This page shows what was measured, who it was measured in, and what that does not settle.
What Bicalutamide does in the body
Stage D 2 metastatic carcinoma of the prostate
From the FDA-approved label: Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen. When bicalutamide is combined with LHRH analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with bicalutamide as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted.
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
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · A0Z3NAU9DP · read 2026-08-29
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 117 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What 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
Energy
∅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.
Which registered measures put each goal on this table
Energy
vitality
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.
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.
Disease-specific survival (i.e., death due to prostate cancer) (RADICALS-HD)
✗ The study did not show it
Who was studied
NCT00541047
How many people
4236
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
Time to clinical progression
✗ The study did not show it
Who was studied
NCT00657904
How many people
3618
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
Time to clinical progression
✗ The study did not show it
Who was studied
NCT00673205
How many people
3588
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
NCT00002651
How many people
3040
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
Progression-Free Survival
✗ The study did not show it
Who was studied
NCT00303784
How many people
2200
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.10 registered measures of this kind. 6 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 lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
quality of life questionnaire core 30
quality of life
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
overall survival
disease free survival at 5 years
disease free survival
disease specific survival
progression free survival
clinical progression free survival
time to disease progression
progression free survival in intent to treat population
progression free survival rate at month 36 in itt population
time to prostate specific antigen relapse
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 (28)
physical functioning as measured by the sf 36
erectile dysfunction
high libido
vitality
time to progression
toxicity
biological response prostate specific antigen level
cancer progression as measured by ultrasound
acute and late toxicity during the study
growth rate
free of psa progression at 6 months
progression free at 18 months
interval before biochemical failure
maximum tolerated dose of samarium 153
safety
efficacy
prostate specific antigen failures
toxicity rate
psa response rate
free from progression at 3 years
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
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.
Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2)].
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: “Pediatric Use The safety and effectiveness of bicalutamide in pediatric patients have not been established.”
US prescribing information · c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6 · read 2026-08-30
On older people, the label states: “Geriatric Use In two studies in patients given 50 or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown.”
US prescribing information · c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6 · read 2026-08-30
On people who are pregnant, the label states: “Pregnancy Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm.”
US prescribing information · c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6 · read 2026-08-30
On people who are breastfeeding, the label states: “Lactation Risk Summary Bicalutamide is not indicated for use in pregnant women.”
US prescribing information · c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6 · 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
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
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.
Bicalutamide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 850 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
interstitial lung disease — 142 reaction mentions
prostatic specific antigen increased — 119 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
22 products list this as an active ingredient in the United States drug directory. 22 of them contain it and nothing else.
FDA National Drug Code directory · 54893-0001 · read 2026-08-29
They are sold as powder, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 54893-0001 · read 2026-08-29
The regulator's established pharmacologic class for it is androgen receptor antagonists [moa] and androgen receptor inhibitor [epc].
FDA National Drug Code directory · 54893-0001 · read 2026-08-29
11 published labels name it as an active ingredient. 11 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6 · read 2026-08-29
Bicalutamide is oral at 3., recorded as fda label in effect 2022-11-01 in the United States.
US prescribing information · c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6 · read 2026-08-30
Recorded price in US: 0.4163 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 5 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Bicalutamide 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 Bicalutamide 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)
A0Z3NAU9DP
RxNorm concept
199123
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ 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
15 approved applications cover products containing this substance. The earliest was NDA020498, approved 19951004 to ANI PHARMS.
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.
The path through the body — found nothing in the sources checked.
How long anything takes — 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 (14)
Q1
What did Bicalutamide's largest trial (4236 people) and its longest (27 years) measure?
4236 people in Bicalutamide's largest registered study, 27 years in its longest registered window, measuring Survival time. ClinicalTrials.gov · 2026-09-01
79 phase2, 49 phase3, 32 phase1, 6 na, 5 phase4, 4 na or unstated, 2 early phase1; NCT00223145; 2027-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT01251861.
Interpretation These counts include studies where Bicalutamide 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
79
phase3
49
phase1
32
na
6
phase4
5
na or unstated
4
2 more recorded rows
early phase1
2
Last recorded human testNCT01251861
2026-05-26
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Bicalutamide shown lifespan?
5 recorded entries; human; tablet; also "Casodex 150mg", "Casodex 80 mg tablet", "Bicalutamide 150 mg"
Show the evidence
human
NCT00223145
Bicalutamide 50 mg
NCT00590213
Casodex 150mg
NCT01415778
tablet; Casodex 80 mg tablet
NCT03055312
Bicalutamide 150 mg
NCT04374279
Bicalutamide 150 Mg Oral Tablet
recorded 2026-09-01 · last checked 2026-09-04
Q5
Could one person measure Bicalutamide's effect on overall survival?
Overall survival: measured in Bicalutamide's trials.
Interpretation overall survival is the recorded endpoint.
Show the evidence
biomarkers
overall survival; 2026-09-01
physical functioning as measured by the sf 36; 2026-09-01
erectile dysfunction; 2026-09-01
high libido; 2026-09-01
vitality; 2026-09-01
time to progression; 2026-09-01
14 more recorded rows
biomarkers
disease free survival at 5 years; 2026-09-01
biomarkers
disease free survival; 2026-09-01
biomarkers
disease specific survival; 2026-09-01
biomarkers
toxicity; 2026-09-01
biomarkers
progression free survival; 2026-09-01
biomarkers
biological response prostate specific antigen level; 2026-09-01
biomarkers
cancer progression as measured by ultrasound; 2026-09-01
biomarkers
clinical progression free survival; 2026-09-01
biomarkers
acute and late toxicity during the study; 2026-09-01
biomarkers
quality of life questionnaire core 30; 2026-09-01
biomarkers
growth rate; 2026-09-01
biomarkers
free of psa progression at 6 months; 2026-09-01
biomarkers
progression free at 18 months; 2026-09-01
biomarkers
interval before biochemical failure; 2026-09-01
half life
2026-09-04; halfLife; 2026-04-23
human trials at or under30
57
smallest human trial
0; NCT00003517; PHASE2; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q6
Which of acute and late toxicity during the study, biological response prostate specific antigen level and cancer progression as measured by ultrasound did Bicalutamide's trials measure?
acute and late toxicity during the study, biological response prostate specific antigen level and cancer progression as measured by ultrasound lead 40 outcome terms across Bicalutamide's trials. ClinicalTrials.gov · 2026-09-01
high libido, vitality, time to progression, disease free survival at 5 years, disease free survival and disease specific survival follow.
Show the evidence
overall survival
1
physical functioning as measured by the sf 36
1
erectile dysfunction
1
high libido
1
vitality
1
time to progression
1
14 more recorded rows
disease free survival at 5 years
1
disease free survival
1
disease specific survival
1
toxicity
1
progression free survival
1
biological response prostate specific antigen level
1
cancer progression as measured by ultrasound
1
clinical progression free survival
1
acute and late toxicity during the study
1
quality of life questionnaire core 30
1
growth rate
1
free of psa progression at 6 months
1
progression free at 18 months
1
interval before biochemical failure
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Bicalutamide's 30 ongoing trials reports first?
Interval before biochemical failure; Time to Prostate-specific Antigen (PSA) Relapse; latest 2038-12-31
Show the evidence
Trial
NCT00223145
"Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone"; n 600; "Interval before biochemical failure"; 2027-12-31
NCT00544830
"Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer"; n 29; "Time to Prostate-specific Antigen (PSA) Relapse"; 2027-02-15
NCT01342367
"Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer"; n 74; "Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire"; 2026-02
NCT01786265
"Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer"; n 310; "Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml)"; 2027-02-01
NCT02299999
"SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"; n 1460; "Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm"; 2025-12
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
14 further recorded trials
NCT02605486
"Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)"; n 46; "recommended phase II dose (RP2D) (phase I)"; 2026-11
NCT03090165
"Ribociclib and Bicalutamide in AR+ TNBC"; n 37; "Phase I: Maximum Tolerated Dose"; 2026-10
NCT03541928
"Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery"; n 60; "Biochemical control rate"; 2023-07
NCT03650894
"Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients"; n 30; "iRECIST Clinical Benefit Rate (the number of patients with objective response or ongoing stable disease at week 24 using iRECIST guidelines)"; 2026-12
NCT03678025
"Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer"; n 1273; "Overall survival (OS)"; 2031-10-01
NCT03809000
"A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery"; n 188; "Percentage of Participants Alive Without Progression (Progression-Free Survival)"; 2029-09-15
NCT04025372
"INTREPId (INTermediate Risk Erection PreservatIon Trial)"; n 234; "The percentage of patients with a PSA nadir <= 0.5"; 2028-03-01
NCT04513717
"Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial"; n 2753; "Metastasis-free survival (MFS)"; 2038-12-31
NCT04734730
"Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer"; n 70; "Prostate specific antigen (PSA) nadir < 0.2"; 2027-08-23
NCT04943536
"Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer"; n 20; "Feasibility of replacing systemic androgen tx with targeted local delivery"; 2027-08-15
NCT05019846
"SRT Versus SRT+ADT in Prostate Cancer"; n 310; "biochemical disease free survival"; 2029-12-01
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
NCT05095207
"Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer"; n 42; "The Dose-Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)"; 2028-06
NCT05327647
"A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer"; n 160; "Rate of bladder tumour recurrence"; 2026-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Bicalutamide could settle lifespan?
NCT02299999 measures Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm, reading out 2025-12.
8 open trials; n 1460; "SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"
Show the evidence
Trial
NCT02299999
"SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"; n 1460; "Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm"; 2025-12
NCT01786265
"Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer"; n 310; "Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml)"; 2027-02-01
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
NCT03809000
"A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery"; n 188; "Percentage of Participants Alive Without Progression (Progression-Free Survival)"; 2029-09-15
NCT05019846
"SRT Versus SRT+ADT in Prostate Cancer"; n 310; "biochemical disease free survival"; 2029-12-01
NCT07340541
"Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies"; n 700; "Intra-Individual Progression-Free Survival (PFS)"; 2031-06-02
2 further recorded trials
NCT03678025
"Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer"; n 1273; "Overall survival (OS)"; 2031-10-01
NCT04513717
"Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial"; n 2753; "Metastasis-free survival (MFS)"; 2038-12-31
Q9
Which 42 trials of Bicalutamide posted no result?
Posted no result
42 of 42 completed trials
Registrations
NCT00026377, NCT00972855, NCT00973050, NCT00086736, NCT00012090 and NCT00023829, and 36 more
Completion dates
oldest 2003-04; newest 2024-08-13
Show the evidence
Trial
NCT00026377
2003-04
NCT00972855
2003-09
NCT00973050
2003-09
NCT00086736
2003-11
NCT00012090
2004-04
NCT00023829
2004-06
14 further recorded trials
NCT00030654
2005-02-04
NCT00002855
2005-06
NCT00551044
2005-08
NCT00637871
2005-08
NCT00684905
2005-10
NCT00165399
2005-12-31
NCT00418080
2006-12
NCT00233610
2007-10
NCT00657904
2008-08
NCT00672282
2008-08
NCT00673205
2008-08
NCT00067015
2008-09
NCT00482807
2010-03-09
NCT01415791
2011-09
Q10
At the median, Bicalutamide's trials enrolled 56 people — anything larger?
Median enrolment
56
Largest enrolment
4236
Registered trials counted
165
Q11
What do 850 spontaneous reports say about Bicalutamide — 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.
Bicalutamide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 850 reaction mentions were counted: interstitial lung disease 142; prostatic specific antigen increased 119; malignant neoplasm progression 108; dementia alzheimer's type 100. open-targets-adr · CHEMBL409 · 2026-06-24
Show the evidence
interstitial lung disease
142
prostatic specific antigen increased
119
malignant neoplasm progression
108
dementia alzheimer's type
100
prostate cancer
93
hepatic function abnormal
70
4 more recorded rows
hot flush
58
cardiac failure
56
metastases to bone
54
haematuria
50
recorded 2026-06-24 · last checked 2026-09-04
Q12
Bicalutamide and CYP 3A4: shared by which compounds?
CYP 3A4 appear in Bicalutamide's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-04-23
Interpretation drug_interactions
Show the evidence
CYP 3A4
drug_interactions
In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4 with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity.
drug_interactions
Clinical studies have shown that with co-administration of bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5-fold (for C max ) and 1.9-fold (for AUC).
drug_interactions
Hence, caution should be exercised when bicalutamide is co-administered with CYP 3A4 substrates.
drug_interactions
R-bicalutamide is an inhibitor of CYP 3A4; therefore, caution should be used when bicalutamide is co-administered with CYP 3A4 substrates.
recorded 2026-04-23 · last checked 2026-09-04
Q13
Was Bicalutamide studied with fasting?
fasting is named in Bicalutamide's label sentences: "Healthy male volunteers (n = 15) were administered single oral doses of bicalutamide (50 mg) after food and after fasting as part of a three-treatment, three-period, randomized cross-over study, with a 9 week washout." openfda-label+europepmc · 2026-04-23
1 recorded statement; fasting
Show the evidence
fasting
Healthy male volunteers (n = 15) were administered single oral doses of bicalutamide (50 mg) after food and after fasting as part of a three-treatment, three-period, randomized cross-over study, with a 9 week washout.
recorded 2026-04-23 · last checked 2026-09-04
Q14
What is recorded about Bicalutamide and mTOR?
"In addition, bicalutamide (an AKT inhibitor) and rapamycin (an mTOR inhibitor) increased the epalrestat-induced reduction in apoptosis and autophagy related protein levels in bEnd.3 cells with OGD treatment." — where Bicalutamide and mTOR appear together. Europe PMC · pathway abstract search · 2023-03-20
"In addition, bicalutamide (an AKT inhibitor) and rapamycin (an mTOR inhibitor) increased the epalrestat-induced reduction in apoptosis and autophagy related protein levels in bEnd.3 cells with OGD treatment."
autophagy
PMID 36940077
"In addition, bicalutamide (an AKT inhibitor) and rapamycin (an mTOR inhibitor) increased the epalrestat-induced reduction in apoptosis and autophagy related protein levels in bEnd.3 cells with OGD treatment."
PMID 36717478
"In an in vitro SBMA neuronal model, we previously showed that the antiandrogen bicalutamide and trehalose, a natural disaccharide stimulating autophagy, block ARpolyQ activation, reduce its nuclear translocation and toxicity and facilitate the autophagic degradation of cytoplasmic AR aggregates."
PMID 24662833
"Androgen deprivation or treatment with androgen receptor (AR) signaling inhibitor (ARSI), Enzalutamide (MDV-3100, ENZA) or bicalutamide induced autophagy in androgen-dependent and in castration-resistant CaP (castration-resistant prostate cancer (CRPC)) cell lines."
mTOR
PMID 28745319
"We previously showed that resistance to bicalutamide results from activation of mechanistic target of rapamycin (mTOR)."
PMID 28745319
"Interestingly, clinical trials testing combinations of the mTOR inhibitor RAD001 with bicalutamide were effective in bicalutamide-naïve CRPC patients, but not in bicalutamide-pretreated ones."
recorded 2023-03-20 · last checked 2026-09-04
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