This page shows what was measured, who it was measured in, and what that does not settle.
What Capivasertib does in the body
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic
From the FDA-approved label: Capivasertib is an inhibitor of all 3 isoforms of serine/threonine kinase AKT (AKT1, AKT2 and AKT3) and inhibits phosphorylation of downstream AKT substrates. AKT activation in tumors is a result of activation of upstream signaling pathways, mutations in AKT1 , loss of phosphatase and tensin homolog (PTEN) function and mutations in the catalytic subunit alpha of phosphatidylinositol 3-kinase ( PIK3CA ). In vitro , capivasertib reduced growth of breast cancer cell lines including those with relevant PIK3CA or AKT1 mutations or PTEN alteration.
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 · WFR23M21IE · 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 113 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Objective response rate (ORR)
✗ The study did not show it
Who was studied
NCT02465060
How many people
6452
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
Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm
✗ The study did not show it
Who was studied
NCT02299999
How many people
1460
Study design
Phase 2
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
The primary endpoint for Cohorts A to E is confirmed objective response rate as defined by RECIST v1.1 for each cohort separately
✗ The study did not show it
Who was studied
NCT03182634
How many people
1150
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
Overall Survival (OS) in the overall population
✗ The study did not show it
Who was studied
NCT05348577
How many people
1035
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
Radiographic Progression-free Survival (rPFS)
✗ The study did not show it
Who was studied
NCT04493853
How many people
1012
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
progression-free survival in the targeted drug arm compared to standard maintenance therapy arm
✗ The study did not show it
Who was studied
NCT02117167
How many people
999
Study design
Phase 2
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. 4 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.2 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it 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.
maximum observed drug concentration of dextromethorphan
maximum plasma drug concentration
Meaningful
Things that change how a life goes, not only a number.
progression free survival
overall survival
radiographic progression free survival
phase iii 1 progression free survival
progression free survival 1 among in step 2
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 (23)
maximum tolerated dose
objective response rate
recommended phase ii dose
dose limiting toxicity events
dose limiting toxicity for part a1
dlt for part a2
adverse events
overall response rate
occurrence of adverse events part 1
occurrence of serious adverse events part 1
occurrence of adverse events part 2
occurrence of serious adverse events part 2
complete pathologic response
pathological minimal residual disease
phase ib 2 the number of treatment related adverse events
incidence of adverse events
dlts observed during the first cycle
pathologic complete response or minimal residual disease
time to next treatment
phase i maximum tolerated dose / recommended phase 2 dose
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 8.3 hours hours
Read from the label, which states: “Elimination The half-life is 8.3 hours, and the steady-state oral clearance is 50 L/h (37% 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.
TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following…
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 TRUQAP have not been established in pediatric patients.”
US prescribing information · d698c106-2322-401e-b738-cbd83c843ecf · read 2026-08-30
On older people, the label states: “Of the 355 patients who received TRUQAP in CAPItello-291, 115 (32%) patients were ≥ 65 years of age and 24 (7%) patients were ≥ 75 years of age.”
US prescribing information · d698c106-2322-401e-b738-cbd83c843ecf · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary TRUQAP is used in combination with fulvestrant.”
US prescribing information · d698c106-2322-401e-b738-cbd83c843ecf · read 2026-08-30
On people with reduced liver function, the label states: “No dosage modification is recommended for patients with mild hepatic impairment (bilirubin ≤ upper limit of normal (ULN) and AST > ULN or bilirubin > 1 to 1.5x ULN and any AST) [see Clinical Pharmacology (12.3) ] .”
US prescribing information · d698c106-2322-401e-b738-cbd83c843ecf · read 2026-08-30
On people with reduced kidney function, the label states: “No dosage modification is recommended for patients with mild to moderate (creatinine clearance (CLcr) 30 to 89 mL/min) renal impairment [see Clinical Pharmacology (12.3) ] .”
US prescribing information · d698c106-2322-401e-b738-cbd83c843ecf · 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.
Capivasertib appears in spontaneous reports to regulators. Across the 1 most-reported reaction terms, 3 reaction mentions were counted. One report can name several reactions.
The recorded terms (1)
hyperglycaemia — 3 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
4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 17228-9501 · read 2026-08-29
They are sold as tablet, film coated, taken oral.
FDA National Drug Code directory · 17228-9501 · 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 · d698c106-2322-401e-b738-cbd83c843ecf · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · d698c106-2322-401e-b738-cbd83c843ecf · read 2026-08-29
TRUQAP is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: • 160 mg: beige film-coated, round, biconvex tablets debossed with ‘CAV’ above ‘160’ on one side and plain on the reverse. • 200 mg: beige film-coated, capsule-shaped, biconvex tabl…, recorded as fda label in effect 2026-06-12 in the United States.
US prescribing information · d698c106-2322-401e-b738-cbd83c843ecf · 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 Capivasertib 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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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 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)
WFR23M21IE
RxNorm concept
2669972
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
1 approved application covers products containing this substance. The earliest was NDA218197, approved 20231116 to ASTRAZENECA.
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
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (13)
Q2
What did Capivasertib's largest trial (6452 people) and its longest (14 years) measure?
6452 people in Capivasertib's largest registered study, 14 years in its longest registered window, measuring Area under plasma concentration-time curve from zero to infinity (AUCinf) of capivasertib. ClinicalTrials.gov · 2026-09-01
21 phase2, 18 phase1, 9 phase3; NCT02813135; 2031-02; no ageing endpoint recorded. Last human test completed 2026, NCT07241065.
Interpretation These counts include studies where Capivasertib 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
21
phase1
18
phase3
9
Last recorded human testNCT07241065
2026-07-20
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Capivasertib shown healthspan?
withdrawn; "Study was stopped because funder pulled funding for the study. 2 patients were screened however none of the screen patients were eventually recruited"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Capivasertib's half-life is 8.3 hours — which schedules were studied?
8.3 hours, the half-life Capivasertib's label states. openfda-label · d698c106-2322-401e-b738-cbd83c843ecf · 2026-08-30
bioavailability 29% %.
Show the evidence
half life
8.3 hours hours; Elimination The half-life is 8.3 hours, and the steady-state oral clearance is 50 L/h (37% CV).
bioavailability
29% %; The absolute bioavailability is 29%.
metabolism
Metabolism Capivasertib is primarily metabolized by CYP3A4 and UGT2B7.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Which of adverse events, complete pathologic response and dlt for part a2 did Capivasertib's trials measure?
adverse events, complete pathologic response and dlt for part a2 lead 30 outcome terms across Capivasertib's trials. ClinicalTrials.gov · 2026-09-01
recommended phase ii dose, dose limiting toxicity events, overall survival, dose limiting toxicity for part a1, dlt for part a2 and adverse events follow.
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maximum tolerated dose
1
progression free survival
1
objective response rate
1
recommended phase ii dose
1
dose limiting toxicity events
1
overall survival
1
14 more recorded rows
dose limiting toxicity for part a1
1
dlt for part a2
1
adverse events
1
overall response rate
1
radiographic progression free survival
1
occurrence of adverse events part 1
1
occurrence of serious adverse events part 1
1
occurrence of adverse events part 2
1
occurrence of serious adverse events part 2
1
complete pathologic response
1
pathological minimal residual disease
1
phase ib 2 the number of treatment related adverse events
1
phase iii 1 progression free survival
1
incidence of adverse events
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Capivasertib's 30 ongoing trials reports first?
Maximum tolerated dose; Objective response rate (ORR); latest 2032-10-01
Show the evidence
Trial
NCT02208375
"mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian"; n 159; "Maximum tolerated dose"; 2028-06-30
NCT02465060
"Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)"; n 6452; "Objective response rate (ORR)"; 2026-12-31
NCT02523014
"Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas"; n 124; "Progression free survival (PFS)"; 2028-01
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
NCT03660826
"Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone"; n 288; "Progression-free Survival"; 2027-07-01
NCT03742102
"A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer"; n 243; "Dose Limiting Toxicity (DLT) Events"; 2027-02-26
14 further recorded trials
NCT03997123
"Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC"; n 923; "Overall Survival (OS)"; 2026-03-16
NCT04305496
"Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer"; n 818; "Progression Free Survival: Overall Population (Months) in the Global Cohort"; 2026-06-22
NCT04439123
"Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)"; n 35; "Overall Response Rate (ORR)"; 2027-03-31
NCT04493853
"Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency"; n 1012; "Radiographic Progression-free Survival (rPFS)"; 2027-03-31
NCT04556773
"A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer"; n 138; "Occurrence of adverse events (AEs)- Part 1"; 2027-06-01
NCT04812366
"Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer"; n 315; "Complete Pathologic Response (pCR)"; 2027-06-01
NCT04862663
"Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)"; n 893; "Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol."; 2029-08-14
NCT05039801
"IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors"; n 54; "Incidence of adverse events (AEs)"; 2028-06-30
NCT05348577
"Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)"; n 1035; "Overall Survival (OS) in the overall population"; 2026-03-04
NCT05563220
"Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer"; n 435; "Number of Participants with DLTs Observed During the First Cycle"; 2028-12-28
NCT05593497
"A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss"; n 30; "Pathologic Complete Response or Minimal Residual Disease (MRD)"; 2027-08-01
NCT05720260
"Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC"; n 42; "Progression-free survival"; 2027-01-31
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
NCT06607757
"Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer"; n 120; "To assess complete cell cycle arrest (CCCA)."; 2026-08-31
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Capivasertib could settle lifespan?
NCT05348577 measures Overall Survival (OS) in the overall population, reading out 2026-03-04.
9 open trials; n 1035; "Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)"
Show the evidence
Trial
NCT05348577
"Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)"; n 1035; "Overall Survival (OS) in the overall population"; 2026-03-04
NCT03997123
"Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC"; n 923; "Overall Survival (OS)"; 2026-03-16
NCT04305496
"Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer"; n 818; "Progression Free Survival: Overall Population (Months) in the Global Cohort"; 2026-06-22
NCT05720260
"Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC"; n 42; "Progression-free survival"; 2027-01-31
NCT04493853
"Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency"; n 1012; "Radiographic Progression-free Survival (rPFS)"; 2027-03-31
NCT03660826
"Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone"; n 288; "Progression-free Survival"; 2027-07-01
3 further recorded trials
NCT02523014
"Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas"; n 124; "Progression free survival (PFS)"; 2028-01
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
NCT06982521
"Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer"; n 540; "Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)"; 2031-12-31
Q9
Which 6 trials of Capivasertib posted no result?
Posted no result
6 of 6 completed trials
Registrations
NCT04712396, NCT04087174, NCT04944771, NCT04742036, NCT04958226 and NCT02423603
Completion dates
oldest 2021-03-25; newest 2024-06-30
Show the evidence
Trial
NCT04712396
2021-03-25
NCT04087174
2021-06-22
NCT04944771
2022-05-04
NCT04742036
2022-07-29
NCT04958226
2023-02-15
NCT02423603
2024-06-30
Q10
At the median, Capivasertib's trials enrolled 101 people — anything larger?
Median enrolment
101
Largest enrolment
6452
Registered trials counted
41
Q11
What do 3 spontaneous reports say about Capivasertib — 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.
Capivasertib appears in spontaneous reports to regulators. Across the 1 most-reported reaction term, 3 reaction mentions were counted: hyperglycaemia 3. open-targets-adr · CHEMBL2325741 · 2026-06-24
Show the evidence
hyperglycaemia
3
recorded 2026-06-24 · last checked 2026-09-04
Q12
Capivasertib and CYP3A4, BCRP and CYP1A2: shared by which compounds?
CYP3A4, BCRP and CYP1A2 appear in Capivasertib's recorded interaction sentences, 7 in all. openfda-label+europepmc · 2026-08-30
Effect of Capivasertib on CYP2C9 Substrates: Concomitant use of TRUQAP with warfarin (CYP2C9 substrate) is not predicted to have a clinically meaningful effect on warfarin pharmacokinetics.
CYP2D6pharmacokinetics
Effect of Capivasertib on CYP2D6 Substrates: TRUQAP is predicted to increase desipramine (CYP2D6 substrate) AUC by up to 2.1-fold on day 4.
CYP3A4
pharmacokinetics
Metabolism Capivasertib is primarily metabolized by CYP3A4 and UGT2B7.
pharmacokinetics
Effect of Strong and Moderate CYP3A Inducers on Capivasertib: Rifampicin (strong CYP3A4 inducer) is predicted to decrease capivasertib AUC by 70% and C max by 60%.
pharmacokinetics
Efavirenz (moderate CYP3A4 inducer) is predicted to decrease capivasertib AUC by 60% and C max by 50%.
pharmacokinetics
Drug Interaction Studies Clinical Studies and Model-Informed Approaches Effect of Strong and Moderate CYP3A Inhibitors on Capivasertib: Itraconazole (strong CYP3A4 inhibitor) is predicted to increase capivasertib AUC by up to 1.7-fold and C max by up to 1.4-fold.
recorded 2026-08-30 · last checked 2026-09-04
Q13
Was Capivasertib studied with fasting?
fasting is named in Capivasertib's label sentences: "In Part 1, healthy participants (n = 24) were randomized to receive single-dose capivasertib after overnight fasting, a high-fat, high-calorie meal and with rabeprazole postovernight fasting in one of six treatment sequences." openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
In Part 1, healthy participants (n = 24) were randomized to receive single-dose capivasertib after overnight fasting, a high-fat, high-calorie meal and with rabeprazole postovernight fasting in one of six treatment sequences.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Capivasertib and mTOR?
"In rats, SalB improved motor function, reduced tissue damage, and enhanced neuronal survival in association with activation of the AKT/mammalian target of rapamycin (mTOR)/hypoxia-inducible factor-1α (HIF-1α) axis and promoted angiogenesis, while these effects were reversed by AZD5363." — where Capivasertib and mTOR appear together. Europe PMC · pathway abstract search · 2026-06-18
"In rats, SalB improved motor function, reduced tissue damage, and enhanced neuronal survival in association with activation of the AKT/mammalian target of rapamycin (mTOR)/hypoxia-inducible factor-1α (HIF-1α) axis and promoted angiogenesis, while these effects were reversed by AZD5363."
PMID 42314829
"Mechanistically, capivasertib treatment increased AKT phosphorylation, consistent with pharmacodynamic target engagement, while suppressing downstream mTOR/4EBP1 signaling and inducing pro-apoptotic levels."
PMID 42314829
"Collectively, these findings demonstrate that Akt/mTOR inhibition by capivasertib enhances therapeutic efficacy in preclinical NPC models and provides rationale for further clinical evaluation of capivasertib in advanced NPC."
AMPKPMID 40388335
"Salt-induced autophagic activity was enhanced by inhibiting Class I PI3-Kinase (PI3KC1) with LY294002 or Akt with AZD5363, but got undermined by AMPK inhibition with Compound C (CC) or SIRT1 inhibition with EX-527."
sirtuinPMID 40388335
"Salt-induced autophagic activity was enhanced by inhibiting Class I PI3-Kinase (PI3KC1) with LY294002 or Akt with AZD5363, but got undermined by AMPK inhibition with Compound C (CC) or SIRT1 inhibition with EX-527."
autophagyPMID 40388335
"Salt-induced autophagic activity was enhanced by inhibiting Class I PI3-Kinase (PI3KC1) with LY294002 or Akt with AZD5363, but got undermined by AMPK inhibition with Compound C (CC) or SIRT1 inhibition with EX-527."
senolyticPMID 42299774
"Notably, low-dose Capivasertib, an AKT inhibitor targeting tumors with PIK3CA/AKT1/PTEN mutation(s), induced senescence selectively in FUCA2-high LUAD irrespective of PIK3CA/AKT1/PTEN/TP53 mutational status, and its combination with the nutraceutical senolytic procyanidin C1 achieved potent and low-toxicity suppression of LUAD across multiple preclinical models."
autophagy
PMID 38096965
"We explored the effects of AZD5363 (a potent pan-Akt inhibitor) alone and in combination with autophagy inhibitor hydroxycholoroquine sulfate (HCQ) in cultured CCRF-CEM, Jurkat and PF382 cells and a T-ALL xenograft mouse model."
PMID 32681102
"Treatment of THH with AZD5363 and FH535 inhibited cell-cycle progression, enhanced autophagy marker protein expression, and autophagy-associated death, while FH535 treatment alone induced apoptosis."
recorded 2026-06-18 · last checked 2026-09-04
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