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Axitinib

  • 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 Axitinib does in the body

Advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy

From the FDA-approved label: Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.

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 · C9LVQ0YUXG · read 2026-08-29

  • Its recorded molecular formula is C22H18N4OS, weighing 386.47 Daltons.

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 97 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.

Percentage of patients that are treated based on their molecular tumor profile

The study did not show it

Who was studied
NCT02925234
How many people
1550
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

Overall Survival (OS).

The study did not show it

Who was studied
NCT06364631
How many people
1250
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

DRSS 2-step change status at Week 52 from baseline in the study eye (≥ 2 step improvement, ≥ 2-step worsening, < 2-step change in either direction)

The study did not show it

Who was studied
NCT07235085
How many people
930
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants

The study did not show it

Who was studied
NCT02684006
How many people
886
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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review

The study did not show it

Who was studied
NCT02853331
How many people
861
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

Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144

The study did not show it

Who was studied
NCT07516132
How many people
850
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

  • INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

Who is missing from the studies

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

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of INLYTA in pediatric patients have not been established.”

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · read 2026-08-30

  • On older people, the label states: “In a controlled clinical study with INLYTA for the treatment of patients with RCC, 123/359 patients (34%) treated with INLYTA were ≥65 years of age.”

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings in animal studies and its mechanism of action, INLYTA can cause fetal harm when administered to a pregnant woman.”

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · read 2026-08-30

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

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · read 2026-08-30

  • On people with reduced liver function, the label states: “In a dedicated hepatic impairment trial, compared to subjects with normal hepatic function, systemic exposure following a single dose of INLYTA was similar in subjects with baseline mild hepatic impairment (Child-Pugh class A) and higher in subjects with baseline moderate hepatic impairment (Child-Pugh class B).”

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dedicated renal impairment trial for axitinib has been conducted.”

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · 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

  • 7 products list this as an active ingredient in the United States drug directory. 7 of them contain it and nothing else.

    FDA National Drug Code directory · 0069-0145 · read 2026-08-29

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

    FDA National Drug Code directory · 0069-0145 · read 2026-08-29

  • The regulator's established pharmacologic class for it is kinase inhibitor [epc] and receptor tyrosine kinase inhibitors [moa].

    FDA National Drug Code directory · 0069-0145 · read 2026-08-29

  • 2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · read 2026-08-29

  • INLYTA is oral at 3 DOSAGE FORMS AND STRENGTHS • 1 mg tablets of INLYTA: red, film-coated, oval tablets, debossed with "Pfizer" on one side and "1 XNB" on the other side. • 5 mg tablets of INLYTA: red, film-coated, triangular tablets, de…, recorded as fda label in effect 2025-02-19 in the United States.

    US prescribing information · 84137882-e000-47da-bd5b-fa76ab3c76f9 · 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 Axitinib 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 Axitinib 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.

How many documents were read

  • 2 documents were read for this substance.

    RNAWiki source record

  • 2 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 2 of them state the same bioavailability, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
C9LVQ0YUXG
RxNorm concept
1243004

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: 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

  • 4 approved applications cover products containing this substance. The earliest was NDA202324, approved 20120127 to PF PRISM CV.

    Drugs@FDA application register · NDA202324 · read 2026-08-29

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

    Drugs@FDA application register · NDA202324 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20120127.

    FDA National Drug Code directory · 0069-0145 · 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 Axitinib label: indicated for what?


"INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC.": indications and usage on Axitinib's label. DailyMed label · 8a903e31-936e-4ed7-8a59-59f32374f338 · 2026-03-12

172 registered trials of Axitinib — at which phases?


Registered studies posting no result
96 of 172

172 registered studies of Axitinib: 114 phase2, 48 phase1, 14 na or unstated, 10 phase3, 4 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

186 with a PubMed record

Show the evidence
  • phase2
    114
  • phase1
    48
  • na or unstated
    14
  • phase3
    10
  • na
    4
  • completed
    100
8 more recorded rows
  • terminated
    19
  • recruiting
    18
  • active not recruiting
    12
  • unknown
    8
  • withdrawn
    7
  • not yet recruiting
    4
  • no longer available
    3
  • suspended
    1

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

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


safety (4), futility/efficacy (1), accrual/recruitment (7), funding/business (2), sponsor decision unspecified (1) and other (12): Axitinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"See termination reason in detailed description."; 27 of 172 registered studies

Show the evidence

Trial

  • NCT01441414
    terminated; "See termination reason in detailed description."
  • NCT01483638
    terminated; "The trial was prematurely closed due to lack of accrual"
  • NCT01508117
    terminated; "transferred study sponsor"
  • NCT01533948
    terminated; "low accrual"
  • NCT01599754
    terminated; "Primary endpoint did not reach statistical significance"
  • NCT01649180
    terminated; "Closed due to prolonged enrollment timelines"
14 further recorded trials
  • NCT01727336
    terminated; "The study was terminated by the sponsor following unblinding of the Progression Free Survival endpoint."
  • NCT01806064
    terminated; "The study did not meet endpoint."
  • NCT02560012
    terminated; "Loss of laboratory performing molecular analysis"
  • NCT02782403
    terminated; "Terminated per PI's request at the time of CR. Study was closed due to low/slow accrual due to other competing studies."
  • NCT03275558
    withdrawn; "Study halted prior to enrollment of first participant. (It has been determined on 2018 May 15 that the NCT03275558 study will be stopped by sponsor decision)"
  • NCT03386929
    terminated; "The SPRING trial had to be early terminated at the end of the Phase 1 portion of the study due to the absence of funding necessary for the performance of the Phase 2."
  • NCT03472560
    terminated; "The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)"
  • NCT03481842
    withdrawn; "Change in study design and sponsor"
  • NCT04197219
    withdrawn; "PI is leaving institution"
  • NCT04370509
    terminated; "Collaborating sponsor decision"
  • NCT04458259
    terminated; "Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities."
  • NCT04555603
    withdrawn; "Failed at data quality assurance process before any analyses would be performed"
  • NCT04585815
    terminated; "Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions"
  • NCT04873895
    terminated; "failure to accrue"

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

Human studies of Axitinib used Axitinib 1 MG — over how long?


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

2 recorded entries; human; also "Axitinib 1 MG", "Axitinib 5 MG"

Show the evidence

human

  • NCT03275558
    Axitinib 1 MG
  • NCT04873895
    Axitinib 5 MG

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

Axitinib's half-life is 2 to 3 days — which schedules were studied?


2 to 3 days, the half-life Axitinib's label states: "Based on the plasma half-life, steady state is expected within 2 to 3 days of dosing." DailyMed label · 8a903e31-936e-4ed7-8a59-59f32374f338 · 2026-03-12

tmax 2.5 to 4.1 hours; bioavailability 58 %.

Show the evidence
  • half life pharmacokinetics
    2 to 3 days; Based on the plasma half-life, steady state is expected within 2 to 3 days of dosing.
  • tmax pharmacokinetics
    2.5 to 4.1 hours; Absorption and Distribution Following single oral 5-mg dose administration, the median Tmax ranged from 2.5 to 4.1 hours.
  • bioavailability pharmacokinetics
    58 %; The mean absolute bioavailability of axitinib after an oral 5 mg dose is 58%.
  • metabolism pharmacokinetics
    Metabolism and Elimination The plasma half-life of INLYTA ranges from 2.5 to 6.1 hours.

recorded 2026-03-12 · last checked 2026-09-04

Which running trial of Axitinib could settle lifespan?


NCT03595124 measures Progression Free Survival (PFS), reading out 2026-11-13.

7 open trials; n 15; "A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)"

Show the evidence

Trial

  • NCT03595124
    "A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)"; n 15; "Progression Free Survival (PFS)"; 2026-11-13
  • NCT03092856
    "Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer"; n 62; "Progression-free survival (PFS)"; 2027-12-31
  • NCT06889649
    "SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC"; n 30; "Progression-Free Survival 1 (PFS1)"; 2028-02-20
  • NCT07776717
    "TACTIC-RCC: Toripalimab Plus Axitinib Induction With Selective Deferred Cytoreductive Nephrectomy in TLS-Positive Advanced Clear Cell Renal Cell Carcinoma"; n 30; "Progression-Free Survival Rate From Deferred Cytoreductive Nephrectomy (24 months DCN-PFS rate)"; 2028-12-31
  • NCT06364631
    "CARE1 Pragmatic Clinical Trial"; n 1250; "Overall Survival (OS)."; 2032-05-05
  • NCT05327686
    "Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial"; n 240; "Nephrectomy and radiographic progression-free survival (nrPFS)"; 2033-06-15
  • 1 further recorded trial NCT07383441
    "Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer"; n 718; "Progression-free survival (PFS)"; 2034-01-31

Which 33 trials of Axitinib posted no result?


Posted no result
33 of 33 completed trials
Registrations
NCT00949624, NCT00918632, NCT00919204, NCT00905814, NCT01020136 and NCT01211275, and 27 more
Completion dates
oldest 2008-06; newest 2024-08-19
Show the evidence

Trial

  • NCT00949624
    2008-06
  • NCT00918632
    2009-07
  • NCT00919204
    2009-08
  • NCT00905814
    2009-09
  • NCT01020136
    2010-02
  • NCT01211275
    2013-05-06
14 further recorded trials
  • NCT01529138
    2014-03
  • NCT01486251
    2014-09
  • NCT00859118
    2014-12
  • NCT01540526
    2014-12
  • NCT01249547
    2016-12
  • NCT01273662
    2016-12
  • NCT01798446
    2016-12
  • NCT02597322
    2017-06
  • NCT02164838
    2017-10-19
  • NCT01334112
    2018-03
  • NCT02261207
    2018-03
  • NCT01352728
    2018-06-07
  • NCT02700568
    2018-08
  • NCT02814461
    2018-11

At the median, Axitinib's trials enrolled 40 people — anything larger?


Median enrolment
40
Largest enrolment
1550
Registered trials counted
169

What do 3756 spontaneous reports say about Axitinib — 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.

Axitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3756 reaction mentions were counted: diarrhoea 797; fatigue 527; disease progression 510; hypertension 426. FAERS via Open Targets · CHEMBL1289926 · 2026-06-24

Show the evidence
  • diarrhoea
    797
  • fatigue
    527
  • disease progression
    510
  • hypertension
    426
  • decreased appetite
    307
  • neoplasm progression
    305
4 more recorded rows
  • dysphonia
    282
  • weight decreased
    220
  • blood pressure increased
    210
  • renal cancer
    172

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

Which 10 reactions does Axitinib's label not list?


blood pressure increased, decreased appetite and diarrhoea and 7 more reported for Axitinib, absent from its label. FAERS via Open Targets · CHEMBL1289926 · 2026-06-24

2 label terms; 10 reported and unlisted; 8a903e31-936e-4ed7-8a59-59f32374f338

Show the evidence
  • blood pressure increased
    count not stated
  • decreased appetite
    count not stated
  • diarrhoea
    count not stated
  • disease progression
    count not stated
  • dysphonia
    count not stated
  • fatigue
    count not stated
4 more recorded rows
  • hypertension
    count not stated
  • neoplasm progression
    count not stated
  • renal cancer
    count not stated
  • weight decreased
    count not stated

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

Axitinib and CYP3A4: shared by which compounds?


CYP3A4 appear in Axitinib's recorded interaction sentences, 8 in all. DailyMed label · 8a903e31-936e-4ed7-8a59-59f32374f338 · 2026-03-12

CYP3A4, CYP3A4; 2 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    • Avoid strong CYP3A4/5 inhibitors.
  • drug_interactions
    ( 2.2 , 7.1 ) • Avoid strong CYP3A4/5 inducers.
  • drug_interactions
    ( 7.2 ) 7.1 CYP3A4/5 Inhibitors Co-administration of ketoconazole, a strong inhibitor of CYP3A4/5, increased the plasma exposure of axitinib in healthy volunteers.
  • drug_interactions
    Co-administration of INLYTA with strong CYP3A4/5 inhibitors should be avoided.
  • drug_interactions
    Selection of concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended.
  • drug_interactions
    If a strong CYP3A4/5 inhibitor must be co-administered, the INLYTA dose should be reduced [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] .
2 more recorded rows
  • Interaction statement drug_interactions
    7.2 CYP3A4/5 Inducers Co-administration of rifampin, a strong inducer of CYP3A4/5, reduced the plasma exposure of axitinib in healthy volunteers.
  • Interaction statement drug_interactions
    Co-administration of INLYTA with strong CYP3A4/5 inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St.

CYP3A4

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

recorded 2026-03-12 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1289926
PubChem CID
6450551
CAS number
319460-85-0
RxCUI
1242999
InChIKey
RITAVMQDGBJQJZ-FMIVXFBMSA-N
Development code
AG-013736, AG-13736, NSC-757441
Trade name
Inlyta, Axitinib Accord
Also called
aiv001, otx-tki, Axitinib [INN], Axitinib [JAN], Axitinib [MART.], Axitinib [MI], Axitinib [ORANGE BOOK], Axitinib [USAN], Axitinib [VANDF], Axitinib [WHO-DD]
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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