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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 M. tuberculosis, MRSA and E. coli. 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.

  • Bempedoic Acid Therapy for Polycystic Kidney Disease

    NCT07282821 · start 2026-09-21

    Registered record
    Registry ID
    NCT07282821
    Conditions
    ADPKD (Autosomal Dominant Polycystic Kidney Disease)
    Interventions
    Bempedoic Acid 180 MG Oral Tablet; Placebo Capsule(s)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-09-21
    Completion
    2030-03-31
    Enrolment
    120

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

    ConditionADPKD (Autosomal Dominant Polycystic Kidney Disease)
    InterventionBempedoic Acid 180 MG Oral Tablet; Placebo Capsule(s)
    PhasePhase 2
    Registry statusNot yet recruiting
  • A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

    NCT04782258 · start 2023-01-23

    Registered record
    Registry ID
    NCT04782258
    Conditions
    Autosomal Recessive Polycystic Kidney (ARPKD)
    Interventions
    Tolvaptan Suspension; Tolvaptan Tablets
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2023-01-23
    Completion
    2028-08-14
    Enrolment
    20

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

    ConditionAutosomal Recessive Polycystic Kidney (ARPKD)
    InterventionTolvaptan Suspension; Tolvaptan Tablets
    PhasePhase 3
    Registry statusRecruiting
  • Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction

    NCT04331132 · start 2021-12-01

    Registered record
    Registry ID
    NCT04331132
    Conditions
    Acute Heart Failure
    Interventions
    Tolvaptan 15 MG
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2021-12-01
    Completion
    2023-07-26
    Enrolment
    128

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

    ConditionAcute Heart Failure
    InterventionTolvaptan 15 MG
    PhaseNot applicable
    Registry statusUnknown
  • Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

    NCT05408104 · start 2019-03-28

    Registered record
    Registry ID
    NCT05408104
    Conditions
    Heart Failure; Heart Assist Device; Hyponatremic
    Interventions
    tolvaptan
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2019-03-28
    Completion
    2022-05-01
    Enrolment
    28

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

    ConditionHeart Failure; Heart Assist Device; Hyponatremic
    Interventiontolvaptan
    PhaseNot recorded
    Registry statusCompleted
  • Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

    NCT03772041 · start 2019-01-16

    Registered record
    Registry ID
    NCT03772041
    Conditions
    Congestive Heart Failure
    Interventions
    OPC-61815; Tolvaptan Tab 15 MG
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-01-16
    Completion
    2020-07-29
    Enrolment
    294

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

    ConditionCongestive Heart Failure
    InterventionOPC-61815; Tolvaptan Tab 15 MG
    PhasePhase 3
    Registry statusCompleted
  • Tolvaptan-Octreotide LAR Combination in ADPKD

    NCT03541447 · start 2018-12-12

    Registered record
    Registry ID
    NCT03541447
    Conditions
    Autosomal Dominant Polycystic Kidney Disease
    Interventions
    Tolvaptan; Octreotide LAR; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2018-12-12
    Completion
    2021-12-23
    Enrolment
    20

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

    ConditionAutosomal Dominant Polycystic Kidney Disease
    InterventionTolvaptan; Octreotide LAR; Placebo
    PhasePhase 2
    Registry statusCompleted
  • Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

    NCT03596957 · start 2018-09-12

    Registered record
    Registry ID
    NCT03596957
    Conditions
    Autosomal Dominant Polycystic Kidney
    Interventions
    Tolvaptan
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2018-09-12
    Completion
    2020-04
    Enrolment
    90

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

    ConditionAutosomal Dominant Polycystic Kidney
    InterventionTolvaptan
    PhasePhase 4
    Registry statusUnknown
  • A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH

    NCT03048747 · start 2017-03-02

    Registered record
    Registry ID
    NCT03048747
    Conditions
    Syndrome of Inappropriate Antidiuretic Hormone Secretion
    Interventions
    Tolvaptan Oral Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-03-02
    Completion
    2019-03-19
    Enrolment
    16

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

    ConditionSyndrome of Inappropriate Antidiuretic Hormone Secretion
    InterventionTolvaptan Oral Tablet
    PhasePhase 3
    Registry statusCompleted
  • A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects

    NCT02994394 · start 2017-01-06

    Registered record
    Registry ID
    NCT02994394
    Conditions
    Healthy Adult Male
    Interventions
    OPC-41061
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2017-01-06
    Completion
    2017-02-28
    Enrolment
    84

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

    ConditionHealthy Adult Male
    InterventionOPC-41061
    PhasePhase 1
    Registry statusCompleted
  • Samsca PMS in ADPKD Patients

    NCT03406286 · start 2016-07-19

    Registered record
    Registry ID
    NCT03406286
    Conditions
    Safety
    Interventions
    Tolvaptan
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2016-07-19
    Completion
    2024-12
    Enrolment
    2,067

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

    ConditionSafety
    InterventionTolvaptan
    PhaseNot recorded
    Registry statusCompleted
  • Canadian Medical Assessment of JINARC™ Outcomes Registry

    NCT02925221 · start 2016-02-26

    Registered record
    Registry ID
    NCT02925221
    Conditions
    Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2016-02-26
    Completion
    2025-12-31
    Enrolment
    530

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

    ConditionAutosomal Dominant Polycystic Kidney Disease (ADPKD)
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure

    NCT02606253 · start 2016-02

    Registered record
    Registry ID
    NCT02606253
    Conditions
    Heart Failure
    Interventions
    tolvaptan; Chlorothiazide; Metolazone
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2016-02
    Completion
    2018-10-31
    Enrolment
    60

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

    ConditionHeart Failure
    Interventiontolvaptan; Chlorothiazide; Metolazone
    PhasePhase 4
    Registry statusCompleted
  • AiDing Diuresis wIth Tolvaptan (ADD-IT)

    NCT02646540 · start 2016-01

    Registered record
    Registry ID
    NCT02646540
    Conditions
    Cardiomyopathy; Congestive Heart Failure
    Interventions
    Tolvaptan 30 mg + IV Diuretics; Metolazone 5 mg + IV Diuretics; 2.5 times the Diuretics Dose
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-01
    Completion
    2018-12-30
    Enrolment
    14

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

    ConditionCardiomyopathy; Congestive Heart Failure
    InterventionTolvaptan 30 mg + IV Diuretics; Metolazone 5 mg + IV Diuretics; 2.5 times the Diuretics Dose
    PhasePhase 1
    Registry statusCompleted
  • A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia

    NCT02442674 · start 2015-11

    Registered record
    Registry ID
    NCT02442674
    Conditions
    Hyponatremia
    Interventions
    Tolvaptan; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Withdrawn
    Start
    2015-11
    Completion
    2017-06-22
    Enrolment
    0

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

    ConditionHyponatremia
    InterventionTolvaptan; Placebo
    PhasePhase 3
    Registry statusWithdrawn
  • An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH

    NCT02545101 · start 2015-11

    Registered record
    Registry ID
    NCT02545101
    Conditions
    Hyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2015-11
    Completion
    2016-04
    Enrolment
    100

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

    ConditionHyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted