This page shows what was measured, who it was measured in, and what that does not settle.
What Nintedanib does in the body
OFEV is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 )
Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, colony stimulating factor 1 receptor (CSF1R), and Fms-like tyrosine kinase-3 (FLT-3). These kinases except for FLT-3 have been implicated in pathogenesis of interstitial lung diseases (ILD). Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these kinases and blocks the intracellular signaling cascades, which have been demonstrated to be involved in the pathogenesis of fibrotic tissue remodeling in ILD.
Why people take it. OFEV is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 )
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 · 42F62RTZ4G · read 2026-08-29
Its recorded molecular formula is C31H33N5O4∙C2H6O3S, weighing 649.76 g/mol.
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-30
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 149 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 people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.
✗ The study did not show it
Who was studied
NCT01015118
How many people
1366
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Progression Free Survival (PFS) as Assessed by Central Independent Review
✗ The study did not show it
Who was studied
NCT00805194
How many people
1314
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Absolute Change From Baseline in Forced Vital Capacity (FVC) in Milliliters [mL] at Week 52
✗ The study did not show it
Who was studied
NCT05321082
How many people
1178
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52
✗ The study did not show it
Who was studied
NCT05321069
How many people
1177
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52
✗ The study did not show it
Who was studied
NCT03733444
How many people
781
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Progression-Free Survival (PFS) by Central Review Assessment
✗ The study did not show it
Who was studied
NCT02149108
How many people
768
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · 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 unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
No description of who was studied is recorded.
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 effectiveness of OFEV have not been established in pediatric patients for the treatment of fibrosing interstitial lung diseases.”
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-30
On older people, the label states: “Of the total number of subjects in phase 2 and 3 clinical studies of OFEV in IPF (Study 1, Study 2, and Study 3), 61% were 65 and over, while 16% were 75 and over.”
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , OFEV can cause fetal harm when administered to a pregnant woman.”
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information on the presence of nintedanib in human milk, the effects on the breast-fed infant or the effects on milk production.”
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-30
On people with reduced liver function, the label states: “Nintedanib is predominantly eliminated via biliary/fecal excretion (greater than 90%).”
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-30
On people with reduced kidney function, the label states: “Based on a single-dose study, less than 1% of the total dose of nintedanib is excreted via the kidney [see Clinical Pharmacology (12.3) ] .”
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied 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 take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No form or route is recorded.
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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing is recorded about product quality.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
The exact form studied is not recorded.
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
8 products list this as an active ingredient in the United States drug directory. 8 of them contain it and nothing else.
FDA National Drug Code directory · 51869-0040 · read 2026-08-29
They are sold as capsule and powder.
FDA National Drug Code directory · 51869-0040 · read 2026-08-29
10 published labels name it as an active ingredient. 10 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-29
Ofev is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: 150 mg, brown, opaque, oblong, soft capsules marked in dark gray with the Boehringer Ingelheim company symbol and "150". 100 mg, peach, opaque, oblong, soft capsules marked in dark…, recorded as fda label in effect 2025-11-20 in the United States.
US prescribing information · da1c9f37-779e-4682-816f-93d0faa4cfc9 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Nintedanib studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Nintedanib are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
How many documents were read
11 documents were read for this substance.
RNAWiki source record
11 of them state the same halfLife, and they agree.
RNAWiki source record
11 of them state the same bioavailability, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
42F62RTZ4G
RxNorm concept
1592742
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 unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
5 approved applications cover products containing this substance. The earliest was ANDA218472, approved 20260709 to HUMANWELL PURACAP.
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 (10)
Q2
On the Nintedanib label: indicated for what?
"1 INDICATIONS & USAGE Nintedanib capsules are kinase inhibitor indicated in adults for: • Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) • Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis Nintedanib capsules are indicated…": indications and usage on Nintedanib's label. DailyMed label · 9925b305-c1fb-43b6-a5fd-e03f14f28e6c · 2026-08-03
Q3
157 registered trials of Nintedanib — at which phases?
18 of Nintedanib's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?
futility/efficacy (2), accrual/recruitment (8), funding/business (4) and other (4): Nintedanib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Funding withdrawn due to drug unavailability"; 18 of 157 registered studies
Show the evidence
Trial
NCT01485874
terminated; "Funding withdrawn due to drug unavailability"
NCT01666600
terminated; "Interim Analysis for Feasibility"
NCT02152059
withdrawn; "contract issues"
NCT02389764
terminated; "Slow Accrual"
NCT02452463
terminated; "low accrual"
NCT02751385
terminated; "Terminated- Study halted due to low recruitment."
12 further recorded trials
NCT02780700
terminated; "Substance discontinued"
NCT02808247
terminated; "Exceed of pre-specified number of failures in the experimental arm"
NCT02863055
terminated; "lack of scientific relevance (change in the treatment landscape) and poor recruitment"
NCT02902484
terminated; "The study was terminated due to futility and lack of future funding"
NCT03287947
terminated; "Low enrollment"
NCT03361319
withdrawn; "Withdrawal of financial support from funder"
NCT03562416
terminated; "Low enrollment"
NCT03717012
terminated; "The trial was terminated prematurely due to difficulties with recruitment because of the COVID-19 pandemic."
NCT05067517
withdrawn; "Unable to enroll any subjects. IRB closed study in agreement with PI."
NCT05503030
terminated; "Company decision"
NCT05644600
terminated; "The study was terminated as no drug-drug interactions were observed in Part-A of the study and therefore Part-B of the study was not required as per protocol."
NCT05676112
withdrawn; "Company decision"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Nintedanib used Nintedanib 150 MG [Ofev] — over how long?
studies of Nintedanib used the recorded amount. ClinicalTrials.gov · 2026-09-01
8 recorded entries; human; also "Nintedanib 150 MG [Ofev]", "Nintedanib 150 MG", "nintedanib 25 mg"
Show the evidence
human
NCT04161014
Nintedanib 150 MG [Ofev]
NCT04338802
Nintedanib 150 MG
NCT04938453
nintedanib 25 mg
NCT04938453
nintedanib 100 mg
NCT04939467
Nintedanib 150 mg Oral Capsule
NCT05635071
Nintedanib 100 MG [Ofev]
2 more recorded rows
humanNCT05635071
Nintedanib 100 MG Oral Capsule
humanNCT05635071
Nintedanib 150 MG Oral Capsule
recorded 2026-09-01 · last checked 2026-09-04
Q6
Nintedanib's half-life is 9.5 hours — which schedules were studied?
9.5 hours; Elimination The effective half-life of nintedanib in patients with IPF was 9.5 hours (gCV 31.9%).
tmaxpharmacokinetics
2.00 hours; After food intake, nintedanib exposure increased by approximately 20% compared to administration under fasted conditions (90% CI: 95.3% to 152.5%) and absorption was delayed (median t max fasted: 2.00 hours; fed: 3.98 hours), irrespective of the food type.
bioavailabilitypharmacokinetics
4.7 %; The absolute bioavailability of a 100 mg dose was 4.7% (90% CI: 3.62 to 6.08) in healthy volunteers.
metabolismpharmacokinetics
Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism.
recorded 2026-08-03 · last checked 2026-09-04
Q7
Which 21 trials of Nintedanib posted no result?
Posted no result
21 of 21 completed trials
Registrations
NCT01251484, NCT01583322, NCT01441297, NCT01658462, NCT01610869 and NCT02619162, and 15 more
Completion dates
oldest 2012-08; newest 2024-05-06
Show the evidence
Trial
NCT01251484
2012-08
NCT01583322
2016-03
NCT01441297
2016-03-31
NCT01658462
2017-10-30
NCT01610869
2018-01-11
NCT02619162
2018-06
14 further recorded trials
NCT02835833
2018-06-14
NCT03363815
2018-07-29
NCT01788982
2019-08-28
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Q8
At the median, Nintedanib's trials enrolled 50 people — anything larger?
Median enrolment
50
Largest enrolment
13264
Registered trials counted
152
Q9
What do 4842 spontaneous reports say about Nintedanib — 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.
Nintedanib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4842 reaction mentions were counted: diarrhoea 1426; nausea 694; dyspnoea 484; weight decreased 428. FAERS via Open Targets · CHEMBL3039504 · 2026-06-24
Show the evidence
diarrhoea
1426
nausea
694
dyspnoea
484
weight decreased
428
decreased appetite
428
vomiting
403
4 more recorded rows
idiopathic pulmonary fibrosis
291
cough
262
malignant neoplasm progression
225
constipation
201
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Nintedanib's label not list?
• Coadministration of P-gp and CYP3A4 inhibitors may increase nintedanib exposure.
drug_interactions
( 7.1 ) 7.1 P-glycoprotein (P-gp) and CYP3A4 Inhibitors and Inducers Nintedanib is a substrate of P-gp and, to a minor extent, CYP3A4 [see Clinical Pharmacology ( 12.3 )].
drug_interactions
Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%.
drug_interactions
Concomitant use of P-gp and CYP3A4 inhibitors (e.g., erythromycin) with nintedanib capsules may increase exposure to nintedanib [see Clinical Pharmacology ( 12.3 )].
drug_interactions
Coadministration with oral doses of a P-gp and CYP3A4 inducer, rifampicin, decreased exposure to nintedanib by 50%.
drug_interactions
Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St.
2 more recorded rows
Interaction statementpharmacokinetics
Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism.
Interaction statementpharmacokinetics
Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways, with CYP3A4 being the predominant enzyme involved.
ChEMBL 37 — CC BY-SA 3.0 Unported · 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
✗ required summary fields resolved: 3 required field(s) not terminal: 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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