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Ambrisentan

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Ambrisentan does in the body

Pulmonary arterial hypertension

From the FDA-approved label: Endothelin-1 (ET-1) is a potent autocrine and paracrine peptide. Two receptor subtypes, ET A and ET B , mediate the effects of ET-1 in the vascular smooth muscle and endothelium. The primary actions of ET A are vasoconstriction and cell proliferation, while the predominant actions of ET B are vasodilation, antiproliferation, and ET-1 clearance. In patients with PAH, plasma ET-1 concentrations are increased as much as 10-fold and correlate with increased mean right atrial pressure and disease severity. ET-1 and ET-1 mRNA concentrations are increased as much as 9-fold in the lung tissue of patients with PAH, primarily in the endothelium of pulmonary arteries.

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 · HW6NV07QEC · read 2026-08-29

  • Its recorded molecular formula is C22H22N2O4, weighing 378.42.

    US prescribing information · 32549c43-f8ff-422c-b42d-ca0877e661cf · 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 123 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 peopleRead 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

Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV

The study did not show it

Who was studied
NCT01178073
How many people
610
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 Death or Disease (IPF) Progression.

The study did not show it

Who was studied
NCT00768300
How many people
494
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 incidence of the composite endpoint of: Death, Mechanical ventilation, ECMO, Cardiovascular organ support, or Renal failure

The study did not show it

Who was studied
NCT04393246
How many people
454
Study design
Phase 2/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

Incidence of diagnostic PAH (mPAP ≥25 mmHg)

The study did not show it

Who was studied
NCT04972656
How many people
420
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

The primary efficacy endpoint is the composite of pulmonary hypertension progression at 12 months

The study did not show it

Who was studied
NCT06987097
How many people
410
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
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 unclearRead 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.

  • Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability [see Clinical Studies ( 14.2 )].

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: “Infertility Males In a 6-month study of another endothelin receptor antagonist, bosentan, 25 male patients with WHO functional class III and IV PAH and normal baseline sperm count were evaluated for effects on testicular function.”

    US prescribing information · 32549c43-f8ff-422c-b42d-ca0877e661cf · read 2026-08-30

  • On older people, the label states: “8.4 Pediatric Use Safety and effectiveness of ambrisentan in pediatric patients have not been established.”

    US prescribing information · 32549c43-f8ff-422c-b42d-ca0877e661cf · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on data from animal reproduction studies, ambrisentan may cause fetal harm, including birth defects and fetal death, when administered to a pregnant woman and is contraindicated during pregnancy.”

    US prescribing information · 32549c43-f8ff-422c-b42d-ca0877e661cf · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary It is not known whether ambrisentan is present in human milk.”

    US prescribing information · 32549c43-f8ff-422c-b42d-ca0877e661cf · read 2026-08-30

  • On people with reduced liver function, the label states: “Pre-existing Hepatic Impairment The influence of pre-existing hepatic impairment on the pharmacokinetics of ambrisentan has not been evaluated.”

    US prescribing information · 32549c43-f8ff-422c-b42d-ca0877e661cf · read 2026-08-30

  • On people with reduced kidney function, the label states: “The impact of renal impairment on the pharmacokinetics of ambrisentan has been examined using a population pharmacokinetic approach in PAH patients with creatinine clearances ranging between 20 and 150 mL/min.”

    US prescribing information · 32549c43-f8ff-422c-b42d-ca0877e661cf · 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 takeRead 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 takeRead 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, film 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 takeNothing 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 unclearRead 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

  • 34 products list this as an active ingredient in the United States drug directory. 34 of them contain it and nothing else.

    FDA National Drug Code directory · 0591-2406 · read 2026-08-29

  • They are sold as powder and tablet, film coated, taken oral.

    FDA National Drug Code directory · 0591-2406 · read 2026-08-29

  • The regulator's established pharmacologic class for it is endothelin receptor antagonist [epc] and endothelin receptor antagonists [moa].

    FDA National Drug Code directory · 0591-2406 · read 2026-08-29

  • 14 published labels name it as an active ingredient. 14 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac · read 2026-08-29

  • Ambrisentan is oral at 3 DOSAGE FORMS AND STRENGTHS 5 mg and 10 mg film - coated tablets for oral administration Each 5 mg tablet is white to off-white, capsule shaped, film-coated, and debossed with "5" on one side and "405" on the other sid…, recorded as fda label in effect 2025-05-30 in the United States.

    US prescribing information · 32549c43-f8ff-422c-b42d-ca0877e661cf · read 2026-08-30

  • Recorded price in US: 8.20943 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 9 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 takeRead 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 Ambrisentan 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 unclearRead 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 Ambrisentan 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 peopleRead 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

  • 13 documents were read for this substance.

    RNAWiki source record

  • 13 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 13 of them state the same tMax, and they agree.

    RNAWiki source record

  • 13 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
HW6NV07QEC
RxNorm concept
722116

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 unclearRead 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

  • 10 approved applications cover products containing this substance. The earliest was NDA022081, approved 20070615 to GILEAD.

    Drugs@FDA application register · NDA022081 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA022081 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20070615.

    FDA National Drug Code directory · 0591-2406 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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 (10)

On the Ambrisentan label: indicated for what?


"Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of…": indications and usage on Ambrisentan's label. DailyMed label · 37af3191-0ed3-4783-8747-065f1462f2d2 · 2026-07-15

56 registered trials of Ambrisentan — at which phases?


Registered studies posting no result
26 of 56

56 registered studies of Ambrisentan: 19 phase3, 16 phase2, 10 phase4, 7 na, 7 phase1, 2 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

59 with a PubMed record

Show the evidence
  • phase3
    19
  • phase2
    16
  • phase4
    10
  • na
    7
  • phase1
    7
  • na or unstated
    2
7 more recorded rows
  • completed
    36
  • terminated
    10
  • unknown
    4
  • recruiting
    2
  • withdrawn
    2
  • active not recruiting
    1
  • not yet recruiting
    1

recorded 2026-09-01 · last checked 2026-09-04

9 of Ambrisentan's trials stopped: futility/efficacy, accrual/recruitment, other?


futility/efficacy (1), accrual/recruitment (7) and other (1): Ambrisentan's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Lack of efficacy"; 9 of 56 registered studies

Show the evidence

Trial

  • NCT00768300
    terminated; "Lack of efficacy"
  • NCT00840463
    terminated; "Poor enrolment"
  • NCT01733095
    withdrawn; "slow recruitment"
  • NCT02169752
    terminated; "PI left National Jewish Health"
  • NCT02253394
    terminated; "Low enrollment"
  • NCT02885012
    terminated; "Study ending due to lack of enrollment."
3 further recorded trials
  • NCT03309592
    withdrawn; "Lack of eligible participants and failure to meeting study enrollment."
  • NCT03827200
    terminated; "Lack of recruitment, result of COVID-19 pandemic"
  • NCT04771000
    terminated; "Lack of recruitment"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Ambrisentan used Ambrisentan 5 mg — over how long?


studies of Ambrisentan used the recorded amount. ClinicalTrials.gov · 2026-09-01

2 recorded entries; human; also "Ambrisentan 5 mg", "Ambrisentan 10 MG"

Show the evidence

human

  • NCT01794078
    Ambrisentan 5 mg
  • NCT04450095
    Ambrisentan 10 MG

recorded 2026-09-01 · last checked 2026-09-04

Ambrisentan's half-life is 9 hours — which schedules were studied?


9 hours, the half-life Ambrisentan's label states: "Although ambrisentan has a 15-hour terminal half-life, the mean trough concentration of ambrisentan at steady-state is about 15% of the mean peak concentration and the accumulation factor is about 1.2 after long-term daily dosing, indicating that the effective half-life of ambrisentan is about 9 hours." DailyMed label · 37af3191-0ed3-4783-8747-065f1462f2d2 · 2026-07-15

tmax 2 hours.

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  • half life pharmacokinetics
    9 hours; Although ambrisentan has a 15-hour terminal half-life, the mean trough concentration of ambrisentan at steady-state is about 15% of the mean peak concentration and the accumulation factor is about 1.2 after long-term daily dosing, indicating that the effective half-life of ambrisentan is about 9 hours.
  • tmax pharmacokinetics
    2 hours; Ambrisentan is absorbed with peak concentrations occurring approximately 2 hours after oral administration in healthy subjects and PAH patients.
  • metabolism pharmacokinetics
    The elimination of ambrisentan is predominantly by non-renal pathways, but the relative contributions of metabolism and biliary elimination have not been well characterized.

recorded 2026-07-15 · last checked 2026-09-04

Which 13 trials of Ambrisentan posted no result?


Posted no result
13 of 13 completed trials
Registrations
NCT00423202, NCT00091598, NCT00423748, NCT00424034, NCT00851929 and NCT01352065, and 7 more
Completion dates
oldest 2005-10; newest 2022-06-08
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Trial

  • NCT00423202
    2005-10
  • NCT00091598
    2006-02
  • NCT00423748
    2006-02
  • NCT00424034
    2007-02
  • NCT00851929
    2011-11
  • NCT01352065
    2013-05
7 further recorded trials
  • NCT00679224
    2013-07
  • NCT01794078
    2014-12
  • NCT02712346
    2019-11-30
  • NCT01406327
    2020-02-28
  • NCT02936687
    2021-09-30
  • NCT05437224
    2022-02-06
  • NCT04393246
    2022-06-08

At the median, Ambrisentan's trials enrolled 34.5 people — anything larger?


Median enrolment
34.5
Largest enrolment
900
Registered trials counted
56

What do 16734 spontaneous reports say about Ambrisentan — 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.

Ambrisentan appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 16734 reaction mentions were counted: dyspnoea 4727; headache 2761; dizziness 1565; oedema peripheral 1334. FAERS via Open Targets · CHEMBL1111 · 2026-06-24

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  • dyspnoea
    4727
  • headache
    2761
  • dizziness
    1565
  • oedema peripheral
    1334
  • peripheral swelling
    1287
  • fluid retention
    1201
4 more recorded rows
  • nasal congestion
    1142
  • oedema
    1133
  • chest pain
    806
  • unevaluable event
    778

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Ambrisentan's label not list?


chest pain, dizziness and dyspnoea and 7 more reported for Ambrisentan, absent from its label. FAERS via Open Targets · CHEMBL1111 · 2026-06-24

2 label terms; 10 reported and unlisted; 37af3191-0ed3-4783-8747-065f1462f2d2

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  • chest pain
    count not stated
  • dizziness
    count not stated
  • dyspnoea
    count not stated
  • fluid retention
    count not stated
  • headache
    count not stated
  • nasal congestion
    count not stated
4 more recorded rows
  • oedema
    count not stated
  • oedema peripheral
    count not stated
  • peripheral swelling
    count not stated
  • unevaluable event
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Ambrisentan and P-GP, OATP1B1 and OATP1B3: shared by which compounds?


P-GP, OATP1B1 and OATP1B3 appear in Ambrisentan's recorded interaction sentences, 8 in all. DailyMed label · 37af3191-0ed3-4783-8747-065f1462f2d2 · 2026-07-15

CYP2C19, CYP3A, BSEP, MRP2, OATP1B1, OATP1B1; 10 shared nodes; pharmacokinetics, clinical_pharmacology

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Interaction statement

  • pharmacokinetics
    In vitro studies indicate that ambrisentan is a substrate of P-gp.
  • pharmacokinetics
    Drug Interactions In Vitro Studies Studies with human liver tissue indicate that ambrisentan is metabolized by CYP3A, CYP2C19, and uridine 5'-diphosphate glucuronosyltransferases (UGTs) 1A9S, 2B7S, and 1A3S.
  • pharmacokinetics
    In vitro studies suggest that ambrisentan is a substrate of the Organic Anion Transporting Polypeptides OATP1B1 and OATP1B3, and P-glycoprotein (P-gp).
  • pharmacokinetics
    Ambrisentan demonstrated weak dose-dependent inhibition of OATP1B1, OATP1B3, and NTCP (IC 50 of 47 µM, 45 µM, and approximately 100 µM, respectively) and no transporter-specific inhibition of BSEP, BRCP, P-gp, or MRP2.
  • clinical_pharmacology
    In vitro studies indicate that ambrisentan is a substrate of P-gp.
  • clinical_pharmacology
    Drug Interactions In Vitro Studies Studies with human liver tissue indicate that ambrisentan is metabolized by CYP3A, CYP2C19, and uridine 5'-diphosphate glucuronosyltransferases (UGTs) 1A9S, 2B7S, and 1A3S.
2 more recorded rows
  • Interaction statement clinical_pharmacology
    In vitro studies suggest that ambrisentan is a substrate of the Organic Anion Transporting Polypeptides OATP1B1 and OATP1B3, and P-glycoprotein (P-gp).
  • Interaction statement clinical_pharmacology
    Ambrisentan demonstrated weak dose-dependent inhibition of OATP1B1, OATP1B3, and NTCP (IC 50 of 47 µM, 45 µM, and approximately 100 µM, respectively) and no transporter-specific inhibition of BSEP, BRCP, P-gp, or MRP2.
  • CYP2C19
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • CYP3A
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • BSEP
    Ceftobiprole Medocaril, Eravacycline, Prucalopride, Chenodeoxycholic acid, Trametinib, Eluxadoline, Histidine, Tirbanibulin
  • MRP2
    Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Omadacycline, Prucalopride, Methylnaltrexone, Sonidegib, Trametinib

OATP1B1

  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline
  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline

OATP1B3

  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline
  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline

P-gp

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2026-07-15 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1111
PubChem CID
6918493
CAS number
177036-94-1
RxCUI
358274
InChIKey
OUJTZYPIHDYQMC-LJQANCHMSA-N
Trade name
Ambrisentan mylan, Letairis, Volibris, Ambrisentan Viatris (previously Ambrisentan Mylan), Ambrisentan Zentiva
Development code
GSK-1325760, GSK1325760, GSK-1325760A, GSK1325760A, LU-208075
Also called
amb, AMBRISENTAN [EMA EPAR], AMBRISENTAN [JAN], AMBRISENTAN [MART.], AMBRISENTAN [MI], AMBRISENTAN [ORANGE BOOK], AMBRISENTAN [VANDF], Ambrisentan [WHO-DD]
Sources (6)

Sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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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