This page shows what was measured, who it was measured in, and what that does not settle.
What Ribociclib does in the body
HR-positive, HER2-negative advanced or metastatic breast cancer
From the FDA-approved label: Ribociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6. These kinases are activated upon binding to D-cyclins and are downstream of signaling pathways which lead to cell cycle progression and cellular proliferation. The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the retinoblastoma protein (pRb). In vitro , ribociclib decreased pRb phosphorylation, resulting in arrest in the G1 phase of the cell cycle and reduced proliferation in breast cancer-derived models.
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 · BG7HLX2919 · read 2026-08-29
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 98 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
NCT03701334
How many people
5101
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
NCT07237256
How many people
3902
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
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment With Ribociclib + Letrozole in the Core Phase
✗ The study did not show it
Who was studied
NCT02941926
How many people
3246
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. 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
NCT06996093
How many people
2508
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
NCT07391774
How many people
1978
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 disease-free survival (iDFS)
✗ The study did not show it
Who was studied
NCT04055493
How many people
1684
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.5 registered measures of this kind. 5 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. 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.
phase ii progression free survival
progression free survival by investigator assessment
progression free survival
progression free survival phase ll only
progression free survival per investigator assessment
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)
dose limiting toxicities phase 1b
phase ib incidence of dose limiting toxicities in cycle 1
phase ii objective response rate
dose limiting toxicities
objective response rate
dose escalation incidence of dose limiting toxicity
incidence of dose limiting toxicities phase lb only
safety and tolerability
incidence of dose limiting toxicities
cell cycle response rate per cell proliferation marker ki67
phase ib dose expansion number of adverse events
phase ib dose expansion number of serious adverse events
adverse events
maximally tolerated dose
50 reduction in prostate specific antigen
recommended phase ii dose
cohort a recommended phase2 dose
cohort b clinical benefit rate
cohort c clinical benefit rate
alive and free of progression at 12 weeks
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. 32.0 hours hours
Read from the label, which states: “Elimination The mean plasma effective half-life (CV%) was 32.0 hours (63%) and the mean apparent oral clearance (CL/F) was 25.5 L/hr (66%) at steady-state following 600 mg dose of KISQALI in patients with advanced cancer.”
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.
KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III 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 KISQALI in pediatric patients have not been established.”
US prescribing information · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · read 2026-08-30
On older people, the label states: “Of the 2549 adults with early breast cancer who received KISQALI in NATALEE, 407 patients (16%) were ≥ 65 years of age and 123 patients (2.4%) were ≥ 75 years of age.”
US prescribing information · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies and the mechanism of action, KISQALI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] .”
US prescribing information · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary It is not known if ribociclib is present in human milk.”
US prescribing information · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · read 2026-08-30
On people with reduced liver function, the label states: “No dose adjustment is necessary in patients with breast cancer who have mild hepatic impairment (Child-Pugh class A) [see Clinical Pharmacology (12.3)] .”
US prescribing information · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · read 2026-08-30
On people with reduced kidney function, the label states: “No dose adjustment is necessary in patients with breast cancer who have mild to moderate (30 mL/min to 89 mL/min/1.73 m 2 ≤ estimated glomerular filtration rate (eGFR)) renal impairment.”
US prescribing information · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · 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, tablet, film coated, 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.
Ribociclib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3456 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
11 products list this as an active ingredient in the United States drug directory. 11 of them contain it and nothing else.
FDA National Drug Code directory · 54893-0101 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 54893-0101 · read 2026-08-29
The regulator's established pharmacologic class for it is cytochrome p450 3a inhibitors [moa], kinase inhibitor [epc] and kinase inhibitors [moa].
FDA National Drug Code directory · 54893-0101 · 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 · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · read 2026-08-29
KISQALI is oral at 3 DOSAGE FORMS AND STRENGTHS Tablet: 200 mg ribociclib (equivalent to 254.40 mg ribociclib succinate)., recorded as fda label in effect 2026-07-01 in the United States.
US prescribing information · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · 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 Ribociclib 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 Ribociclib 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.
Where else this substance is registered
FDA substance identifier (UNII)
BG7HLX2919
RxNorm concept
1873983
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: Written into the record, not signed off.
✗ 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
4 approved applications cover products containing this substance. The earliest was NDA209092, approved 20170313 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.
The path through the body — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
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Recorded evidence blocks (13)
Q2
What did Ribociclib's largest trial (5101 people) and its longest (18 years) measure?
5101 people in Ribociclib's largest registered study, 18 years in its longest registered window, measuring Area under the curve from time zero to last quantifiable concentration. ClinicalTrials.gov · 2026-09-01
72 phase1, 71 phase2, 25 phase3, 16 na or unstated, 5 phase4, 3 early phase1, 1 na; NCT06805812; 2040-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT06375707.
Interpretation These counts include studies where Ribociclib 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
phase1
72
phase2
71
phase3
25
na or unstated
16
phase4
5
early phase1
3
2 more recorded rows
na
1
Last recorded human testNCT06375707
2026-05-30
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Ribociclib shown biomarker?
"Lack of efficacy caused enrollment to be stopped at the end of dose escalation"; 28 of 168 registered studies
Show the evidence
Trial
NCT01747876
terminated; "Lack of efficacy caused enrollment to be stopped at the end of dose escalation"
NCT01777776
terminated; "Study was withdrawn due to scientific and business considerations."
NCT01919229
terminated; "Due to low recruitment, it was decided to terminate the study."
NCT02414724
terminated; "PI left institute"
NCT02429089
terminated; "Decided by the investigator due to the difficulties to recruit"
NCT02524119
terminated; "This study was terminated after the sponsor withdrew our support"
14 further recorded trials
NCT02555189
terminated; "Sponsor-PI decision. An analysis of the primary endpoint concluded that the addition of ribociclib to standard of care enzalutamide did not demonstrate benefit, an all active subjects were removed from the study."
NCT02607124
terminated; "A competing trial was opened for patient population with combination of ribociclib and everolimus."
NCT02703571
terminated; "Company decision"
NCT02734615
terminated; "Sponsor's decision"
NCT02780128
terminated; "The goals of Part 1 (molecular screening) were met, but lack of therapies to match molecular aberrations made Part 2 (treatment) no longer feasible."
NCT02974725
terminated; "Business reasons"
NCT03050398
terminated; "GCP issues."
NCT03081234
withdrawn; "Withdrawn due to change in plan for this study and not due to safety reasons."
NCT03179956
terminated; "Slow accrual"
NCT03294694
terminated; "Safety Implications"
NCT03439046
terminated; "Novartis terminated the trial early because the collected data were sufficient to perform the analysis stated for the primary endpoint."
NCT03905343
terminated; "Feasibility (low patient accrual and financial reasons)"
NCT04000529
terminated; "Business reasons"
NCT04256941
terminated; "Despite modifications, accrual was poor and the closed"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Ribociclib used Ribociclib 200Mg Oral Tablet — over how long?
3 recorded entries; human; also "Ribociclib 200Mg Oral Tablet", "Ribociclib 400mg", "Ribociclib 600mg"
Show the evidence
human
NCT04055493
Ribociclib 200Mg Oral Tablet
NCT05216432
Ribociclib 400mg
NCT05216432
Ribociclib 600mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Ribociclib's half-life is 32.0 hours — which schedules were studied?
32.0 hours, the half-life Ribociclib's label states. openfda-label · aaeaef94-f3f5-4367-8ea2-b181d7be2da8 · 2026-08-30
bioavailability 65.8% %.
Show the evidence
half life
32.0 hours hours; Elimination The mean plasma effective half-life (CV%) was 32.0 hours (63%) and the mean apparent oral clearance (CL/F) was 25.5 L/hr (66%) at steady-state following 600 mg dose of KISQALI in patients with advanced cancer.
tmax
Following repeated 600 mg once daily administration, steady-state was generally achieved after 8 days and ribociclib accumulated with a mean accumulation ratio of 2.5 (range, 0.97 to 6.4), and mean (coefficient of variation (CV%)) steady-state ribociclib C max was 1820 (62%) ng/mL and AUC was 23800 (66%) ng*h/mL. Absorption The T max following KISQALI administration was between 1 and 4 hours.
bioavailability
65.8% %; The mean absolute bioavailability of ribociclib after a single oral dose of 600 mg was 65.8%.
metabolism
The apparent volume of distribution at steady-state (Vss/F) was 1090 L. Metabolism Ribociclib undergoes extensive hepatic metabolism mainly via CYP3A4 in humans.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 50 reduction in prostate specific antigen, adverse events and adverse events and serious adverse events did Ribociclib's trials measure?
50 reduction in prostate specific antigen, adverse events and adverse events and serious adverse events lead 40 outcome terms across Ribociclib's trials. ClinicalTrials.gov · 2026-09-01
Interpretation phase ii objective response rate, dose limiting toxicities, objective response rate, dose escalation incidence of dose limiting toxicity, incidence of dose limiting toxicities phase lb only and safety and tolerability follow.
Show the evidence
dose limiting toxicities phase 1b
1
phase ib incidence of dose limiting toxicities in cycle 1
1
phase ii progression free survival
1
phase ii objective response rate
1
dose limiting toxicities
1
objective response rate
1
14 more recorded rows
dose escalation incidence of dose limiting toxicity
1
incidence of dose limiting toxicities phase lb only
1
safety and tolerability
1
incidence of dose limiting toxicities
1
cell cycle response rate per cell proliferation marker ki67
1
progression free survival by investigator assessment
1
progression free survival
1
progression free survival phase ll only
1
phase ib dose expansion number of adverse events
1
phase ib dose expansion number of serious adverse events
1
adverse events
1
progression free survival per investigator assessment
1
maximally tolerated dose
1
50 reduction in prostate specific antigen
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Ribociclib's 78 ongoing trials reports first?
Incidence of Dose limiting toxicities (DLTs) - Phase lb only; Measure changes in [18F]FLT uptake in metastatic tumors before and during treatment with ribociclib (LEE011) only, patient will have FLT PET/CT scan at baseline, run-in day -3,…; latest 2040-12-31
Show the evidence
Trial
NCT01872260
"Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer"; n 255; "Incidence of Dose limiting toxicities (DLTs) - Phase lb only"; 2027-02-26
NCT02608216
"[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer"; n 20; "Measure changes in [18F]FLT uptake in metastatic tumors before and during treatment with ribociclib (LEE011) only, patient will have FLT PET/CT scan at baseline, run-in day -3, and cycle 1, day 1 of ribociclib (LEE011)/paclitaxel therapy"; 2026-11
NCT02712723
"Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer"; n 121; "Rate of PEPI Score 0 at Surgery Between Ribociclib Containing Arms (Combined) vs. Letrozole Alone Arm."; 2026-12
NCT02813135
"European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors"; n 472; "Recommended phase II dose (RP2D)"; 2031-02
NCT02925234
"The Drug Rediscovery Protocol (DRUP Trial)"; n 1550; "Percentage of patients that are treated based on their molecular tumor profile"; 2027-12
NCT02933736
"Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients"; n 48; "Plasma Exposure"; 2027-03
14 further recorded trials
NCT02934568
"Ribociclib (LEE011) Rollover Study for Continued Access"; n 22; "Number of Patients enrolled and received LEE011"; 2027-02-01
NCT03008408
"A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma"; n 90; "Clinical benefit rate (CBR)"; 2028-08-31
NCT03090165
"Ribociclib and Bicalutamide in AR+ TNBC"; n 37; "Phase I: Maximum Tolerated Dose"; 2026-10
NCT03114527
"Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)"; n 48; "Antitumor activity of Ribociclib in combination with Everolimus in advanced LMS or DDL"; 2026-12
NCT03285412
"CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer"; n 120; "ctDNA clearance"; 2026-10
NCT03333343
"Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC"; n 105; "Number of patients with adverse events and serious adverse events"; 2026-10-05
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
NCT03673124
"Ribociclib and Letrozole Treatment in Ovarian Cancer"; n 51; "Objective Response Rate (ORR)"; 2026-12-31
NCT03701334
"A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer"; n 5101; "Invasive Disease-Free Survival (iDFS)"; 2030-05-29
NCT03740334
"Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL"; n 45; "Pharmacokinetic analysis - AUC(0-24hr):"; 2027-04-30
NCT03944434
"FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer"; n 116; "Treatment feasibility"; 2025-11-27
NCT04055493
"Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC"; n 1684; "invasive disease-free survival (iDFS)"; 2027-07-31
NCT04116541
"A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors."; n 455; "Progression free rate after 3 months (12 weeks) of treatment"; 2027-10
NCT04315233
"Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics"; n 34; "MTD of ribociclib and belinostat combination"; 2026-08
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Ribociclib could settle lifespan?
NCT06495164 measures Overall Survival (OS), reading out 2026-12-30.
22 open trials; n 1; "A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer"
Show the evidence
Trial
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
NCT06587789
"Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer"; n 286; "Invasive Disease-Free Survival(iDFS)"; 2027-01-01
NCT04055493
"Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC"; n 1684; "invasive disease-free survival (iDFS)"; 2027-07-31
NCT07195227
"Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer"; n 150; "Progression Free Survival (PFS)"; 2028-03
NCT04964934
"Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)"; n 315; "Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST version 1.1)"; 2028-09-01
NCT06797531
"RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia"; n 177; "Invasive Breast Cancer-Free Survival (iBCFS)"; 2028-11-30
14 further recorded trials
NCT06065748
"A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)"; n 1050; "Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup"; 2029-02-12
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
NCT07391774
"Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial"; n 1978; "Invasive breast cancer-free survival (iBCFS)"; 2029-07-31
NCT05467891
"Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer"; n 200; "Recurrence Free Survival (RFS)"; 2029-08-15
NCT03701334
"A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer"; n 5101; "Invasive Disease-Free Survival (iDFS)"; 2030-05-29
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
NCT05827081
"Phase IIIb Study of Ribociclib + ET in Early Breast Cancer"; n 1400; "Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years"; 2030-09-20
NCT05296746
"Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer"; n 1100; "Distant metastasis-free survival (DMFS) in the ROR-low cohort (responder cohort)"; 2031-12-01
NCT06380751
"Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer"; n 788; "Progression-Free Survival (Arm 1 vs arm 2)"; 2031-12-30
NCT07085767
"Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer"; n 1000; "Progression-Free Survival (PFS)"; 2032-01
NCT06930859
"Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia"; n 2766; "Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort"; 2032-12-31
NCT05843253
"Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant"; n 120; "Progression-Free Survival (PFS) in HGG (Part 2, Stratum A)"; 2034-08-28
NCT07492641
"BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease"; n 1056; "Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)"; 2037-08-07
NCT06760637
"Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease"; n 1035; "Progression Free Survival (PFS) by BICR"; 2037-12-29
Q10
Which 23 trials of Ribociclib posted no result?
Posted no result
23 of 23 completed trials
Registrations
NCT01898845, NCT02154776, NCT02388620, NCT01237236, NCT02088684 and NCT02431481, and 17 more
Completion dates
oldest 2015-01; newest 2024-06-30
Show the evidence
Trial
NCT01898845
2015-01
NCT02154776
2016-10-26
NCT02388620
2017-01-09
NCT01237236
2017-03-09
NCT02088684
2018-04-17
NCT02431481
2018-05-11
14 further recorded trials
NCT02292550
2018-09-26
NCT02599363
2019-03-12
NCT03248427
2019-07-20
NCT02343172
2019-10-16
NCT01857193
2020-04-16
NCT05153135
2020-07-31
NCT02370706
2020-11-09
NCT05569187
2021-10-29
NCT03237390
2022-05-17
NCT03555877
2022-07-21
NCT03355794
2022-07-31
NCT03056833
2022-08-01
NCT02333370
2022-09-29
NCT03009201
2023-06-30
Q11
At the median, Ribociclib's trials enrolled 104 people — anything larger?
Median enrolment
104
Largest enrolment
5101
Registered trials counted
167
Q12
What do 3456 spontaneous reports say about Ribociclib — 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.
Ribociclib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3456 reaction mentions were counted: neutropenia 879; nausea 464; fatigue 412; malignant neoplasm progression 335. open-targets-adr · CHEMBL3545110 · 2026-06-24
Show the evidence
neutropenia
879
nausea
464
fatigue
412
malignant neoplasm progression
335
leukopenia
293
electrocardiogram qt prolonged
289
4 more recorded rows
anaemia
226
white blood cell count decreased
216
alanine aminotransferase increased
173
metastases to bone
169
recorded 2026-06-24 · last checked 2026-09-04
Q13
Ribociclib and CYP3A4, CYP1A2 and BCRP: shared by which compounds?
CYP3A4, CYP1A2 and BCRP appear in Ribociclib's recorded interaction sentences, 21 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2
pharmacokinetics
It has no potential for time-dependent inhibition of CYP1A2, CYP2C9, and CYP2D6, and no induction of CYP1A2, CYP2B6, CYP2C9, and CYP3A4 at clinically relevant concentrations.
pharmacokinetics
In vitro Studies Effect of Ribociclib on CYP Enzymes: In vitro , ribociclib was a reversible inhibitor of CYP1A2, CYP2E1 and CYP3A4/5 and a time-dependent inhibitor of CYP3A4/5, at clinically relevant concentrations.
pharmacokinetics
Drugs That are Affected by KISQALI CYP3A4 and CYP1A2 Substrates: In a cocktail study with midazolam (sensitive CYP3A4 substrate) multiple doses of ribociclib (400 mg once daily for 8 days) increased midazolam C max by 2.1-fold and increased AUC inf by 3.8-fold compared to midazolam alone.
pharmacokinetics
Only weak inhibitory effects on CYP1A2 substrates are predicted at KISQALI 600 mg once daily dose.
pharmacokinetics
The effect of multiple doses of 400 mg ribociclib on caffeine (sensitive CYP1A2 substrate) was minimal, with C max decreased by 10% and AUC inf increased by 20%.
CYP2A6pharmacokinetics
In vitro evaluations indicated that ribociclib has no potential to inhibit the activities of CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant concentrations.
CYP2B6
pharmacokinetics
It has no potential for time-dependent inhibition of CYP1A2, CYP2C9, and CYP2D6, and no induction of CYP1A2, CYP2B6, CYP2C9, and CYP3A4 at clinically relevant concentrations.
pharmacokinetics
In vitro evaluations indicated that ribociclib has no potential to inhibit the activities of CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant concentrations.
CYP2C19pharmacokinetics
In vitro evaluations indicated that ribociclib has no potential to inhibit the activities of CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant concentrations.
CYP2C8pharmacokinetics
In vitro evaluations indicated that ribociclib has no potential to inhibit the activities of CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant concentrations.
CYP2C9
pharmacokinetics
It has no potential for time-dependent inhibition of CYP1A2, CYP2C9, and CYP2D6, and no induction of CYP1A2, CYP2B6, CYP2C9, and CYP3A4 at clinically relevant concentrations.
pharmacokinetics
In vitro evaluations indicated that ribociclib has no potential to inhibit the activities of CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant concentrations.
CYP2D6
pharmacokinetics
It has no potential for time-dependent inhibition of CYP1A2, CYP2C9, and CYP2D6, and no induction of CYP1A2, CYP2B6, CYP2C9, and CYP3A4 at clinically relevant concentrations.
pharmacokinetics
In vitro evaluations indicated that ribociclib has no potential to inhibit the activities of CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant concentrations.
CYP2E1pharmacokinetics
In vitro Studies Effect of Ribociclib on CYP Enzymes: In vitro , ribociclib was a reversible inhibitor of CYP1A2, CYP2E1 and CYP3A4/5 and a time-dependent inhibitor of CYP3A4/5, at clinically relevant concentrations.
CYP3A4
pharmacokinetics
Metabolism Ribociclib undergoes extensive hepatic metabolism mainly via CYP3A4 in humans.
pharmacokinetics
It has no potential for time-dependent inhibition of CYP1A2, CYP2C9, and CYP2D6, and no induction of CYP1A2, CYP2B6, CYP2C9, and CYP3A4 at clinically relevant concentrations.
pharmacokinetics
CYP3A Inducers: Following a single 600 mg dose of KISQALI with rifampicin (a strong CYP3A4 inducer) at 600 mg daily for 14 days, ribociclib C max decreased by 81% and AUC inf decreased by 89%, while LEQ803 C max increased 1.7-fold and AUC inf decreased by 27% compared to ribociclib alone.
pharmacokinetics
A moderate CYP3A4 inhibitor (erythromycin) is predicted to increase ribociclib steady-state C max and AUC by 1.1-fold and 1.2-fold, respectively, following KISQALI 400 mg once daily, and 1.1-fold and 1.1-fold, respectively, following KISQALI 600 mg once daily.
pharmacokinetics
In vitro Studies Effect of Ribociclib on CYP Enzymes: In vitro , ribociclib was a reversible inhibitor of CYP1A2, CYP2E1 and CYP3A4/5 and a time-dependent inhibitor of CYP3A4/5, at clinically relevant concentrations.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Ribociclib and mTOR?
"Using HR<sup>+</sup>/HER2<sup>-</sup> BC models with acquired resistance to the CDK4/6 inhibitors Palbociclib or Ribociclib, we uncovered a metabolic vulnerability in highly resistant clones, mediated by mTORC1 hyperactivation and autophagy suppression." — where Ribociclib and mTOR appear together. Europe PMC · pathway abstract search · 2026-04-09
"Using HR<sup>+</sup>/HER2<sup>-</sup> BC models with acquired resistance to the CDK4/6 inhibitors Palbociclib or Ribociclib, we uncovered a metabolic vulnerability in highly resistant clones, mediated by mTORC1 hyperactivation and autophagy suppression."
autophagyPMID 41714320
"Using HR<sup>+</sup>/HER2<sup>-</sup> BC models with acquired resistance to the CDK4/6 inhibitors Palbociclib or Ribociclib, we uncovered a metabolic vulnerability in highly resistant clones, mediated by mTORC1 hyperactivation and autophagy suppression."
mTOR
PMID 41206763
"A Phase 0/1 clinical trial combined the 2 targeted inhibitors ribociclib (CDK4/6 inhibitor) and everolimus (mTOR inhibitor) in recurrent HGG patients, aiming to identify brain-penetrant combinations and assess their impact on malignant cell states."
PMID 41963133
"Indeed, the frequency and presentation of these CV toxicities vary according to the TT: arterial hypertension with VEGFR inhibitors, thromboembolic events with abemaciclib, left ventricular dysfunction with osimertinib or BRAF/MEK inhibitors, QTc prolongation with ribociclib or vandetanib, and metabolic disorders (dyslipidemia, hyperglycemia) with PI3K/AKT/mTOR pathway inhibitors."
autophagy
PMID 34138895
"Combining high concentrations of FRAX486, which weakly inhibits PAK4, and Ribociclib, mimics the autophagy and apoptotic effect of PF03758309 combined with Ribociclib."
PMID 34138895
"FRAX597, a PAKi that does not inhibit PAK4 did not reduce autophagy in combination with Ribociclib."
AMPKPMID 28453226
"Moreover, two other CDK4/6 inhibitors (ribociclib and abemaciclib) had minimal effects on HCC cell viability and the PP5/AMPK axis."
recorded 2026-04-09 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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