This page shows what was measured, who it was measured in, and what that does not settle.
What Gefitinib does in the body
Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14 ) ] .
From the FDA-approved label: The epidermal growth factor receptor (EGFR) is expressed on the cell surface of both normal and cancer cells and plays a role in the processes of cell growth and proliferation. Some EGFR activating mutations (exon 19 deletion or exon 21 point mutation L858R) within NSCLC cells have been identified as contributing to the promotion of tumor cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis.
Why people take it. Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14 ) ] .
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 · S65743JHBS · read 2026-08-29
Its recorded molecular formula is C22H24ClFN4O3.
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · 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 176 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.
Progression-free survival (PFS)
✗ The study did not show it
Who was studied
NCT04322890
How many people
6000
Study design
Phase 2
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 objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
✗ The study did not show it
Who was studied
NCT00242801
How many people
1692
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
To compare overall survival between ZD1839 and docetaxel
✗ The study did not show it
Who was studied
NCT00076388
How many people
1440
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
Median Progression Free Survival (PFS) in Months
✗ The study did not show it
Who was studied
NCT00322452
How many people
1329
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Progression Free Survival (Part B)
✗ The study did not show it
Who was studied
NCT01085136
How many people
1154
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
Objective Response Rate (ORR) (Investigator)
✗ The study did not show it
Who was studied
NCT01203917
How many people
1060
Study design
Phase 4
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
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
People similar to this profile were included.
Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14 ) ].
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 gefitinib tablets in pediatric patients have not been established.”
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · read 2026-08-30
On older people, the label states: “Of the 823 patients enrolled in two randomized, active-controlled clinical trials 374 patients (45%) were 65 years and older, and 93 patients (11%) were 75 years and older.”
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action and animal data, gefitinib tablets can cause fetal harm when administered to a pregnant woman.”
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary It is not known whether gefitinib is excreted in human milk.”
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · read 2026-08-30
On people with reduced liver function, the label states: “The systemic exposure of gefitinib was compared in patients with mild, moderate, or severe hepatic impairment due to cirrhosis (according to Child-Pugh classification) and healthy subjects with normal hepatic function (N=10/group).”
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · read 2026-08-30
On people with reduced kidney function, the label states: “Less than four percent (<4%) of gefitinib and its metabolites are excreted via the kidney.”
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · 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
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, tablet, film coated, tablet, coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
14 products list this as an active ingredient in the United States drug directory. 14 of them contain it and nothing else.
FDA National Drug Code directory · 68554-0060 · read 2026-08-29
They are sold as powder, tablet, tablet, coated and tablet, film coated, taken oral.
FDA National Drug Code directory · 68554-0060 · read 2026-08-29
The regulator's established pharmacologic class for it is kinase inhibitor [epc] and protein kinase inhibitors [moa].
FDA National Drug Code directory · 68554-0060 · read 2026-08-29
5 published labels name it as an active ingredient. 5 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · read 2026-08-29
Gefitinib is oral at 3 DOSAGE FORMS AND STRENGTHS 250 mg tablets: round, standard convex, light brown to brown, film-coated tablet debossed with " 250 " on one side of the tablet and plain on the other side., recorded as fda label in effect 2022-02-01 in the United States.
US prescribing information · 3dd135f0-5db1-4236-9756-04533b66dc9d · 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 Gefitinib 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 Gefitinib 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
5 documents were read for this substance.
RNAWiki source record
5 of them state the same halfLife, and they agree.
RNAWiki source record
5 of them state the same bioavailability, and they agree.
RNAWiki source record
5 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
S65743JHBS
RxNorm concept
349472
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
7 approved applications cover products containing this substance. The earliest was NDA021399, approved 20030505 to ASTRAZENECA.
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)
Q2
On the Gefitinib label: indicated for what?
"Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14) ]. Limitation…": indications and usage on Gefitinib's label. DailyMed label · 1a3c0ce7-06a1-4e04-9106-14ddb2a866a5 · 2026-03-10
Q3
287 registered trials of Gefitinib — at which phases?
"Administratively complete."; 32 of 287 registered studies
Show the evidence
Trial
NCT00033449
terminated; "Administratively complete."
NCT00048087
withdrawn; "Slow accrual."
NCT00052585
terminated; "Administratively complete."
NCT00082667
terminated; "PI left VICC"
NCT00087334
terminated; "Withdrawn due to poor/low accrual"
NCT00088907
terminated; "It was unlikely that the primary endpoint would be reached based on the fifth interim analysis results."
14 further recorded trials
NCT00090675
withdrawn; "No patients randomised"
NCT00091156
terminated; "low accrual"
NCT00098462
withdrawn; "Withdrawn as study never opened"
NCT00104728
terminated; "Early Stopping Rule: Would not meet interim analysis goal to proceed with enrollment"
NCT00169221
terminated; "Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity"
NCT00206414
terminated; "Difficulty accruing subjects the study accrual was closed"
NCT00206492
terminated; "halted by the PI only 3 of 45 subjects were accrued."
NCT00234442
terminated; "Closed due to insufficient recruitment."
NCT00234468
terminated; "Closed due to insufficient recruitment"
NCT00258297
terminated; "Withdrawn for lack of funding and accrual"
NCT00268255
withdrawn; "Study never moved forward with accrual."
NCT00290719
terminated; "low enrollment"
NCT00352079
terminated; "terminated due to poor accrual"
NCT00467077
terminated; "Protocol was closed due to slow accrual."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Gefitinib used Gefitinib 500mg/Gefitinib 250mg — over how long?
studies of Gefitinib used the recorded amount. ClinicalTrials.gov · 2026-09-01
12 recorded entries; human; also "Gefitinib 500mg/Gefitinib 250mg", "ZD 1839 500mg", "Gefitinib 250mg"
Show the evidence
human
NCT01017679
Gefitinib 500mg/Gefitinib 250mg
NCT01185171
ZD 1839 500mg
NCT01530334
Gefitinib 250mg
NCT02296125
Placebo Gefitinib 250 mg
NCT02296125
Placebo Iressa 250 mg
NCT02296125
Gefitinib 250 mg
6 more recorded rows
humanNCT02296125
Iressa 250mg
humanNCT03050164
Gefitinib Tablet 250mg of Hunan Kelun
humanNCT03050164
Iressa® Tablet 250mg of AZN
humanNCT04248829
Iressa 250 mg
humanNCT04248829
Gefitinib-matching placebo 250 mg
humanNCT04248829
Iressa-matching placebo 250 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Gefitinib's half-life is 48 hours — which schedules were studied?
48 hours; Gefitinib is cleared primarily by the liver, with total plasma clearance and elimination half-life of 48 hours after intravenous administration.
bioavailabilitypharmacokinetics
60 %; Absorption and Distribution The mean oral bioavailability of gefitinib is 60%, with peak plasma levels occurring 3-7 hours after dosing.
metabolismpharmacokinetics
Metabolism and Elimination Gefitinib undergoes extensive hepatic metabolism in humans, predominantly by CYP3A4.
recorded 2026-03-10 · last checked 2026-09-04
Q7
Which running trial of Gefitinib could settle lifespan?
NCT03787992 measures Median Progression Free Survival (PFS) (Months), reading out 2026-03.
4 open trials; n 358; "Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）"
Show the evidence
Trial
NCT03787992
"Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）"; n 358; "Median Progression Free Survival (PFS) (Months)"; 2026-03
NCT04143607
"ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC"; n 337; "Median Progression Free Survival (PFS)"; 2026-09-30
NCT02411448
"A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)"; n 545; "Part B: Progression Free Survival (PFS)"; 2026-12
NCT07477457
"A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma"; n 45; "12-month progression free survival (PFS) (cohort 1)"; 2028-03-11
Q8
Which 114 trials of Gefitinib posted no result?
Posted no result
114 of 114 completed trials
Registrations
NCT00005806, NCT00635856, NCT00030524, NCT00034879, NCT00635973 and NCT00012337, and 108 more
Completion dates
oldest 2002-03; newest 2022-07-12
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Trial
NCT00005806
2002-03
NCT00635856
2003-02
NCT00030524
2003-09
NCT00034879
2003-10
NCT00635973
2003-10
NCT00012337
2004-03
14 further recorded trials
NCT00062270
2004-09
NCT00217698
2004-10
NCT00026299
2005-02
NCT00637026
2005-02
NCT00234416
2005-03
NCT00016991
2005-04
NCT00242801
2005-04
NCT00080340
2005-05
NCT00247481
2005-06
NCT00015964
2005-07
NCT00014183
2005-08
NCT00193336
2005-09
NCT00241475
2005-10
NCT00252798
2005-10
Q9
At the median, Gefitinib's trials enrolled 60.5 people — anything larger?
Median enrolment
60.5
Largest enrolment
5279
Registered trials counted
266
Q10
What do 3928 spontaneous reports say about Gefitinib — 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.
Gefitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3928 reaction mentions were counted: diarrhoea 797; malignant neoplasm progression 580; drug resistance 564; rash 556. FAERS via Open Targets · CHEMBL939 · 2026-06-24
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diarrhoea
797
malignant neoplasm progression
580
drug resistance
564
rash
556
disease progression
322
dehydration
272
4 more recorded rows
anaemia
267
decreased appetite
214
interstitial lung disease
202
hepatic function abnormal
154
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Gefitinib's label not list?
CYP3A4 Inducer: Increase gefitinib tablets to 500 mg daily in patients receiving a strong CYP3A4 inducer.
drug_interactions
( 2.4 , 7.1 ) CYP3A4 Inhibitor: Monitor adverse reactions if concomitant use with gefitinib tablets.
drug_interactions
( 7.2 ) 7.1 Drugs Affecting Gefitinib Exposure CYP3A4 Inducer Drugs that are strong inducers of CYP3A4 increase the metabolism of gefitinib and decrease gefitinib plasma concentrations.
drug_interactions
Increase gefitinib tablets to 500 mg daily in patients receiving a strong CYP3A4 inducer (e.g., rifampicin, phenytoin, or tricyclic antidepressant) and resume gefitinib tablets at 250 mg 7 days after discontinuation of the strong inducer [see Dosage and Administration (2.4) , Clinical Pharmacology (12.3) ].
drug_interactions
CYP3A4 Inhibitor Drugs that are strong inhibitors of CYP3A4 (e.g., ketoconazole and itraconazole) decrease gefitinib metabolism and increase gefitinib plasma concentrations.
drug_interactions
Monitor adverse reactions when administering strong CYP3A4 inhibitors with gefitinib tablets.
2 more recorded rows
Interaction statementpharmacokinetics
Gefitinib is a substrate for the membrane transport Pglycoprotein (P-gp), but it is unlikely to influence gefitinib absorption as P-gp is saturated at higher concentrations.
Interaction statementpharmacokinetics
Metabolism and Elimination Gefitinib undergoes extensive hepatic metabolism in humans, predominantly by CYP3A4.
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
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