This page shows what was measured, who it was measured in, and what that does not settle.
What Apalutamide does in the body
ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
From the FDA-approved label: Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.
Why people take it. ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
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 · 4T36H88UA7 · read 2026-08-29
Its recorded molecular formula is C21H15F4N5O2S, weighing 477.44.
US prescribing information · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · read 2026-08-30
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 164 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
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.
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.
Overall Survival (OS)
✗ The study did not show it
Who was studied
NCT06320067
How many people
3360
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
Metastasis-free survival (MFS)
✗ The study did not show it
Who was studied
NCT04513717
How many people
2753
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percentage of Participants with Pathologic complete response (pCR)
✗ The study did not show it
Who was studied
NCT03767244
How many people
2517
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
overall survival
✗ The study did not show it
Who was studied
NCT05974774
How many people
1600
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
Metastasis-Free Survival (MFS)
✗ The study did not show it
Who was studied
NCT02531516
How many people
1503
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
Overall survival (primary efficacy)
✗ The study did not show it
Who was studied
NCT07751133
How many people
1500
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.7 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 healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.6 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.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
■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 plasma concentration
time to reach maximum concentration
time to last quantifiable plasma concentration
maximum observed plasma concentration
allocation serum marker decline
time to reach maximum observed plasma concentration
Meaningful
Things that change how a life goes, not only a number.
radiographic progression free survival
overall survival
metastasis free survival
2 year progression free survival
psa progression free survival
progression free survival
disease free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (27)
safety
pharmacokinetics
maximum tolerated dose
dose limiting toxicity
extrapolated auc
elimination half life
rate constant
androgen receptor response marker signature
biochemical failure
pathologic response
time to second injection
apparent clearance
apparent terminal elimination half life
apparent terminal elimination rate constant
apparent volume of distribution
that achieves an undetectable psa level defined as 0 2
combined pcr or mrd rate
time to prostate specific antigen progression
dose limiting toxicities
incidence and severity of adverse events
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. 3 days
Read from the label, which states: “Elimination Apalutamide half-life is approximately 3 days.”
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.
ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )
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: “Safety and effectiveness of ERLEADA in pediatric patients have not been established.”
US prescribing information · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · read 2026-08-30
On older people, the label states: “Of the 1327 patients who received ERLEADA in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over.”
US prescribing information · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The safety and efficacy of ERLEADA have not been established in females.”
US prescribing information · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · read 2026-08-30
On people with reduced liver function, the label states: “The recommended ERLEADA dosage in patients with severe hepatic impairment (Child-Pugh C) is lower than the recommended dosage in patients with normal hepatic function [see Dosage and Administration (2.3) ] .”
US prescribing information · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · 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: S3.
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.
Apalutamide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 784 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
rash — 282 reaction mentions
fatigue — 164 reaction mentions
hot flush — 71 reaction mentions
decreased appetite — 66 reaction mentions
pruritus — 65 reaction mentions
disease progression — 49 reaction mentions
prostatic specific antigen increased — 47 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
17 products list this as an active ingredient in the United States drug directory. 17 of them contain it and nothing else.
FDA National Drug Code directory · 71796-033 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 71796-033 · 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 · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · read 2026-08-29
ERLEADA is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 240 mg: bluish grey to grey, oval, film-coated and debossed with "E240" on one side. 60 mg: slightly yellowish to greyish green, oblong, film-coated and debossed with "AR 60" on one…, recorded as fda label in effect 2026-07-02 in the United States.
US prescribing information · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · 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 Apalutamide 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 Apalutamide 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)
4T36H88UA7
RxNorm concept
1999581
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Quoted from a stored source.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S3.
✓ 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
2 approved applications cover products containing this substance. The earliest was NDA210951, approved 20180214 to JANSSEN BIOTECH.
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 Apalutamide's largest trial (13779 people) and its longest (18 years) measure?
13779 people in Apalutamide's largest registered study, 18 years in its longest registered window, measuring Physical function: 400m Walk. ClinicalTrials.gov · 2026-09-01
52 phase2, 24 phase1, 20 phase3, 18 na or unstated, 2 na, 2 phase4; NCT04513717; 2038-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT05901649.
Interpretation These counts include studies where Apalutamide 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
52
phase1
24
phase3
20
na or unstated
18
na
2
phase4
2
1 more recorded row
Last recorded human testNCT05901649
2026-06-16
recorded 2026-09-01 · last checked 2026-09-04
Q3
Apalutamide was tested only in human — what did it show?
1 recorded entry; human; also "Apalutamide 240 mg"
Show the evidence
humanNCT03551782
Apalutamide 240 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Apalutamide's half-life is 3 days — which schedules were studied?
3 days, the half-life Apalutamide's label states. openfda-label · d1cda4f7-cb33-46ea-b9ac-431f6452b1a5 · 2026-08-30
bioavailability 100% %.
Show the evidence
half life
3 days; Elimination Apalutamide half-life is approximately 3 days.
tmax
Apalutamide median (min, max) time to maximum plasma concentration (t max ) is 2 hours (1, 5 hours).
bioavailability
100% %; Absorption Apalutamide absolute oral bioavailability is approximately 100%.
metabolism
Metabolism Apalutamide is primarily metabolized by CYP2C8 and CYP3A4 to form active metabolite, N-desmethyl apalutamide.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 2 year progression free survival, adverse events and aes by severity did Apalutamide's trials measure?
2 year progression free survival, adverse events and aes by severity lead 40 outcome terms across Apalutamide's trials. ClinicalTrials.gov · 2026-09-01
Interpretation dose limiting toxicity, maximum plasma concentration, time to reach maximum concentration, extrapolated auc, elimination half life and rate constant follow.
Show the evidence
safety
1
pharmacokinetics
1
maximum tolerated dose
1
dose limiting toxicity
1
maximum plasma concentration
1
time to reach maximum concentration
1
14 more recorded rows
extrapolated auc
1
elimination half life
1
rate constant
1
time to last quantifiable plasma concentration
1
radiographic progression free survival
1
overall survival
1
metastasis free survival
1
maximum observed plasma concentration
1
androgen receptor response marker signature
1
allocation serum marker decline
1
biochemical failure
1
pathologic response
1
time to second injection
1
time to reach maximum observed plasma concentration
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Apalutamide's 51 ongoing trials reports first?
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR); Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone; latest 2039-05-08
Show the evidence
Trial
NCT01946204
"A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer"; n 1207; "Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)"; 2027-12-31
NCT02123758
"A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer"; n 57; "Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone"; 2027-12-31
NCT02257736
"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)"; n 982; "Radiographic Progression-free Survival (rPFS)"; 2027-12-31
NCT02489318
"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC"; n 1052; "Radiographic Progression-free Survival (rPFS)"; 2027-12-31
NCT02531516
"An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS"; n 1503; "Metastasis-Free Survival (MFS)"; 2028-12-29
NCT02592317
"A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer"; n 23; "Maximum Observed Plasma Concentration (Cmax)"; 2027-12-31
14 further recorded trials
NCT02703623
"Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer"; n 196; "Overall survival (OS)"; 2028-03-31
NCT03371719
"Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial"; n 298; "Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)"; 2026-10-27
NCT03412396
"Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy"; n 45; "Number of Adverse Surgical Pathology Features at Risk of Pelvic Radiation Therapy"; 2026-03-30
NCT03436654
"Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma"; n 102; "Pathologic Response (pCR + MRD) in the RP specimen"; 2027-02-14
NCT03523442
"A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer"; n 19; "Plasma Concentration of Apalutamide"; 2026-12-31
NCT03767244
"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy"; n 2517; "Percentage of Participants with Pathologic complete response (pCR)"; 2028-10-13
NCT03821792
"Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer"; n 60; "Time on treatment"; 2026-10-11
NCT03902951
"Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer"; n 28; "Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL"; 2028-01-01
NCT03903835
"ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer"; n 750; "Progression free survival (PFS) in mCRPC"; 2026-12
NCT04134260
"Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial"; n 586; "Metastasis-free survival (MFS)"; 2031-11-01
NCT04181203
"Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy"; n 490; "Progression-free survival (PFS)"; 2033-12-28
NCT04267887
"Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer"; n 7; "Complete prostate specific antigen (PSA) response"; 2030-01-01
NCT04325828
"A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma"; n 31; "Overall Response Rate (ORR)"; 2027-12-31
NCT04423211
"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging"; n 804; "Progression-free survival (PFS)"; 2032-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Apalutamide could settle lifespan?
NCT06758882 measures Radiological progression-free survival (RPFS), reading out 2026-06.
22 open trials; n 94; "Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET"
Show the evidence
Trial
NCT06758882
"Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET"; n 94; "Radiological progression-free survival (RPFS)"; 2026-06
NCT03371719
"Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial"; n 298; "Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)"; 2026-10-27
NCT03903835
"ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer"; n 750; "Progression free survival (PFS) in mCRPC"; 2026-12
NCT05534646
"Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer"; n 100; "Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab"; 2027-01
NCT01946204
"A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer"; n 1207; "Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)"; 2027-12-31
NCT02257736
"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)"; n 982; "Radiographic Progression-free Survival (rPFS)"; 2027-12-31
14 further recorded trials
NCT02489318
"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC"; n 1052; "Radiographic Progression-free Survival (rPFS)"; 2027-12-31
NCT02703623
"Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer"; n 196; "Overall survival (OS)"; 2028-03-31
NCT04947254
"Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer"; n 200; "Composite radiographic progression-free survival(rPFS) and biochemical (PSA) progression-free survival (PFS)"; 2028-06-07
NCT05884398
"A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC"; n 420; "Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)"; 2028-10-12
NCT06473259
"Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients"; n 3000; "progression free survival"; 2028-12
NCT02531516
"An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS"; n 1503; "Metastasis-Free Survival (MFS)"; 2028-12-29
NCT07611110
"AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)"; n 670; "Radiographic Progression-Free Survival (rPFS)"; 2030-06-06
NCT06378866
"Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial"; n 532; "Modified radiographic progression-free survival (mrPFS) (Groups A & B)"; 2031-02-28
NCT06592924
"Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response"; n 830; "Overall Survival"; 2031-04-15
NCT04557059
"A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer"; n 691; "Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)"; 2031-09-15
NCT04134260
"Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial"; n 586; "Metastasis-free survival (MFS)"; 2031-11-01
NCT06430411
"Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study"; n 500; "Radiographic progression-free survival (rPFS)"; 2031-12-31
NCT04423211
"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging"; n 804; "Progression-free survival (PFS)"; 2032-12-31
NCT04181203
"Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy"; n 490; "Progression-free survival (PFS)"; 2033-12-28
Q10
Which 19 trials of Apalutamide posted no result?
Posted no result
19 of 19 completed trials
Registrations
NCT02031666, NCT02230033, NCT02835508, NCT02524717, NCT03802682 and NCT02162836, and 13 more
Completion dates
oldest 2014-04; newest 2024-08-13
Show the evidence
Trial
NCT02031666
2014-04
NCT02230033
2014-12
NCT02835508
2016-12
NCT02524717
2017-02-09
NCT03802682
2019-04-11
NCT02162836
2019-05-27
13 further recorded trials
NCT02924766
2019-07-19
NCT03365297
2019-07-25
NCT03124433
2019-08-22
NCT02366494
2021-05-11
NCT02106507
2021-06-28
NCT02867020
2021-06-30
NCT03551782
2021-11-11
NCT02789878
2022-08-01
NCT02578797
2022-10-13
NCT05362149
2023-06-30
NCT06204302
2024-04-04
NCT04666129
2024-05-28
NCT04034095
2024-08-13
Q11
At the median, Apalutamide's trials enrolled 90 people — anything larger?
Median enrolment
90
Largest enrolment
13779
Registered trials counted
115
Q12
What do 784 spontaneous reports say about Apalutamide — 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.
Apalutamide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 784 reaction mentions were counted: rash 282; fatigue 164; hot flush 71; decreased appetite 66. open-targets-adr · CHEMBL3183409 · 2026-06-24
Show the evidence
rash
282
fatigue
164
hot flush
71
decreased appetite
66
pruritus
65
disease progression
49
4 more recorded rows
prostatic specific antigen increased
47
blood thyroid stimulating hormone increased
16
headache
13
dermatitis exfoliative generalised
11
recorded 2026-06-24 · last checked 2026-09-04
Q13
Apalutamide and CYP3A4, CYP2C8 and BCRP: shared by which compounds?
CYP3A4, CYP2C8 and BCRP appear in Apalutamide's recorded interaction sentences, 18 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Apalutamide does not inhibit or induce CYP1A2 and CYP2D6.
CYP2B6pharmacokinetics
In Vitro Studies CYP450 Enzymes : Apalutamide and N-desmethyl apalutamide induce and inhibit CYP2B6.
CYP2C19pharmacokinetics
CYP3A4, CYP2C19, CYP2C9, and CYP2C8 substrates : Co-administration of ERLEADA with single oral doses of sensitive CYP substrates resulted in a 92% decrease in the AUC of midazolam (a CYP3A4 substrate), 85% decrease in the AUC of omeprazole (a CYP2C19 substrate), and 46% decrease in the AUC of S-warfarin (a CYP2C9 substrate).
CYP2C8
pharmacokinetics
Metabolism Apalutamide is primarily metabolized by CYP2C8 and CYP3A4 to form active metabolite, N-desmethyl apalutamide.
pharmacokinetics
The contribution of CYP2C8 and CYP3A4 in the metabolism of apalutamide is estimated to be 58% and 13% following single dose but changes to 40% and 37%, respectively at steady-state.
pharmacokinetics
Strong CYP3A4 and moderate CYP2C8 inducers : Rifampin (a strong CYP3A4 and moderate CYP2C8 inducer) is predicted to decrease the steady-state apalutamide C max by 25% and AUC by 34%.
pharmacokinetics
Drug Interactions Clinical Studies and Model-Informed Approaches Strong CYP2C8 inhibitors : Apalutamide C max decreased by 21% while AUC increased by 68% following co-administration of ERLEADA as a 240 mg single dose with gemfibrozil (a strong CYP2C8 inhibitor).
pharmacokinetics
CYP3A4, CYP2C19, CYP2C9, and CYP2C8 substrates : Co-administration of ERLEADA with single oral doses of sensitive CYP substrates resulted in a 92% decrease in the AUC of midazolam (a CYP3A4 substrate), 85% decrease in the AUC of omeprazole (a CYP2C19 substrate), and 46% decrease in the AUC of S-warfarin (a CYP2C9 substrate).
pharmacokinetics
ERLEADA did not cause clinically significant changes in exposure to a CYP2C8 substrate.
CYP2C9pharmacokinetics
CYP3A4, CYP2C19, CYP2C9, and CYP2C8 substrates : Co-administration of ERLEADA with single oral doses of sensitive CYP substrates resulted in a 92% decrease in the AUC of midazolam (a CYP3A4 substrate), 85% decrease in the AUC of omeprazole (a CYP2C19 substrate), and 46% decrease in the AUC of S-warfarin (a CYP2C9 substrate).
CYP2D6pharmacokinetics
Apalutamide does not inhibit or induce CYP1A2 and CYP2D6.
CYP3A4
pharmacokinetics
Metabolism Apalutamide is primarily metabolized by CYP2C8 and CYP3A4 to form active metabolite, N-desmethyl apalutamide.
pharmacokinetics
The contribution of CYP2C8 and CYP3A4 in the metabolism of apalutamide is estimated to be 58% and 13% following single dose but changes to 40% and 37%, respectively at steady-state.
pharmacokinetics
The CL/F of apalutamide is 1.3 L/h after single dosing and increases to 2.0 L/h at steady-state after once-daily dosing likely due to CYP3A4 auto-induction.
pharmacokinetics
Strong CYP3A4 and moderate CYP2C8 inducers : Rifampin (a strong CYP3A4 and moderate CYP2C8 inducer) is predicted to decrease the steady-state apalutamide C max by 25% and AUC by 34%.
pharmacokinetics
Strong CYP3A4 inhibitors : Apalutamide C max decreased by 22% while AUC was similar following co-administration of ERLEADA 240 mg as a single dose with itraconazole (a strong CYP3A4 inhibitor).
pharmacokinetics
Ketoconazole (a strong CYP3A4 inhibitor) is predicted to increase the single-dose apalutamide AUC by 24% but have no impact on C max .
1 more recorded row
CYP3A4pharmacokinetics
CYP3A4, CYP2C19, CYP2C9, and CYP2C8 substrates : Co-administration of ERLEADA with single oral doses of sensitive CYP substrates resulted in a 92% decrease in the AUC of midazolam (a CYP3A4 substrate), 85% decrease in the AUC of omeprazole (a CYP2C19 substrate), and 46% decrease in the AUC of S-warfarin (a CYP2C9 substrate).
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Apalutamide and autophagy?
"First, this study established apalutamide-resistant prostate cancer (PCa) cells, and confirmed that apalutamide activated the release of calcium ions (Ca<sup>2+</sup>) and endoplasmic reticulum stress (ERS) to enhance autophagy." — where Apalutamide and autophagy appear together. Europe PMC · pathway abstract search · 2024-06-06
autophagy; PMID 38844946, 32466878
Show the evidence
autophagy
PMID 38844946
"First, this study established apalutamide-resistant prostate cancer (PCa) cells, and confirmed that apalutamide activated the release of calcium ions (Ca<sup>2+</sup>) and endoplasmic reticulum stress (ERS) to enhance autophagy."
PMID 38844946
"Furthermore, immunofluorescence and transmission electron microscopy (TEM) showed that CAPN2 promoted apalutamide resistance by activating protective autophagy."
PMID 32466878
"Therefore, we investigated the characteristics of autophagic response to ARN-509 treatment and evaluated the potential effect of a combination with autophagy inhibition."
recorded 2024-06-06 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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