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Neratinib

  • 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 Neratinib does in the body

NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

From the FDA-approved label: Neratinib is an intracellular kinase inhibitor that irreversibly binds to epidermal growth factor receptor (EGFR), HER2, and HER4. In vitro , neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2, and HER4 in vitro. In vivo , oral administration of neratinib inhibited tumor growth in mouse xenograft models with tumor cell lines expressing HER2 and EGFR.

Why people take it. NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

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 · 9RM7XY23ZS · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 155 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

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.

Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.

The study did not show it

Who was studied
NCT01042379
How many people
5000
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Accrual of patients to ComboMATCH treatment trials

The study did not show it

Who was studied
NCT05564377
How many people
2900
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2

The study did not show it

Who was studied
NCT00878709
How many people
2840
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

The primary endpoint for Cohorts A to E is confirmed objective response rate as defined by RECIST v1.1 for each cohort separately

The study did not show it

Who was studied
NCT03182634
How many people
1150
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Progression-free survival (PFS)

The study did not show it

Who was studied
NCT05615818
How many people
800
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

Centrally Assessed Progression Free Survival

The study did not show it

Who was studied
NCT01808573
How many people
621
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 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.

  • NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and efficacy of NERLYNX in pediatric patients has not been established.”

    US prescribing information · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · read 2026-08-30

  • On older people, the label states: “In the ExteNET trial, in the NERLYNX arm; 1236 patients were <65 years, 172 patients were ≥65 years, of whom 25 patients were 75 years or older.”

    US prescribing information · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies and the mechanism of action, NERLYNX can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] .”

    US prescribing information · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary No data are available regarding the presence of neratinib or its metabolites in human milk or its effects on the breastfed infant or on milk production.”

    US prescribing information · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage modifications are recommended for patients with mild to moderate hepatic impairment (Child Pugh A or B).”

    US prescribing information · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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: S1, S3, S4.

No source is stored against this line.

What is in the pack

Sold as 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.

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

  • 5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.

    FDA National Drug Code directory · 11722-079 · read 2026-08-29

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

    FDA National Drug Code directory · 11722-079 · read 2026-08-29

  • The regulator's established pharmacologic class for it is kinase inhibitor [epc], kinase inhibitors [moa] and p-glycoprotein inhibitors [moa].

    FDA National Drug Code directory · 11722-079 · 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 · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · read 2026-08-29

  • Nerlynx is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 40 mg neratinib (equivalent to 48.31 mg of neratinib maleate)., recorded as fda label in effect 2026-07-02 in the United States.

    US prescribing information · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · 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 Neratinib 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 Neratinib 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)
9RM7XY23ZS
RxNorm concept
1940648

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S3, S4.

  • 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

  • 2 approved applications cover products containing this substance. The earliest was NDA208051, approved 20170717 to PUMA BIOTECH.

    Drugs@FDA application register · NDA208051 · read 2026-08-29

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

    Drugs@FDA application register · NDA208051 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20170717.

    FDA National Drug Code directory · 11722-079 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 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.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — 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 (11)

On the Neratinib label: indicated for what?

"NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. ( 1.1 ) In combination with capecitabine, for the treatment of adult patients with advanced or metastatic…": indications and usage on Neratinib's label. DailyMed label · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · 2026-07-02

85 registered trials of Neratinib — at which phases?

Registered studies posting no result
55 of 85

85 registered studies of Neratinib: 51 phase2, 36 phase1, 6 na or unstated, 3 phase3, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

68 with a PubMed record

Show the evidence
  • phase2
    51
  • phase1
    36
  • na or unstated
    6
  • phase3
    3
  • early phase1
    1
  • completed
    41
8 more recorded rows
  • recruiting
    14
  • terminated
    7
  • unknown
    7
  • active not recruiting
    5
  • withdrawn
    5
  • not yet recruiting
    4
  • no longer available
    1
  • suspended
    1

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

13 of Neratinib's trials stopped: safety, accrual/recruitment, funding/business, other?

safety (2), accrual/recruitment (2), funding/business (1) and other (8): Neratinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Study withdrawn as it no longer is deemed necessary per project status."; 13 of 85 registered studies

Show the evidence

Trial

  • NCT00932464
    withdrawn; "Study withdrawn as it no longer is deemed necessary per project status."
  • NCT01953926
    terminated; "The study was terminated to align with the sponsor's current development plans for neratinib. The decision was not based on any new efficacy or safety data for neratinib."
  • NCT01960023
    withdrawn; "This registry was planned to report on the Phase II portion of the study. NSABP decided not to proceed with the Phase II portion of the study."
  • NCT02593708
    terminated; "toxicity"
  • NCT03065387
    terminated; "\<75% participation"
  • NCT03101748
    terminated; "\<75% accrued"
7 further recorded trials
  • NCT03289039
    terminated; "Slow accrual"
  • NCT03878524
    terminated; "Low accrual"
  • NCT03919292
    suspended; "Pending amendment approval"
  • NCT04781374
    withdrawn; "Withdrawal of funding"
  • NCT04856475
    withdrawn; "Termination of collaboration with PUMA"
  • NCT04901299
    withdrawn; "Team decision"
  • NCT05243641
    terminated; "Sponsor Withdrew Support"

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

Human studies of Neratinib used Neratinib 160 mg — over how long?

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

3 recorded entries; human; also "Neratinib 160 mg", "Neratinib 200 mg", "Neratinib 240 mg"

Show the evidence

human

  • NCT04502602
    Neratinib 160 mg
  • NCT04502602
    Neratinib 200 mg
  • NCT04502602
    Neratinib 240 mg

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

Neratinib's half-life is 7 to 17 hours — which schedules were studied?

7 to 17 hours, the half-life Neratinib's label states: "The mean elimination half-life of neratinib ranged from 7 to 17 hours following a single oral dose in patients." DailyMed label · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · 2026-07-02

tmax 2 to 8 hours.

Show the evidence
  • half life pharmacokinetics
    7 to 17 hours; The mean elimination half-life of neratinib ranged from 7 to 17 hours following a single oral dose in patients.
  • tmax pharmacokinetics
    2 to 8 hours; Absorption Peak concentrations of neratinib and major active metabolites M3, M6 and M7 are reached in the range of 2 to 8 hours after oral administration.
  • metabolism pharmacokinetics
    Metabolism Neratinib is metabolized primarily in the liver by CYP3A4 and to a lesser extent by flavin-containing monooxygenase (FMO).

recorded 2026-07-02 · last checked 2026-09-04

Which running trial of Neratinib could settle lifespan?

NCT06126276 measures Progression free survival, reading out 2027-02-20.

7 open trials; n 70; "Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)"

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Trial

  • NCT06126276
    "Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)"; n 70; "Progression free survival"; 2027-02-20
  • NCT02977780
    "INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)"; n 460; "Overall Survival in Experimental Arms Compared with Standard Therapy"; 2028-04-30
  • NCT05615818
    "Personalized Medicine for Advanced Biliary Cancer Patients"; n 800; "Progression-free survival (PFS)"; 2028-06
  • NCT07152782
    "T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis"; n 202; "Progression Free Survival(PFS)"; 2029-11
  • NCT07019272
    "Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study"; n 170; "Invasive Disease Free Survival (IDFS)"; 2030-10-31
  • NCT06693024
    "Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer"; n 2806; "invasive disease free survival"; 2031-12-31
  • 1 further recorded trial NCT07729046
    "Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer"; n 150; "Median Progression-Free Survival"; 2035-06

Which 13 trials of Neratinib posted no result?

Posted no result
13 of 13 completed trials
Registrations
NCT00380328, NCT00366600, NCT00498745, NCT00550212, NCT00708903 and NCT00757809, and 7 more
Completion dates
oldest 2006-11; newest 2014-10
Show the evidence

Trial

  • NCT00380328
    2006-11
  • NCT00366600
    2006-12
  • NCT00498745
    2007-09
  • NCT00550212
    2008-04
  • NCT00708903
    2008-07
  • NCT00757809
    2008-10
7 further recorded trials
  • NCT00814060
    2009-03
  • NCT00860223
    2009-04
  • NCT00864487
    2009-05
  • NCT00781430
    2010-02
  • NCT01142063
    2010-09
  • NCT01423123
    2014-03
  • NCT02334501
    2014-10

At the median, Neratinib's trials enrolled 49.5 people — anything larger?

Median enrolment
49.5
Largest enrolment
5000
Registered trials counted
84

What do 1902 spontaneous reports say about Neratinib — 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.

Neratinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1902 reaction mentions were counted: diarrhoea 632; nausea 331; fatigue 239; vomiting 165. FAERS via Open Targets · CHEMBL180022 · 2026-06-24

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  • diarrhoea
    632
  • nausea
    331
  • fatigue
    239
  • vomiting
    165
  • constipation
    154
  • decreased appetite
    119
4 more recorded rows
  • headache
    70
  • dehydration
    66
  • abdominal pain
    63
  • abdominal pain upper
    63

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

Which 10 reactions does Neratinib's label not list?

abdominal pain, abdominal pain upper and constipation and 7 more reported for Neratinib, absent from its label. FAERS via Open Targets · CHEMBL180022 · 2026-06-24

2 label terms; 10 reported and unlisted; d1e41dcf-e82a-47c2-a0ad-6c6eef621834

Show the evidence
  • abdominal pain
    count not stated
  • abdominal pain upper
    count not stated
  • constipation
    count not stated
  • decreased appetite
    count not stated
  • dehydration
    count not stated
  • diarrhoea
    count not stated
4 more recorded rows
  • fatigue
    count not stated
  • headache
    count not stated
  • nausea
    count not stated
  • vomiting
    count not stated

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

Neratinib and CYP3A4 and P-GP: shared by which compounds?

CYP3A4 and P-GP appear in Neratinib's recorded interaction sentences, 8 in all. DailyMed label · d1e41dcf-e82a-47c2-a0ad-6c6eef621834 · 2026-07-02

CYP3A4, CYP3A4, P-gp, P-gp; 4 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    ( 2.5 , 7.1 ) Strong CYP3A4 inhibitors: Avoid concomitant use.
  • drug_interactions
    ( 7.1 ) P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
  • drug_interactions
    ( 7.1 ) Strong or moderate CYP3A4 inducers: Avoid concomitant use.
  • drug_interactions
    ( 7.1 ) Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX.
  • drug_interactions
    Strong CYP3A4 Inhibitors Clinical Impact Concomitant use of NERLYNX with a strong CYP3A4 inhibitor increased neratinib C max and AUC [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of NERLYNX toxicity.
  • drug_interactions
    Prevention or Management Avoid concomitant use of NERLYNX with strong CYP3A4 inhibitors.
2 more recorded rows
  • Interaction statement drug_interactions
    P-gp and Moderate CYP3A4 Dual Inhibitors Clinical Impact Concomitant use of NERLYNX with a P-gp and moderate CYP3A4 dual inhibitor may increase neratinib C max and AUC [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of NERLYNX toxicity.
  • Interaction statement drug_interactions
    Prevention or Management Avoid concomitant use of NERLYNX with P-gp and moderate CYP3A4 dual inhibitors.

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

P-gp

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2026-07-02 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL180022
PubChem CID
9915743
CAS number
698387-09-6
RxCUI
1940643
InChIKey
JWNPDZNEKVCWMY-VQHVLOKHSA-N
Development code
CDP-820, HKI-272, WAY-179272
Also called
NERATINIB MALEATE, NERATINIB MALEATE [MI], NERATINIB MALEATE [ORANGE BOOK], Neratinib maleate [WHO-DD]
Salt form
Neratinib maleate anhydrous
Trade name
Nerlynx
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · 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: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 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

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