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Enzalutamide

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Enzalutamide does in the body

The treatment of patients

From the FDA-approved label: Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors; and consequently, inhibits nuclear translocation of androgen receptors and their interaction with DNA. A major metabolite, N‑desmethyl enzalutamide, exhibited similar in vitro activity to enzalutamide. Enzalutamide decreased proliferation and induced cell death of prostate cancer cells in vitro , and decreased tumor volume in a mouse prostate cancer xenograft model.

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 · 93T0T9GKNU · read 2026-08-29

  • Its recorded molecular formula is C21H16F4N4O2S, weighing 464.44.

    US prescribing information · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · 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 100 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 peopleRead 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

The study did not show it

Who was studied
NCT00268476
How many people
11992
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

The study did not show it

Who was studied
NCT07620574
How many people
5000
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 (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

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
NCT01212991
How many people
1717
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
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 peopleRead 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.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.9 registered measures of this kind. 5 written-up studies measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health No evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence 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.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No 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 takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

No registered study measured anything of this kind.

Meaningful

Things that change how a life goes, not only a number.

  • overall survival
  • radiographic progression free survival
  • progression free survival
  • metastasis free survival
  • psa progression free survival
  • two year progression free survival
  • radiological progression free survival
  • part b progression free survival
  • overall survival time

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 (31)
  • dose limiting toxicities
  • maximum tolerated dose of ipatasertib
  • recommended phase ii dose of ipatasertib
  • adverse events
  • pathologic complete response rate
  • who discontinued study drug due to an adverse event
  • dose escalation phase percentage of dose limiting toxicity
  • treatment emergent serious adverse events
  • who require dose reductions due to adverse events
  • time to progression
  • tumor growth rate
  • pathologic stage less than or equal to ypt2n0
  • overall response rate
  • partial response
  • n cadherin and vimentin expression
  • bone scan response rate
  • bone scan lesion area
  • clinical benefit rate
  • prostate specific antigen response rate
  • serious and non serious adverse events

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead 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.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. 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.

  7. How fast the body clears it. 5.8 days

    Read from the label, which states: “The mean terminal half-life (t 1/2 ) for enzalutamide after a single oral dose is 5.8 days (2.8 to 10.2 days).”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. 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 unclearRead 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.

  • XTANDI ® is indicated for the treatment of patients with: • castration-resistant prostate cancer (CRPC) • metastatic castration-sensitive prostate cancer (mCSPC) • non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: • castration-resistant prostate…

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 XTANDI in pediatric patients have not been established.”

    US prescribing information · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · read 2026-08-30

  • On older people, the label states: “Of 5112 patients who received XTANDI in eight randomized, controlled clinical trials, 78% were 65 and over, while 33% were 75 and over.”

    US prescribing information · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary The safety and efficacy of XTANDI have not been established in females.”

    US prescribing information · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage modification is recommended for patients with mild, moderate, or severe hepatic impairment [see Clinical Pharmacology ( 12.3 )].”

    US prescribing information · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dosage modification is recommended for patients with mild to moderate renal impairment (creatinine clearance [CLcr] ≥ 30 mL/min).”

    US prescribing information · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · 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 takeRead 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 takeRead 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 capsule, tablet, 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 takeNothing 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.

Enzalutamide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5915 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • fatigue — 1436 reaction mentions
  • malignant neoplasm progression — 1431 reaction mentions
  • prostatic specific antigen increased — 751 reaction mentions
  • asthenia — 589 reaction mentions
  • decreased appetite — 502 reaction mentions
  • dysphagia — 359 reaction mentions
  • back pain — 300 reaction mentions
  • hot flush — 298 reaction mentions
  • prostate cancer — 145 reaction mentions
  • metastases to bone — 104 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 unclearRead 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

  • 26 products list this as an active ingredient in the United States drug directory. 26 of them contain it and nothing else.

    FDA National Drug Code directory · 0469-0625 · read 2026-08-29

  • They are sold as capsule, powder and tablet, taken oral.

    FDA National Drug Code directory · 0469-0625 · read 2026-08-29

  • The regulator's established pharmacologic class for it is androgen receptor antagonists [moa], androgen receptor inhibitor [epc] and cytochrome p450 2c19 inducers [moa].

    FDA National Drug Code directory · 0469-0625 · 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 · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · read 2026-08-29

  • Xtandi is oral at 3 DOSAGE FORMS AND STRENGTHS XTANDI 40 mg capsules are white to off-white oblong soft gelatin capsules imprinted in black ink with ENZ., recorded as fda label in effect 2026-07-28 in the United States.

    US prescribing information · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · 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 takeRead 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 Enzalutamide 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 unclearRead 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 Enzalutamide 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 peopleRead 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)
93T0T9GKNU
RxNorm concept
1307303

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S3.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead 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

  • 9 approved applications cover products containing this substance. The earliest was NDA203415, approved 20120831 to ASTELLAS.

    Drugs@FDA application register · NDA203415 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA203415 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20120422.

    FDA National Drug Code directory · 0469-0625 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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What is not here

6 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
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  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
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Recorded evidence blocks (14)

What did Enzalutamide's largest trial (500000 people) and its longest (26 years) measure?


500000 people in Enzalutamide's largest registered study, 26 years in its longest registered window, measuring Overall Survival Time. ClinicalTrials.gov · 2026-09-01

175 phase2, 93 phase1, 49 phase3, 29 na or unstated, 11 phase4, 2 na, 1 early phase1; NCT02023463; 2040-01-01; no ageing endpoint recorded. Last human test completed 2026, NCT05901649.

Interpretation These counts include studies where Enzalutamide 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
    175
  • phase1
    93
  • phase3
    49
  • na or unstated
    29
  • phase4
    11
  • na
    2
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT05901649
    2026-06-16

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Enzalutamide shown lifespan?


mouse: mechanism-only and human: lifespan (321): the rungs where Enzalutamide has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Overall Survival Time — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat Dog Non-human primate Human lifespan
Show the evidence
  • mouse
    mechanism-only
  • human NCT02446405
    lifespan; Overall Survival Time; 321

recorded 2026-09-01 · last checked 2026-09-04

47 of Enzalutamide's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (6), futility/efficacy (3), accrual/recruitment (16), funding/business (6), sponsor decision unspecified (4) and other (12): Enzalutamide's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"A business decision was made to not initiate this study."; 47 of 321 registered studies

Show the evidence

Trial

  • NCT01663415
    withdrawn; "A business decision was made to not initiate this study."
  • NCT01885949
    terminated; "Slow accrual"
  • NCT02159690
    withdrawn; "loss of funding"
  • NCT02379390
    terminated; "Unsatisfactory patient accrual"
  • NCT02380313
    withdrawn; "Study cancelled: Withdrawn before enrollment of any participants"
  • NCT02441517
    terminated; "The study is closed early due to lck of enrollment."
14 further recorded trials
  • NCT02457910
    terminated; "Interim analysis - toxicity"
  • NCT02489123
    terminated; "Accrual goal not met"
  • NCT02491411
    terminated; "The study is terminated due to lower enrollment"
  • NCT02500901
    terminated; "Suspended by funder"
  • NCT02508636
    terminated; "Low Accrual"
  • NCT02555189
    terminated; "Sponsor-PI decision. An analysis of the primary endpoint concluded that the addition of ribociclib to standard of care enzalutamide did not demonstrate benefit, an all active subjects were removed from the study."
  • NCT02605863
    terminated; "Low enrollment, sponsor withdrew support for study"
  • NCT02640534
    terminated; "The decision is based on the fact that with the current follow up of around 10 years, the relevant secondary endpoints can adequately be addressed according to protocol. The addition of follow up data will not significantly impact these…"
  • NCT02758132
    terminated; "Low accruals"
  • NCT02885649
    terminated; "Funding unavailable"
  • NCT02929576
    withdrawn; "Further understanding about the role of androgen signaling in TNBC was required"
  • NCT03150056
    terminated; "This study has been terminated due to meeting protocol defined futility."
  • NCT03177187
    terminated; "Discontinuation of production of IMP"
  • NCT03300505
    terminated; "Cancelled by the sponsor"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Enzalutamide used Enzalutamide 160mg daily (oral) — over how long?


studies of Enzalutamide used the recorded amount. ClinicalTrials.gov · 2026-09-01

5 recorded entries; human; oral, capsule; also "Enzalutamide 160mg daily (oral)", "Enzalutamide 160 mg", "Enzalutamide 40 MG"

Show the evidence

human

  • NCT02254785
    oral; Enzalutamide 160mg daily (oral)
  • NCT02861573
    Enzalutamide 160 mg
  • NCT03177187
    Enzalutamide 40 MG
  • NCT06126731
    Enzalutamide 40mg
  • NCT07683013
    capsule; Enzalutamide 40 mg capsule

recorded 2026-09-01 · last checked 2026-09-04

Enzalutamide's half-life is 5.8 days — which schedules were studied?


5.8 days, the half-life Enzalutamide's label states. openfda-label · b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf · 2026-08-30

Show the evidence
  • half life
    5.8 days; The mean terminal half-life (t 1/2 ) for enzalutamide after a single oral dose is 5.8 days (2.8 to 10.2 days).
  • metabolism
    Elimination Enzalutamide is primarily eliminated by hepatic metabolism.

recorded 2026-08-30 · last checked 2026-09-04

Which of acute treatment related toxicity, adverse events and bone scan lesion area did Enzalutamide's trials measure?


acute treatment related toxicity, adverse events and bone scan lesion area lead 40 outcome terms across Enzalutamide's trials. ClinicalTrials.gov · 2026-09-01

Interpretation maximum tolerated dose of ipatasertib, recommended phase ii dose of ipatasertib, adverse events, pathologic complete response rate, who discontinued study drug due to an adverse event and dose escalation phase percentage of dose limiting toxicity follow.

Show the evidence
  • overall survival
    1
  • radiographic progression free survival
    1
  • dose limiting toxicities
    1
  • maximum tolerated dose of ipatasertib
    1
  • recommended phase ii dose of ipatasertib
    1
  • adverse events
    1
14 more recorded rows
  • pathologic complete response rate
    1
  • who discontinued study drug due to an adverse event
    1
  • dose escalation phase percentage of dose limiting toxicity
    1
  • treatment emergent serious adverse events
    1
  • who require dose reductions due to adverse events
    1
  • progression free survival
    1
  • time to progression
    1
  • tumor growth rate
    1
  • pathologic stage less than or equal to ypt2n0
    1
  • overall response rate
    1
  • partial response
    1
  • n cadherin and vimentin expression
    1
  • metastasis free survival
    1
  • psa progression free survival
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Enzalutamide's 108 ongoing trials reports first?


108 registered trials of Enzalutamide are open; earliest completion 2023-04-30. ClinicalTrials.gov · 2026-09-01

Overall survival; N-cadherin and vimentin expression; latest 2041-08

Show the evidence

Trial

  • NCT00268476
    "Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy"; n 11992; "Overall survival"; 2030-12
  • NCT01990196
    "Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer"; n 45; "N-cadherin and vimentin expression"; 2026-09-30
  • NCT02023463
    "Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer"; n 25; "Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria"; 2040-01-01
  • NCT02194842
    "Phase III Radium 223 mCRPC-PEACE III"; n 446; "radiological progression-free survival"; 2028-12
  • NCT02312557
    "Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide"; n 58; "PSA Response, Defined by a PSA Decrease of at Least 50% Confirmed by a Second Measurement at Least 3 Weeks Later"; 2026-10-31
  • NCT02319837
    "Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)"; n 1068; "Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide"; 2026-09-19
14 further recorded trials
  • NCT02446405
    "Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer"; n 1125; "Overall Survival Time"; 2027-06-30
  • NCT02446444
    "Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer"; n 802; "Metastasis-free survival"; 2026-06
  • NCT02452008
    "Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer"; n 60; "Progression free survival in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2) using RECIST 1.1 criteria."; 2026-12
  • NCT02522715
    "Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer"; n 37; "Percentage of Participants With Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (Phase I)"; 2027-01-01
  • NCT02685397
    "Management of Castration-Resistant Prostate Cancer with Oligometastases"; n 102; "Radiographic Progression-free Survival"; 2041-08
  • NCT02749903
    "Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers"; n 46; "Best Overall Response Rate"; 2028-07-05
  • NCT02750358
    "Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer"; n 50; "The treatment discontinuation rate of enzalutamide in the adherent population"; 2027-05
  • NCT02861573
    "Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)"; n 1200; "Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA)"; 2028-07-24
  • NCT02955394
    "Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer"; n 61; "Number of Patients With a PEPI Score Equal to Zero at Post Treatment"; 2027-02
  • NCT02960022
    "A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study"; n 900; "Number of participants with adverse events"; 2029-07-31
  • NCT03016741
    "Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer"; n 100; "Cognitive function defined by overall Cogstate score and Cogstate module scores for each domain"; 2029-08
  • NCT03246347
    "A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer"; n 40; "52-week PSA Complete Response (CR) Rate"; 2028-03
  • NCT03344211
    "Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer"; n 30; "Changes in prostate cancer bone involvement"; 2027-12-31
  • NCT03460977
    "A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma"; n 453; "Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)"; 2029-07-07

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Enzalutamide could settle lifespan?


NCT02446444 measures Metastasis-free survival, reading out 2026-06.

40 open trials; n 802; "Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer"

Show the evidence

Trial

  • NCT02446444
    "Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer"; n 802; "Metastasis-free survival"; 2026-06
  • NCT02319837
    "Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)"; n 1068; "Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide"; 2026-09-19
  • NCT04446117
    "Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC"; n 575; "Duration of Progression Free Survival (PFS) Per Response Evaluable Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC)"; 2026-10-16
  • NCT02452008
    "Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer"; n 60; "Progression free survival in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2) using RECIST 1.1 criteria."; 2026-12
  • NCT03903835
    "ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer"; n 750; "Progression free survival (PFS) in mCRPC"; 2026-12
  • NCT04015622
    "PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA"; n 100; "Progression free survival (PFS)"; 2026-12-01
14 further recorded trials
  • NCT04419402
    "Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer"; n 162; "Prostate Specific Antigen (PSA) Progression-Free Survival"; 2026-12-01
  • NCT05457257
    "Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations"; n 43; "Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR)"; 2026-12-31
  • NCT04986423
    "ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer"; n 200; "Cohort A: Radiographic progression-free survival (rPFS) by BICR"; 2027-06
  • NCT02446405
    "Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer"; n 1125; "Overall Survival Time"; 2027-06-30
  • NCT04455750
    "A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy"; n 61; "Radiographic progression-free survival (rPFS)"; 2027-09
  • NCT06099769
    "A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer"; n 201; "progression-free survival (PFS)"; 2027-10
  • NCT04647526
    "Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment"; n 455; "Randomization Phase: Radiographic Progression-Free Survival (rPFS)"; 2028-03
  • 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
  • NCT04363164
    "Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression"; n 150; "Clinical or Radiographic Progression free survival"; 2028-07
  • NCT05189457
    "First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer"; n 32; "Overall Survival"; 2028-07
  • NCT06551324
    "A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1)."; n 600; "Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)"; 2028-10-29
  • NCT06629779
    "A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer."; n 900; "Radiographic Progression Free Survival (rPFS)"; 2028-11-30
  • NCT02194842
    "Phase III Radium 223 mCRPC-PEACE III"; n 446; "radiological progression-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

Which 56 trials of Enzalutamide posted no result?


Posted no result
56 of 56 completed trials
Registrations
NCT01911715, NCT01913379, NCT01901133, NCT01911728, NCT01911741 and NCT02138799, and 50 more
Completion dates
oldest 2011-07; newest 2024-08-30
Show the evidence

Trial

  • NCT01911715
    2011-07
  • NCT01913379
    2011-12
  • NCT01901133
    2012-01
  • NCT01911728
    2012-02-21
  • NCT01911741
    2013-03
  • NCT02138799
    2013-09
14 further recorded trials
  • NCT01902251
    2013-10
  • NCT02225093
    2014-02-03
  • NCT02138162
    2014-03
  • NCT01284920
    2014-07-02
  • NCT02676986
    2016-12-31
  • NCT03297385
    2017-04-01
  • NCT02124668
    2017-05-25
  • NCT02532114
    2017-11-30
  • NCT03328364
    2017-12-24
  • NCT02353715
    2018-11-14
  • NCT02669771
    2018-11-30
  • NCT02507570
    2019-01-18
  • NCT02346578
    2019-01-22
  • NCT02495974
    2019-02-08

At the median, Enzalutamide's trials enrolled 66 people — anything larger?


Median enrolment
66
Largest enrolment
500000
Registered trials counted
320

What do 5915 spontaneous reports say about Enzalutamide — 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.

Enzalutamide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5915 reaction mentions were counted: fatigue 1436; malignant neoplasm progression 1431; prostatic specific antigen increased 751; asthenia 589. open-targets-adr · CHEMBL1082407 · 2026-06-24

Show the evidence
  • fatigue
    1436
  • malignant neoplasm progression
    1431
  • prostatic specific antigen increased
    751
  • asthenia
    589
  • decreased appetite
    502
  • dysphagia
    359
4 more recorded rows
  • back pain
    300
  • hot flush
    298
  • prostate cancer
    145
  • metastases to bone
    104

recorded 2026-06-24 · last checked 2026-09-04

Enzalutamide and CYP2C8, CYP3A4 and BCRP: shared by which compounds?


CYP2C8, CYP3A4 and BCRP appear in Enzalutamide's recorded interaction sentences, 14 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP1A2 pharmacokinetics
    No clinically meaningful changes in exposure of pioglitazone (a sensitive CYP2C8 substrate), caffeine (a sensitive CYP1A2 substrate), dextromethorphan (a sensitive CYP2D6 substrate), or rosuvastatin (a BCRP substrate) were observed following coadministration with XTANDI.
  • CYP2B6 pharmacokinetics
    In Vitro Studies Cytochrome P450 (CYP) Enzymes : Enzalutamide induces CYP2B6 at clinically achievable concentrations.
  • CYP2C19 pharmacokinetics
    Coadministration of XTANDI 160 mg orally once daily with omeprazole (a sensitive CYP2C19 substrate) decreased omeprazole AUC by 72% and C max by 62%.

CYP2C8

  • pharmacokinetics
    Metabolism Enzalutamide is metabolized by CYP2C8 and CYP3A4.
  • pharmacokinetics
    CYP2C8 is primarily responsible for the formation of the active metabolite (N-desmethyl enzalutamide).
  • pharmacokinetics
    Drug Interaction Studies Clinical Studies Effect of CYP2C8 Inhibitors on XTANDI : The coadministration of XTANDI 160 mg with gemfibrozil (strong CYP2C8 inhibitor) increased the AUC of enzalutamide plus N-desmethyl enzalutamide by 2.2-fold with minimal effect on C max .
  • pharmacokinetics
    Effect of CYP3A4 and CYP2C8 Inducers on XTANDI : The coadministration of XTANDI 160 mg after multiple oral doses of rifampin (strong CYP3A4 and moderate CYP2C8 inducer) decreased the AUC of enzalutamide plus N-desmethyl enzalutamide by 37% with no effect on C max .
  • pharmacokinetics
    No clinically meaningful changes in exposure of pioglitazone (a sensitive CYP2C8 substrate), caffeine (a sensitive CYP1A2 substrate), dextromethorphan (a sensitive CYP2D6 substrate), or rosuvastatin (a BCRP substrate) were observed following coadministration with XTANDI.
  • CYP2C9 pharmacokinetics
    Coadministration of XTANDI 160 mg orally once daily with warfarin (a sensitive CYP2C9 substrate) decreased S‑warfarin AUC by 56% and C max by 17%.
  • CYP2D6 pharmacokinetics
    No clinically meaningful changes in exposure of pioglitazone (a sensitive CYP2C8 substrate), caffeine (a sensitive CYP1A2 substrate), dextromethorphan (a sensitive CYP2D6 substrate), or rosuvastatin (a BCRP substrate) were observed following coadministration with XTANDI.

CYP3A4

  • pharmacokinetics
    Metabolism Enzalutamide is metabolized by CYP2C8 and CYP3A4.
  • pharmacokinetics
    Effect of CYP3A4 and CYP2C8 Inducers on XTANDI : The coadministration of XTANDI 160 mg after multiple oral doses of rifampin (strong CYP3A4 and moderate CYP2C8 inducer) decreased the AUC of enzalutamide plus N-desmethyl enzalutamide by 37% with no effect on C max .
  • pharmacokinetics
    Effect of CYP3A4 Inhibitors on XTANDI : The coadministration of XTANDI 160 mg after multiple oral doses of itraconazole (strong CYP3A4 inhibitor) increased the AUC of enzalutamide plus N-desmethyl enzalutamide by 1.3-fold with no effect on C max .
  • pharmacokinetics
    Effect of XTANDI on Other Drugs: The coadministration of XTANDI 160 mg orally once daily with midazolam (a sensitive CYP3A4 substrate) decreased midazolam AUC by 86% and C max by 77%.

recorded 2026-08-30 · last checked 2026-09-04

Was Enzalutamide studied with exercise?


exercise is named in Enzalutamide's label sentences: "We randomized 26 patients to 16 weeks of supervised exercise (aerobic and resistance), starting 4 weeks before initiation of ADT and enzalutamide, or usual care." openfda-label+europepmc · 2026-08-30

1 recorded statement; exercise

Show the evidence
  • exercise
    We randomized 26 patients to 16 weeks of supervised exercise (aerobic and resistance), starting 4 weeks before initiation of ADT and enzalutamide, or usual care.

recorded 2026-08-30 · last checked 2026-09-04

What is recorded about Enzalutamide and AMPK?


"We revealed that CAMK1D interacts with and phosphorylates AMPK at Thr172, which in turn activates PINK1 to modulate mitophagy, ultimately supporting the expansion of PCSCs under enzalutamide treatment." — where Enzalutamide and AMPK appear together. Europe PMC · pathway abstract search · 2026-01-28

AMPK, autophagy, NAD+, mTOR; PMID 41419457, 41605902, 41366824, 42327601

Show the evidence

AMPK

  • PMID 41419457
    "We revealed that CAMK1D interacts with and phosphorylates AMPK at Thr172, which in turn activates PINK1 to modulate mitophagy, ultimately supporting the expansion of PCSCs under enzalutamide treatment."
  • PMID 41419457
    "In a mouse orthotopic PCa model, targeting the CAMK1D/AMPK pathway with the siCAM/HLNP nanoformulation suppresses tumor growth by depleting the PCSCs population, achieving a synergistic effect with enzalutamide therapy."
  • autophagy PMID 41605902
    "Furthermore, inhibition of autophagy or GNG4 knockdown significantly increased the antitumor efficacy of enzalutamide both in vitro and in vivo."
  • NAD+ PMID 41366824
    "NAPRT-deficiency (NAPRT-low) can be a novel vulnerability associated with the AR-low/EMT-high phenotype and thus can be targeted by NAD+ inhibitors to improve enzalutamide efficacy."
  • mTOR PMID 42327601
    "This review comprehensively examines the multifaceted mechanisms underlying enzalutamide resistance, including AR amplification, point mutations, splice variants such as AR-V7, and the activation of bypass signaling pathways, including glucocorticoid receptor signaling, PI3K/Akt/mTOR, and Wnt signaling."
  • autophagy PMID 39531508
    "ATC-324 was designed to comprise enzalutamide, an AR inhibitor, as a target-binding ligand and YT 6-2, a ligand of the autophagy receptor p62/SQSTM1, as an autophagy-targeting ligand."
  • NAD+
    "Indeed, treating AR low/- cells with NAD+ synthesis inhibitors, FK866 and OT-82, significantly inhibited the survival and proliferation of AR low/- cells, thus suggesting a possible novel therapeutic option for ADT and enzalutamide resistant PCa."
  • autophagy PMID 38859837
    "Transcriptomic analysis revealed the essential role of TPT1-AS1 in synaptogenesis and autophagy activation in neuroendocrine differentiated PCA cells induced by IL-6 and enzalutamide treatment."

mTOR

  • PMID 37228586
    "This follow-up screen provided validation of inhibitors of JAK/STAT and PI3K/mTOR as therapeutic vulnerabilities for both Snail+ and enzalutamide-resistant prostate cancer."
  • PMID 35811549
    "Activation of AR signaling by dihydrotestosterone (DHT) downregulated miR-99b expression and promoted cell PCa cell growth/survival, whereas inactivation of mTOR by rapamycin or AR by enzalutamide decreased miR-99b mediated PCa cell growth."

recorded 2026-01-28 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1082407
PubChem CID
15951529
CAS number
915087-33-1
RxCUI
1307298
InChIKey
WXCXUHSOUPDCQV-UHFFFAOYSA-N
Also called
Enzalutamida, Mdv 3100, arpi, asp9785, enz, formerly mdv3100, Enzalutamide [INN], Enzalutamide [JAN], Enzalutamide [MI], Enzalutamide [ORANGE BOOK], Enzalutamide [USAN], Enzalutamide [VANDF]
Development code
MDV3100
Trade name
Xtandi, Enzalutamide Viatris, Enzalutamide Accordpharma
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.