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Azilsartan medoxomil

  • 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 Azilsartan medoxomil does in the body

Azilsartan medoxomil is indicated for the treatment of hypertension in adults, to lower blood pressure.

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Azilsartan medoxomil is an orally administered prodrug that is rapidly converted by esterases during absorption to the active moiety, azilsartan. Azilsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland.

Why people take it. Azilsartan medoxomil is indicated for the treatment of hypertension in adults, to lower blood pressure.

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 · LL0G25K7I2 · read 2026-08-29

  • Its recorded molecular formula is C30H23KN4O8, weighing 606.62.

    US prescribing information · c09103d8-c094-473d-a303-bbb4f334aa8c · read 2026-08-30

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 143 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.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 10 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Healthy ageingWaiting for a reviewer1 registered study measure of this kind. No reviewed result yet.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
mortality

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Waiting for a reviewer
1 registered study measure of this kind. No reviewed result yet.
Nothing in the sources checked
No registered study lists a performance measure for this goal.
Not recorded
Harms were not a registered measure for this goal.

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.

Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)

The study did not show it

Who was studied
NCT00847626
How many people
1711
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The study did not show it

Who was studied
NCT00696436
How many people
1291
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The study did not show it

Who was studied
NCT00696241
How many people
1275
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.

The study did not show it

Who was studied
NCT00846365
How many people
1085
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.

The study did not show it

Who was studied
NCT01033071
How many people
1071
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The study did not show it

Who was studied
NCT00591578
How many people
984
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · 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 happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. No reviewed result.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.5 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • sitting clinic diastolic blood pressure
  • trough clinic sitting systolic blood pressure
  • trough sitting clinic systolic blood pressure
  • blood pressure
  • systolic blood pressure

Meaningful

Things that change how a life goes, not only a number.

  • mortality

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (4)
  • 24 hour bp
  • on study retention rate at 6 months
  • sustained decline in egfr 30
  • uacr

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 11 hours hours

    Read from the label, which states: “The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 mL/min.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

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

No description of who was studied is recorded.

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 in pediatric patients have not been established.”

    US prescribing information · c09103d8-c094-473d-a303-bbb4f334aa8c · read 2026-08-30

  • On older people, the label states: “No dose adjustment with azilsartan medoxomil is necessary in elderly patients.”

    US prescribing information · c09103d8-c094-473d-a303-bbb4f334aa8c · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Azilsartan medoxomil can cause fetal harm when administered to a pregnant woman.”

    US prescribing information · c09103d8-c094-473d-a303-bbb4f334aa8c · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is limited information regarding the presence of azilsartan in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · c09103d8-c094-473d-a303-bbb4f334aa8c · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is necessary for subjects with mild or moderate hepatic impairment.”

    US prescribing information · c09103d8-c094-473d-a303-bbb4f334aa8c · read 2026-08-30

  • On people with reduced kidney function, the label states: “Dose adjustment is not required in patients with mild-to-severe renal impairment or end-stage renal disease.”

    US prescribing information · c09103d8-c094-473d-a303-bbb4f334aa8c · 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 for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

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 (10)
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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

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, S6.

No source is stored against this line.

What is in the pack

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

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.

Reports sent to a regulator

  • 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.

Azilsartan medoxomil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 104 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • dizziness — 18 reaction mentions
  • wrong technique in product usage process — 17 reaction mentions
  • product odour abnormal — 15 reaction mentions
  • hypotension — 12 reaction mentions
  • blood pressure increased — 11 reaction mentions
  • muscle spasms — 9 reaction mentions
  • poor quality drug administered — 7 reaction mentions
  • blood pressure decreased — 6 reaction mentions
  • product dispensing error — 5 reaction mentions
  • blood pressure systolic increased — 4 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

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

  • 8 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.

    FDA National Drug Code directory · 11532-6001 · read 2026-08-29

  • They are sold as tablet.

    FDA National Drug Code directory · 11532-6001 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · b1c8de43-3b26-408f-8c7e-6c7d76348199 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · b1c8de43-3b26-408f-8c7e-6c7d76348199 · read 2026-08-29

  • Azilsartan Medoxomil is oral at 3 DOSAGE FORMS AND STRENGTHS Azilsartan Medoxomil Tablets, USP are supplied as white to nearly white round tablets in the following dosage strengths: 40-mg tablets – debossed "ASL" on one side and "40" on the other 80-m…, recorded as fda label in effect 2026-04-20 in the United States.

    US prescribing information · c09103d8-c094-473d-a303-bbb4f334aa8c · read 2026-08-30

  • Recorded price in US: 5.615 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, for the one priced product, 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 Azilsartan medoxomil 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 Azilsartan medoxomil 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.

Where else this substance is registered

FDA substance identifier (UNII)
LL0G25K7I2
CAS registry number
863031-21-4
PubChem compound
135409642
ChEMBL
CHEMBL2028661
ChEBI
68845
WHO international nonproprietary name list entry
8874
RxNorm concept
1091642
EMA substance identifier
100000124197
DrugBank
DB08822

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: Quoted from a stored source.

  • Not passed

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  • Passed

    Safety mode resolved

    Suppression classes recorded: S3, S6.

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    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

  • 1 approved application covers products containing this substance.

    Drugs@FDA application register · ANDA219062 · read 2026-08-29

  • Marketing status on the register: none (tentative approval).

    Drugs@FDA application register · ANDA219062 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20111011.

    FDA National Drug Code directory · 11532-6001 · read 2026-08-29

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What to learn next

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Recorded evidence blocks (11)

What did Azilsartan medoxomil's largest trial (3438 people) and its longest (4.8 years) measure?


3438 people in Azilsartan medoxomil's largest registered study, 4.8 years in its longest registered window, measuring Mortality. ClinicalTrials.gov · 2026-09-01

18 phase3, 4 na or unstated, 3 phase1, 2 phase2, 2 phase4, 1 na; NCT04470817; 2023-05-25; no ageing endpoint recorded. Last human test completed 2023, NCT04470817.

Interpretation These counts include studies where Azilsartan medoxomil was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase3
    18
  • na or unstated
    4
  • phase1
    3
  • phase2
    2
  • phase4
    2
  • na
    1
1 more recorded row
  • Last recorded human test NCT04470817
    2023-05-25

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

Azilsartan medoxomil was tested only in human — what did it show?


human: lifespan (29): the rungs where Azilsartan medoxomil has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human lifespan
Show the evidence
  • human NCT04606563
    lifespan; Mortality; 29

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

3 of Azilsartan medoxomil's trials stopped: safety, futility/efficacy, funding/business?


safety (1), futility/efficacy (1) and funding/business (1): Azilsartan medoxomil's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Business Decision (see below)"; 3 of 29 registered studies

Show the evidence

Trial

  • NCT01078376
    terminated; "Business Decision (see below)"
  • NCT01496430
    terminated; "Business Decision; No Safety Or Efficacy Concerns. (See below)"
  • NCT04606563
    terminated; "DSMC recommendation due to futility"

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

Human studies of Azilsartan medoxomil used Edarbi 40 mg — over how long?


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

5 recorded entries; human; tablet; also "Edarbi 40 mg", "Edarbi 80 mg", "Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]"

Show the evidence

human

  • NCT02235519
    Edarbi 40 mg
  • NCT02235519
    Edarbi 80 mg
  • NCT03539627
    Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]
  • NCT06990204
    tablet; Azilsartan medoxomil 80 mg tablet
  • NCT06990204
    Edarbi® 80 mg tablets

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

Azilsartan medoxomil's half-life is 11 hours — which schedules were studied?


11 hours, the half-life Azilsartan medoxomil's label states. openfda-label · b1c8de43-3b26-408f-8c7e-6c7d76348199 · 2026-08-30

Show the evidence
  • half life
    11 hours hours; The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 mL/min.
  • bioavailability
    The estimated absolute bioavailability of azilsartan following administration of azilsartan medoxomil is approximately 60%.

recorded 2026-08-30 · last checked 2026-09-04

Which of 24 hour bp, blood pressure and mortality did Azilsartan medoxomil's trials measure?


24 hour bp, blood pressure and mortality lead 10 outcome terms across Azilsartan medoxomil's trials. ClinicalTrials.gov · 2026-09-01

24 hour bp, blood pressure, systolic blood pressure, mortality, on study retention rate at 6 months and sustained decline in egfr 30 follow.

Show the evidence
  • sitting clinic diastolic blood pressure
    1
  • trough clinic sitting systolic blood pressure
    1
  • trough sitting clinic systolic blood pressure
    1
  • 24 hour bp
    1
  • blood pressure
    1
  • systolic blood pressure
    1
4 more recorded rows
  • mortality
    1
  • on study retention rate at 6 months
    1
  • sustained decline in egfr 30
    1
  • uacr
    1

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

Which of Azilsartan medoxomil's 2 ongoing trials reports first?


2 registered trials of Azilsartan medoxomil are open; earliest completion 2025-07-01. ClinicalTrials.gov · 2026-09-01

Bioequivalence of Azilsartan medoxomil 80 mg tablets and Edarbi® 80 mg tablets by measuring the AUC from time 0 to last collection time t (AUC0-t); On-study retention rate at 6 months; latest 2029-03-31

Show the evidence

Trial

  • NCT06990204
    "Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC Nizhpharm, Russia)"; n 56; "Bioequivalence of Azilsartan medoxomil 80 mg tablets and Edarbi® 80 mg tablets by measuring the AUC from time 0 to last collection time t (AUC0-t)"; 2025-07-01
  • NCT07547878
    "Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)"; n 64; "On-study retention rate at 6 months"; 2029-03-31

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

Which 2 trials of Azilsartan medoxomil posted no result?


Posted no result
2 of 2 completed trials
Registrations
NCT03539627 and NCT04470817
Completion dates
oldest 2022-04-29; newest 2023-05-25
Show the evidence

Trial

  • NCT03539627
    2022-04-29
  • NCT04470817
    2023-05-25

At the median, Azilsartan medoxomil's trials enrolled 507 people — anything larger?


Median enrolment
507
Largest enrolment
3438
Registered trials counted
29

What do 104 spontaneous reports say about Azilsartan medoxomil — 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.

Azilsartan medoxomil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 104 reaction mentions were counted: dizziness 18; wrong technique in product usage process 17; product odour abnormal 15; hypotension 12. open-targets-adr · CHEMBL2028661 · 2026-06-24

Show the evidence
  • dizziness
    18
  • wrong technique in product usage process
    17
  • product odour abnormal
    15
  • hypotension
    12
  • blood pressure increased
    11
  • muscle spasms
    9
4 more recorded rows
  • poor quality drug administered
    7
  • blood pressure decreased
    6
  • product dispensing error
    5
  • blood pressure systolic increased
    4

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

Azilsartan medoxomil and CYP2C9: shared by which compounds?


CYP2C9 appear in Azilsartan medoxomil's recorded interaction sentences, 1 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP2C9 pharmacokinetics
    The major enzyme responsible for azilsartan metabolism is CYP2C9.

recorded 2026-08-30 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2028661
PubChem CID
135409642
CAS number
863031-21-4
RxCUI
1091642
InChIKey
QJFSABGVXDWMIW-UHFFFAOYSA-N
Development code
AR-14, TAK 491
Also called
Azilsartan medoxomilo, azl-m, AZILSARTAN KAMEDOXOMIL, Azilsartan medoxomil [INN], Azilsartan medoxomil [MART.], Azilsartan medoxomil [MI], Azilsartan medoxomil [ORANGE BOOK], Azilsartan medoxomil [USAN], Azilsartan medoxomil [VANDF], Azilsartan medoxomil [WHO-DD]
Trade name
Edarbi, Azilsartan kamedoxomil component of edarbyclor, Ipreziv, Azilsartan Medoxomil / Edarbi
Salt form
Azilsartan medoxomil potassium
Sources (9)

Sources

3 more sources
  • openfda-label b1c8de43-3b26-408f-8c7e-6c7d76348199 ·
  • openfda-label+europepmc K1:LL0G25K7I2 ·
  • national registers US, EU, CA ·

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · 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: Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 9 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

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.