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Aliskiren

  • 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 Aliskiren does in the body

Aliskiren is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure.

Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptide angiotensin II (Ang II) by ACE and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings.

Why people take it. Aliskiren is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, 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 · C8A0P8G029 · read 2026-08-29

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 147 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.

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.

Enzyme

An enzyme is a protein that speeds up one chemical change.

A picture of it, and where the picture fails

An enzyme is like a machine on a production line doing one cut.

Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.

What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.

A catalytic protein that lowers the activation energy of a specific reaction.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

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 40 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
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.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.Only a number moved3 registered test measure.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.
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
Blood sugar
plasma insulin; plasma glucose; insulin sensitivity by homa at 12 weeks
Healthy ageing
all cause 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
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
3 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

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.

Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)

The study did not show it

Who was studied
NCT00549757
How many people
8606
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
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot
  • CMS National Average Drug Acquisition Cost · a recorded source, not a stored snapshot

Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization

The study did not show it

Who was studied
NCT00853658
How many people
7064
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.

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
  • Europe PMC · a recorded source, not a stored snapshot
  • CMS National Average Drug Acquisition Cost · a recorded source, not a stored snapshot

Change from baseline in diastolic blood pressure after 8 weeks

The study did not show it

Who was studied
NCT00219024
How many people
2775
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
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot
  • CMS National Average Drug Acquisition Cost · a recorded source, not a stored snapshot

Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The study did not show it

Who was studied
NCT00739973
How many people
2694
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
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot
  • CMS National Average Drug Acquisition Cost · a recorded source, not a stored snapshot

Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen

The study did not show it

Who was studied
NCT01259297
How many people
2336
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
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot
  • CMS National Average Drug Acquisition Cost · a recorded source, not a stored snapshot

Adverse events, laboratory abnormalities, serious adverse events

The study did not show it

Who was studied
NCT00219037
How many people
1955
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
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot
  • CMS National Average Drug Acquisition Cost · 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.3 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  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.21 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 Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  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.

  • diastolic blood pressure after 8 weeks
  • sitting diastolic blood pressure after 8 weeks
  • decrease in supine systolic blood pressure
  • sitting systolic blood pressure to week 12
  • plasma renin concentration
  • sitting systolic blood pressure from baseline to week 4
  • sitting systolic blood pressure
  • sitting systolic blood pressure at week 24
  • 24 hour ambulatory systolic blood pressure at week 8
  • systolic blood pressure before and after treatment

and 11 more.

Meaningful

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

  • cardiovascular death
  • all cause mortality
  • any adverse events serious adverse events and death

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 (16)
  • overall percentage of adverse events
  • n terminal prob type natriuretic peptide at week 8
  • occurrence of primary composite endpoint
  • colonic pathology
  • summary of the end of study colonoscopy results
  • arterial stiffness and platelet function
  • plasminogen activator inhibitor 1
  • venous angiotensin ii levels after 12 weeks of treatment
  • endothelial progenitor cells
  • reactive hyperemia index
  • rate of change in gfr
  • flow mediated vasodilation
  • c terminal propeptide of procollagen type i
  • renal function
  • egfr
  • changing in modified peritoneal equilibrium test

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. 24 hours hours

    Read from the label, which states: “12.3 Pharmacokinetics Aliskiren is poorly absorbed (bioavailability about 2.5%) with an approximate accumulation half-life of 24 hours.”

  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: “The safety and effectiveness of Aliskiren have not been established in pediatric patients younger than 6 years of age and patients less than 20 kg.”

    US prescribing information · 41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db · read 2026-08-30

  • On older people, the label states: “Of the total number of patients receiving aliskiren in clinical studies, 1,275 (19%) were 65 years or older and 231 (3.4%) were 75 years or older.”

    US prescribing information · 41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db · read 2026-08-30

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

    US prescribing information · 41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of aliskiren in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · 41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db · read 2026-08-30

  • On people with reduced kidney function, the label states: “Safety and effectiveness of Aliskiren in patients with severe renal impairment [creatinine clearance (CrCl) less than 30 mL/min] have not been established as these patients were excluded in efficacy trials [see Clinical Studies ( 14 )].”

    US prescribing information · 41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db · 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.

Aliskiren appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1401 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • blood creatinine increased — 216 reaction mentions
  • dyspnoea — 172 reaction mentions
  • blood pressure increased — 139 reaction mentions
  • cerebrovascular accident — 135 reaction mentions
  • hyperkalaemia — 134 reaction mentions
  • renal impairment — 132 reaction mentions
  • renal failure — 125 reaction mentions
  • cardiac failure — 121 reaction mentions
  • renal failure acute — 119 reaction mentions
  • hypertension — 108 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

  • 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 · f3fd2503-25ef-4660-a29a-f62c491e28fb · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · f3fd2503-25ef-4660-a29a-f62c491e28fb · read 2026-08-29

  • Aliskiren is oral at 3 DOSAGE FORMS AND STRENGTHS 150 mg light pink biconvex round tablet, imprinted NVR/IL (Side 1/Side 2). 300 mg light red biconvex ovaloid round tablet, imprinted NVR/IU (Side 1/Side 2)., recorded as fda label in effect 2023-05-01 in the United States.

    US prescribing information · 41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db · read 2026-08-30

  • Recorded price in US: 4.04744–5.71826 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 4 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 Aliskiren 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 Aliskiren 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.

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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)
C8A0P8G029
RxNorm concept
1011736

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Recorded evidence blocks (13)

What did Aliskiren's largest trial (22213 people) and its longest (16 years) measure?


22213 people in Aliskiren's largest registered study, 16 years in its longest registered window, measuring Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase). ClinicalTrials.gov · 2026-09-01

49 phase3, 46 phase4, 17 phase2, 13 phase1, 10 na, 3 na or unstated; NCT00223717; 2017-01; no ageing endpoint recorded. Last human test completed 2024, NCT06718062.

Interpretation These counts include studies where Aliskiren 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
    49
  • phase4
    46
  • phase2
    17
  • phase1
    13
  • na
    10
  • na or unstated
    3
1 more recorded row
  • Last recorded human test NCT06718062
    2024-10-01

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

From mouse to human: where has Aliskiren shown lifespan?


mouse: mechanism-only and human: lifespan (134): the rungs where Aliskiren has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase) — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat Dog Non-human primate Human lifespan
Show the evidence
  • mouse
    mechanism-only
  • human NCT00549757
    lifespan; Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase); 134

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

23 of Aliskiren's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (4), futility/efficacy (2), accrual/recruitment (3), funding/business (1), sponsor decision unspecified (1) and other (12): Aliskiren's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Early termination resulted from interim analysis of the ALTITUDE trial"; 23 of 134 registered studies

Show the evidence

Trial

  • NCT00498433
    terminated; "Early termination resulted from interim analysis of the ALTITUDE trial"
  • NCT00542269
    terminated; "Early termination of the study due to slow recruitment."
  • NCT00549757
    terminated; "Lack of benefit and safety concern"
  • NCT00627861
    terminated; "The renin laboratory used in the study is no longer available."
  • NCT00768040
    terminated; "Inadequate enrollment"
  • NCT00773084
    withdrawn; "Difficulty in recruiting patients and then the PI left the institution"
14 further recorded trials
  • NCT00881439
    terminated; "Futility"
  • NCT00961207
    terminated; "Altitude trial which used similar drugs was terminated due to increased ADR."
  • NCT00974922
    terminated; "Administrative/Sponsor Business Decision - terminated - study was not completed"
  • NCT00994253
    withdrawn; "Due to safety concerns re: the concomitant use of aliskiren with an ACEi or ARB."
  • NCT01060865
    terminated; "The participants signed an old version of the informed consent."
  • NCT01067326
    terminated; "Novartis ended all studies regarding Aliskiren."
  • NCT01093781
    withdrawn; "Manufacturer asked to close study due to AEs experienced by subjects in other studies."
  • NCT01235910
    terminated; "Study was stopped early due to difficulty finding patients who met I/E criteria."
  • NCT01252238
    terminated; "Study sponsor terminated study due to AE's reported with valsartan and aliskiren"
  • NCT01259297
    terminated; "Terminated early in agreement with Health Authorities for feasibility reasons"
  • NCT01302899
    terminated; "In consequence of termination of ALTITUDE. A number of studies were continued in consultation with the Altitude Data Monitoring Committee."
  • NCT01349114
    terminated; "Sponsor requested termination."
  • NCT01409408
    withdrawn; "Due to preliminary results of Altitude Trial."
  • NCT01417104
    terminated; "Safety concerns with approved medication identified in an unrelated trial"

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

Human studies of Aliskiren used Aliskiren 300 mg — over how long?


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

20 recorded entries; human; tablet; also "Aliskiren 300 mg", "Aliskiren/valsartan 300/320 mg", "Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)"

Show the evidence

human

  • NCT00409578
    Aliskiren 300 mg
  • NCT00409578
    Aliskiren/valsartan 300/320 mg
  • NCT00705575
    Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
  • NCT00705575
    Aliskiren (300 mg)
  • NCT00706134
    Aliskiren 75 mg
  • NCT00706134
    Aliskiren 150 mg
14 more recorded rows
  • human NCT00719316
    Rasilez 300mg per day
  • human NCT00739973
    tablet; Aliskiren 150 mg tablet
  • human NCT00739973
    tablet; Aliskiren 300 mg tablet
  • human NCT00739973
    tablet; Aliskiren/amlodipine 150/5 mg tablet
  • human NCT00739973
    tablet; Aliskiren/amlodipine 150/10 mg tablet
  • human NCT00739973
    tablet; Aliskiren/amlodipine 300/5 mg tablet
  • human NCT00739973
    tablet; Aliskiren/amlodipine 300/10 mg tablet
  • human NCT00777946
    Aliskiren/Amlodipine 300/5 mg
  • human NCT00777946
    Aliskiren/Amlodipine 300/10 mg
  • human NCT00949351
    Aliskiren 300mg/d
  • human NCT01103245
    Aliskiren 150 mg (ALI 150)
  • human NCT01103245
    Aliskiren 300 mg (ALI 300)
  • human NCT01150357
    Aliskiren (6.25/12.5/25 mg)
  • human NCT01150357
    Aliskiren (37.5/75/150 mg)

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

Aliskiren's half-life is 24 hours — which schedules were studied?


24 hours, the half-life Aliskiren's label states. openfda-label · 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2 · 2026-08-30

bioavailability 2.5% %.

Show the evidence
  • half life
    24 hours hours; 12.3 Pharmacokinetics Aliskiren is poorly absorbed (bioavailability about 2.5%) with an approximate accumulation half-life of 24 hours.
  • bioavailability
    2.5% %; 12.3 Pharmacokinetics Aliskiren is poorly absorbed (bioavailability about 2.5%) with an approximate accumulation half-life of 24 hours.
  • metabolism
    Based on the in vitro studies, the major enzyme responsible for aliskiren metabolism appears to be CYP3A4.

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

Which of 24 hour ambulatory systolic blood pressure at week 8, all cause mortality and ambulatory diastolic blood pressure did Aliskiren's trials measure?


24 hour ambulatory systolic blood pressure at week 8, all cause mortality and ambulatory diastolic blood pressure lead 40 outcome terms across Aliskiren's trials. ClinicalTrials.gov · 2026-09-01

sitting systolic blood pressure to week 12, overall percentage of adverse events, n terminal prob type natriuretic peptide at week 8, occurrence of primary composite endpoint, cardiovascular death and all cause mortality follow.

Show the evidence
  • diastolic blood pressure after 8 weeks
    1
  • sitting diastolic blood pressure after 8 weeks
    1
  • decrease in supine systolic blood pressure
    1
  • sitting systolic blood pressure to week 12
    1
  • overall percentage of adverse events
    1
  • n terminal prob type natriuretic peptide at week 8
    1
14 more recorded rows
  • occurrence of primary composite endpoint
    1
  • cardiovascular death
    1
  • all cause mortality
    1
  • plasma renin concentration
    1
  • colonic pathology
    1
  • summary of the end of study colonoscopy results
    1
  • any adverse events serious adverse events and death
    1
  • arterial stiffness and platelet function
    1
  • sitting systolic blood pressure from baseline to week 4
    1
  • sitting systolic blood pressure
    1
  • sitting systolic blood pressure at week 24
    1
  • plasminogen activator inhibitor 1
    1
  • venous angiotensin ii levels after 12 weeks of treatment
    1
  • 24 hour ambulatory systolic blood pressure at week 8
    1

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

What will the one ongoing trial of Aliskiren report, and when?


1 registered trial of Aliskiren is open; earliest completion 2029-12. ClinicalTrials.gov · 2026-09-01

C3 levels in serum

Show the evidence
  • Trial NCT04183101
    "Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy"; n 30; "C3 levels in serum"; 2029-12

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

Which 38 trials of Aliskiren posted no result?


Posted no result
38 of 38 completed trials
Registrations
NCT00311012, NCT00219024, NCT00219128, NCT00219089, NCT00219037 and NCT00219050, and 32 more
Completion dates
oldest 2005-03; newest 2020-12-31
Show the evidence

Trial

  • NCT00311012
    2005-03
  • NCT00219024
    2005-06
  • NCT00219128
    2005-06
  • NCT00219089
    2005-08
  • NCT00219037
    2005-10
  • NCT00219050
    2005-11
14 further recorded trials
  • NCT00219154
    2006-01
  • NCT00171405
    2006-02
  • NCT00219167
    2006-02
  • NCT00219063
    2006-03
  • NCT00219115
    2006-03
  • NCT00294710
    2006-07
  • NCT00262236
    2006-08
  • NCT00219180
    2006-09
  • NCT00260923
    2006-11
  • NCT00299806
    2006-11
  • NCT00461136
    2006-11
  • NCT00219193
    2007-01
  • NCT00219011
    2007-02
  • NCT00097955
    2007-04

At the median, Aliskiren's trials enrolled 113 people — anything larger?


Median enrolment
113
Largest enrolment
22213
Registered trials counted
134

What do 1401 spontaneous reports say about Aliskiren — 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.

Aliskiren appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1401 reaction mentions were counted: blood creatinine increased 216; dyspnoea 172; blood pressure increased 139; cerebrovascular accident 135. open-targets-adr · CHEMBL1639 · 2026-06-24

Show the evidence
  • blood creatinine increased
    216
  • dyspnoea
    172
  • blood pressure increased
    139
  • cerebrovascular accident
    135
  • hyperkalaemia
    134
  • renal impairment
    132
4 more recorded rows
  • renal failure
    125
  • cardiac failure
    121
  • renal failure acute
    119
  • hypertension
    108

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

Aliskiren and CYP3A4, PGP and CYP1A2: shared by which compounds?


CYP3A4, PGP and CYP1A2 appear in Aliskiren's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP1A2 pharmacokinetics
    Aliskiren does not inhibit the CYP450 isoenzymes (CYP 1A2, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A) or induce CYP3A4.

CYP3A4

  • pharmacokinetics
    Based on the in vitro studies, the major enzyme responsible for aliskiren metabolism appears to be CYP3A4.
  • pharmacokinetics
    Aliskiren does not inhibit the CYP450 isoenzymes (CYP 1A2, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A) or induce CYP3A4.

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

Was Aliskiren studied with exercise?


exercise is named in Aliskiren's label sentences: "The data from this preliminary trial strongly suggest that clinicians should exercise caution when prescribing aliskiren in combination with losartan until appropriate pediatric trials establish dosing, efficacy, and safety." openfda-label+europepmc · 2026-08-30

1 recorded statement; exercise

Show the evidence
  • exercise
    The data from this preliminary trial strongly suggest that clinicians should exercise caution when prescribing aliskiren in combination with losartan until appropriate pediatric trials establish dosing, efficacy, and safety.

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

What is recorded about Aliskiren and autophagy?


"The beneficial effects of aliskiren were associated with decreased apoptosis and mitochondrial membrane potential as well as increased autophagy via increased autophagosome formation." — where Aliskiren and autophagy appear together. Europe PMC · pathway abstract search · 2017-11-14

autophagy, AMPK, NAD+, mTOR; PMID 29184499, 26988296, 24768585

Show the evidence
  • autophagy PMID 29184499
    "The beneficial effects of aliskiren were associated with decreased apoptosis and mitochondrial membrane potential as well as increased autophagy via increased autophagosome formation."
  • AMPK PMID 29184499
    "We also found that aliskiren-induced cardiomyocyte survival occurred via AMP-activated protein kinase (AMPK)-dependent autophagy."
  • autophagy PMID 29184499
    "We also found that aliskiren-induced cardiomyocyte survival occurred via AMP-activated protein kinase (AMPK)-dependent autophagy."
  • AMPK PMID 29184499
    "Taken together, these results indicated that aliskiren increased cardiomyocyte survival through increased autophagosomal formation and decreased apoptosis and necrosis via modulating AMPK expression."
  • autophagy PMID 29184499
    "Taken together, these results indicated that aliskiren increased cardiomyocyte survival through increased autophagosomal formation and decreased apoptosis and necrosis via modulating AMPK expression."
  • AMPK PMID 29184499
    "AMPK-dependent autophagy may represent a novel mechanism for aliskiren in ischemic cardiac disease therapy."
2 more recorded rows
  • NAD+ PMID 26988296
    "In conclusion, aliskiren ameliorated insulin resistance in HF by improving insulin signaling in the skeletal muscle, at least partly by inhibiting systemic and (pro)renin receptor-mediated local RAS activation, and subsequent NAD(P)H oxidase-induced oxidative stress."
  • mTOR PMID 24768585
    "Aliskiren, a renin inhibitor attenuated phosphorylation of both mTOR and p70S6K in renal tissues of HIVAN mice."

recorded 2017-11-14 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1639
PubChem CID
5493444
CAS number
173334-57-1
RxCUI
325646
InChIKey
UXOWGYHJODZGMF-QORCZRPOSA-N
Also called
Aliskirene, Aliskireno, ALISKIREN FUMARATE, Aliskiren hemifumarate, ALISKIREN [EMA EPAR], ALISKIREN [HSDB], ALISKIREN [MI], ALISKIREN [USAN], ALISKIREN [VANDF], Aliskiren [WHO-DD], aliskiren [INN]
Trade name
Rasilez, Aliskiren hemifumarate component of amturnide, Aliskiren hemifumarate component of tekamlo, Aliskiren hemifumarate component of valturna, Enviage, Riprazo, Sprimeo, Tekturna, Rasilez HCT, Rasitrio, Riprazo HCT
Development code
SPP-100, SPP100, NSC-759185, SPP-100B
Salt form
Aliskiren fumarate component of amturnide aliskiren hemifumarate, Aliskiren fumarate component of raprazo-hct aliskiren hemifumarate, Aliskiren fumarate component of rasilamlo aliskiren hemifumarate, Aliskiren fumarate component of rasilez-hct aliskiren hemifumarate, Aliskiren fumarate component of rasitrio aliskiren hemifumarate, Aliskiren fumarate component of sprimeo-hct aliskiren hemifumarate, Aliskiren fumarate component of tekamlo aliskiren hemifumarate, Aliskiren fumarate component of tekturna hct aliskiren hemifumarate, Aliskiren fumarate component of valturna aliskiren hemifumarate
Sources (10)

Sources

4 more sources
  • open-targets-adr CHEMBL1639 ·
  • openfda-label 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2 ·
  • openfda-label+europepmc K1:502FWN4Q32 ·
  • 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: 10 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.