
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema

    NCT00479336 · start 2007-06

    Registered record
    Registry ID
    NCT00479336
    Conditions
    Cirrhosis
    Interventions
    OPC-41061 7.5mg; OPC-41061 placebo; OPC-41061 15mg; OPC-41601 30mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2007-06
    Completion
    2009-01
    Enrolment
    104

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCirrhosis
    InterventionOPC-41061 7.5mg; OPC-41061 placebo; OPC-41061 15mg; OPC-41601 30mg
    PhasePhase 2
    Registry statusCompleted
  • A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

    NCT00462670 · start 2007-04

    Registered record
    Registry ID
    NCT00462670
    Conditions
    Edema, Cardiac
    Interventions
    OPC-41061(Tolvaptan)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2007-04
    Completion
    2008-10
    Enrolment
    110

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionEdema, Cardiac
    InterventionOPC-41061(Tolvaptan)
    PhasePhase 3
    Registry statusCompleted
  • Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

    NCT00428948 · start 2007-01

    Registered record
    Registry ID
    NCT00428948
    Conditions
    Polycystic Kidney Disease, Autosomal Dominant
    Interventions
    Tolvaptan; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2007-01
    Completion
    2012-01
    Enrolment
    1,445

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPolycystic Kidney Disease, Autosomal Dominant
    InterventionTolvaptan; Placebo
    PhasePhase 3
    Registry statusCompleted
  • a Phase I PK Study in Healthy Male Subjects. 2 Groups of Healthy Male Subjects

    NCT07166796 · start 2006-10-01

    Registered record
    Registry ID
    NCT07166796
    Conditions
    Health Subjects
    Interventions
    singe dose 15mg; single dose 30mg; single dose 60mg; single dose 120mg; multi dose 30mg; multi dose 60mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2006-10-01
    Completion
    2007-01-31
    Enrolment
    64

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealth Subjects
    Interventionsinge dose 15mg; single dose 30mg; single dose 60mg; single dose 120mg +2 more
    PhasePhase 1
    Registry statusCompleted