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Regorafenib Anhydrous

  • 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 Regorafenib Anhydrous does in the body

The treatment of adult patients

From the FDA-approved label: Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. In in vitro biochemical or cellular assays, regorafenib or its major human active metabolites M-2 and M-5 inhibited the activity of RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, TrkA, Eph2A, RAF-1, BRAF, BRAF V600E, SAPK2, PTK5, Abl and CSF1R at concentrations of regorafenib that have been achieved clinically.

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 · MGN125FS9D · read 2026-08-29

  • Its recorded molecular formula is C21H15ClF4N4O3•H2O, weighing 500.83.

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · read 2026-08-30

Where each sentence above came from

The recorded explanation is written in label language rather than for a beginner. 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 104 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 defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria

The study did not show it

Who was studied
NCT02693535
How many people
4200
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
NCT03970447
How many people
2250
Study design
Phase 2/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

Event Free Survival (RT2)

The study did not show it

Who was studied
NCT04625907
How many people
1672
Study design
Phase 1/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

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) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants

The study did not show it

Who was studied
NCT05425940
How many people
901
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

Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1

The study did not show it

Who was studied
NCT05328908
How many people
770
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.

Who is missing from the studies

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

What the label states about particular groups

  • On pediatric, the label states: “The safety and efficacy of STIVARGA in pediatric patients less than 18 years of age have not been established.”

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · read 2026-08-30

  • On older people, the label states: “Of the 1142 STIVARGA-treated patients enrolled in randomized, placebo-controlled trials, 40% were 65 years of age and over, while 10% were 75 and over.”

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · read 2026-08-30

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

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · read 2026-08-30

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

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is recommended in patients with mild (total bilirubin ≤ULN and AST >ULN, or total bilirubin >ULN to ≤1.5 times ULN) or moderate (total bilirubin >1.5 to ≤3 times ULN and any AST) hepatic impairment, [see Clinical Pharmacology ( 12.3 )] .”

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dose adjustment is recommended for patients with renal impairment.”

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · 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, S6.

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

  • 6 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.

    FDA National Drug Code directory · 68554-0092 · read 2026-08-29

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

    FDA National Drug Code directory · 68554-0092 · read 2026-08-29

  • The regulator's established pharmacologic class for it is breast cancer resistance protein inhibitors [moa], cytochrome p450 2c9 inhibitors [moa] and kinase inhibitor [epc].

    FDA National Drug Code directory · 68554-0092 · 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 · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · read 2026-08-29

  • Stivarga is oral at 3 DOSAGE FORMS AND STRENGTHS STIVARGA is a 40 mg, light pink, oval-shaped, film-coated tablet, debossed with 'BAYER' on one side and '40' on the other side., recorded as fda label in effect 2026-02-09 in the United States.

    US prescribing information · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · 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 Regorafenib Anhydrous 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 Regorafenib Anhydrous 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)
MGN125FS9D
RxNorm concept
1312402

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, S6.

  • 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

  • 3 approved applications cover products containing this substance. The earliest was NDA203085, approved 20120927 to BAYER HLTHCARE.

    Drugs@FDA application register · NDA203085 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA203085 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20120927.

    FDA National Drug Code directory · 68554-0092 · 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 Regorafenib Anhydrous label: indicated for what?

"STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) • Locally advanced,…": indications and usage on Regorafenib Anhydrous's label. DailyMed label · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · 2026-02-09

259 registered trials of Regorafenib Anhydrous — at which phases?

Registered studies posting no result
193 of 259

259 registered studies of Regorafenib Anhydrous: 155 phase2, 66 phase1, 31 phase3, 29 na or unstated, 7 na, 3 phase4, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

195 with a PubMed record

Show the evidence
  • phase2
    155
  • phase1
    66
  • phase3
    31
  • na or unstated
    29
  • na
    7
  • phase4
    3
10 more recorded rows
  • early phase1
    1
  • completed
    120
  • unknown
    38
  • recruiting
    33
  • terminated
    29
  • active not recruiting
    18
  • not yet recruiting
    10
  • withdrawn
    7
  • no longer available
    3
  • suspended
    1

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

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

safety (2), futility/efficacy (1), accrual/recruitment (14), funding/business (5), sponsor decision unspecified (2) and other (6): Regorafenib Anhydrous's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision."; 30 of 259 registered studies

Show the evidence

Trial

  • NCT02119676
    terminated; "Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision."
  • NCT02175654
    terminated; "The trial was prematurely closed due to lack of accrual"
  • NCT02241720
    terminated; "Low Accrual"
  • NCT02278783
    terminated; "Slow Accrual"
  • NCT02383433
    terminated; "PI discretion based on low accrual"
  • NCT02425683
    terminated; "insufficient accrual"
14 further recorded trials
  • NCT02439723
    withdrawn; "Withdrawal of supply of investigational product"
  • NCT02581059
    terminated; "Funder terminated."
  • NCT02587650
    terminated; "Funding"
  • NCT02664077
    terminated; "Due to the significantly lower than expected accrual it was impossible to evaluate the endpoint in a timely fashion."
  • NCT02910843
    terminated; "due to structural financial deficit of SAKK"
  • NCT03099486
    terminated; "Administrative change"
  • NCT03555149
    terminated; "The Sponsor made the decision to terminate the study due to start up and recruitment issues caused by limited resource availability at the treating centers."
  • NCT03563157
    terminated; "low enrollment"
  • NCT03644511
    terminated; "The interest of potential centers is very limited."
  • NCT03722108
    terminated; "Unfavorable benefit-risk balance in the experimental arm following the IDMC for intermediate efficacy and safety analysis"
  • NCT03878524
    terminated; "Low accrual"
  • NCT04327700
    terminated; "Slow accruals"
  • NCT04450836
    terminated; "Following the presentation of the SUNLIGHT study results at ASCO GI and the rapid change in patient management in the majority of centers, the IDMC experts recommended halting inclusion in the SOREGATT study with immediate effect."
  • NCT04476329
    terminated; "Enrollment rate not sufficient to meet funding entity's corporation timeline expectations, entity terminated study's fiscal support. Termination decision was purely administrative in nature and did not involve drug or patient safety issues."

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

Human studies of Regorafenib Anhydrous used Regorafenib 160 mg — over how long?

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

6 recorded entries; human; also "Regorafenib 160 mg", "Regorafenib 40 MG", "Regorafenib 30 MG Oral Tablet"

Show the evidence

human

  • NCT02788006
    Regorafenib 160 mg
  • NCT04476329
    Regorafenib 40 MG
  • NCT04503694
    Regorafenib 30 MG Oral Tablet
  • NCT04803877
    Regorafenib 20MG
  • NCT05370807
    Regorafenib 40 MG Oral Tablet
  • NCT05382741
    Regorafenib 30 mg capsules

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

Regorafenib Anhydrous's half-life is 28 hours — which schedules were studied?

28 hours, the half-life Regorafenib Anhydrous's label states: "Elimination Following a single 160 mg oral dose of STIVARGA, the geometric mean (minimum to maximum) elimination half-lives for regorafenib and the M-2 metabolite in plasma are 28 hours (14 to 58 hours) and 25 hours (14 to 32 hours), respectively." DailyMed label · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · 2026-02-09

bioavailability 69 %.

Show the evidence
  • half life pharmacokinetics
    28 hours; Elimination Following a single 160 mg oral dose of STIVARGA, the geometric mean (minimum to maximum) elimination half-lives for regorafenib and the M-2 metabolite in plasma are 28 hours (14 to 58 hours) and 25 hours (14 to 32 hours), respectively.
  • bioavailability pharmacokinetics
    69 %; The mean relative bioavailability of tablets compared to an oral solution is 69% to 83%.
  • metabolism pharmacokinetics
    Metabolism Regorafenib is metabolized by CYP3A4 and UGT1A9.

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

Which running trial of Regorafenib Anhydrous could settle lifespan?

NCT04117945 measures Overall Survival (OS), reading out 2025-03-31.

26 open trials; n 22; "Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer"

Show the evidence

Trial

  • NCT04117945
    "Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer"; n 22; "Overall Survival (OS)"; 2025-03-31
  • NCT04803877
    "SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma"; n 48; "Compare the 4-month progression-free survival rate to historical controls"; 2026-06
  • NCT03829462
    "Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients"; n 377; "Overall Survival"; 2026-09
  • NCT04055220
    "Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas"; n 168; "Relapse-Free Survival (RFS)"; 2026-10-01
  • NCT06099821
    "KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade"; n 39; "Progression free survival"; 2026-12-31
  • NCT05425940
    "Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer"; n 901; "Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants"; 2027-01-31
14 further recorded trials
  • NCT04757363
    "A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer"; n 39; "6-month progression free Survival"; 2027-02
  • NCT06275919
    "Regorafenib for Recurrent Meningioma (MIRAGE Trial)"; n 104; "Progression free survival (PFS)"; 2027-03
  • NCT07213570
    "STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer"; n 60; "Progression Free Survival rate at 6 months in the two arms."; 2027-04
  • NCT07300488
    "Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma"; n 60; "9-month Overall Survival (OS) rate"; 2027-04-30
  • NCT06820957
    "Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body"; n 2; "Time to event-free survival (EFS) post-Consolidation I (C1)"; 2027-08-19
  • NCT04701476
    "TATE and Pembrolizumab (MK3475) in mCRC and NSCLC"; n 110; "Overall Survival for the mCRC cohort"; 2027-09-30
  • NCT07343791
    "Efficacy and Safety Study of DC-CIK Cell Therapy Combined With Epaloliposide, Vortexil, and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer."; n 14; "progression free survival (PFS)- Evaluate the effectiveness of DC-CIK cell therapy combined with aparolitovorelizumab and regorafenib regimen as a third line therapy in patients with advanced colorectal cancer."; 2027-11-30
  • NCT07730489
    "A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan"; n 130; "BICR-assessed Progression-free Survival (PFS)"; 2027-12
  • NCT07310173
    "Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma"; n 75; "9-month overall survival rate"; 2027-12-01
  • NCT06829355
    ""Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer""; n 52; "Progression-free survival (PFS)"; 2027-12-31
  • NCT05794971
    "Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases"; n 126; "Overall Survival (OS)"; 2028-03-31
  • NCT07514429
    "Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial"; n 24; "progression free survival"; 2028-06-30
  • NCT07514455
    "Regorafenib After Treatment Failure of First Line Immune Checkpoint Inhibitor Treatment in Advanced Hepatocellular Carcinoma Patients"; n 20; "Progression Free Survival"; 2028-06-30
  • NCT06425133
    "Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers"; n 174; "To evaluate the impact of a Regorafenib combined with metronomic chemotherapy and low-dose aspirin compared to standard Regorafenib treatment by assessing progression-free survival"; 2028-09

Which 59 trials of Regorafenib Anhydrous posted no result?

Posted no result
59 of 59 completed trials
Registrations
NCT01002378, NCT00934882, NCT01096030, NCT01339104, NCT00960258 and NCT02001909, and 53 more
Completion dates
oldest 2010-02; newest 2024-07-09
Show the evidence

Trial

  • NCT01002378
    2010-02
  • NCT00934882
    2012-04
  • NCT01096030
    2012-11
  • NCT01339104
    2013-08
  • NCT00960258
    2013-11-11
  • NCT02001909
    2014-04
14 further recorded trials
  • NCT02310477
    2014-12
  • NCT01584830
    2016-01
  • NCT01875380
    2016-04
  • NCT01996969
    2016-05
  • NCT02116894
    2016-05
  • NCT02398513
    2016-06
  • NCT02347852
    2016-09-08
  • NCT01843400
    2016-11-14
  • NCT02656524
    2017-02-15
  • NCT03010722
    2017-07
  • NCT01959269
    2017-07-07
  • NCT02042144
    2017-11-10
  • NCT02465502
    2017-12-11
  • NCT02889328
    2018-01

At the median, Regorafenib Anhydrous's trials enrolled 53 people — anything larger?

Median enrolment
53
Largest enrolment
4103
Registered trials counted
255

What do 5183 spontaneous reports say about Regorafenib Anhydrous — 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.

Regorafenib Anhydrous appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5183 reaction mentions were counted: fatigue 836; palmar-plantar erythrodysaesthesia syndrome 730; diarrhoea 690; decreased appetite 544. FAERS via Open Targets · CHEMBL1946170 · 2026-06-24

Show the evidence
  • fatigue
    836
  • palmar-plantar erythrodysaesthesia syndrome
    730
  • diarrhoea
    690
  • decreased appetite
    544
  • dysphonia
    437
  • asthenia
    421
4 more recorded rows
  • pain in extremity
    401
  • pyrexia
    397
  • nausea
    382
  • hypertension
    345

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

Which 10 reactions does Regorafenib Anhydrous's label not list?

asthenia, decreased appetite and diarrhoea and 7 more reported for Regorafenib Anhydrous, absent from its label. FAERS via Open Targets · CHEMBL1946170 · 2026-06-24

2 label terms; 10 reported and unlisted; 824f19c9-0546-4a8a-8d8f-c4055c04f7c7

Show the evidence
  • asthenia
    count not stated
  • decreased appetite
    count not stated
  • diarrhoea
    count not stated
  • dysphonia
    count not stated
  • fatigue
    count not stated
  • hypertension
    count not stated
4 more recorded rows
  • nausea
    count not stated
  • pain in extremity
    count not stated
  • palmar-plantar erythrodysaesthesia syndrome
    count not stated
  • pyrexia
    count not stated

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

Regorafenib Anhydrous and CYP3A4 and BCRP: shared by which compounds?

CYP3A4 and BCRP appear in Regorafenib Anhydrous's recorded interaction sentences, 8 in all. DailyMed label · 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 · 2026-02-09

CYP3A4, CYP3A4, BCRP; 3 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    • Strong CYP3A4 inducers: Avoid strong CYP3A4 inducers.
  • drug_interactions
    ( 7.1 ) • Strong CYP3A4 inhibitors: Avoid strong CYP3A4 inhibitors.
  • drug_interactions
    ( 7.2 ) • BCRP substrates: Monitor patients closely for symptoms of increased exposure to BCRP substrates.
  • drug_interactions
    ( 7.3 ) 7.1 Effect of Strong CYP3A4 Inducers on Regorafenib Co-administration of a strong CYP3A4 inducer with STIVARGA decreased the plasma concentrations of regorafenib, increased the plasma concentrations of the active metabolite M-5, and resulted in no change in the plasma concentrations of the active metabolite M-2 [see Clinical Pharmacology ( 12.3 )] , and may lead to decreased efficacy.
  • drug_interactions
    Avoid concomitant use of STIVARGA with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St.
  • drug_interactions
    7.2 Effect of Strong CYP3A4 Inhibitors on Regorafenib Co-administration of a strong CYP3A4 inhibitor with STIVARGA increased the plasma concentrations of regorafenib and decreased the plasma concentrations of the active metabolites M-2 and M-5 [see Clinical Pharmacology ( 12.3 )] , and may lead to increased toxicity.
2 more recorded rows
  • Interaction statement drug_interactions
    Avoid concomitant use of STIVARGA with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole).
  • Interaction statement drug_interactions
    7.3 Effect of Regorafenib on Breast Cancer Resistance Protein (BCRP) Substrates Co-administration of STIVARGA with a BCRP substrate increased the plasma concentrations of the BCRP substrate [see Clinical Pharmacology ( 12.3 )] .

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
  • BCRP
    TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Omadacycline

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1946170
PubChem CID
24768591
CAS number
1019206-88-2
RxCUI
1371319
InChIKey
FNHKPVJBJVTLMP-UHFFFAOYSA-N
Also called
Regorafenib
Development code
BAY 73-4506, BAY-734506
Salt form
BAY 73-4506 monohydrate, BAY-734506 MONOHYDRATE, Regorafenib hydrate, Regorafenib monohydrate
Trade name
Stivarga
Also called
bay73-4506, reg, regofinib, REGORAFENIB HYDRATE [JAN], REGORAFENIB MONOHYDRATE [EP MONOGRAPH], REGORAFENIB [ORANGE BOOK], REGORAFENIB [USAN], REGORAFENIB [USP MONOGRAPH], REGORAFENIB [USP-RS]
Component
Regorafenib
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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