This page shows what was measured, who it was measured in, and what that does not settle.
What Alirocumab does in the body
Used when cholesterol stays high after a recent heart problem despite standard medicines.
The liver clears cholesterol using surface receptors that PCSK9 destroys after a single use. Alirocumab catches PCSK9 in the blood so those receptors survive to be reused. It is the same idea as evolocumab from a different company, and its outcome trial deliberately recruited people in the fragile months after a heart attack.
What happened in people
Serious heart-related problems fell from 11.1 in 100 people to 9.5 in 100 over nearly three years.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
The study could not firmly prove that alirocumab reduced deaths.
Where it acts
Blood plasma and the hepatocyte surface
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · PP0SHH6V16 · read 2026-08-29
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 87 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.
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.
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 people◇Read 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 35 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.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Cholesterol
∅Nothing 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 moved12 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 ageing
…Waiting 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
Cholesterol
calculated ldl c at week 12 on treatment analysis; calculated ldl c at week 8 on treatment analysis; calculated ldl c at week 24 intent to treat analysis; non hdl c at week 24 overall intent to treat analysis; calculated low density lipoprotein cholesterol at week 8; changes in low density lipoprotein cholesterol; low density lipoprotein cholesterol from baseline to week 12; total cholesterol
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
12 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 people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Composite of coronary heart disease death, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospitalisation
✓ The study showed what it set out to show
Who was studied
ODYSSEY OUTCOMES (NCT01663402)
How many people
18924
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
HR 0.85 (95% CI 0.78-0.93), p = 0.0003
Repeated elsewhere
Replicated
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. The all-cause mortality difference sat outside protected alpha in the hierarchical testing plan and is nominal rather than confirmatory.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous prefilled pen or syringe
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
ClinicalTrials.gov, ODYSSEY OUTCOMES (NCT01663402) · a recorded source, not a stored snapshot
Drugs@FDA, PRALUENT BLA 125559, original approval 24 July 2015 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125559) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 1 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 people◇Read 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.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.3 registered measures of this kind. No reviewed result.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.15 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo 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 body◇Read 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.
Start
Alirocumab
What a person takes: Subcutaneous prefilled pen or syringe.
The measurement behind this step
75 mg or 150 mg in 1 mL every two weeks, or 300 mg monthly given as two 150 mg injections, self-administered after training.
Getting in
Subcutaneous injection every two or four weeks
A pen delivers 75 mg or 150 mg under the skin every fortnight, or 300 mg monthly. The dose is adjusted to hit a cholesterol target rather than fixed.
╌╌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
Non-linear pharmacokinetics driven by target-mediated clearance; effective half-life of 17-20 days at steady state with titration between 75 mg and 150 mg every two weeks.
ClinicalTrials.gov, ODYSSEY OUTCOMES (NCT01663402) · a recorded source, not a stored snapshot
What it acts on
Blocking the PCSK9 to LDL receptor interface
The antibody covers the exact patch on PCSK9 that grips the cholesterol 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
Binds the catalytic domain of PCSK9 at the EGF-A binding interface, preventing formation of the PCSK9-LDLR complex that would otherwise route the receptor to lysosomal degradation.
ClinicalTrials.gov, ODYSSEY OUTCOMES (NCT01663402) · a recorded source, not a stored snapshot
The change it makes
Receptor recycling is restored
Each liver receptor now makes many trips instead of one, pulling far more cholesterol out of the blood.
╌╌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
LDL receptors dissociate from LDL in the endosome and return to the hepatocyte surface. Surface receptor density and the fractional catabolic rate of LDL apolipoprotein B both rise.
ClinicalTrials.gov, ODYSSEY OUTCOMES (NCT01663402) · a recorded source, not a stored snapshot
What that does for a person
Fewer recurrent coronary events after a heart attack
LDL falls into the 25-50 mg/dL band and stays there. In the outcome trial, roughly one and a half fewer people in every hundred had a major cardiac event over the next three years.
──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
Sustained low LDL reduces plaque lipid content and inflammation, with the absolute benefit concentrated in patients whose baseline LDL was highest, where the risk reduction was correspondingly larger.
ClinicalTrials.gov, ODYSSEY OUTCOMES (NCT01663402) · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 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 take◇Read 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.
calculated ldl c at week 12 on treatment analysis
calculated ldl c at week 8 on treatment analysis
calculated ldl c at week 24 intent to treat analysis
non hdl c at week 24 overall intent to treat analysis
calculated low density lipoprotein cholesterol at week 8
changes in low density lipoprotein cholesterol
low density lipoprotein cholesterol from baseline to week 12
vascular inflammation carotid artery
vascular inflammation aortic artery
total cholesterol
and 5 more.
Meaningful
Things that change how a life goes, not only a number.
survival
all cause mortality
stroke of any kind
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 (17)
adverse events
who experienced adverse events
treatment emergent adverse events
normalized total atheroma volume at week 36
atheroma volume
fdg pet/ct endpoint
plaque volume
major cardiovascular adverse events
myocardial salvage index
plaque burden
degree of stenosis caused by the plaque
plaque enhancement
remodeling index of the plaque
presence of t1 hyperintensity in the plaque
plaque distribution whether it is a concentric plaque or not
hemodynamic characteristics hypoperfusion volume
lp 125
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 take◇Read 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.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
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.
How fast the body clears it. 17 to 20 days
Read from the label, which states: “Based on a population pharmacokinetic analysis, the median apparent half-life of alirocumab at steady state was 17 to 20 days in patients receiving alirocumab at subcutaneous doses of 75 mg every 2 weeks or 150 mg every 2 weeks.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
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 unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults with established atherosclerotic cardiovascular disease or familial hypercholesterolaemia whose LDL remains above target on maximum tolerated statin therapy.
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 PRALUENT have not been established in pediatric patients with HeFH who are younger than 8 years of age or in pediatric patients with other types of hypercholesterolemia.”
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-30
On older people, the label states: “In controlled trials, 3663 patients treated with PRALUENT were ≥65 years of age and 734 patients treated with PRALUENT were ≥75 years of age.”
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data from clinical trials and postmarketing reports on PRALUENT use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of alirocumab in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-30
On people with reduced liver function, the label states: “No dose adjustment is needed for patients with mild or moderate hepatic impairment.”
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-30
On people with reduced kidney function, the label states: “No dose adjustment is needed for patients with mild or moderately impaired renal function.”
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-30
Where the result stopped carrying
The 2015 launch price of roughly $14,000 per year drew a cost-effectiveness assessment concluding it exceeded value benchmarks, and was cut by around 60% in 2018
Bococizumab, the humanised member of the class, was defeated by anti-drug antibodies and discontinued
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied 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.
There was nothing to correct
Where a level is already normal, topping it up may change nothing.
On this record: Absolute benefit was concentrated in patients with the highest baseline LDL, which is the basis for restricting use to those still above target on maximal statin therapy
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)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ 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
Subcutaneous prefilled pen or syringe
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
The identity record classes it as Monoclonal Antibody (mAb).
No source is stored against this line.
What is in the pack
75 mg or 150 mg in 1 mL every two weeks, or 300 mg monthly given as two 150 mg injections, self-administered after training.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read 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
No boxed warning. Injection site reactions, nasopharyngitis and influenza-like symptoms predominate. Hypersensitivity vasculitis and nummular eczema have been reported rarely. Anti-drug antibodies are uncommon and generally not neutralising.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
ClinicalTrials.gov, ODYSSEY OUTCOMES (NCT01663402) · a recorded source, not a stored snapshot
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.
Alirocumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2087 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
myalgia — 403 reaction mentions
arthralgia — 223 reaction mentions
injection site pain — 222 reaction mentions
muscle spasms — 211 reaction mentions
influenza like illness — 199 reaction mentions
pain in extremity — 196 reaction mentions
low density lipoprotein increased — 182 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 unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Subcutaneous prefilled pen or syringe
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.
FDA National Drug Code directory · 61755-021 · read 2026-08-29
They are sold as injection, solution, taken subcutaneous.
FDA National Drug Code directory · 61755-021 · read 2026-08-29
The regulator's established pharmacologic class for it is antibodies, monoclonal [cs] and pcsk9 inhibitor [epc].
FDA National Drug Code directory · 61755-021 · read 2026-08-29
2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-29
Praluent is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS PRALUENT injection is a clear, colorless to pale yellow solution available as follows: 75 mg/mL single-dose pre-filled pen 150 mg/mL single-dose pre-filled pen Injection: 75 mg/mL or 150 mg/…, recorded as fda label in effect 2026-07-07 in the United States.
US prescribing information · 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Alirocumab studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
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 alirocumab has been shown to reduce all-cause mortality; the difference was nominal and outside the protected testing hierarchy
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 ODYSSEY and FOURIER results can be directly compared; one used blinded titration to a target and the other fixed dosing, in different populations
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 unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Alirocumab are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
ODYSSEY OUTCOMES: major adverse cardiovascular events fell from 11.1% to 9.5%
In plain words
In 18,924 people who had had an acute coronary syndrome one to twelve months earlier and were on high-intensity statins, alirocumab reduced the combined rate of coronary death, heart attack, ischaemic stroke and unstable angina hospitalisation from 11.1 in 100 to 9.5 in 100 over a median of 2.8 years.
What was measured
Primary composite 9.5% versus 11.1%, HR 0.85 (95% CI 0.78-0.93)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, placebo-controlled trial with 9,462 patients per arm, dosed at 75 mg every two weeks and blindly titrated to a target LDL of 25 to 50 mg/dL. The primary composite occurred in 903 (9.5%) versus 1,052 (11.1%), hazard ratio 0.85 (95% CI 0.78-0.93). Absolute risk reduction of 1.6 percentage points over 2.8 years corresponds to a number needed to treat of roughly 63.
Written into the record, not signed off as a reviewed claim
The all-cause mortality difference was nominal, not a formally established finding
In plain words
Fewer people died in the alirocumab arm, and that result is frequently quoted as proof that the drug saves lives. It sat below the pre-specified hierarchical testing sequence, which means it was descriptive rather than confirmatory.
What was measured
That alirocumab has been shown to reduce all-cause mortality
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Death from any cause was lower in the alirocumab group, but the trial used a hierarchical testing procedure and the mortality comparison did not have protected alpha at the point it was reached. The authors and subsequent commentary describe the finding as nominal. It is a genuine and encouraging observation, and it is not the same as a demonstrated mortality benefit.
Source
Schwartz et al., NEJM 2018, pre-specified hierarchical testing plan
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
Blinded titration to a target band, not a fixed dose
In plain words
Rather than giving everyone the same dose, the trial adjusted the dose blindly to keep LDL between 25 and 50 mg/dL and stepped patients down or onto placebo if LDL fell too low. Very few trials of this size do that.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Patients started at 75 mg every two weeks and were blindly up-titrated to 150 mg if LDL remained above 50 mg/dL, and blindly down-titrated or switched to placebo if two consecutive LDL measurements fell below 15 mg/dL. This treat-to-target design makes the trial a better test of an LDL strategy than of a fixed drug exposure, and it complicates direct comparison with the fixed-dose FOURIER trial.
Source
Schwartz et al., NEJM 2018, trial design and dose adjustment protocol
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
Value-based pricing was applied to this drug before it was applied to almost any other
In plain words
An independent cost-effectiveness body judged the launch price too high for the benefit measured. The manufacturer then cut the US list price by around 60% and tied access to it. This is one of the first cases where a published value assessment visibly moved a price.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Both PCSK9 antibodies launched around $14,000 per year in 2015, drew cost-effectiveness assessments concluding the price exceeded value-based benchmarks, and encountered payer rejection rates high enough to suppress uptake. Sanofi and Regeneron reduced the alirocumab US list price to roughly $5,850 per year in 2018 in exchange for reduced utilisation management. The clinical evidence did not change; the commercial environment did.
Source
Publicly announced 2018 US list price reduction for Praluent
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 class lesson: a humanised PCSK9 antibody was destroyed by anti-drug antibodies
In plain words
Pfizer took a humanised rather than fully human PCSK9 antibody into six large trials. Patients formed antibodies against the drug, the cholesterol lowering faded, and the programme was abandoned. Alirocumab and evolocumab are both fully human, which is why they survived.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The SPIRE programme in 4,300 patients found bococizumab produced a 54.2% LDL reduction at 12 weeks that was substantially attenuated in patients who developed anti-drug antibodies, with wide variability even in those who did not. Pfizer discontinued development in 2016. Alirocumab is fully human and its immunogenicity rate is low, but anti-drug antibody monitoring remains part of the release and pharmacovigilance programme for the class.
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What is not here
3 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
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The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
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 fully human antibody against PCSK9 that reduced major adverse cardiovascular events from 11.1% to 9.5% over a median 2.8 years in 18,924 patients recruited after an acute coronary syndrome.
Recorded evidence blocks (15)
Q1
What did Alirocumab's largest trial (18924 people) and its longest (8 years) measure?
18924 people in Alirocumab's largest registered study, 8 years in its longest registered window, measuring all-cause mortality. ClinicalTrials.gov · 2026-09-01
31 phase3, 15 phase2, 15 phase4, 10 na or unstated, 10 phase1, 2 na, 1 early phase1; NCT03533959; 2025-12; no ageing endpoint recorded. Last human test completed 2026, NCT07615166.
Interpretation These counts include studies where Alirocumab 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
31
phase2
15
phase4
15
na or unstated
10
phase1
10
na
2
2 more recorded rows
early phase1
1
Last recorded human testNCT07615166
2026-06-30
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Alirocumab shown lifespan?
2 recorded entries; human; also "Alirocumab 150 mg"
Show the evidence
human
NCT03355027
Alirocumab 150 MG/ML
NCT07615166
Alirocumab 150 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Alirocumab's half-life is 17 to 20 days — which schedules were studied?
17 to 20 days, the half-life Alirocumab's label states. openfda-label · 7bcfbac2-e8ac-4569-8edc-bcde3b1fd172 · 2026-08-30
bioavailability 85% %.
Show the evidence
half life
17 to 20 days; Based on a population pharmacokinetic analysis, the median apparent half-life of alirocumab at steady state was 17 to 20 days in patients receiving alirocumab at subcutaneous doses of 75 mg every 2 weeks or 150 mg every 2 weeks.
tmax
12.3 Pharmacokinetics Absorption After subcutaneous administration of 75 mg to 300 mg alirocumab, median times to maximum serum concentrations (t max ) were 3-7 days.
bioavailability
85% %; The absolute bioavailability of alirocumab after subcutaneous administration was about 85% as determined by population pharmacokinetics analysis.
metabolism
Elimination Specific metabolism studies were not conducted, because alirocumab is a protein.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Alirocumab's effect on calculated ldl c at week 12 on treatment analysis?
Calculated ldl c at week 12 on treatment analysis: measured in Alirocumab's trials.
calculated ldl c at week 12 on treatment analysis is the recorded endpoint.
Show the evidence
biomarkers
calculated ldl c at week 12 on treatment analysis; 2026-09-01
calculated ldl c at week 8 on treatment analysis; 2026-09-01
adverse events; 2026-09-01
who experienced adverse events; 2026-09-01
calculated ldl c at week 24 intent to treat analysis; 2026-09-01
treatment emergent adverse events; 2026-09-01
14 more recorded rows
biomarkers
non hdl c at week 24 overall intent to treat analysis; 2026-09-01
biomarkers
calculated low density lipoprotein cholesterol at week 8; 2026-09-01
biomarkers
changes in low density lipoprotein cholesterol; 2026-09-01
biomarkers
normalized total atheroma volume at week 36; 2026-09-01
biomarkers
atheroma volume; 2026-09-01
biomarkers
low density lipoprotein cholesterol from baseline to week 12; 2026-09-01
biomarkers
fdg pet/ct endpoint; 2026-09-01
biomarkers
vascular inflammation carotid artery; 2026-09-01
biomarkers
vascular inflammation aortic artery; 2026-09-01
biomarkers
plaque volume; 2026-09-01
biomarkers
survival; 2026-09-01
biomarkers
total cholesterol; 2026-09-01
biomarkers
triglycerides; 2026-09-01
biomarkers
concentration of lp and snp in the lpa gene; 2026-09-01
half life
2026-09-04; halfLife; 17 to 20 days; 2026-08-30
human trials at or under30
9
smallest human trial
0; NCT03750760; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adverse events, all cause mortality and atheroma volume did Alirocumab's trials measure?
adverse events, all cause mortality and atheroma volume lead 35 outcome terms across Alirocumab's trials. ClinicalTrials.gov · 2026-09-01
who experienced adverse events, calculated ldl c at week 24 intent to treat analysis, treatment emergent adverse events, non hdl c at week 24 overall intent to treat analysis, calculated low density lipoprotein cholesterol at week 8 and changes in low density lipoprotein cholesterol follow.
Show the evidence
calculated ldl c at week 12 on treatment analysis
1
calculated ldl c at week 8 on treatment analysis
1
adverse events
1
who experienced adverse events
1
calculated ldl c at week 24 intent to treat analysis
1
treatment emergent adverse events
1
14 more recorded rows
non hdl c at week 24 overall intent to treat analysis
1
calculated low density lipoprotein cholesterol at week 8
1
changes in low density lipoprotein cholesterol
1
normalized total atheroma volume at week 36
1
atheroma volume
1
low density lipoprotein cholesterol from baseline to week 12
1
fdg pet/ct endpoint
1
vascular inflammation carotid artery
1
vascular inflammation aortic artery
1
plaque volume
1
survival
1
total cholesterol
1
triglycerides
1
concentration of lp and snp in the lpa gene
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Alirocumab's 12 ongoing trials reports first?
The primary objective is to assess the safety and tolerability of alirocumab in subjects who are heavy drinkers.; all-cause mortality; latest 2030-09
Show the evidence
Trial
NCT04781322
"Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers"; n 100; "The primary objective is to assess the safety and tolerability of alirocumab in subjects who are heavy drinkers."; 2026-12-31
NCT04847752
"Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis"; n 1000; "all-cause mortality"; 2028-12-31
NCT05001984
"Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis"; n 60; "The changes of intracranial atherosclerotic plaque: stenosis degree"; 2025-04-15
NCT05292404
"Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction"; n 160; "myocardial salvage index"; 2026-12
NCT06083961
"The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile"; n 200; "LDL change rate"; 2026-11-15
NCT06858332
"Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia"; n 2382; "Percentage of patients (%) with Lp(a) ≥125 nmol/L"; 2027-09-30
6 further recorded trials
NCT07174375
"PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy"; n 478; "Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points"; 2027-12-15
NCT07375225
"Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy"; n 1500; "Description of adherence of treatment with alirocumab 300mg in a real-life Italian population."; 2027-12-01
NCT07477704
"A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia"; n 420; "Percent change in LDL-C"; 2027-02-23
NCT07581808
"Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention"; n 60; "Percent Change in LDL-C From Baseline"; 2027-06
NCT07586540
"Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque"; n 280; "Absolute change in intraplaque haemorrhage (IPH) volume from baseline to week 26"; 2030-09
NCT07734753
"Impact of Alirocumab on Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events"; n 4006; "Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality"; 2026-08-15
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Alirocumab could settle lifespan?
NCT07734753 measures Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality, reading out 2026-08-15.
2 open trials; n 4006; "Impact of Alirocumab on Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events"
Show the evidence
Trial
NCT07734753
"Impact of Alirocumab on Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events"; n 4006; "Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality"; 2026-08-15
NCT04847752
"Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis"; n 1000; "all-cause mortality"; 2028-12-31
Q10
Which 14 trials of Alirocumab posted no result?
Posted no result
14 of 14 completed trials
Registrations
NCT01026597, NCT01074372, NCT01161082, NCT01448317, NCT01723735 and NCT01959971, and 8 more
Completion dates
oldest 2010-10; newest 2023-05-08
Show the evidence
Trial
NCT01026597
2010-10
NCT01074372
2010-11
NCT01161082
2011-05
NCT01448317
2012-01
NCT01723735
2013-07
NCT01959971
2015-05
8 further recorded trials
NCT03014830
2018-07-30
NCT04851769
2021-03-01
NCT03718286
2021-10-08
NCT03067844
2021-10-13
NCT05465278
2022-03-30
NCT03344692
2022-04-28
NCT04790513
2022-12-31
NCT02959047
2023-05-08
Q11
At the median, Alirocumab's trials enrolled 116 people — anything larger?
Median enrolment
116
Largest enrolment
18924
Registered trials counted
82
Q12
What do 2087 spontaneous reports say about Alirocumab — 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.
Alirocumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2087 reaction mentions were counted: myalgia 403; arthralgia 223; injection site pain 222; muscle spasms 211. open-targets-adr · CHEMBL2109540 · 2026-06-24
Show the evidence
myalgia
403
arthralgia
223
injection site pain
222
muscle spasms
211
influenza like illness
199
pain in extremity
196
4 more recorded rows
low density lipoprotein increased
182
injection site erythema
155
injection site bruising
155
product dose omission issue
141
recorded 2026-06-24 · last checked 2026-09-04
Q13
Alirocumab and CYP2C9, CYP3A4 and OATP: shared by which compounds?
CYP2C9, CYP3A4 and OATP appear in Alirocumab's recorded interaction sentences, 2 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2C9pharmacokinetics
In clinical studies where alirocumab was administered in combination with atorvastatin or rosuvastatin, no relevant changes in statin concentrations were observed in the presence of repeated administration of alirocumab, indicating that cytochrome P450 enzymes (mainly CYP3A4 and CYP2C9) and transporter proteins such as P-gp and OATP were not affected by alirocumab.
CYP3A4pharmacokinetics
In clinical studies where alirocumab was administered in combination with atorvastatin or rosuvastatin, no relevant changes in statin concentrations were observed in the presence of repeated administration of alirocumab, indicating that cytochrome P450 enzymes (mainly CYP3A4 and CYP2C9) and transporter proteins such as P-gp and OATP were not affected by alirocumab.
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Alirocumab studied with fasting?
fasting is named in Alirocumab's label sentences: "Alirocumab treatment reduced fasting plasma TG levels (between group median change -24.7%; P = 0.018) and fasting apoB48 serum levels (-35.9%; P = 0.039) compared with placebo." openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
Alirocumab treatment reduced fasting plasma TG levels (between group median change -24.7%; P = 0.018) and fasting apoB48 serum levels (-35.9%; P = 0.039) compared with placebo.
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Alirocumab and AMPK?
"PCSK9 monoclonal antibodies, particularly evolocumab and alirocumab, appear promising because they may confer renal benefit through lipid lowering and kidney-intrinsic effects on lipotoxicity, oxidative stress, AMPK signaling, and profibrotic pathways." — where Alirocumab and AMPK appear together. Europe PMC · pathway abstract search · 2026-07-09
AMPK; PMID 42494867
Show the evidence
AMPKPMID 42494867
"PCSK9 monoclonal antibodies, particularly evolocumab and alirocumab, appear promising because they may confer renal benefit through lipid lowering and kidney-intrinsic effects on lipotoxicity, oxidative stress, AMPK signaling, and profibrotic pathways."
recorded 2026-07-09 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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