This page shows what was measured, who it was measured in, and what that does not settle.
What Bosentan Anhydrous does in the body
Pulmonary arterial hypertension
From the FDA-approved label: Bosentan is a specific and competitive antagonist at endothelin receptor types ET A and ET B . Bosentan has a slightly higher affinity for ET A receptors than for ET B receptors. The clinical impact of dual endothelin blockage is unknown. Endothelin-1 (ET-1) is a neurohormone, the effects of which are mediated by binding to ET A and ET B receptors in the endothelium and vascular smooth muscle. ET-1 concentrations are elevated in plasma and lung tissue of patients with PAH, suggesting a pathogenic role for ET-1 in this disease.
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 · Q326023R30 · read 2026-08-29
Its recorded molecular formula is C27H29N5O6S∙H2O, weighing 569.64.
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · 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 109 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.
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events
✗ The study did not show it
Who was studied
NCT04273945
How many people
935
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
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
Time to Occurrence of Disease Worsening or Death up to End of Study.
✗ The study did not show it
Who was studied
NCT00391443
How many people
616
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
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
Time to First Confirmed Morbidity/Mortality Event up to the End of Study
✗ The study did not show it
Who was studied
NCT00303459
How many people
334
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
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
Flow-Mediated Dilation (FMD)
✗ The study did not show it
Who was studied
NCT02116335
How many people
320
Study design
Not applicable
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 exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).
✗ The study did not show it
Who was studied
NCT00644605
How many people
275
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
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
Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension
✗ The study did not show it
Who was studied
NCT00080457
How many people
240
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.
Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with…
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: “The efficacy of TRACLEER in patients <18 years is supported by data from an uncontrolled trial in which 19 pediatric patients were treated with TRACLEER.”
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · read 2026-08-30
On older people, the label states: “Clinical studies of TRACLEER did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.”
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on data from animal reproduction studies, TRACLEER may cause fetal harm, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy [see Contraindications (4.1) ] .”
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Data from a case report describe the presence of bosentan in human milk.”
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · read 2026-08-30
On people with reduced liver function, the label states: “Because there is in vitro and in vivo evidence that the main route of excretion of bosentan is biliary, liver impairment could be expected to increase exposure (C max and AUC) of bosentan.”
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · read 2026-08-30
On people with reduced kidney function, the label states: “The effect of renal impairment on the pharmacokinetics of bosentan is small and does not require dosing adjustment [see Clinical Pharmacology (12.3) ] .”
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · 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: S3, S5, S6.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet, for suspension, tablet, film coated, tablet, coated, 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
24 products list this as an active ingredient in the United States drug directory. 24 of them contain it and nothing else.
FDA National Drug Code directory · 14501-0041 · read 2026-08-29
They are sold as powder, tablet, tablet, coated, tablet, film coated and tablet, for suspension, taken oral.
FDA National Drug Code directory · 14501-0041 · read 2026-08-29
The regulator's established pharmacologic class for it is cytochrome p450 2c9 inducers [moa], cytochrome p450 3a inducers [moa] and endothelin receptor antagonist [epc].
FDA National Drug Code directory · 14501-0041 · read 2026-08-29
8 published labels name it as an active ingredient. 8 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · read 2026-08-29
Tracleer is oral at 3 DOSAGE FORMS AND STRENGTHS 62.5 mg tablets : round, biconvex, orange-white tablets, debossed with identification marking "62,5" 125 mg tablets : oval, biconvex, orange-white tablets, debossed with identification marki…, recorded as fda label in effect 2025-11-17 in the United States.
US prescribing information · 749e42fb-2fe0-45dd-9268-b43bb3f4081c · read 2026-08-30
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 Bosentan Anhydrous 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 Bosentan Anhydrous 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
6 documents were read for this substance.
RNAWiki source record
6 of them state the same halfLife, and they agree.
RNAWiki source record
6 of them state the same bioavailability, and they agree.
RNAWiki source record
6 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
Q326023R30
RxNorm concept
349253
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: S3, 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
15 approved applications cover products containing this substance. The earliest was NDA021290, approved 20011120 to ACTELION.
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 (11)
Q2
On the Bosentan Anhydrous label: indicated for what?
"Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or…": indications and usage on Bosentan Anhydrous's label. DailyMed label · 8444da17-6c31-492b-8842-93740f083d9d · 2026-06-02
Q3
95 registered trials of Bosentan Anhydrous — at which phases?
Registered studies posting no result
71 of 95
95 registered studies of Bosentan Anhydrous: 29 phase3, 26 phase2, 16 phase1, 16 phase4, 8 na, 5 na or unstated, 3 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
221 with a PubMed record
Show the evidence
phase3
29
phase2
26
phase1
16
phase4
16
na
8
na or unstated
5
10 more recorded rows
early phase1
3
completed
59
terminated
14
unknown
14
active not recruiting
2
recruiting
2
enrolling by invitation
1
not yet recruiting
1
suspended
1
withdrawn
1
recorded 2026-09-01 · last checked 2026-09-04
Q4
16 of Bosentan Anhydrous's trials stopped: accrual/recruitment, funding/business, other?
accrual/recruitment (12), funding/business (1) and other (3): Bosentan Anhydrous's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"failure of recruiting a sufficient number of patients"; 16 of 95 registered studies
Show the evidence
Trial
NCT00226889
terminated; "failure of recruiting a sufficient number of patients"
NCT00302211
terminated; "Terminated due to slow enrollment"
NCT00310830
terminated; "Slow enrollment"
NCT00313196
terminated; "Slow enrollment"
NCT00360087
terminated; "Slow enrollment"
NCT00377455
terminated; "Study was terminated due to inadequate enrolment"
10 further recorded trials
NCT00625469
withdrawn; "competing studies did not allow enrollment"
NCT00638131
terminated; "problem of recruitment"
NCT00679068
terminated; "lack of recruitment of patients"
NCT00815347
terminated; "Difficulty in recruitment."
NCT00825266
terminated; "difficulty in finding eligible subjects"
NCT00926627
terminated; "Not enough patients with the specified criteria could not"
NCT01389856
terminated; "To be compliant with the timelines as agreed with Paediatric Committee (PC) within the Paediatric Investigational Plan"
NCT01518595
terminated; "too slow patient recruitment"
NCT04158635
suspended; "Accrual Goal met"
NCT04770155
terminated; "Despite significant effort, we were unable to obtain the supply of drugs and supplements needed for the various arms of this Clinical Trial."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Bosentan Anhydrous used Bosentan 62.5 mg — over how long?
studies of Bosentan Anhydrous used the recorded amount. ClinicalTrials.gov · 2026-09-01
4 recorded entries; human; also "Bosentan 62.5 mg", "Bosentan 125 mg", "Tracleer 125Mg Tablet"
Show the evidence
human
NCT00077584
Bosentan 62.5 mg
NCT00077584
Bosentan 125 mg
NCT03229694
Tracleer 125Mg Tablet
NCT05146089
Oral Bosentan 62.5 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Bosentan Anhydrous's half-life is 3 hours — which schedules were studied?
3 hours, the half-life Bosentan Anhydrous's label states: "General After oral administration, maximum plasma concentrations of bosentan are attained within 3 hours to 5 hours and the terminal elimination half-life is about 5 hours in healthy adult subjects." DailyMed label · 8444da17-6c31-492b-8842-93740f083d9d · 2026-06-02
bioavailability 50 %.
Show the evidence
half lifepharmacokinetics
3 hours; General After oral administration, maximum plasma concentrations of bosentan are attained within 3 hours to 5 hours and the terminal elimination half-life is about 5 hours in healthy adult subjects.
bioavailabilitypharmacokinetics
50 %; Absorption The absolute bioavailability of bosentan in normal volunteers is about 50% and is unaffected by food.
metabolismpharmacokinetics
Elimination Metabolism Bosentan has three metabolites, one of which is pharmacologically active and may contribute 10% to 20% of the effect of bosentan.
recorded 2026-06-02 · last checked 2026-09-04
Q7
Which running trial of Bosentan Anhydrous could settle lifespan?
NCT06957002 measures Failure free survival at Week 52, reading out 2030-06.
1 open trial; n 40; "Bosentan in the Treatment of Giant Cell Arteritis"
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TrialNCT06957002
"Bosentan in the Treatment of Giant Cell Arteritis"; n 40; "Failure free survival at Week 52"; 2030-06
Q8
Which 40 trials of Bosentan Anhydrous posted no result?
Posted no result
40 of 40 completed trials
Registrations
NCT00317486, NCT00077584, NCT00070590, NCT00319033, NCT00319267 and NCT00313222, and 34 more
Completion dates
oldest 2005-04; newest 2022-05-20
Show the evidence
Trial
NCT00317486
2005-04
NCT00077584
2005-05
NCT00070590
2005-09
NCT00319033
2006-02
NCT00319267
2007-02
NCT00313222
2007-03
14 further recorded trials
NCT00318175
2007-05
NCT00701597
2007-10
NCT00082186
2007-11
NCT01009177
2008-02-29
NCT00260819
2008-04
NCT01100736
2010-01
NCT00071461
2010-05
NCT00909337
2010-06
NCT00595049
2010-06-30
NCT01738542
2010-11
NCT01357109
2011-01
NCT01447550
2011-01
NCT00091715
2011-02
NCT00777985
2012-01
Q9
At the median, Bosentan Anhydrous's trials enrolled 30 people — anything larger?
Median enrolment
30
Largest enrolment
5000
Registered trials counted
95
Q10
What do 10814 spontaneous reports say about Bosentan Anhydrous — 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.
Bosentan Anhydrous appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10814 reaction mentions were counted: dyspnoea 2869; pneumonia 1348; aspartate aminotransferase increased 977; alanine aminotransferase increased 957. FAERS via Open Targets · CHEMBL957 · 2026-06-24
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dyspnoea
2869
pneumonia
1348
aspartate aminotransferase increased
977
alanine aminotransferase increased
957
fall
944
condition aggravated
873
4 more recorded rows
cough
774
fluid retention
722
oedema peripheral
679
chest pain
671
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Bosentan Anhydrous's label not list?
alanine aminotransferase increased, aspartate aminotransferase increased and chest pain and 7 more reported for Bosentan Anhydrous, absent from its label. FAERS via Open Targets · CHEMBL957 · 2026-06-24
3 label terms; 10 reported and unlisted; 8444da17-6c31-492b-8842-93740f083d9d
Show the evidence
alanine aminotransferase increased
count not stated
aspartate aminotransferase increased
count not stated
chest pain
count not stated
condition aggravated
count not stated
cough
count not stated
dyspnoea
count not stated
4 more recorded rows
fall
count not stated
fluid retention
count not stated
oedema peripheral
count not stated
pneumonia
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Q12
Bosentan Anhydrous and CYP3A, CYP2C9 and CYTOCHROME P450: shared by which compounds?
Cytochrome P450: Coadministration of bosentan with drugs metabolized by CYP2C9 and CYP3A can increase exposure to bosentan and/or the coadministered drug ( 4.2 , 4.3 , 7.1 ).
drug_interactions
7.1 Cytochrome P450 Drug Interactions Bosentan is metabolized by CYP2C9 and CYP3A.
drug_interactions
Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g. ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g. amprenavir, erythromycin, fluconazole, diltiazem) with bosentan will likely lead to large increases in plasma concentrations of bosentan.
drug_interactions
Coadministration of such combinations of a CYP2C9 inhibitor plus a strong or moderate CYP3A inhibitor with bosentan is not recommended.
drug_interactions
Bosentan is an inducer of CYP3A and CYP2C9.
drug_interactions
Bosentan had no relevant inhibitory effect on any CYP isozyme in vitro (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A).
2 more recorded rows
Interaction statementdrug_interactions
Figure 1 CYP3A induction-mediated effect of bosentan on other drugs Figure 2 Effect of other drugs on bosentan 7.2 Hormonal Contraceptives Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when bosentan is coadministered.
Interaction statementdrug_interactions
CYP3A induction-mediated effect of bosentan on other drugs CYP3A induction-mediated effect of bosentan on other drugs Effect of other drugs on bosentan
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
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✓ source coverage passed: 6 source rows
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