This page shows what was measured, who it was measured in, and what that does not settle.
What Tolvaptan does in the body
Clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic
8 times that of native arginine vasopressin (AVP). Tolvaptan affinity for the V 2 -receptor is 29 times that for the V 1a - receptor. Decreased binding of vasopressin to the V 2 -receptor in the kidney lowers adenylate cyclase activity resulting in a decrease in intracellular adenosine 3′, 5′-cyclic monophosphate (cAMP) concentrations. Decreased cAMP concentrations prevent aquaporin 2 containing vesicles from fusing with the plasma membrane, which in turn causes an increase in urine water excretion, an increase in free water clearance (aquaresis) and a decrease in urine osmolality.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 21G72T1950 · read 2026-08-29
Its recorded molecular formula is C26H25ClN2O3, weighing 448.94.
US prescribing information · 3febc0a1-9e5a-4ce0-843d-210f21d862c4 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 121 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan
✗ The study did not show it
Who was studied
NCT00071331
How many people
3600
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
✗ The study did not show it
Who was studied
NCT02251275
How many people
1803
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36
✗ The study did not show it
Who was studied
NCT00428948
How many people
1445
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.
✗ The study did not show it
Who was studied
NCT02160145
How many people
1370
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271)
✗ The study did not show it
Who was studied
NCT01214421
How many people
1083
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change from baseline in body weight after 7 days randomized treatment (Day 8).
✗ The study did not show it
Who was studied
NCT01349348
How many people
535
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness of JYNARQUE in pediatric patients have not been established.”
US prescribing information · 3febc0a1-9e5a-4ce0-843d-210f21d862c4 · read 2026-08-30
On older people, the label states: “Clinical studies of tolvaptan did not include sufficient numbers of subjects aged 65 years old and over to determine whether they respond differently from younger subjects.”
US prescribing information · 3febc0a1-9e5a-4ce0-843d-210f21d862c4 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data with JYNARQUE use in pregnant women are insufficient to determine if there is a drug associated risk of adverse developmental outcomes.”
US prescribing information · 3febc0a1-9e5a-4ce0-843d-210f21d862c4 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of tolvaptan in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 3febc0a1-9e5a-4ce0-843d-210f21d862c4 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S5, S6.
No source is stored against this line.
What is in the pack
Sold as tablet, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
41 products list this as an active ingredient in the United States drug directory. 41 of them contain it and nothing else.
FDA National Drug Code directory · 72761-032 · read 2026-08-29
They are sold as powder and tablet, taken oral.
FDA National Drug Code directory · 72761-032 · read 2026-08-29
The regulator's established pharmacologic class for it is vasopressin v2 receptor antagonist [epc] and vasopressin v2 receptor antagonists [moa].
FDA National Drug Code directory · 72761-032 · read 2026-08-29
10 published labels name it as an active ingredient. 10 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 3febc0a1-9e5a-4ce0-843d-210f21d862c4 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 3febc0a1-9e5a-4ce0-843d-210f21d862c4 · read 2026-08-29
Jynarque is oral at 3 DOSAGE FORMS AND STRENGTHS JYNARQUE (tolvaptan) is supplied as non-scored, blue, shallow-convex, immediate release tablets, debossed with "OTSUKA" and the tablet strength (mg) on one side as follows: Strength Shape 15…, recorded as fda label in effect 2025-11-06 in the United States.
US prescribing information · 3febc0a1-9e5a-4ce0-843d-210f21d862c4 · read 2026-08-30
Recorded price in US: 14.61173 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 8 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Tolvaptan studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Tolvaptan are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
How many documents were read
10 documents were read for this substance.
RNAWiki source record
10 of them state the same halfLife, and they agree.
RNAWiki source record
10 of them state the same bioavailability, and they agree.
RNAWiki source record
10 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
21G72T1950
RxNorm concept
2044355
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S5, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
11 approved applications cover products containing this substance. The earliest was NDA022275, approved 20090519 to OTSUKA.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (9)
Q2
On the Tolvaptan label: indicated for what?
"1 INDICATIONS & USAGE Tolvaptan tablet is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan tablet is a selective vasopressin V 2 -receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly…": indications and usage on Tolvaptan's label. DailyMed label · 82ef58ef-ce46-434e-bf99-89fce51094f1 · 2026-08-20
Q3
99 registered trials of Tolvaptan — at which phases?
11 of Tolvaptan's trials stopped: safety, futility/efficacy, accrual/recruitment, other?
safety (2), futility/efficacy (2), accrual/recruitment (5) and other (2): Tolvaptan's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Recruitment challenges and results of interim futility analysis, which showed less than likely to achieve primary endpoint goal-length of hospital stay."; 11 of 99 registered studies
Show the evidence
Trial
NCT01227512
terminated; "Recruitment challenges and results of interim futility analysis, which showed less than likely to achieve primary endpoint goal-length of hospital stay."
NCT01386372
terminated; "futility"
NCT01663662
withdrawn; "Lack of eligible patients"
NCT01733134
withdrawn; "Sponsor decided to quit funding before any enrollments"
NCT02012959
terminated; "Issues with participant recruitment \& enrollment which made the trial impossible or highly impracticable. Trial termination was not due to safety reasons."
NCT02020278
terminated; "Issues with recruitment and enrollment made the trial impossible or highly impracticable. Termination of this trial was not due to safety reasons."
5 further recorded trials
NCT02215148
terminated; "Slow subject enrollment and contracting issues; sponsor decided to abort study"
NCT02442674
withdrawn; "Trial withdrawn due to inability to meet the trial objectives (Pilot)."
NCT02545114
terminated; "Major protocol revision needed, current project terminated after enrollment of 25 patients."
NCT02959411
terminated; "Low accrual rate"
NCT04786574
withdrawn; "Study stopped before enrolling any participants."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Tolvaptan used OPC-41061 7.5mg — over how long?
studies of Tolvaptan used the recorded amount. ClinicalTrials.gov · 2026-09-01
8 recorded entries; human; tablet; also "OPC-41061 7.5mg", "OPC-41061 15mg", "15 mg tolvaptan"
Show the evidence
human
NCT00479336
OPC-41061 7.5mg
NCT00479336
OPC-41061 15mg
NCT02078973
15 mg tolvaptan
NCT02078973
30 mg tolvaptan
NCT02078973
45 mg tolvaptan
NCT02173288
Tolvaptan 15 mg twice a day
2 more recorded rows
humanNCT03254108
tablet; Tolvaptan tablet 15mg
humanNCT03931369
Tolvaptan 15 MG
recorded 2026-09-01 · last checked 2026-09-04
Q6
Tolvaptan's half-life is 180 h — which schedules were studied?
180 h; The oxobutyric acid metabolite shows a plasma half-life of ~180 h.
tmaxpharmacokinetics
4 hours; Absorption: In healthy subjects, peak concentrations of tolvaptan are observed between 2 and 4 hours post-dose.
bioavailabilitypharmacokinetics
56 %; The absolute bioavailability of tolvaptan following an oral dose of 30 mg is 56% (range 42 to 80%).
metabolismpharmacokinetics
Metabolism and Elimination: Tolvaptan is metabolized almost exclusively by CYP 3A.
recorded 2026-08-20 · last checked 2026-09-04
Q7
Which 29 trials of Tolvaptan posted no result?
Posted no result
29 of 29 completed trials
Registrations
NCT00043771, NCT00043758, NCT00201994, NCT00072683, NCT00071331 and NCT00132886, and 23 more
Completion dates
oldest 2002-09; newest 2022-05-25
Show the evidence
Trial
NCT00043771
2002-09
NCT00043758
2004-07
NCT00201994
2005-07-01
NCT00072683
2005-12-01
NCT00071331
2006-07
NCT00132886
2006-12
14 further recorded trials
NCT01359462
2010-01
NCT00664014
2010-02
NCT01349335
2010-04
NCT07166783
2011-07-04
NCT07166887
2011-07-27
NCT01261481
2012-02
NCT01349348
2012-07
NCT01556646
2013-06
NCT01651156
2013-07
NCT01638663
2014-03
NCT01618448
2014-12
NCT03910231
2015-02-01
NCT01850940
2015-05
NCT02096965
2015-11
Q8
At the median, Tolvaptan's trials enrolled 52 people — anything larger?
Median enrolment
52
Largest enrolment
3600
Registered trials counted
99
Q9
What do 1530 spontaneous reports say about Tolvaptan — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Tolvaptan appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1530 reaction mentions were counted: renal impairment 192; hepatic function abnormal 173; hypernatraemia 169; thirst 161. FAERS via Open Targets · CHEMBL344159 · 2026-06-24
Show the evidence
renal impairment
192
hepatic function abnormal
173
hypernatraemia
169
thirst
161
blood urea increased
159
dehydration
157
4 more recorded rows
blood creatinine increased
146
alanine aminotransferase increased
129
rapid correction of hyponatraemia
125
aspartate aminotransferase increased
119
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Tolvaptan's label not list?
alanine aminotransferase increased, aspartate aminotransferase increased and blood creatinine increased and 7 more reported for Tolvaptan, absent from its label. FAERS via Open Targets · CHEMBL344159 · 2026-06-24
2 label terms; 10 reported and unlisted; 82ef58ef-ce46-434e-bf99-89fce51094f1
Show the evidence
alanine aminotransferase increased
count not stated
aspartate aminotransferase increased
count not stated
blood creatinine increased
count not stated
blood urea increased
count not stated
dehydration
count not stated
hepatic function abnormal
count not stated
4 more recorded rows
hypernatraemia
count not stated
rapid correction of hyponatraemia
count not stated
renal impairment
count not stated
thirst
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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