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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.

  • Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders

    NCT02476409 · start 2015-07

    Registered record
    Registry ID
    NCT02476409
    Conditions
    Congestive Heart Failure
    Interventions
    tolvaptan; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2015-07
    Completion
    2021-05-13
    Enrolment
    40

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

    ConditionCongestive Heart Failure
    Interventiontolvaptan; Placebo
    PhasePhase 4
    Registry statusCompleted
  • The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement

    NCT02644616 · start 2014-11

    Registered record
    Registry ID
    NCT02644616
    Conditions
    Tricuspid Regurgitation; Right Heart Failure
    Interventions
    tolvaptan+torasemide; placebo+torasemide
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2014-11
    Completion
    2016-12
    Enrolment
    40

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

    ConditionTricuspid Regurgitation; Right Heart Failure
    Interventiontolvaptan+torasemide; placebo+torasemide
    PhasePhase 4
    Registry statusCompleted
  • Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

    NCT02160145 · start 2014-05

    Registered record
    Registry ID
    NCT02160145
    Conditions
    Chronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease
    Interventions
    Tolvaptan (OPC-41061); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-05
    Completion
    2017-04-18
    Enrolment
    1,370

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

    ConditionChronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease
    InterventionTolvaptan (OPC-41061); Placebo
    PhasePhase 3
    Registry statusCompleted
  • Effects of Tolvaptan in Healthy Adults

    NCT01973140 · start 2013-11

    Registered record
    Registry ID
    NCT01973140
    Conditions
    Healthy
    Interventions
    Tolvaptan; Hypertonic saline infusion
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2013-11
    Completion
    2016-03
    Enrolment
    17

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

    ConditionHealthy
    InterventionTolvaptan; Hypertonic saline infusion
    PhasePhase 4
    Registry statusCompleted
  • A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

    NCT02009878 · start 2013-11

    Registered record
    Registry ID
    NCT02009878
    Conditions
    Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
    Interventions
    tolvaptan
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2013-11
    Completion
    2015-06
    Enrolment
    30

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

    ConditionSyndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
    Interventiontolvaptan
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • Samsca Post Marketing Surveillance Study

    NCT02722863 · start 2013-07-09

    Registered record
    Registry ID
    NCT02722863
    Conditions
    Hypervolemic and Euvolemic Hyponatremia
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2013-07-09
    Completion
    2017-06-15
    Enrolment
    908

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

    ConditionHypervolemic and Euvolemic Hyponatremia
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure

    NCT01863511 · start 2013-05

    Registered record
    Registry ID
    NCT01863511
    Conditions
    Acute Decompensated Heart Failure
    Interventions
    loop diuretic; tolvaptan; ultrafiltration
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2013-05
    Completion
    2015-12
    Enrolment
    45

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

    ConditionAcute Decompensated Heart Failure
    Interventionloop diuretic; tolvaptan; ultrafiltration
    PhasePhase 4
    Registry statusCompleted
  • Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites

    NCT01716611 · start 2012-11

    Registered record
    Registry ID
    NCT01716611
    Conditions
    Hyponatremia; Ascites
    Interventions
    Tolvaptan; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2012-11
    Completion
    2014-02
    Enrolment
    105

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

    ConditionHyponatremia; Ascites
    InterventionTolvaptan; placebo
    PhasePhase 4
    Registry statusUnknown
  • Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure

    NCT01644331 · start 2012-10

    Registered record
    Registry ID
    NCT01644331
    Conditions
    Heart Failure; Dyspnea
    Interventions
    Tolvaptan; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-10
    Completion
    2016-02
    Enrolment
    257

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

    ConditionHeart Failure; Dyspnea
    InterventionTolvaptan; Placebo
    PhasePhase 3
    Registry statusCompleted
  • The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study

    NCT01663662 · start 2012-08

    Registered record
    Registry ID
    NCT01663662
    Conditions
    Heart Failure
    Interventions
    Tolvaptan; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2012-08
    Completion
    2013-11
    Enrolment
    0

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

    ConditionHeart Failure
    InterventionTolvaptan; placebo
    PhasePhase 4
    Registry statusWithdrawn
  • Efficacy and Safety of Tolvaptan in Japanese Patients With Acute Heart Failure

    NCT01635517 · start 2012-07-01

    Registered record
    Registry ID
    NCT01635517
    Conditions
    Heart Failure
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2012-07-01
    Completion
    2015-12-31
    Enrolment
    274

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

    ConditionHeart Failure
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure

    NCT01618448 · start 2012-07

    Registered record
    Registry ID
    NCT01618448
    Conditions
    Cardiac-induced Edema
    Interventions
    Tolvaptan; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-07
    Completion
    2014-12
    Enrolment
    85

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

    ConditionCardiac-induced Edema
    InterventionTolvaptan; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema

    NCT01651156 · start 2012-07

    Registered record
    Registry ID
    NCT01651156
    Conditions
    Cardiac Edema
    Interventions
    Tolvaptan; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-07
    Completion
    2013-07
    Enrolment
    244

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

    ConditionCardiac Edema
    InterventionTolvaptan; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

    NCT01507727 · start 2012-01

    Registered record
    Registry ID
    NCT01507727
    Conditions
    Non-hypovolemic Non-acute Hyponatremia
    Interventions
    Tolvaptan; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Unknown
    Start
    2012-01
    Completion
    2012-09
    Enrolment
    240

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

    ConditionNon-hypovolemic Non-acute Hyponatremia
    InterventionTolvaptan; Placebo
    PhasePhase 2 / Phase 3
    Registry statusUnknown
  • Fractional Urate Excretion in Nonedematous Hyponatremia

    NCT01425125 · start 2011-11

    Registered record
    Registry ID
    NCT01425125
    Conditions
    Cerebral Hyponatremia; SIADH; Cerebral Salt-wasting Syndrome; Reset Hypothalamic Osmostat
    Interventions
    Tolvaptan in euvolemic hyponatremia
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Withdrawn
    Start
    2011-11
    Completion
    2014-12
    Enrolment
    0

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

    ConditionCerebral Hyponatremia; SIADH; Cerebral Salt-wasting Syndrome; Reset Hypothalamic Osmostat
    InterventionTolvaptan in euvolemic hyponatremia
    PhaseNot applicable
    Registry statusWithdrawn