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Osimertinib

  • 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 Osimertinib does in the body

TAGRISSO is a kinase inhibitor indicated for: • adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

From the FDA-approved label: Osimertinib is a kinase inhibitor of the epidermal growth factor receptor (EGFR), which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately 9-fold lower concentrations than wild-type. Two pharmacologically-active metabolites (AZ7550 and AZ5104 circulating at approximately 10% of the parent) with similar inhibitory profiles to osimertinib have been identified in the plasma after oral administration of osimertinib. AZ7550 showed a similar potency to osimertinib, while AZ5104 showed greater potency against exon 19 deletion and T790M mutants (approximately 8-fold) and wild-type (approximately 15-fold) EGFR.

Why people take it. TAGRISSO is a kinase inhibitor indicated for: • adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

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 · 3C06JJ0Z2O · 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 191 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.

Objective response rate (ORR)

The study did not show it

Who was studied
NCT02465060
How many people
6452
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
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

Overall Survival (OS)

The study did not show it

Who was studied
NCT02474355
How many people
3017
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 (PFS)

The study did not show it

Who was studied
NCT06824792
How many people
3000
Study design
Phase 4
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 (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

The study did not show it

Who was studied
NCT04487080
How many people
1074
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

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs

The study did not show it

Who was studied
NCT05785741
How many people
1000
Study design
Phase 1/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
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.

  • TAGRISSO is a kinase inhibitor indicated for: • adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

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 TAGRISSO in pediatric patients have not been established.”

    US prescribing information · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · read 2026-08-30

  • On older people, the label states: “Monotherapy Of the 1813 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive NSCLC who were treated with TAGRISSO monotherapy, 770 patients were ≥65 years and 207 patients were ≥75 years of age [see Adverse Reactions (6.1) ] .”

    US prescribing information · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · read 2026-08-30

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

    US prescribing information · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of osimertinib or its active metabolites in human milk, the effects of osimertinib on the breastfed infant or on milk production.”

    US prescribing information · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is recommended in patients with mild to moderate hepatic impairment (Child-Pugh A and B or total bilirubin ≤ ULN and AST > ULN or total bilirubin 1 to 3 times ULN and any AST).”

    US prescribing information · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dose adjustment is recommended in patients with creatinine clearance (CLcr) 15 - 89 mL/min, as estimated by Cockcroft-Gault.”

    US prescribing information · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · 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, tablet, film coated, given by the oral route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to 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

  • 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 · 0310-1354 · read 2026-08-29

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

    FDA National Drug Code directory · 0310-1354 · read 2026-08-29

  • The regulator's established pharmacologic class for it is breast cancer resistance protein inhibitors [moa], cytochrome p450 1a2 inducers [moa] and cytochrome p450 3a inhibitors [moa].

    FDA National Drug Code directory · 0310-1354 · 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 · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · read 2026-08-29

  • TAGRISSO is oral at 3 DOSAGE FORMS AND STRENGTHS 80 mg tablets: beige, oval and biconvex tablet marked with “AZ 80” on one side and plain on the reverse. 40 mg tablets: beige, round and biconvex tablet marked with “AZ 40” on one side and p…, recorded as fda label in effect 2024-09-25 in the United States.

    US prescribing information · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · 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 Osimertinib 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 Osimertinib 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)
3C06JJ0Z2O
RxNorm concept
1721565

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 NDA208065, approved 20151113 to ASTRAZENECA.

    Drugs@FDA application register · NDA208065 · read 2026-08-29

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

    Drugs@FDA application register · NDA208065 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20151113.

    FDA National Drug Code directory · 0310-1354 · 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 Osimertinib label: indicated for what?

"TAGRISSO is a kinase inhibitor indicated for: • adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. ( 1.1 , 2.2 ) • the treatment of…": indications and usage on Osimertinib's label. DailyMed label · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · 2024-09-25

249 registered trials of Osimertinib — at which phases?

Registered studies posting no result
204 of 249

249 registered studies of Osimertinib: 139 phase2, 74 phase1, 40 phase3, 19 na or unstated, 5 na, 3 phase4, 2 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

209 with a PubMed record

Show the evidence
  • phase2
    139
  • phase1
    74
  • phase3
    40
  • na or unstated
    19
  • na
    5
  • phase4
    3
10 more recorded rows
  • early phase1
    2
  • completed
    61
  • active not recruiting
    58
  • recruiting
    56
  • unknown
    36
  • not yet recruiting
    22
  • terminated
    12
  • withdrawn
    2
  • no longer available
    1
  • suspended
    1

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

15 of Osimertinib's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?

safety (4), futility/efficacy (1), accrual/recruitment (3), funding/business (4) and other (3): Osimertinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Lack of accrual"; 15 of 249 registered studies

Show the evidence

Trial

  • NCT02954523
    terminated; "Lack of accrual"
  • NCT03255083
    terminated; "This study was terminated based on a business decision by the Sponsor."
  • NCT03784599
    terminated; "insufficient effectiveness"
  • NCT04816214
    terminated; "Novartis decided to terminate the study based on a business consideration and not related with any safety concerns. Randomized part was not initiated"
  • NCT04862780
    terminated; "Sponsor decision, not related to safety concerns"
  • NCT04908956
    terminated; "The trial struggled with low activation due to the COVID pandemic. The Steering Committee took the decision to close the accrual in the STEREO trial as of 31 October 2023. It is important to note that no safety concerns have led to this…"
9 further recorded trials
  • NCT05153408
    terminated; "Lack of efficacy"
  • NCT05215951
    terminated; "Enrollment delay study timeline seriously."
  • NCT05228015
    terminated; "Sponsor strategic reasons"
  • NCT05421936
    suspended; "Result summarized and published"
  • NCT05493501
    terminated; "The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with aumolertinib."
  • NCT05693090
    withdrawn; "This study was withdrawn due to a strategic business decision; no patients were enrolled."
  • NCT06032936
    terminated; "Business reason"
  • NCT06093503
    withdrawn; "Strategic considerations"
  • NCT06630325
    terminated; "Loss of support."

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

Human studies of Osimertinib used AZD9291 80 mg/40 mg — over how long?

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

13 recorded entries; human; also "AZD9291 80 mg/40 mg", "Placebo AZD9291 80 mg/40 mg", "Open-label AZD9291 80 mg/40 mg"

Show the evidence

human

  • NCT02511106
    AZD9291 80 mg/40 mg
  • NCT02511106
    Placebo AZD9291 80 mg/40 mg
  • NCT02511106
    Open-label AZD9291 80 mg/40 mg
  • NCT02529995
    AZD9291 40 mg
  • NCT02529995
    AZD9291 80 mg
  • NCT03521154
    Osimertinib 80mg/40mg
7 more recorded rows
  • human NCT03521154
    Placebo Osimertinib 80mg/40mg
  • human NCT03865511
    TAGRISSO® 80mg (Osimertinib)
  • human NCT04184921
    Osimertinib 80 MG
  • human NCT04563871
    80mg Osimertinib
  • human NCT04563871
    Tagrisso 80mg
  • human NCT05526755
    Osimertinib 80 mg/40 mg
  • human NCT05528458
    Osimertinib 80Mg Tab

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

Osimertinib's half-life is 48 hours — which schedules were studied?

48 hours, the half-life Osimertinib's label states: "Elimination Osimertinib plasma concentrations decreased with time and a population estimated mean half-life of osimertinib was 48 hours, and oral clearance (CL/F) was 14.3 (L/h)." DailyMed label · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · 2024-09-25

Show the evidence
  • half life pharmacokinetics
    48 hours; Elimination Osimertinib plasma concentrations decreased with time and a population estimated mean half-life of osimertinib was 48 hours, and oral clearance (CL/F) was 14.3 (L/h).
  • metabolism pharmacokinetics
    Metabolism The main metabolic pathways of osimertinib were oxidation (predominantly CYP3A) and dealkylation in vitro .

recorded 2024-09-25 · last checked 2026-09-04

Which running trial of Osimertinib could settle lifespan?

NCT03769103 measures Intracranial progression free survival, reading out 2025-04.

48 open trials; n 40; "Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC"

Show the evidence

Trial

  • NCT03769103
    "Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC"; n 40; "Intracranial progression free survival"; 2025-04
  • NCT05103605
    "Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations"; n 274; "Overall survival"; 2026-01-15
  • NCT07491211
    "Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases"; n 300; "Real-world Progression-Free Survival (rwPFS)"; 2026-03-31
  • NCT05281406
    "Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)"; n 50; "Progression Free Survival (PFS1)"; 2026-11
  • NCT05261399
    "Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment"; n 341; "Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib."; 2026-11-23
  • 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
14 further recorded trials
  • NCT04545710
    "Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance"; n 18; "Progression Free Survival at 6 months"; 2026-12-01
  • NCT06319950
    "High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases"; n 255; "progression free survival(PFS)"; 2026-12-30
  • NCT04181060
    "Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer"; n 300; "Progression-free survival (PFS)"; 2026-12-31
  • NCT03909334
    "Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)"; n 160; "Progression Free Survival (PFS)"; 2027-01
  • NCT03410043
    "Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study"; n 173; "Progression free survival (PFS)"; 2027-04-01
  • NCT04410796
    "Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers"; n 571; "Determine the progression-free survival"; 2027-05
  • NCT06670196
    "A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer"; n 420; "Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)"; 2027-07
  • NCT02971501
    "Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases"; n 5; "Progression Free Survival (PFS)"; 2027-07-01
  • NCT06194448
    "To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations"; n 76; "PFS (Progression-Free Survival)"; 2027-07-07
  • NCT03667820
    "Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC"; n 41; "Determine efficacy of Osimertinib plus SABR in patients with EGFR mutant lung cancer measured by Progression-Free Survival (PFS)"; 2027-09-30
  • NCT03521154
    "A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)"; n 216; "Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)"; 2027-10-29
  • NCT05382728
    "Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)"; n 680; "Median Progression Free Survival (PFS)"; 2027-12
  • NCT06741085
    "A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain"; n 56; "intracranial progression-free survival (iPFS)"; 2027-12
  • NCT04322890
    "Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation"; n 6000; "Progression-free survival (PFS)"; 2027-12-24

Which 27 trials of Osimertinib posted no result?

Posted no result
27 of 27 completed trials
Registrations
NCT01951599, NCT03133234, NCT02959749, NCT03790397, NCT02769286 and NCT02228369, and 21 more
Completion dates
oldest 2014-06-04; newest 2024-06-20
Show the evidence

Trial

  • NCT01951599
    2014-06-04
  • NCT03133234
    2017-09-13
  • NCT02959749
    2017-12-31
  • NCT03790397
    2020-04-01
  • NCT02769286
    2020-05
  • NCT02228369
    2020-10-28
14 further recorded trials
  • NCT03219970
    2020-10-28
  • NCT03394118
    2021-04-08
  • NCT04798638
    2021-09-09
  • NCT03535363
    2022-04-01
  • NCT03810066
    2022-09-30
  • NCT02908750
    2022-10-11
  • NCT02923947
    2022-10-28
  • NCT04959981
    2023-04-27
  • NCT04965701
    2023-05-31
  • NCT03755102
    2023-07-07
  • NCT04764214
    2023-07-20
  • NCT04479306
    2023-07-27
  • NCT04563871
    2023-10-25
  • NCT02664935
    2023-11-29

At the median, Osimertinib's trials enrolled 80 people — anything larger?

Median enrolment
80
Largest enrolment
6452
Registered trials counted
248

What do 2151 spontaneous reports say about Osimertinib — 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.

Osimertinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2151 reaction mentions were counted: malignant neoplasm progression 615; drug resistance 386; diarrhoea 252; interstitial lung disease 185. FAERS via Open Targets · CHEMBL3353410 · 2026-06-24

Show the evidence
  • malignant neoplasm progression
    615
  • drug resistance
    386
  • diarrhoea
    252
  • interstitial lung disease
    185
  • acquired gene mutation
    178
  • decreased appetite
    129
4 more recorded rows
  • disease progression
    110
  • metastases to central nervous system
    100
  • pleural effusion
    99
  • hepatic function abnormal
    97

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

Which 10 reactions does Osimertinib's label not list?

acquired gene mutation, decreased appetite and diarrhoea and 7 more reported for Osimertinib, absent from its label. FAERS via Open Targets · CHEMBL3353410 · 2026-06-24

2 label terms; 10 reported and unlisted; 5e81b4a7-b971-45e1-9c31-29cea8c87ce7

Show the evidence
  • acquired gene mutation
    count not stated
  • decreased appetite
    count not stated
  • diarrhoea
    count not stated
  • disease progression
    count not stated
  • drug resistance
    count not stated
  • hepatic function abnormal
    count not stated
4 more recorded rows
  • interstitial lung disease
    count not stated
  • malignant neoplasm progression
    count not stated
  • metastases to central nervous system
    count not stated
  • pleural effusion
    count not stated

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

Osimertinib and CYP3A, CYP3A4 and BCRP: shared by which compounds?

CYP3A, CYP3A4 and BCRP appear in Osimertinib's recorded interaction sentences, 8 in all. DailyMed label · 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 · 2024-09-25

CYP3A, CYP3A4, BCRP, P-gp; 4 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Strong CYP3A Inducers : Avoid concomitant use.
  • drug_interactions
    If not possible, increase TAGRISSO to 160 mg daily in patients receiving a strong CYP3A4 inducer.
  • drug_interactions
    ( 2.5 , 7.1 ) 7.1 Effect of Other Drugs on Osimertinib Strong CYP3A Inducers Co-administering TAGRISSO with a strong CYP3A4 inducer decreased the exposure of osimertinib compared to administering TAGRISSO alone [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Avoid co-administering TAGRISSO with strong CYP3A inducers.
  • drug_interactions
    Increase the TAGRISSO dosage when co-administering with a strong CYP3A4 inducer if concurrent use is unavoidable [see Dosage and Administration (2.5) ] .
  • drug_interactions
    No dose adjustments are required when TAGRISSO is used with moderate and/or weak CYP3A inducers.
2 more recorded rows
  • Interaction statement drug_interactions
    7.2 Effect of Osimertinib on Other Drugs Co-administering TAGRISSO with a breast cancer resistant protein (BCRP) or P-glycoprotein (P-gp) substrate increased the exposure of the substrate compared to administering it alone [see Clinical Pharmacology (12.3) ] .
  • Interaction statement drug_interactions
    Increased BCRP or P-gp substrate exposure may increase the risk of exposure-related toxicity.
  • CYP3A
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • CYP3A4
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • BCRP
    TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Omadacycline
  • P-gp
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2024-09-25 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3353410
PubChem CID
71496458
CAS number
1421373-65-0
RxCUI
1721560
InChIKey
DUYJMQONPNNFPI-UHFFFAOYSA-N
Also called
Azd-9291, Mereletinib, egfr-tki, third-generation egfr-tki, OSIMERTINIB MESYLATE, Mereletinib mesilate, Osimertinib mesilate, OSIMERTINIB [MI], OSIMERTINIB [USAN], Osimertinib [WHO-DD], osimertinib [INN]
Development code
AZD9291, AZD-9291 FREE BASE
Trade name
Tagrisso
Salt form
osimertinib mesylate tablets, AZD9291 mesylate, AZD-9291 MESYLATE, Mereletinib mesylate
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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