This page shows what was measured, who it was measured in, and what that does not settle.
What Abemaciclib does in the body
VERZENIO ® is a kinase inhibitor indicated: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
From the FDA-approved label: Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases are activated upon binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation. In vitro, continuous exposure to abemaciclib inhibited Rb phosphorylation and blocked progression from G1 into S phase of the cell cycle, resulting in senescence and apoptosis. In breast cancer xenograft models, abemaciclib dosed daily without interruption as a single agent or in combination with antiestrogens resulted in reduction of tumor size.
Why people take it. VERZENIO ® is a kinase inhibitor indicated: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
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 · 60UAB198HK · read 2026-08-29
Its recorded molecular formula is C27H32F2N8.
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · read 2026-08-30
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 203 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.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
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.
Invasive Disease Free Survival (IDFS)
✗ The study did not show it
Who was studied
NCT03155997
How many people
5637
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
Invasive breast cancer-free survival (IBCFS)
✗ The study did not show it
Who was studied
NCT05952557
How many people
5511
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
Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.
✗ The study did not show it
Who was studied
NCT01042379
How many people
5000
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
Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria
✗ The study did not show it
Who was studied
NCT02693535
How many people
4200
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
Invasive disease free survival
✗ The study did not show it
Who was studied
NCT06341621
How many people
1900
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
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
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.10 registered measures of this kind. 3 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 healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■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 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.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
progression free survival
overall survival
progression free survival rate at 3 months
stage 2 progression free survival
6 month progression free survival
progression free survival at 18 months
invasive disease free survival
overall survival rate
progression free survival rate
radiographic progression free survival
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 (30)
clinically significant effects
recommended phase 2 dose
one or more drug related adverse events
complete response or partial response
who experienced dose limiting toxicities
one or more serious adverse event
non serious adverse event
ly3039478 dose limiting toxicities in part a b c d and e
progression free
pharmacokinetics renal clearance of metformin
that are treated based on their molecular tumor profile
objective tumor response
stable disease
treatment related grade 3 and serious adverse events
maximum tolerated dose of xentuzumab
number of dlts in the mtd evaluation period
number of objective response
disease control
objective response rate
radiographic response rate
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. 18.3 hours hours
Read from the label, which states: “Elimination The geometric mean hepatic clearance (CL) of abemaciclib in patients was 26.0 L/h (51% CV), and the mean plasma elimination half-life for abemaciclib in patients was 18.3 hours (72% CV).”
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.
VERZENIO ® is a kinase inhibitor indicated: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
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 VERZENIO have not been established in pediatric patients.”
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · read 2026-08-30
On older people, the label states: “Of the 2791 VERZENIO-treated patients in monarchE, 15% were 65 years of age or older and 2.7% were 75 years of age or older.”
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings in animals and its mechanism of action, VERZENIO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] .”
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of abemaciclib in human milk, or its effects on the breastfed child or on milk production.”
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · read 2026-08-30
On people with reduced liver function, the label states: “No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B).”
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · read 2026-08-30
On people with reduced kidney function, the label states: “No dosage adjustment is required for patients with mild or moderate renal impairment (CLcr ≥30-89 mL/min, estimated by Cockcroft-Gault [C-G]).”
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · 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, 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.
Abemaciclib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1442 reaction mentions were counted. One report can name several reactions.
white blood cell count decreased — 75 reaction mentions
interstitial lung disease — 57 reaction mentions
therapy interrupted — 57 reaction mentions
therapy change — 35 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
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
16 products list this as an active ingredient in the United States drug directory. 16 of them contain it and nothing else.
FDA National Drug Code directory · 63419-0554 · read 2026-08-29
They are sold as powder and tablet, taken oral.
FDA National Drug Code directory · 63419-0554 · read 2026-08-29
The regulator's established pharmacologic class for it is kinase inhibitor [epc] and kinase inhibitors [moa].
FDA National Drug Code directory · 63419-0554 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · read 2026-08-29
Verzenio is oral at 3 DOSAGE FORMS AND STRENGTHS 50 mg tablets: oval beige tablet with “Lilly” debossed on one side and “50” on the other side. 100 mg tablets: oval white to practically white tablet with “Lilly” debossed on one side and “1…, recorded as fda label in effect 2026-07-13 in the United States.
US prescribing information · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · 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 Abemaciclib 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.
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.
Where else this substance is registered
FDA substance identifier (UNII)
60UAB198HK
RxNorm concept
1946830
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 NDA208716, approved 20170928 to ELI LILLY AND CO.
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What is not here
6 questions this page could not answer
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Recorded evidence blocks (14)
Q2
What did Abemaciclib's largest trial (5637 people) and its longest (18 years) measure?
5637 people in Abemaciclib's largest registered study, 18 years in its longest registered window, measuring Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms. ClinicalTrials.gov · 2026-09-01
120 phase2, 81 phase1, 23 phase3, 10 na or unstated, 6 phase4, 5 early phase1, 1 na; NCT06805812; 2040-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT05617885.
Interpretation These counts include studies where Abemaciclib 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
120
phase1
81
phase3
23
na or unstated
10
phase4
6
early phase1
5
2 more recorded rows
na
1
Last recorded human testNCT05617885
2026-06-01
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Abemaciclib shown lifespan?
"The study was terminated due to business considerations"; 33 of 211 registered studies
Show the evidence
Trial
NCT02784795
terminated; "The study was terminated due to business considerations"
NCT03130439
terminated; "Slow accrual"
NCT03284957
terminated; "Sponsor decision to prematurely stop the study, not linked to any safety concern."
NCT03655444
terminated; "Provider of drug decided to discontinue study."
NCT03781960
terminated; "Safety letter from sponsor"
NCT03846583
withdrawn; "Study halted prematurely, prior to enrollment of first participant."
14 further recorded trials
NCT03878524
terminated; "Low accrual"
NCT03905889
terminated; "Funding withdrawn"
NCT03979508
terminated; "The primary biomarker (CD8/FOXP3) was rarely observed to be \< 1.6 in residual tumors examined in first stage of study."
NCT03988114
withdrawn; "Strategic decision due to emerging new data for patients with HR+, HER2- metastatic breast cancer."
NCT03997448
terminated; "Funder decision"
NCT04003896
terminated; "The manufacturer and funder Eli Lilly requested to terminate the study"
NCT04031885
terminated; "Business decision based on the inability to enroll subjects into the trial"
NCT04074785
terminated; "Administratively closed by the IRB."
NCT04118036
withdrawn; "safety concerns"
NCT04165031
terminated; "The study was terminated due to an unexpected toxicity finding."
NCT04169074
terminated; "Standard of care therapy for Stage III-IVA HNSCC updated in June to include neoadjuvant + adjuvant immunotherapy."
NCT04220892
withdrawn; "One of the study drugs will no longer be supplied by manufacturer and the pembrolizumab + abemaciclib study arm is removed due to toxicity seen in other trials."
NCT04227327
terminated; "Difficulties in patient recruitment"
NCT04256941
terminated; "Despite modifications, accrual was poor and the closed"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Abemaciclib used Abemaciclib 200 MG — over how long?
3 recorded entries; human; also "Abemaciclib 200 MG", "Abemaciclib 150 MG", "Abemaciclib 150 MG Oral Tablet"
Show the evidence
human
NCT03969706
Abemaciclib 200 MG
NCT04272645
Abemaciclib 150 MG
NCT05691400
Abemaciclib 150 MG Oral Tablet
recorded 2026-09-01 · last checked 2026-09-04
Q6
Abemaciclib's half-life is 18.3 hours — which schedules were studied?
18.3 hours, the half-life Abemaciclib's label states. openfda-label · be4bc0de-0fdc-4d46-8d25-be43c79e6a06 · 2026-08-30
bioavailability 45% %.
Show the evidence
half life
18.3 hours hours; Elimination The geometric mean hepatic clearance (CL) of abemaciclib in patients was 26.0 L/h (51% CV), and the mean plasma elimination half-life for abemaciclib in patients was 18.3 hours (72% CV).
tmax
The median T max of abemaciclib is 8.0 hours (range: 4.1-24.0 hours).
bioavailability
45% %; Absorption The absolute bioavailability of abemaciclib after a single oral dose of 200 mg is 45% (19% CV).
metabolism
Metabolism Hepatic metabolism is the main route of clearance for abemaciclib.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 6 month progression free survival, changes in ki 67 expression and clinical benefit rate did Abemaciclib's trials measure?
6 month progression free survival, changes in ki 67 expression and clinical benefit rate lead 40 outcome terms across Abemaciclib's trials. ClinicalTrials.gov · 2026-09-01
complete response or partial response, progression free survival, overall survival, progression free survival rate at 3 months, who experienced dose limiting toxicities and one or more serious adverse event follow.
Show the evidence
clinically significant effects
1
recommended phase 2 dose
1
one or more drug related adverse events
1
complete response or partial response
1
progression free survival
1
overall survival
1
14 more recorded rows
progression free survival rate at 3 months
1
who experienced dose limiting toxicities
1
one or more serious adverse event
1
non serious adverse event
1
ly3039478 dose limiting toxicities in part a b c d and e
1
progression free
1
pharmacokinetics renal clearance of metformin
1
that are treated based on their molecular tumor profile
1
objective tumor response
1
stable disease
1
treatment related grade 3 and serious adverse events
1
stage 2 progression free survival
1
6 month progression free survival
1
maximum tolerated dose of xentuzumab
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Abemaciclib's 113 ongoing trials reports first?
Number of Participants with One or More Drug-Related Adverse Events; Progression-Free Survival (PFS); latest 2040-12-31
Show the evidence
Trial
NCT02057133
"A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread"; n 198; "Number of Participants with One or More Drug-Related Adverse Events"; 2026-12
NCT02107703
"A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer"; n 669; "Progression-Free Survival (PFS)"; 2027-12
NCT02152631
"A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer"; n 453; "Overall Survival (OS)"; 2026-12
NCT02246621
"A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer"; n 493; "Progression Free Survival (PFS)"; 2026-12
NCT02523014
"Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas"; n 124; "Progression free survival (PFS)"; 2028-01
NCT02693535
"TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer"; n 4200; "Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria"; 2028-12-31
14 further recorded trials
NCT02747004
"A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer"; n 234; "Progression Free Survival (PFS)"; 2026-12
NCT02763566
"A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer"; n 463; "Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)"; 2028-03
NCT02779751
"A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer"; n 100; "Number of Participants with One or More Serious Adverse Event(s) (SAEs)"; 2026-12
NCT02846987
"Study of Abemaciclib in Dedifferentiated Liposarcoma"; n 33; "progression-free"; 2027-07
NCT02925234
"The Drug Rediscovery Protocol (DRUP Trial)"; n 1550; "Percentage of patients that are treated based on their molecular tumor profile"; 2027-12
NCT02977780
"INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)"; n 460; "Overall Survival in Experimental Arms Compared with Standard Therapy"; 2028-04-30
NCT02981940
"A Study of Abemaciclib in Recurrent Glioblastoma"; n 45; "Intratumoral Abemaciclib Concentration"; 2026-06-30
NCT03155997
"Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer"; n 5637; "Invasive Disease Free Survival (IDFS)"; 2029-05
NCT03220646
"Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors"; n 64; "radiographic response rate"; 2027-07
NCT03310879
"Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6"; n 38; "Progression-Free Rate"; 2027-09-30
NCT03424005
"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer"; n 1132; "Objective Response Rate (ORR)"; 2030-09-30
NCT03531645
"Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma"; n 18; "Clinical Benefit Rate (CBR)"; 2027-09-30
NCT03675893
"RESOLVE: Abemaciclib + Letrozole +/- Metformin or Gedatolisib in Endometrial Cancer"; n 110; "Progression Free Survival Rate"; 2031-08-01
NCT03706365
"A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer"; n 393; "Radiographic Progression Free Survival (rPFS)"; 2026-12
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Abemaciclib could settle lifespan?
NCT02152631 measures Overall Survival (OS), reading out 2026-12.
35 open trials; n 453; "A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer"
Show the evidence
Trial
NCT02152631
"A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer"; n 453; "Overall Survival (OS)"; 2026-12
NCT02246621
"A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer"; n 493; "Progression Free Survival (PFS)"; 2026-12
NCT02747004
"A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer"; n 234; "Progression Free Survival (PFS)"; 2026-12
NCT03706365
"A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer"; n 393; "Radiographic Progression Free Survival (rPFS)"; 2026-12
NCT04923542
"Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases"; n 31; "Intracranial Progression Free Survival (PFS)"; 2026-12
NCT04967521
"SARC041: Study of Abemaciclib Versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma"; n 108; "To determine the progression-free survival of patients treated with abemaciclib versus placebo"; 2026-12
14 further recorded trials
NCT05440786
"CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma"; n 46; "Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis"; 2026-12
NCT04545710
"Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance"; n 18; "Progression Free Survival at 6 months"; 2026-12-01
NCT06495164
"A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer"; n 1; "Overall Survival (OS)"; 2026-12-30
NCT04393285
"Abemaciclib and Letrozole to Treat Endometrial Cancer"; n 53; "Progression-free survival"; 2026-12-31
NCT03969706
"Abemaciclib in Patients with Oligodendroglioma"; n 10; "Progression-free survival"; 2027-05-15
NCT04040205
"Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration"; n 44; "Progression-free survival"; 2027-06-01
NCT04975308
"A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer"; n 874; "Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)"; 2027-08
NCT05288166
"A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)"; n 925; "Radiographic Progression-Free Survival (rPFS) Assessed by Investigator"; 2027-10
NCT02107703
"A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer"; n 669; "Progression-Free Survival (PFS)"; 2027-12
NCT05169567
"Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer"; n 368; "Progression-Free Survival (PFS)"; 2027-12
NCT02523014
"Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas"; n 124; "Progression free survival (PFS)"; 2028-01
NCT06413706
"A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy"; n 45; "Event Free Survival as Determined by Blinded Independent Review Committee"; 2028-02
NCT02763566
"A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer"; n 463; "Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)"; 2028-03
NCT02977780
"INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)"; n 460; "Overall Survival in Experimental Arms Compared with Standard Therapy"; 2028-04-30
Q10
Which 15 trials of Abemaciclib posted no result?
Posted no result
15 of 15 completed trials
Registrations
NCT02831530, NCT02745769, NCT05141240, NCT05153135, NCT04071262 and NCT01655225, and 9 more
Completion dates
oldest 2018-02-02; newest 2024-06-27
Show the evidence
Trial
NCT02831530
2018-02-02
NCT02745769
2019-01-22
NCT05141240
2020-06-15
NCT05153135
2020-07-31
NCT04071262
2021-08-30
NCT01655225
2022-02-02
9 further recorded trials
NCT03292250
2022-03-10
NCT02857270
2022-10-24
NCT04514159
2022-10-24
NCT05789771
2022-12-01
NCT03356223
2022-12-05
NCT04049227
2023-05-15
NCT02644460
2023-10-10
NCT03339843
2023-12-20
NCT02791334
2024-06-27
Q11
At the median, Abemaciclib's trials enrolled 48 people — anything larger?
Median enrolment
48
Largest enrolment
5637
Registered trials counted
209
Q12
What do 1442 spontaneous reports say about Abemaciclib — 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.
Abemaciclib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1442 reaction mentions were counted: diarrhoea 642; vomiting 147; disease progression 134; malignant neoplasm progression 105. open-targets-adr · CHEMBL3301610 · 2026-06-24
Show the evidence
diarrhoea
642
vomiting
147
disease progression
134
malignant neoplasm progression
105
dehydration
98
decreased appetite
92
4 more recorded rows
white blood cell count decreased
75
interstitial lung disease
57
therapy interrupted
57
therapy change
35
recorded 2026-06-24 · last checked 2026-09-04
Q13
Abemaciclib and BCRP, P-GP and MATE1: shared by which compounds?
BCRP, P-GP and MATE1 appear in Abemaciclib's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
CYP Metabolic Pathways: In a clinical drug interaction study in patients with cancer, multiple doses of abemaciclib (200 mg twice daily for 7 days) did not result in clinically meaningful changes in the pharmacokinetics of CYP1A2, CYP2C9, CYP2D6 and CYP3A4 substrates.
CYP2C9pharmacokinetics
CYP Metabolic Pathways: In a clinical drug interaction study in patients with cancer, multiple doses of abemaciclib (200 mg twice daily for 7 days) did not result in clinically meaningful changes in the pharmacokinetics of CYP1A2, CYP2C9, CYP2D6 and CYP3A4 substrates.
CYP2D6pharmacokinetics
CYP Metabolic Pathways: In a clinical drug interaction study in patients with cancer, multiple doses of abemaciclib (200 mg twice daily for 7 days) did not result in clinically meaningful changes in the pharmacokinetics of CYP1A2, CYP2C9, CYP2D6 and CYP3A4 substrates.
CYP3A4
pharmacokinetics
CYP Metabolic Pathways: In a clinical drug interaction study in patients with cancer, multiple doses of abemaciclib (200 mg twice daily for 7 days) did not result in clinically meaningful changes in the pharmacokinetics of CYP1A2, CYP2C9, CYP2D6 and CYP3A4 substrates.
pharmacokinetics
Abemaciclib is a substrate of CYP3A4, and time-dependent changes in pharmacokinetics of abemaciclib as a result of autoinhibition of its metabolism were not observed.
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Abemaciclib studied with fasting?
fasting is named in Abemaciclib's label sentences: "This Phase 2 study (I3Y-MC-JPCP, NCT03703466) randomized 72 patients 1:1:1 to receive abemaciclib 200 mg monotherapy twice daily (1) with a meal, (2) in a modified fasting state or (3) without regard to food." openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
This Phase 2 study (I3Y-MC-JPCP, NCT03703466) randomized 72 patients 1:1:1 to receive abemaciclib 200 mg monotherapy twice daily (1) with a meal, (2) in a modified fasting state or (3) without regard to food.
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Abemaciclib and mTOR?
"Based on preclinical studies showing synergism with simultaneous inhibition of the estrogen receptor (ER), CDK4/6 and PI3K pathways and based on window of opportunity studies showing that metformin suppresses PI3K/mTOR signaling in endometrial cancer (EC), we conduct a non-randomized phase 2 study of letrozole/abemaciclib/metformin in ER…" — where Abemaciclib and mTOR appear together. Europe PMC · pathway abstract search · 2026-04-22
"Based on preclinical studies showing synergism with simultaneous inhibition of the estrogen receptor (ER), CDK4/6 and PI3K pathways and based on window of opportunity studies showing that metformin suppresses PI3K/mTOR signaling in endometrial cancer (EC), we conduct a non-randomized phase 2 study of letrozole/abemaciclib/metformin in ER positive endometrioid EC (NCT03675893)."
PMID 40035822
"The biochemical assays revealed that abemaciclib hindered the progression of breast cancer cells MDA-MB-231 and MCF-7 and enhanced RT (10 Gy) by provoking cell cycle arrest throughout the restraint of CDK4 and CDK6 expression and increasing apoptosis, in addition to decreasing the PI3K/AKT/mTOR and NF-κβ/TGF-β pathway expression; inhibiting CK18 and COX2 activity; boosting the protein…"
PMID 42017452
"We explore how molecular insights may guide novel therapeutic strategies, including targeted agents against the PI3K/AKT/mTOR and Sonic Hedgehog pathways (e.g., everolimus, vismodegib), CDK4/6 inhibitors (e.g., palbociclib, abemaciclib), angiogenesis inhibitors (e.g., sunitinib), and immunotherapies such as PD-1/PD-L1 checkpoint inhibitors."
autophagy
PMID 37132760
"We also demonstrated that both the pro-survival autophagy pathway and the ERK pathway in HNSCC cells were activated with abemaciclib treatment through the generation of reactive oxygen species (ROS)."
PMID 34885226
"Therefore, this study aimed to combine an autophagy inhibitor, MPT0L145, with abemaciclib to improve therapeutic efficiency."
PMID 34885226
"The use of abemaciclib effectively inhibited cell proliferation via suppression of RB phosphorylation and induced autophagy activation in GBM cancer cells."
recorded 2026-04-22 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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