This page shows what was measured, who it was measured in, and what that does not settle.
What Darolutamide does in the body
The treatment of adult patients
From the FDA-approved label: Darolutamide is an androgen receptor (AR) inhibitor. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. A major metabolite, ketodarolutamide, exhibited similar in vitro activity to darolutamide. In addition, darolutamide functioned as a progesterone receptor (PR) antagonist in vitro (approximately 1% activity compared to AR). Darolutamide decreased prostate cancer cell proliferation in vitro and tumor volume in mouse xenograft models of 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 · X05U0N2RCO · read 2026-08-29
Its recorded molecular formula is C19H19ClN6O2, weighing 398.85.
US prescribing information · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. 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 87 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 was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Focus
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Fertility and sexual health
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved1 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Focus
maximally changed cognitive domain
Fertility and sexual health
serum testosterone
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
△ Only a number moved
1 registered test measure.
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
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
NCT06120491
How many people
1898
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
✗ 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
✗ The study did not show it
Who was studied
NCT02200614
How many people
1509
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.8 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.7 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. A result in animals says what to test next. It does not say what happens in people.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□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 drug concentration in plasma of rosuvastatin
c in plasma of non conjugated dabigatran
auc in plasma of midazolam if auc cannot be calculated
c in plasma of midazolam
maximum plasma concentration
time to maximum observed concentration
serum testosterone
Meaningful
Things that change how a life goes, not only a number.
metastasis free survival
progression free survival in mcrpc
progression free survival in mhspc
radiographic progression free survival
recurrence free survival
symptomatic skeletal event free survival
rate of radiographic progression free survival
progression free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (25)
clinical benefit rate
incidence of treatment related adverse events
laboratory assessments
a psa nadir 0 5
occurrence of treatment emergent adverse events
worsening in tug time during the 24 week period
maximally changed cognitive domain
incidence of treatment emergent adverse events
incidence of treatment emergent serious adverse events
distant metastasis
discontinuation rate of sgari treatment
time to discontinuation of sgari treatment
adherence of sgari treatment
clinically significant changes in vital signs
composite event of treatment discontinuation/progression
adverse events and serious adverse events
part a number of dose limiting toxicities
recommended phase 2 dose
area under the curve
incidence of dose limiting toxicities
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. 20 hours hours
Read from the label, which states: “Elimination The effective half-life of darolutamide and ketodarolutamide is approximately 20 hours in patients.”
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.
NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
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 NUBEQA in pediatric patients have not been established.”
US prescribing information · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · read 2026-08-30
On older people, the label states: “Of the 954 patients who received NUBEQA in ARAMIS, 88% of patients were 65 years and over, and 49% were 75 years and over.”
US prescribing information · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The safety and efficacy of NUBEQA have not been established in females.”
US prescribing information · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · read 2026-08-30
On people with reduced liver function, the label states: “Patients with moderate hepatic impairment (Child-Pugh Class B) have a higher exposure to NUBEQA and reduction of the dose is recommended [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ].”
US prescribing information · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · read 2026-08-30
On people with reduced kidney function, the label states: “Patients with severe renal impairment (eGFR 15–29 mL/min/1.73 m 2 ) who are not receiving hemodialysis have a higher exposure to NUBEQA and reduction of the dose is recommended [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ].”
US prescribing information · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · 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.
Darolutamide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 59 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
fatigue — 22 reaction mentions
hospitalisation — 11 reaction mentions
hormone-refractory prostate cancer — 7 reaction mentions
prostatic specific antigen increased — 6 reaction mentions
product dose omission issue — 5 reaction mentions
metastases to bone — 4 reaction mentions
brainstem compression — 1 reaction mentions
gastric cancer recurrent — 1 reaction mentions
nothing by mouth order — 1 reaction mentions
parvovirus b19 test positive — 1 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 · 54893-0107 · read 2026-08-29
They are sold as powder, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 54893-0107 · 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 · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · read 2026-08-29
NUBEQA is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets (300 mg): white to off-white oval film-coated tablets marked with "300" on one side and "Bayer" on the other., recorded as fda label in effect 2025-06-03 in the United States.
US prescribing information · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · 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 Darolutamide 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 Darolutamide 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.
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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.
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FDA substance identifier (UNII)
X05U0N2RCO
RxNorm concept
2180330
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1 approved application covers products containing this substance. The earliest was NDA212099, approved 20190730 to BAYER HEALTHCARE.
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5 questions this page could not answer
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Recorded evidence blocks (12)
Q2
What did Darolutamide's largest trial (13779 people) and its longest (20 years) measure?
13779 people in Darolutamide's largest registered study, 20 years in its longest registered window, measuring Physical function: 400m Walk. ClinicalTrials.gov · 2026-09-01
41 phase2, 25 phase1, 21 phase3, 16 na or unstated, 3 phase4, 1 early phase1; NCT06625970; 2045-10; no ageing endpoint recorded. Last human test completed 2026, NCT05938270.
Interpretation These counts include studies where Darolutamide 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
41
phase1
25
phase3
21
na or unstated
16
phase4
3
early phase1
1
1 more recorded row
Last recorded human testNCT05938270
2026-06-15
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Darolutamide shown healthspan?
Physical function: 400m Walk — the recorded outcome words.
Show the evidence
mouse
mechanism-only
humanNCT05612880
healthspan; Physical function: 400m Walk; 100
recorded 2026-09-01 · last checked 2026-09-04
Q4
7 of Darolutamide's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?
futility/efficacy (1), accrual/recruitment (2), funding/business (1) and other (3): Darolutamide's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Decision Board no further financial support after 3 years of follow-up as remaining patients in follow-up phase would not relevantly change the endpoints."; 7 of 100 registered studies
Show the evidence
Trial
NCT02933801
terminated; "Decision Board no further financial support after 3 years of follow-up as remaining patients in follow-up phase would not relevantly change the endpoints."
NCT03878524
terminated; "Low accrual"
NCT04157088
terminated; "The results of the lead-in phase did not fulfill the criteria set for moving into the randomized phase"
NCT04237584
terminated; "The study was stopped due to insurmountable enrollment challenges affecting trial accrual, resulting from the rapidly evolving treatment options for advanced prostate cancer."
NCT04737109
terminated; "Funder Decision"
NCT05771896
withdrawn; "Bayer withdrew their support."
1 further recorded trialNCT05999968
terminated; "The study was terminated early as related study I3Y-MC-JPCM (NCT03706365) did not meet its primary endpoint."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Darolutamide used Darolutamide 300 mg — over how long?
2 recorded entries; human; also "Darolutamide 300 mg", "Darolutamide (Nubeqa®) 300 mg tablets"
Show the evidence
human
NCT04916613
Darolutamide 300 mg
NCT05413421
Darolutamide (Nubeqa®) 300 mg tablets
recorded 2026-09-01 · last checked 2026-09-04
Q6
Darolutamide's half-life is 20 hours — which schedules were studied?
20 hours, the half-life Darolutamide's label states. openfda-label · 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e · 2026-08-30
bioavailability 30% %.
Show the evidence
half life
20 hours hours; Elimination The effective half-life of darolutamide and ketodarolutamide is approximately 20 hours in patients.
bioavailability
30% %; The absolute bioavailability is approximately 30% following oral administration of a NUBEQA tablet containing 300 mg darolutamide under fasted conditions.
metabolism
Metabolism Darolutamide is primarily metabolized by CYP3A4, as well as by UGT1A9 and UGT1A1.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of a psa nadir 0 5, adherence of sgari treatment and adverse events and serious adverse events did Darolutamide's trials measure?
a psa nadir 0 5, adherence of sgari treatment and adverse events and serious adverse events lead 40 outcome terms across Darolutamide's trials. ClinicalTrials.gov · 2026-09-01
Interpretation auc in plasma of midazolam if auc cannot be calculated, c in plasma of midazolam, clinical benefit rate, incidence of treatment related adverse events, laboratory assessments and progression free survival in mcrpc follow.
Show the evidence
metastasis free survival
1
maximum drug concentration in plasma of rosuvastatin
1
c in plasma of non conjugated dabigatran
1
auc in plasma of midazolam if auc cannot be calculated
1
c in plasma of midazolam
1
clinical benefit rate
1
14 more recorded rows
incidence of treatment related adverse events
1
laboratory assessments
1
progression free survival in mcrpc
1
progression free survival in mhspc
1
a psa nadir 0 5
1
radiographic progression free survival
1
occurrence of treatment emergent adverse events
1
worsening in tug time during the 24 week period
1
recurrence free survival
1
symptomatic skeletal event free survival
1
maximally changed cognitive domain
1
incidence of treatment emergent adverse events
1
incidence of treatment emergent serious adverse events
1
rate of radiographic progression free survival
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Darolutamide's 66 ongoing trials reports first?
Clinical benefit rate defined as proportion of patients who had PSA decline ≥ 50%, complete or partial objective response, or Stable disease for ≥ 12 weeks.; Progression free survival (PFS) in mCRPC; latest 2045-10
Show the evidence
Trial
NCT03385655
"Prostate Cancer Biomarker Enrichment and Treatment Selection"; n 200; "Clinical benefit rate defined as proportion of patients who had PSA decline ≥ 50%, complete or partial objective response, or Stable disease for ≥ 12 weeks."; 2025-12-31
NCT03903835
"ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer"; n 750; "Progression free survival (PFS) in mCRPC"; 2026-12
NCT04025372
"INTREPId (INTermediate Risk Erection PreservatIon Trial)"; n 234; "The percentage of patients with a PSA nadir <= 0.5"; 2028-03-01
NCT04070209
"Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)"; n 66; "Radiographic Progression-free Survival"; 2030-11
NCT04122976
"A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described"; n 805; "Occurrence of treatment-emergent adverse events (TEAEs)"; 2026-10-07
NCT04136353
"Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate"; n 1100; "Metastasis-free survival"; 2028-07-31
14 further recorded trials
NCT04176081
"Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer"; n 208; "Recurrence Free Survival"; 2028-12
NCT04319783
"Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA"; n 65; "Undetectable PSA at 12 months"; 2026-06
NCT04464226
"Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer"; n 402; "Incidence of treatment-emergent adverse events (TEAEs)"; 2028-06-26
NCT04484818
"Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study"; n 27; "Metastasis-free survival (MFS)"; 2028-05-31
NCT04916613
"ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)"; n 300; "Radiographic progression-free survival"; 2037-09
NCT05050084
"Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial"; n 2050; "Distant metastasis (DM) (De-intensification study)"; 2031-11-11
NCT05059236
"A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study."; n 223; "Progression-free survival (PFS)"; 2026-06-05
NCT05116475
"Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases"; n 152; "Failure-free survival FFS"; 2027-02
NCT05348876
"A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)"; n 50; "Number of participants with adverse events (AEs) and serious adverse events (SAEs) and their severity."; 2027-04-29
NCT05367440
"Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer"; n 174; "Number of patients with Adverse Events and Serious Adverse Events"; 2031-04-11
NCT05413421
"Study of ORIC-944 in Patients With Metastatic Prostate Cancer"; n 275; "Recommended Phase 2 Dose (RP2D)"; 2028-04
NCT05519449
"Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)"; n 272; "Incidence of Dose Limiting Toxicities (DLT)"; 2028-12
NCT05669664
"Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers"; n 21; "Best overall response (BOR)"; 2026-11-30
NCT05762536
"Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC"; n 245; "Progression free survival"; 2028-05
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Darolutamide could settle lifespan?
NCT05059236 measures Progression-free survival (PFS), reading out 2026-06-05.
26 open trials; n 223; "A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT…"
Show the evidence
Trial
NCT05059236
"A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study."; n 223; "Progression-free survival (PFS)"; 2026-06-05
NCT03903835
"ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer"; n 750; "Progression free survival (PFS) in mCRPC"; 2026-12
NCT05116475
"Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases"; n 152; "Failure-free survival FFS"; 2027-02
NCT06724159
"Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors."; n 500; "Progresion-free survival rate at 18 months"; 2027-12
NCT06177015
"Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC"; n 200; "Radiographic Progression Free Survival"; 2027-12-31
NCT06652607
"PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer"; n 152; "To evaluate the survival based on the PSA response at six months from the beginning of ARPI in patients with mCSPC."; 2028-04-30
14 further recorded trials
NCT05762536
"Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC"; n 245; "Progression free survival"; 2028-05
NCT04484818
"Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study"; n 27; "Metastasis-free survival (MFS)"; 2028-05-31
NCT04136353
"Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate"; n 1100; "Metastasis-free survival"; 2028-07-31
NCT04176081
"Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer"; n 208; "Recurrence Free Survival"; 2028-12
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
NCT05794906
"A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies"; n 985; "Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)"; 2030-03-29
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
NCT06401980
"Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)"; n 162; "Radiographic progression-free survival (rPFS)"; 2030-09
NCT07723248
"A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)"; n 600; "Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)"; 2030-09
NCT04070209
"Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)"; n 66; "Radiographic Progression-free Survival"; 2030-11
NCT06282588
"Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers"; n 493; "Phase 3: PSMA PET metastasis free survival (ppMFS)"; 2030-12-31
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
NCT06120491
"Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents"; n 1898; "Radiographic Progression-Free Survival (rPFS)"; 2031-04-30
Q10
Which 10 trials of Darolutamide posted no result?
Posted no result
10 of 10 completed trials
Registrations
NCT02671097, NCT03048110, NCT02894385, NCT03237416, NCT02363855 and NCT03704519, and 4 more
Completion dates
oldest 2016-08; newest 2024-04-04
Show the evidence
Trial
NCT02671097
2016-08
NCT03048110
2017-07-19
NCT02894385
2017-12-15
NCT03237416
2017-12-18
NCT02363855
2018-01-18
NCT03704519
2019-11-05
4 further recorded trials
NCT03383679
2022-07-20
NCT05362149
2023-06-30
NCT04558866
2024-04-02
NCT06204302
2024-04-04
Q11
At the median, Darolutamide's trials enrolled 118.5 people — anything larger?
Median enrolment
118.5
Largest enrolment
13779
Registered trials counted
100
Q12
What do 59 spontaneous reports say about Darolutamide — 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.
Darolutamide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 59 reaction mentions were counted: fatigue 22; hospitalisation 11; hormone-refractory prostate cancer 7; prostatic specific antigen increased 6. open-targets-adr · CHEMBL4297185 · 2026-06-24
Show the evidence
fatigue
22
hospitalisation
11
hormone-refractory prostate cancer
7
prostatic specific antigen increased
6
product dose omission issue
5
metastases to bone
4
4 more recorded rows
brainstem compression
1
gastric cancer recurrent
1
nothing by mouth order
1
parvovirus b19 test positive
1
recorded 2026-06-24 · last checked 2026-09-04
Q13
Darolutamide and CYP3A4, P-GP and BCRP: shared by which compounds?
CYP3A4, P-GP and BCRP appear in Darolutamide's recorded interaction sentences, 6 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
In vitro , darolutamide did not inhibit the major CYP enzymes (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4) or transporters (MRP2, BSEP, OATs, OCTs, MATEs, OATP2B1, and NTCP) at clinically relevant concentrations.
CYP3A4
pharmacokinetics
Metabolism Darolutamide is primarily metabolized by CYP3A4, as well as by UGT1A9 and UGT1A1.
pharmacokinetics
Drug Interaction Studies Clinical Studies Combined P-gp and Strong CYP3A4 Inducers Concomitant use of rifampicin (a combined P-gp and strong CYP3A4 inducer) decreased mean darolutamide AUC 0-72 by 72% and C max by 52%.
pharmacokinetics
The decrease of darolutamide exposure by moderate CYP3A4 inducers is expected to be in the range of 36% – 58%.
pharmacokinetics
Combined P-gp and Strong CYP3A4 Inhibitors Itraconazole (a strong combined CYP3A4 and P-gp inhibitor) increased mean darolutamide AUC 0-72 by 1.7- and C max by 1.4-fold.
pharmacokinetics
CYP3A4 substrates Concomitant use of darolutamide decreased the mean AUC and C max of midazolam (CYP3A4 substrate) by 29% and 32%, respectively.
recorded 2026-08-30 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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