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Sacubitril / Valsartan

  • 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 Sacubitril / Valsartan does in the body

Half of this tablet blocks that enzyme, so the helpful hormones last longer.

When the heart is failing it makes hormones that tell the body to shed salt and relax the arteries — its own attempt at treatment. An enzyme called neprilysin chews those hormones up almost as fast as they appear. But neprilysin also breaks down angiotensin II, the hormone that tightens arteries and retains salt, so blocking the enzyme alone would make things worse. The other half of the tablet blocks the receptor angiotensin II uses, which cancels that problem. Neither half works properly without the other.

Why people take it. A weakened heart, to reduce dying of it and being admitted for it

What happened in people

Cardiovascular death or heart failure hospitalisation 21.8% against 26.5% on enalapril in 8,442 patients (HR 0.80, p<0.001)

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That the benefit extends across the ejection fraction range, which rests on a trial that missed its primary endpoint and on subgroup heterogeneity within it

Where it acts
Circulating and endothelial neprilysin, which degrades natriuretic peptides, and the angiotensin II type 1 receptor on vascular, renal and adrenal cells
Kind of result
Living longer, or avoiding a major event
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 688RNR55GH · read 2026-08-29

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 134 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.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

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
PainNothing 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.Waiting for a reviewer1 registered symptom measure.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.
EnduranceNothing in the sources checkedNo registered study lists a life outcome for this goal.Waiting for a reviewer1 registered performance measure of this kind.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.
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 moved1 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.
Which registered measures put each goal on this table
Pain
treadmill walk until pain initiated in minutes
Endurance
6 minute walk distance at week 24
Blood sugar
blood glucose

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.
Waiting for a reviewer
1 registered symptom measure.
Not recorded
Harms were not a registered measure for this goal.
Only a number moved
1 registered test measure.

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.

Composite of cardiovascular death or hospitalisation for heart failure, against enalapril

The study showed what it set out to show

Who was studied
PARADIGM-HF (NCT01035255)
How many people
8442
Study design
Phase 3, randomised, double-blind, active-controlled, event-driven
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
21.8% against 26.5%; hazard ratio 0.80 (95% CI 0.73 to 0.87), p<0.001; all-cause mortality 17.0% against 19.8%, HR 0.84 (0.76 to 0.93), p=0.0009
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Stopped early on the prespecified overwhelming-benefit boundary, which tends to overestimate effect size. Randomisation followed sequential single-blind run-ins on both drugs, so patients intolerant of either never entered. Enalapril was fixed at 10 mg twice daily and patients with systolic pressure below 100 mmHg were excluded.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral film-coated tablet at 24/26, 49/51 and 97/103 mg, taken twice daily; an oral pellet sprinkle formulation exists for children from one year

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Total hospitalisations for heart failure and death from cardiovascular causes, against valsartan, at ejection fraction 45% or above

The study did not show it

Who was studied
PARAGON-HF (NCT01920711)
How many people
4822
Study design
Phase 3, randomised, double-blind, active-controlled
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Rate ratio 0.87 (95% CI 0.75 to 1.01), p=0.06
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. Among 12 prespecified subgroups there was suggestion of heterogeneity, with possible benefit at lower ejection fraction and in women. The United States indication was subsequently broadened on the strength of a trial that did not meet its primary endpoint.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral film-coated tablet at 24/26, 49/51 and 97/103 mg, taken twice daily; an oral pellet sprinkle formulation exists for children from one year

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Death from cardiovascular causes or incident heart failure after myocardial infarction, against ramipril

The study did not show it

Who was studied
PARADISE-MI (NCT02924727)
How many people
5661
Study design
Phase 3, randomised, double-blind, active-controlled
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
11.9% against 13.2%; hazard ratio 0.90 (95% CI 0.78 to 1.04), p=0.17 over a median 22 months
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. Every secondary point estimate favoured the drug and none reached significance. A uniformly directional miss is a different signal from a flat one, and it is still a miss.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral film-coated tablet at 24/26, 49/51 and 97/103 mg, taken twice daily; an oral pellet sprinkle formulation exists for children from one year

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 3 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 No evidence recorded. Death, a heart attack, a stroke, a hospital stay.0 registered measures of this kind. 2 written-up studies measured this and did not show a benefit.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.6 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 changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Sacubitril / Valsartan

    What a person takes: Oral film-coated tablet at 24/26, 49/51 and 97/103 mg, taken twice daily; an oral pellet sprinkle formulation exists for children from one year.

    The measurement behind this step

    The strengths are quoted as combined totals of both components because the substance is a co-crystal rather than a blend, and the trials referred to the same strengths as 50, 100 and 200 mg, which is a persistent source of confusion between the literature and the label. The paediatric sprinkle exists so the drug can be given from one year of age, which is why that indication could be written at all.

  2. Getting in

    The failing heart makes its own treatment

    A stretched heart releases hormones that tell the kidney to shed salt and the arteries to relax. They are helpful, and they are destroyed within minutes.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Atrial and B-type natriuretic peptides are released in response to myocyte stretch and act through particulate guanylate cyclase to raise cyclic GMP, producing natriuresis, vasodilatation and inhibition of fibrosis. Neprilysin, a zinc metallopeptidase, degrades them along with bradykinin, substance P, adrenomedullin and angiotensin II.

  3. Reaching the cell

    One half is a prodrug that has to be unmasked

    Sacubitril as swallowed does nothing. The liver removes a chemical cap, and only the unmasked form blocks the destroying enzyme.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Sacubitril is an ethyl ester prodrug hydrolysed by carboxylesterases to LBQ657, the active neprilysin inhibitor. The label attributes the cardiovascular and renal effects to increased levels of neprilysin substrates such as the natriuretic peptides, produced by LBQ657.

  4. What it acts on

    The destroying enzyme is blocked

    With the enzyme inhibited, the helpful hormones survive longer and act for longer. More salt is passed, arteries stay wider, and scarring signals are damped.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Neprilysin inhibition raises circulating and tissue natriuretic peptide concentration, increasing cyclic GMP signalling. This is the reason plasma BNP rises on treatment while NT-proBNP falls — BNP is a neprilysin substrate and NT-proBNP is not, which makes BNP unusable as a monitoring marker on this drug.

  5. The change it makes

    The second half cancels the drug own side effect

    The same enzyme also destroys the hormone that tightens arteries. Blocking it alone would let that hormone build up too, which is why a second drug blocks its receptor.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Neprilysin degrades angiotensin II as well as the natriuretic peptides, so inhibition alone raises angiotensin II. Valsartan blocks the AT1 receptor selectively and inhibits angiotensin II-dependent aldosterone release, which is why single-agent neprilysin inhibitors failed and why the earlier combination with an ACE inhibitor, omapatrilat, was abandoned over angioedema.

  6. What that does for a person

    Fewer deaths and fewer admissions, against the standard drug

    Compared head to head against enalapril in eight and a half thousand patients, deaths from any cause fell from about one in five to about one in six.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    PARADIGM-HF: primary composite 21.8% against 26.5% (HR 0.80, 95% CI 0.73 to 0.87, p<0.001); all-cause mortality 17.0% against 19.8% (HR 0.84, 0.76 to 0.93, p=0.0009), driven entirely by lower cardiovascular mortality (13.3% against 16.5%, HR 0.80). The trial was stopped early on the overwhelming-benefit boundary.

  7. What that does for a person

    Where the same mechanism did not deliver

    In heart failure with a normal-looking pumping fraction, and immediately after a heart attack, the same drug was tested and neither trial reached significance.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    PARAGON-HF: rate ratio 0.87 (95% CI 0.75 to 1.01, p=0.06) in 4,822 patients at ejection fraction 45% or above. PARADISE-MI: hazard ratio 0.90 (0.78 to 1.04, p=0.17) in 5,661 patients after infarction. The indication was nevertheless widened to chronic heart failure generally, with the label directing clinical judgement about ejection fraction.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

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.

  • treadmill walk until pain initiated in minutes

Measured

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

  • plasma n terminal proatrial natriuretic peptide
  • plasma n terminal pro b type natriuretic peptide
  • plasma n terminal brain natriuretic peptide
  • plasma cyclic guanine monophosphate
  • plasma cgmp response
  • blood glucose

Meaningful

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

  • 6 minute walk distance at week 24

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 (32)
  • central aortic systolic pressure at 12 weeks
  • ascending aorta distensibility at 52 week
  • proximal descending aorta distensibility at 52 weeks
  • distal descending aorta distensibility at 52 weeks
  • lv remodeling 2d end diastolic diameter
  • lv remodeling 2d end systolic diameter
  • lv remodeling global longitudinal strain
  • lv remodeling left atrial volume
  • lv remodeling 3d end diastolic volume
  • lv remodeling 3d end systolic volume
  • lv remodeling lv ejection fraction
  • lv remodeling conicity
  • lv remodeling sphericity
  • rv remodeling end diastolic volume
  • nt probnp
  • n terminal pro brain natriuretic peptide at week 12
  • flow mediated vasodilation
  • time spent map 85
  • msna burst frequency
  • intact glucagon like peptide 1 levels after the mixed meal

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

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults with chronic heart failure, in practice mainly those with reduced ejection fraction, and children from one year old with systolic dysfunction. Not people who have had angioedema on an ACE inhibitor or angiotensin receptor blocker, and never within a day and a half of an ACE inhibitor.

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.

Where the result stopped carrying

  • PARAGON-HF missed its primary endpoint at p=0.06 in preserved-ejection-fraction heart failure
  • PARADISE-MI missed its primary endpoint at p=0.17 after myocardial infarction, with every point estimate directionally favourable
  • The predecessor combination, omapatrilat, which paired neprilysin inhibition with ACE inhibition, was abandoned over angioedema — the reason this drug uses a receptor blocker instead
  • Angioedema remains the defining safety issue, is more common in Black patients, and PARADIGM-HF enrolled only 5% Black patients
  • 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.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 2 related forms. Evidence does not carry across all of them.

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 (9)
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

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

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral film-coated tablet at 24/26, 49/51 and 97/103 mg, taken twice daily; an oral pellet sprinkle formulation exists for children from one year

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

The strengths are quoted as combined totals of both components because the substance is a co-crystal rather than a blend, and the trials referred to the same strengths as 50, 100 and 200 mg, which is a persistent source of confusion between the literature and the label.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold. The rest of the recorded wording: The paediatric sprinkle exists so the drug can be given from one year of age, which is why that indication could be written at all.

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 takeRead from sources, not yet reviewed

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.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Boxed warning for fetal toxicity: discontinue when pregnancy is detected. Contraindicated in hypersensitivity, in a history of angioedema on any ACE inhibitor or angiotensin receptor blocker, with concomitant ACE inhibitor use and within 36 hours of switching, and with aliskiren in diabetes. Angioedema with laryngeal oedema may be fatal, the drug must never be re-administered after an episode, and the rate is higher in Black than in non-Black patients. Hypotension is more common than on enalapril; renal impairment, hyperkalaemia and cough are less common. Plasma BNP rises on treatment because BNP is a neprilysin substrate, so NT-proBNP rather than BNP is the usable marker.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral film-coated tablet at 24/26, 49/51 and 97/103 mg, taken twice daily; an oral pellet sprinkle formulation exists for children from one year

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

The paediatric sprinkle exists so the drug can be given from one year of age, which is why that indication could be written at all.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 17 products list this as an active ingredient in the United States drug directory. 17 of them contain it and nothing else.

    FDA National Drug Code directory · 55111-996 · read 2026-08-29

  • They are sold as powder.

    FDA National Drug Code directory · 55111-996 · read 2026-08-29

  • ENTRESTO is oral at 3 DOSAGE FORMS AND STRENGTHS ENTRESTO is supplied as unscored, ovaloid, film-coated tablets in the following strengths: ENTRESTO 24/26 mg, (sacubitril 24 mg and valsartan 26 mg) are violet white and debossed with “NVR”…, recorded as fda label in effect 2024-03-28 in the United States.

    US prescribing information · 14bf8041-0b7f-9acb-e063-6294a90a8256 · read 2026-08-30

  • Recorded price in US: 0.4979–0.59319 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 93 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.

Names and forms linked to this record

  • Contains

    Sacubitril

    Evidence on this page does not automatically apply to this one.

  • Contains

    Valsartan

    Evidence on this page does not automatically apply to this one.

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.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Sacubitril / Valsartan 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

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That the benefit extends across the ejection fraction range, which rests on a trial that missed its primary endpoint and on subgroup heterogeneity within it

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the PARADIGM-HF hazard ratios apply to patients not pre-selected by a double run-in on both drugs

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That an NT-proBNP reduction in children means fewer deaths and admissions — the label says expected, not shown

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the enalapril comparator represented maximal ACE inhibition, when it was fixed at 10 mg twice daily throughout

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

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 Sacubitril / Valsartan 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.

Every line above can be traced to the study named beside it. Follow the link and read it.

PARADIGM-HF: fewer deaths than on enalapril, and the trial was stopped early
In plain words
Eight and a half thousand patients with a weakened heart were randomised to this drug or to enalapril, the standard treatment. The combined measure fell from 26.5% to 21.8%, and deaths from any cause from 19.8% to 17.0%. The trial was halted before its planned end because the benefit was so clear.
What was measured
Composite of cardiovascular death or heart failure hospitalisation, and all-cause mortality, against enalapril
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
PARADIGM-HF randomised 8,442 patients with NYHA class II to IV heart failure and ejection fraction at or below 40% to sacubitril-valsartan 200 mg twice daily (n=4,209) or enalapril 10 mg twice daily (n=4,233), on top of recommended therapy including a beta-blocker in 94% and a mineralocorticoid antagonist in 58%. It was stopped early after a median 27 months on the prespecified overwhelming-benefit boundary. The primary composite of cardiovascular death or heart failure hospitalisation occurred in 914 (21.8%) against 1,117 (26.5%), hazard ratio 0.80 (95% CI 0.73 to 0.87, p<0.001). All-cause mortality was 711 (17.0%) against 835 (19.8%), hazard ratio 0.84 (95% CI 0.76 to 0.93, p=0.0009), a finding the label states was driven entirely by lower cardiovascular mortality: 558 (13.3%) against 693 (16.5%), hazard ratio 0.80 (0.71 to 0.89). Heart failure hospitalisation fell 21%. Sudden death accounted for 45% of cardiovascular deaths. The drug arm had more hypotension and non-serious angioedema and less renal impairment, hyperkalaemia and cough.
Source
McMurray JJ et al., N Engl J Med 2014;371:993-1004 (PARADIGM-HF, NCT01035255); ENTRESTO United States prescribing information section 14.1
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Only patients who tolerated both drugs in a run-in were randomised
In plain words
Before randomisation, everyone was given enalapril for a period and then the new drug at increasing strength. Only those who got through both without a problem entered the trial. The result therefore describes people already known to tolerate both drugs.
What was measured
That the PARADIGM-HF hazard ratios apply unchanged to patients who have not first been shown to tolerate target doses of both drugs — the run-in design means the trial did not test that population
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label describes the design: after discontinuing existing ACE inhibitor or angiotensin receptor blocker therapy, patients entered sequential single-blind run-in periods on enalapril 10 mg twice daily followed by sacubitril-valsartan 100 mg twice daily increasing to 200 mg twice daily, and only patients who successfully completed both run-in periods were randomised. Patients with systolic pressure below 100 mmHg at screening were excluded outright. A sequential double run-in is a legitimate way to reduce dropout noise in a mortality trial and it selects the randomised population: people who could not tolerate the target dose of either drug never appear in the denominator. That makes the measured hazard ratio a valid estimate for people like those randomised and an optimistic one for an unselected clinic population, particularly on the tolerability endpoints.
Source
ENTRESTO United States prescribing information, section 14.1 (NDA 207620); McMurray JJ et al., N Engl J Med 2014;371:993-1004
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
PARAGON-HF missed, at p=0.06, in 4,822 patients
In plain words
In heart failure with a normal-looking pumping fraction, the drug was compared against valsartan alone. The result came within a hair of significance and did not reach it.
What was measured
Total heart failure hospitalisations and cardiovascular death, against valsartan alone, at ejection fraction 45% or above
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
PARAGON-HF randomised 4,822 patients with NYHA class II to IV heart failure, ejection fraction at or above 45%, elevated natriuretic peptides and structural heart disease, to sacubitril-valsartan at a target of 97/103 mg twice daily or valsartan at a target of 160 mg twice daily. The primary outcome, total heart failure hospitalisations and cardiovascular death, gave 894 primary events in 526 patients against 1,009 in 557: rate ratio 0.87 (95% CI 0.75 to 1.01, p=0.06). Cardiovascular death was 8.5% against 8.9% (HR 0.95, 0.79 to 1.16) and total heart failure hospitalisations 690 against 797 (rate ratio 0.85, 0.72 to 1.00). NYHA class improved in 15.0% against 12.6% (OR 1.45, 1.13 to 1.86); renal function worsened in 1.4% against 2.7% (HR 0.50, 0.33 to 0.77); the mean KCCQ clinical summary score at eight months was 1.0 point higher (95% CI 0.0 to 2.1). Hypotension and angioedema were more common and hyperkalaemia less common. Among 12 prespecified subgroups there was suggestion of heterogeneity, with possible benefit at lower ejection fraction and in women. The published conclusion is that the drug did not result in a significantly lower rate of the primary outcome.
Source
Solomon SD et al., N Engl J Med 2019;381:1609-1620 (PARAGON-HF, NCT01920711)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The indication was broadened on the trial that missed
In plain words
After a trial that did not reach statistical significance, the licence was widened from reduced pumping fraction to chronic heart failure generally, with a sentence saying the benefit is clearest when the pumping fraction is below normal and that doctors should use judgement.
What was measured
That the benefit demonstrated at reduced ejection fraction extends across the ejection fraction range — inferred from a trial that missed its primary endpoint and from subgroup heterogeneity within it
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The current United States indication reads: indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in adult patients with chronic heart failure, with benefits most clearly evident in patients with left ventricular ejection fraction below normal, adding that ejection fraction is a variable measure so clinical judgement should be used in deciding whom to treat. That wording replaced the original restriction to reduced ejection fraction, and the evidence that supported the widening is PARAGON-HF, whose primary endpoint gave a rate ratio of 0.87 with a confidence interval touching 1.01 at p=0.06, together with the subgroup suggestion of benefit at lower ejection fraction. Whether this is a regulator reading a body of evidence sensibly or a regulator approving on a negative trial is a genuine argument, and the label unusual instruction to use clinical judgement about a numeric threshold is the sentence in which that argument is visible.
Source
ENTRESTO United States prescribing information, section 1.1 (NDA 207620); Solomon SD et al., N Engl J Med 2019;381:1609-1620
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
PARADISE-MI: no benefit after myocardial infarction, in 5,661 patients
In plain words
Given straight after a heart attack that had weakened the heart, the drug was compared against ramipril. Deaths from heart causes and new heart failure were no less common.
What was measured
Cardiovascular death or incident heart failure after myocardial infarction, against ramipril
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
PARADISE-MI randomised 5,661 patients with myocardial infarction complicated by reduced left ventricular ejection fraction, pulmonary congestion or both, to sacubitril-valsartan 97/103 mg twice daily (n=2,830) or ramipril 5 mg twice daily (n=2,831) in addition to recommended therapy. Over a median 22 months the primary outcome of cardiovascular death or incident heart failure occurred in 338 (11.9%) against 373 (13.2%), hazard ratio 0.90 (95% CI 0.78 to 1.04, p=0.17). Cardiovascular death or heart failure hospitalisation was 10.9% against 11.8% (HR 0.91, 0.78 to 1.07), cardiovascular death 5.9% against 6.7% (HR 0.87, 0.71 to 1.08) and death from any cause 7.5% against 8.5% (HR 0.88, 0.73 to 1.05). Discontinuation for an adverse event was 12.6% against 13.4%. Every point estimate favours the drug and none reaches significance, which is a different failure from a flat one and is not the same as a positive result.
Source
Pfeffer MA et al., N Engl J Med 2021;385:1845-1855 (PARADISE-MI, NCT02924727)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The paediatric indication rests on a blood test and says so
In plain words
For children, the licence was granted on the basis that the drug lowers a heart failure blood marker. The label states in plain words that improved outcomes are expected, not shown.
What was measured
That an NT-proBNP reduction in children translates into fewer deaths and admissions — the label states it is expected, which is the correct word and not a measurement
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 1.2 reads: ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. The word expected is doing the work of an outcome trial. NT-proBNP is a validated prognostic marker and it is not a demonstrated treatment target; a drug can lower it without changing what happens to the child. Extrapolating adult efficacy to children is standard regulatory practice where the disease mechanism is shared, and it is an inference. This label is unusually honest in marking it as one.
Source
ENTRESTO United States prescribing information, section 1.2 (NDA 207620 and NDA 218591)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Angioedema, a boxed warning and a 36-hour rule
In plain words
This drug cannot be combined with an ACE inhibitor, and a day and a half must pass when switching. The reason is swelling of the airway, which can be fatal, and it is more common in Black patients — a group who made up one in twenty of the main trial.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Contraindications are hypersensitivity, a history of angioedema related to previous ACE inhibitor or angiotensin receptor blocker therapy, concomitant ACE inhibitor use with a 36-hour separation required when switching in either direction, and aliskiren in diabetes. The label states that angioedema with laryngeal oedema may be fatal, that the drug must not be re-administered after an episode, and that it has been associated with a higher rate of angioedema in Black than in non-Black patients. PARADIGM-HF enrolled 66% Caucasian, 18% Asian and 5% Black patients, so the population at highest risk of the drug most dangerous adverse effect is the one the pivotal trial characterised least well. A boxed warning for fetal toxicity applies, as with every renin-angiotensin drug.
Source
ENTRESTO United States prescribing information, boxed warning, sections 4, 5.1, 5.2 and 14.1 (NDA 207620)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim

Where else this substance is registered

FDA substance identifier (UNII)
688RNR55GH
CAS registry number
1360873-85-3
PubChem compound
24755620

Checks this page had to pass

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    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

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    enforced by the copy-contract test over the rendered page

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    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • The earliest marketing start date recorded for a listed product is 20150707.

    FDA National Drug Code directory · 55111-996 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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

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What is not here

4 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

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The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A neprilysin inhibitor paired with an angiotensin receptor blocker that cut cardiovascular death or heart failure admission from 26.5% to 21.8% and all-cause death from 19.8% to 17.0% against enalapril in 8,442 patients, in a trial stopped early — and whose indication was later widened to chronic heart failure generally on the basis of PARAGON-HF, which missed its primary endpoint at p=0.06.

Recorded evidence blocks (9)

What did Sacubitril / Valsartan's largest trial (1614719 people) and its longest (8.1 years) measure?


1614719 people in Sacubitril / Valsartan's largest registered study, 8.1 years in its longest registered window, measuring Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels. ClinicalTrials.gov · 2026-09-01

45 phase4, 22 phase2, 20 na or unstated, 19 phase3, 12 na, 7 phase1, 2 early phase1; NCT03508739; 2026-06-30. Last human test completed 2026, NCT07417215.

Interpretation These counts include studies where Sacubitril / Valsartan 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
  • phase4
    45
  • phase2
    22
  • na or unstated
    20
  • phase3
    19
  • na
    12
  • phase1
    7
2 more recorded rows
  • early phase1
    2
  • Last recorded human test NCT07417215
    2026-05-10

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

Sacubitril / Valsartan was tested only in human — what did it show?


human: lifespan (121): the rungs where Sacubitril / Valsartan has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human lifespan
Show the evidence
  • human NCT02957409
    lifespan; Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels; 121

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

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


safety (1), futility/efficacy (1), accrual/recruitment (4), funding/business (5), sponsor decision unspecified (1) and other (5): Sacubitril / Valsartan's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Recruitment"; 17 of 121 registered studies

Show the evidence

Trial

  • NCT02636283
    terminated; "Recruitment"
  • NCT02787798
    terminated; "Today Entresto treatment has marketing authorization and is available for all patients, that is the reason why study was halted prematurely."
  • NCT02788656
    terminated; "Inadequate Recruitment"
  • NCT03119623
    withdrawn; "Lost funding prior to study commencing"
  • NCT03279861
    withdrawn; "protocol change"
  • NCT03415906
    withdrawn; "Difficulties in recruiting patients"
11 further recorded trials
  • NCT03508739
    suspended; "We do not have active funding at this time."
  • NCT03738878
    terminated; "An alternative study was developed to replace this study."
  • NCT03909295
    terminated; "This study was terminated early because the primary endpoint of PARAGON-HF was not met."
  • NCT04128891
    withdrawn; "Funding not approved"
  • NCT04206865
    withdrawn; "New study initiated"
  • NCT04491136
    terminated; "Company decision"
  • NCT04637555
    withdrawn; "CLCZ696G2301E1 extension study did not start as the core study (CLCZ696G2301) did not meet the primary endpoint."
  • NCT05117736
    terminated; "The trial was prematurely terminated due to safety concerns."
  • NCT05870709
    withdrawn; "Terminated due to business decision"
  • NCT06142383
    terminated; "Sponsor Decision"
  • NCT06536309
    withdrawn; "Due to changes in HFpEF treatment landscape, no recruitment activities were initiated and no participants were enrolled."

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

Human studies of Sacubitril / Valsartan used Entresto 100 mg — over how long?


Human studies of Sacubitril / Valsartan used "Entresto 100 mg". ClinicalTrials.gov · 2026-09-01

18 recorded entries; human; tablet; also "Entresto 200 mg", "Entresto™ 49Mg-51 mg tablet", "Sacubitril/Valsartan 200mg (blinded)"

Show the evidence

human

  • NCT02787798
    Entresto 100 mg
  • NCT02787798
    Entresto 200 mg
  • NCT03506412
    tablet; Entresto™ 49Mg-51 mg tablet
  • NCT03508739
    Sacubitril/Valsartan 200mg (blinded)
  • NCT03938389
    Sacubitril-Valsartan Tab 97-103 MG
  • NCT04153136
    Sacubitril-Valsartan 49-51Mg Oral Tablet
12 more recorded rows
  • human NCT04971720
    Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet
  • human NCT05580510
    Sacubitril 49 MG / Valsartan 51 MG [Entresto] BID
  • human NCT05881720
    sacubitril / valsartan (100 mg twice daily)
  • human NCT06193187
    Entresto 50 mg
  • human NCT06266988
    Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)
  • human NCT06273254
    Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg)
  • human NCT06716970
    Sacubitril/valsartan 200mg
  • human NCT06716970
    Sacubitril/valsartan 200mg placebo
  • human NCT07379788
    Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO]
  • human NCT07379788
    Empagliflozin10Mg plus Sacubitril/Valsartan 49 MG-51 MG Oral Tablet
  • human NCT07700875
    Sacubitril / valsartan 200 mg
  • human NCT07700875
    Sacubitril / valsartan 200 mg placebo

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

Could one person measure Sacubitril / Valsartan's effect on central aortic systolic pressure at 12 weeks?


Central aortic systolic pressure at 12 weeks: measured in Sacubitril / Valsartan's trials.

central aortic systolic pressure at 12 weeks is the recorded endpoint.

Show the evidence

biomarkers

  • central aortic systolic pressure at 12 weeks; 2026-09-01
  • ascending aorta distensibility at 52 week; 2026-09-01
  • proximal descending aorta distensibility at 52 weeks; 2026-09-01
  • distal descending aorta distensibility at 52 weeks; 2026-09-01
  • treadmill walk until pain initiated in minutes; 2026-09-01
  • lv remodeling 2d end diastolic diameter; 2026-09-01
14 more recorded rows
  • biomarkers
    lv remodeling 2d end systolic diameter; 2026-09-01
  • biomarkers
    lv remodeling global longitudinal strain; 2026-09-01
  • biomarkers
    lv remodeling left atrial volume; 2026-09-01
  • biomarkers
    lv remodeling 3d end diastolic volume; 2026-09-01
  • biomarkers
    lv remodeling 3d end systolic volume; 2026-09-01
  • biomarkers
    lv remodeling lv ejection fraction; 2026-09-01
  • biomarkers
    lv remodeling conicity; 2026-09-01
  • biomarkers
    lv remodeling sphericity; 2026-09-01
  • biomarkers
    rv remodeling end diastolic volume; 2026-09-01
  • biomarkers
    nt probnp; 2026-09-01
  • biomarkers
    n terminal pro brain natriuretic peptide at week 12; 2026-09-01
  • biomarkers
    6 minute walk distance at week 24; 2026-09-01
  • biomarkers
    flow mediated vasodilation; 2026-09-01
  • biomarkers
    time spent map 85; 2026-09-01
  • human trials at or under30
    22
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    0; NCT03119623; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of 6 minute walk distance at week 24, adverse events and adverse events and serious adverse events did Sacubitril / Valsartan's trials measure?


6 minute walk distance at week 24, adverse events and adverse events and serious adverse events lead 40 outcome terms across Sacubitril / Valsartan's trials. ClinicalTrials.gov · 2026-09-01

distal descending aorta distensibility at 52 weeks, treadmill walk until pain initiated in minutes, lv remodeling 2d end diastolic diameter, lv remodeling 2d end systolic diameter, lv remodeling global longitudinal strain and lv remodeling left atrial volume follow.

Show the evidence
  • central aortic systolic pressure at 12 weeks
    1
  • ascending aorta distensibility at 52 week
    1
  • proximal descending aorta distensibility at 52 weeks
    1
  • distal descending aorta distensibility at 52 weeks
    1
  • treadmill walk until pain initiated in minutes
    1
  • lv remodeling 2d end diastolic diameter
    1
14 more recorded rows
  • lv remodeling 2d end systolic diameter
    1
  • lv remodeling global longitudinal strain
    1
  • lv remodeling left atrial volume
    1
  • lv remodeling 3d end diastolic volume
    1
  • lv remodeling 3d end systolic volume
    1
  • lv remodeling lv ejection fraction
    1
  • lv remodeling conicity
    1
  • lv remodeling sphericity
    1
  • rv remodeling end diastolic volume
    1
  • nt probnp
    1
  • n terminal pro brain natriuretic peptide at week 12
    1
  • 6 minute walk distance at week 24
    1
  • flow mediated vasodilation
    1
  • time spent map 85
    1

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

Which of Sacubitril / Valsartan's 17 ongoing trials reports first?


17 registered trials of Sacubitril / Valsartan are open; earliest completion 2022-12. ClinicalTrials.gov · 2026-09-01

Change from Baseline to 26 weeks in β-cell function (first-phase insulin secretion); Incidence of drug discontinuation from drug-related adverse events due to sacubitril-valsartan versus standard-of-care oral vasodilator therapy at 3 months; latest 2029-02

Show the evidence

Trial

  • NCT03938389
    "The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans"; n 90; "Change from Baseline to 26 weeks in β-cell function (first-phase insulin secretion)"; 2026-06
  • NCT04191681
    "Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study"; n 50; "Incidence of drug discontinuation from drug-related adverse events due to sacubitril-valsartan versus standard-of-care oral vasodilator therapy at 3 months"; 2022-12
  • NCT04971720
    "PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis"; n 160; "Change in mean nocturnal systolic blood pressure"; 2027-01-01
  • NCT05194111
    "Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan"; n 70; "Determine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure."; 2028-11-30
  • NCT05279742
    "Enhancing the Natriuretic Peptide System in HFpEF"; n 60; "Change in Plasma ANP"; 2027-04
  • NCT05465031
    "Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)"; n 600; "Change in left ventricular ejection fraction (LVEF) by ≥5%"; 2029-02
11 further recorded trials
  • NCT05508035
    "The Effect of Sacubitril/Valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients With Ischemic Heart Failure With Mid-range Ejection Fraction"; n 488; "Change in left ventricular end-systolic volume"; 2028-12
  • NCT06218199
    "Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts"; n 80; "Number of participants with recovery from HeartLogic Alert"; 2026-12-31
  • NCT06643819
    "Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A"; n 324; "change from baseline in MASBP(Mean Ambulatory Systolic Blood Pressure)"; 2026-12-31
  • NCT06704633
    "Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania"; n 298; "Proportion of participants with an improved health status based on a large (≥10 points) or very large (≥20 points) improvement of the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score (minimum 0, maximum 100)"; 2028-11-30
  • NCT06712030
    "Effect of Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction"; n 114; "Change in left ventricular systolic function (%) assessed by echocardiogram."; 2027-06
  • NCT06716970
    "QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension"; n 810; "Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)"; 2027-02-28
  • NCT06917664
    "Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease"; n 220; "effective regurgitant orifice area (EROA)"; 2027-06
  • NCT07192341
    "Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction"; n 220; "Effective rate"; 2026-02-01
  • NCT07444398
    "Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial"; n 130; "Requirement of hospitalization for heart failure"; 2026-03-31
  • NCT07491718
    "Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy"; n 100; "Left ventricular myocardial manganese uptake."; 2028-08-09
  • NCT07572032
    "Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study"; n 80; "Change in left ventricular ejection fraction (LVEF) at 12 months"; 2028-12-20

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

Which 27 trials of Sacubitril / Valsartan posted no result?


Posted no result
27 of 27 completed trials
Registrations
NCT03717688, NCT03387163, NCT02916160, NCT05096039, NCT05096143 and NCT02957409, and 21 more
Completion dates
oldest 2019-05-14; newest 2024-06-28
Show the evidence

Trial

  • NCT03717688
    2019-05-14
  • NCT03387163
    2019-06-21
  • NCT02916160
    2020-02-27
  • NCT05096039
    2020-09-30
  • NCT05096143
    2020-10-19
  • NCT02957409
    2020-10-24
14 further recorded trials
  • NCT04218435
    2020-12-30
  • NCT04575675
    2020-12-30
  • NCT04736433
    2021-02-18
  • NCT03893526
    2021-03-01
  • NCT04688294
    2021-07-01
  • NCT05448872
    2021-09-15
  • NCT05387967
    2021-09-30
  • NCT05613140
    2021-11-05
  • NCT03647657
    2021-12-14
  • NCT04434170
    2021-12-15
  • NCT05366101
    2022-03-31
  • NCT04587947
    2022-05-31
  • NCT04735354
    2022-06-01
  • NCT03832660
    2022-06-30

At the median, Sacubitril / Valsartan's trials enrolled 100 people — anything larger?


Median enrolment
100
Largest enrolment
1614719
Registered trials counted
121
Where it is registered
Identifiers, relations and other names

The exact record

PubChem CID
24755620
CAS number
1360873-85-3
InChIKey
ACWBQPMHZXGDFX-QFIPXVFZSA-N

Relations

Trade name
Entresto, Entresto Sprinkle, Entresto / Entresto Sprinkle
Sources (4)

Sources

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · derived from this page's own recorded fields; no external licence

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 4 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.