This page shows what was measured, who it was measured in, and what that does not settle.
What Alpelisib does in the body
PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
From the FDA-approved label: Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and Akt-signaling, cellular transformation and the generation of tumors in in vitro and in vivo models. In breast cancer cell lines, alpelisib inhibited the phosphorylation of PI3K downstream targets, including Akt and showed activity in cell lines harboring a PIK3CA mutation. In vivo, alpelisib inhibited the PI3K/Akt signaling pathway and reduced tumor growth in xenograft models, including models of breast cancer.
Why people take it. PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 08W5N2C97Q · read 2026-08-29
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 197 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in 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.
16 weeks clinical response
✗ The study did not show it
Who was studied
NCT04817956
How many people
3000
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Accrual of patients to ComboMATCH treatment trials
✗ The study did not show it
Who was studied
NCT05564377
How many people
2900
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percentage of patients that are treated based on their molecular tumor profile
✗ The study did not show it
Who was studied
NCT02925234
How many people
1550
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Number of participants who experience at least 1 Dose Limiting Toxicity (DLT)
✗ The study did not show it
Who was studied
NCT05768139
How many people
880
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
✗ The study did not show it
Who was studied
NCT05501886
How many people
701
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort
✗ The study did not show it
Who was studied
NCT02437318
How many people
572
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in 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.4 registered measures of this kind. 2 written-up studies measured this and did not show a benefit.
□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.1 registered measure 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. 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 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.
sub study maximum observed drug concentration for midazolam
Meaningful
Things that change how a life goes, not only a number.
progression free survival
part 2 progression free survival
progression free survival rate at 4 months
progression free survival in the study groups
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 (35)
phase ib incidence of dose limiting toxicities in cycle 1
dose limiting toxicities phase ib
maximum tolerated dose and/or recommended phase ii dose
dose escalation incidence of dose limiting toxicity
incidence of dose limiting toxicities
that are treated based on their molecular tumor profile
objective tumor response
stable disease
treatment related grade 3 and serious adverse events
hotspot mutated genes by scheduled timepoint
screening in target mutation variant allele frequency
partial response in the extension phase
dose limiting toxicities and dlt equivalent toxicities
overall response rate in cdk4/6 inhibitor naive
overall response rate
incidence proportion of hyperglycemia
dose limiting toxicity
descriptive statistics of adverse events
hyperglycemia free rate for
ki67
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. 8 to 9 hours hours
Read from the label, which states: “Elimination The half-life of alpelisib is predicted to be 8 to 9 hours.”
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.
VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response.
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 efficacy of PIQRAY in pediatric patients have not been established.”
US prescribing information · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · read 2026-08-30
On older people, the label states: “Of 284 patients who received PIQRAY in the SOLAR-1 trial, 117 patients were ≥ 65 years of age and 34 patients were ≥ 75 years of age.”
US prescribing information · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary PIQRAY is used in combination with fulvestrant.”
US prescribing information · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · read 2026-08-30
On people who are breastfeeding, the label states: “PIQRAY is used in combination with fulvestrant.”
US prescribing information · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · read 2026-08-30
On people with reduced kidney function, the label states: “The effect of severe renal impairment (CLcr < 30 mL/min) on alpelisib pharmacokinetics is unknown [see Clinical Pharmacology (12.3)] .”
US prescribing information · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to 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.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to 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
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4.
No source is stored against this line.
What is in the pack
Sold as tablet, granule, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Alpelisib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1799 reaction mentions were counted. One report can name several reactions.
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
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
13 products list this as an active ingredient in the United States drug directory. 13 of them contain it and nothing else.
FDA National Drug Code directory · 0078-0701 · read 2026-08-29
They are sold as granule, powder and tablet, taken oral.
FDA National Drug Code directory · 0078-0701 · 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 · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · read 2026-08-29
PIQRAY is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 50 mg, 150 mg, and 200 mg alpelisib 50 mg: Light pink, unscored, round and curved with beveled edges film-coated tablet, imprinted with “L7” on one side and “NVR” on the other side.…, recorded as fda label in effect 2025-12-15 in the United States.
US prescribing information · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · 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 Alpelisib 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
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 Alpelisib 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.
How many documents were read
2 documents were read for this substance.
RNAWiki source record
2 of them state the same halfLife, and they agree.
RNAWiki source record
2 of them state the same proteinBinding, and they agree.
RNAWiki source record
2 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
08W5N2C97Q
RxNorm concept
2169300
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Quoted from a stored source.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S3, S4.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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
3 approved applications cover products containing this substance. The earliest was NDA212526, approved 20190524 to NOVARTIS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
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Recorded evidence blocks (14)
Q2
What did Alpelisib's largest trial (2900 people) and its longest (11 years) measure?
2900 people in Alpelisib's largest registered study, 11 years in its longest registered window, measuring Sub-study: Maximum observed Drug Concentration (Cmax) for Midazolam. ClinicalTrials.gov · 2026-09-01
38 phase2, 22 phase1, 10 phase3, 9 na or unstated, 2 na, 1 early phase1, 1 phase4; NCT02925234; 2027-12; no ageing endpoint recorded. Last human test completed 2026, NCT06083038.
Interpretation These counts include studies where Alpelisib 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
phase2
38
phase1
22
phase3
10
na or unstated
9
na
2
early phase1
1
2 more recorded rows
phase4
1
Last recorded human testNCT06083038
2026-04-21
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Alpelisib shown lifespan?
safety (3), accrual/recruitment (5), funding/business (2), sponsor decision unspecified (2) and other (5): Alpelisib's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"early termination due to Sponsor decision (slow recruitment)"; 17 of 74 registered studies
Show the evidence
Trial
NCT01602315
terminated; "early termination due to Sponsor decision (slow recruitment)"
NCT02620839
terminated; "Funding"
NCT02734615
terminated; "Sponsor's decision"
NCT03284957
terminated; "Sponsor decision to prematurely stop the study, not linked to any safety concern."
NCT03386162
terminated; "Study was halted Prematurely for low recruitment."
NCT03439046
terminated; "Novartis terminated the trial early because the collected data were sufficient to perform the analysis stated for the primary endpoint."
11 further recorded trials
NCT03601507
terminated; "Novartis has chosen to withdraw support for this trial"
NCT04216472
terminated; "\<75% participation"
NCT04251533
terminated; "The study was terminated following a strategic decision to halt recruitment due to persistently slow enrollment. This decision was not driven by any new or unexpected safety concerns."
NCT04729387
terminated; "Sponsor Decision"
NCT04801966
terminated; "low recruitment"
NCT04862143
terminated; "Study early terminated due to low enrollment compared to the anticipated figures"
NCT04899349
terminated; "Study was early terminated due to slow recruitment and emerging data showing that prophylactic use of metformin may prevent or reduce the incidence of all-grades alpelisib-related hyperglycemia. The decision was not driven by safety…"
NCT04967248
terminated; "Low recruitment"
NCT05238831
withdrawn; "Withdrawn due to a change in therapeutic interventions."
NCT05472220
withdrawn; "Sponsor funding"
NCT05967286
withdrawn; "Other - Protocol moved to Withdrawn"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Alpelisib used Alpelisib 150 MG Oral Tablet [Piqray] — over how long?
Alpelisib's half-life is 8 to 9 hours — which schedules were studied?
8 to 9 hours, the half-life Alpelisib's label states. openfda-label · b20b4e18-7a4b-4500-a08f-06c6dab0ee5b · 2026-08-30
Show the evidence
half life
8 to 9 hours hours; Elimination The half-life of alpelisib is predicted to be 8 to 9 hours.
tmax
In adult patients who received PIQRAY 300 mg once daily in the SOLAR-1 trial, population approach derived mean steady-state alpelisib [coefficient of variation (CV%)] for C max was 2480 (23%) ng/mL and AUC 0-24hr was 33224 (21%) ng*h/mL. Absorption The median time to reach peak plasma concentration (T max ) ranged between 2.0 to 4.0 hours.
metabolism
Metabolism Alpelisib is primarily metabolized by chemical and enzymatic hydrolysis to form its metabolite BZG791 and followed by CYP3A4 mediated hydroxylation.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of accrual of to combomatch treatment trials, assignment of to combomatch treatment trials and at least one on treatment adverse events did Alpelisib's trials measure?
accrual of to combomatch treatment trials, assignment of to combomatch treatment trials and at least one on treatment adverse events lead 40 outcome terms across Alpelisib's trials. ClinicalTrials.gov · 2026-09-01
dose escalation incidence of dose limiting toxicity, incidence of dose limiting toxicities, that are treated based on their molecular tumor profile, objective tumor response, stable disease and treatment related grade 3 and serious adverse events follow.
Show the evidence
phase ib incidence of dose limiting toxicities in cycle 1
1
dose limiting toxicities phase ib
1
maximum tolerated dose and/or recommended phase ii dose
1
dose escalation incidence of dose limiting toxicity
1
incidence of dose limiting toxicities
1
that are treated based on their molecular tumor profile
1
14 more recorded rows
objective tumor response
1
stable disease
1
treatment related grade 3 and serious adverse events
1
progression free survival
1
hotspot mutated genes by scheduled timepoint
1
screening in target mutation variant allele frequency
1
partial response in the extension phase
1
dose limiting toxicities and dlt equivalent toxicities
1
part 2 progression free survival
1
overall response rate in cdk4/6 inhibitor naive
1
progression free survival rate at 4 months
1
overall response rate
1
incidence proportion of hyperglycemia
1
dose limiting toxicity
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Alpelisib's 33 ongoing trials reports first?
Percentage of patients that are treated based on their molecular tumor profile; Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities; latest 2033-05-02
Show the evidence
Trial
NCT02925234
"The Drug Rediscovery Protocol (DRUP Trial)"; n 1550; "Percentage of patients that are treated based on their molecular tumor profile"; 2027-12
NCT04085653
"Managed Access Programs for BYL719, Alpelisib"
NCT04188548
"A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer"; n 379; "Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities"; 2027-12
NCT04208178
"Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation"; n 19; "Part 1: Incidence of dose limiting toxicities (DLTs) for each dose level"; 2027-02-26
NCT04524000
"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer"; n 24; "[Part 1] The incidence of Dose Limiting Toxicities (DLTs) of alpelisib in combination with fulvestrant"; 2027-02-27
NCT04544189
"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer"; n 69; "Progression Free Survival (PFS)"; 2027-01-29
14 further recorded trials
NCT04589650
"Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum"; n 206; "Proportion of Participants Randomized to Alpelisib With a Confirmed Objective Response by BIRC in Group 1 and Group 2"; 2031-01-09
NCT04762979
"Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer"; n 44; "Progression-Free Survival (PFS)"; 2026-05
NCT04980833
"Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)"; n 41; "Prospective period only: Proportion of participants with new or worsening grade ≥3 treatment emergent adverse events (AEs)"; 2027-08-20
NCT05038735
"Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor."; n 210; "Progression-free survival (PFS) based on BIRC assessments and using RECIST v1.1 criteria"; 2027-02-26
NCT05063786
"Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)"; n 27; "Progression Free Survival (PFS)"; 2026-06
NCT05090358
"Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer"; n 15; "Hyperglycemia-free rate for participants"; 2027-10-08
NCT05143229
"Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer"; n 18; "Recommended phase II dose (RP2D) of alpelisib + sacituzumab govitecan"; 2026-12
NCT05154487
"A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer"; n 51; "Response rate"; 2028-11-01
NCT05230810
"Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer."; n 40; "Phase Ib Safety and Tolerability of alpelisib and tucatinib combination, summary of all AEs and SAEs on study as evaluated by NCI-CTCAE v 5.0"; 2026-06-30
NCT05293470
"A Post Marketing Surveillance on Piqray in Korea"; n 900; "Incidence of AEs"; 2027-05-12
NCT05392608
"SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)"; n 130; "Progression-free survival (PFS)"; 2028-03
NCT05501886
"Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)"; n 701; "Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer"; 2026-12-31
NCT05508906
"Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer"; n 190; "Dose Limiting Toxicities (DLTs)"; 2028-01-31
NCT05563220
"Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer"; n 435; "Number of Participants with DLTs Observed During the First Cycle"; 2028-12-28
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Alpelisib could settle lifespan?
NCT04762979 measures Progression-Free Survival (PFS), reading out 2026-05.
9 open trials; n 44; "Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer"
Show the evidence
Trial
NCT04762979
"Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer"; n 44; "Progression-Free Survival (PFS)"; 2026-05
NCT05063786
"Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)"; n 27; "Progression Free Survival (PFS)"; 2026-06
NCT05501886
"Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)"; n 701; "Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer"; 2026-12-31
NCT04544189
"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer"; n 69; "Progression Free Survival (PFS)"; 2027-01-29
NCT05038735
"Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor."; n 210; "Progression-free survival (PFS) based on BIRC assessments and using RECIST v1.1 criteria"; 2027-02-26
NCT05392608
"SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)"; n 130; "Progression-free survival (PFS)"; 2028-03
3 further recorded trials
NCT05646862
"A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy"; n 420; "Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)"; 2029-03-30
NCT05826964
"Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer"; n 24; "Progression-Free Survival 1 (PFS1) Among Participants in Step 2"; 2029-07-31
NCT05625087
"Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib"; n 162; "Progression-Free Survival in the study groups"; 2030-06
Q10
Which 6 trials of Alpelisib posted no result?
Posted no result
6 of 6 completed trials
Registrations
NCT02624557, NCT02058381, NCT02077933, NCT05733455, NCT03207529 and NCT05294289
Completion dates
oldest 2017-10-01; newest 2024-06-28
Show the evidence
Trial
NCT02624557
2017-10-01
NCT02058381
2018-06-19
NCT02077933
2019-04-12
NCT05733455
2023-12-01
NCT03207529
2023-12-31
NCT05294289
2024-06-28
Q11
At the median, Alpelisib's trials enrolled 50 people — anything larger?
Median enrolment
50
Largest enrolment
2900
Registered trials counted
71
Q12
What do 1799 spontaneous reports say about Alpelisib — 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.
Alpelisib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1799 reaction mentions were counted: hyperglycaemia 497; rash 403; diarrhoea 223; blood glucose increased 173. open-targets-adr · CHEMBL2396661 · 2026-06-24
Show the evidence
hyperglycaemia
497
rash
403
diarrhoea
223
blood glucose increased
173
nausea
158
malignant neoplasm progression
99
4 more recorded rows
decreased appetite
68
stomatitis
62
breast cancer metastatic
58
weight decreased
58
recorded 2026-06-24 · last checked 2026-09-04
Q13
Alpelisib and CYP3A4, BCRP and P-GP: shared by which compounds?
CYP3A4, BCRP and P-GP appear in Alpelisib's recorded interaction sentences, 11 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2B6pharmacokinetics
CYP3A4, CYP2C8, CYP2C9, CYP2C19 and CYP2B6 Substrates: Coadministration of repeated doses of alpelisib 300 mg with a single-dose of sensitive substrates of CYP3A4 (midazolam), CYP2C8 (repaglinide), CYP2C9 (warfarin), CYP2C19 (omeprazole) and CYP2B6 (bupropion), administered as a cocktail did not show clinically significant pharmacokinetic interactions.
CYP2C19pharmacokinetics
CYP3A4, CYP2C8, CYP2C9, CYP2C19 and CYP2B6 Substrates: Coadministration of repeated doses of alpelisib 300 mg with a single-dose of sensitive substrates of CYP3A4 (midazolam), CYP2C8 (repaglinide), CYP2C9 (warfarin), CYP2C19 (omeprazole) and CYP2B6 (bupropion), administered as a cocktail did not show clinically significant pharmacokinetic interactions.
CYP2C8pharmacokinetics
CYP3A4, CYP2C8, CYP2C9, CYP2C19 and CYP2B6 Substrates: Coadministration of repeated doses of alpelisib 300 mg with a single-dose of sensitive substrates of CYP3A4 (midazolam), CYP2C8 (repaglinide), CYP2C9 (warfarin), CYP2C19 (omeprazole) and CYP2B6 (bupropion), administered as a cocktail did not show clinically significant pharmacokinetic interactions.
CYP2C9pharmacokinetics
CYP3A4, CYP2C8, CYP2C9, CYP2C19 and CYP2B6 Substrates: Coadministration of repeated doses of alpelisib 300 mg with a single-dose of sensitive substrates of CYP3A4 (midazolam), CYP2C8 (repaglinide), CYP2C9 (warfarin), CYP2C19 (omeprazole) and CYP2B6 (bupropion), administered as a cocktail did not show clinically significant pharmacokinetic interactions.
CYP3A4
pharmacokinetics
Metabolism Alpelisib is primarily metabolized by chemical and enzymatic hydrolysis to form its metabolite BZG791 and followed by CYP3A4 mediated hydroxylation.
pharmacokinetics
CYP3A4-mediated metabolites (12%) and glucuronides amounted to approximately 15% of the dose.
pharmacokinetics
CYP3A4, CYP2C8, CYP2C9, CYP2C19 and CYP2B6 Substrates: Coadministration of repeated doses of alpelisib 300 mg with a single-dose of sensitive substrates of CYP3A4 (midazolam), CYP2C8 (repaglinide), CYP2C9 (warfarin), CYP2C19 (omeprazole) and CYP2B6 (bupropion), administered as a cocktail did not show clinically significant pharmacokinetic interactions.
pharmacokinetics
Effect of CYP3A4 Inducers on Alpelisib: Coadministration of repeat doses of rifampin (a strong CYP3A4 inducer) with a single 300 mg dose of alpelisib decreased alpelisib C max by 38% and AUC by 57%, respectively.
pharmacokinetics
Coadministration of repeat doses of efavirenz (a moderate CYP3A4 inducer) with a single 300 mg dose of alpelisib is expected to decrease alpelisib AUC by 30% or less.
pharmacokinetics
Model-Informed Approaches Coadministration of repeat doses of ketoconazole (a strong CYP3A4 inhibitor) with a single 300 mg dose of alpelisib is expected to increase alpelisib AUC by 37% or less.
1 more recorded row
CYP3A4pharmacokinetics
No clinically significant differences in pharmacokinetics of everolimus (a substrate of CYP3A4 and P-gp) were observed when coadministered with alpelisib.
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Alpelisib studied with fasting?
fasting is named in Alpelisib's label sentences: "Fasting plasma glucose trended higher with alpelisib (mean ± SD 93 ± 11 mg/dL) versus placebo (84 ± 5 mg/dL); mean fasting serum insulin increased nearly fivefold (23 ± 12 vs. 5 ± 3 μU/mL, respectively), and HOMA of insulin resistance (IR) scores were 5.4 ± 3.1 for alpelisib and 1.1 ± 0.6 for…" openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
Fasting plasma glucose trended higher with alpelisib (mean ± SD 93 ± 11 mg/dL) versus placebo (84 ± 5 mg/dL); mean fasting serum insulin increased nearly fivefold (23 ± 12 vs. 5 ± 3 μU/mL, respectively), and HOMA of insulin resistance (IR) scores were 5.4 ± 3.1 for alpelisib and 1.1 ± 0.6 for placebo.
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Alpelisib and autophagy?
"Alpelisib (BYL719), a selective PI3Kα inhibitor, has shown promise, but its efficacy is often hampered by compensatory survival mechanisms, including autophagy." — where Alpelisib and autophagy appear together. Europe PMC · pathway abstract search · 2026-07-13
"Alpelisib (BYL719), a selective PI3Kα inhibitor, has shown promise, but its efficacy is often hampered by compensatory survival mechanisms, including autophagy."
PMID 41043199
"This study assesses the therapeutic potential of alpelisib as a monotherapy and in combination with an autophagy inhibitor for PI3K-mutated NSCLC."
PMID 41043199
"Alpelisib significantly reduced cell viability in human NSCLC cell lines in a dose- and time-dependent manner, with enhanced markers of autophagy and apoptosis, with pronounced effects in PI3K-mutant H460 cells."
mTOR
PMID 42621428
"Alpelisib is a US Food and Drug Administration-approved p110α catalytic subunit of phosphoinositide 3-kinase α (PIK3CA) inhibitor for severe manifestations of PIK3CA-related overgrowth spectrum, and inhibits upstream of sirolimus in the phosphoinositide 3-kinase (PI3K)-mTOR pathway."
PMID 42680443
"We are now able to use mTOR inhibitors like sirolimus, PI3K inhibitors like alpelisib and MEK inhibitors like trametinib for targeted therapy of vascular anomalies, often in conjunction with interventional and surgical management."
"In xenografts, PAC-XL outperformed cetuximab, BGT226 and alpelisib, including complete regressions, while reducing hyperglycemia and weight loss caused by systemic PI3K/mTOR inhibition."
recorded 2026-07-13 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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