This page shows what was measured, who it was measured in, and what that does not settle.
What Sorafenib does in the body
Unresectable hepatocellular carcinoma
From the FDA-approved label: Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro . Sorafenib was shown to inhibit multiple intracellular (c-CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT- 3, RET, RET/PTC, VEGFR-1, VEGFR- 2, VEGFR- 3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis and apoptosis. Sorafenib inhibited tumor growth of HCC, RCC, and DTC human tumor xenografts in immunocompromised mice. Reductions in tumor angiogenesis were seen in models of HCC and RCC upon sorafenib treatment, and increases in tumor apoptosis were observed in models of HCC, RCC, and DTC.
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 · 9ZOQ3TZI87 · read 2026-08-29
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 121 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.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Safety parameters
✗ The study did not show it
Who was studied
NCT00111020
How many people
2567
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
Disease-free Survival (DFS)
✗ The study did not show it
Who was studied
NCT00326898
How many people
1943
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
✗ The study did not show it
Who was studied
NCT00858871
How many people
1714
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
Disease-free survival
✗ The study did not show it
Who was studied
NCT00492258
How many people
1656
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
Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations
✗ The study did not show it
Who was studied
NCT01371981
How many people
1645
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) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
✗ The study did not show it
Who was studied
NCT03298451
How many people
1324
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 happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.11 registered measures of this kind. 5 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Mouse, Dog. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
progression free survival
overall survival
4 month progression free survival
time to disease progression
disease free survival
2 year progression free survival
progression free survival rate
overall survival in the itt population
one year survival
survival
and 1 more.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (29)
objective response rate
response rate as measured by recist criteria
objective tumor response rate
response
response rate
adverse events
overall response rate using recist criteria
duration of response
response probability
best overall response rate
safety parameters
objective response
maximum tolerated dose and recommended phase ii dose
confirmed response rate
overall response rate
objective overall response rate
overall rate of response
incidence of adverse events
overall response rate of treated at mtd/phase ii dose level
toxicity
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 25 to 48 hours hours
Read from the label, which states: “Elimination The mean elimination half-life of sorafenib was approximately 25 to 48 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Sorafenib tablets are a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable…
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 sorafenib have not been established in pediatric patients.”
US prescribing information · 93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6 · read 2026-08-30
On older people, the label states: “In total, 59% of HCC patients treated with sorafenib were age 65 years or older and 19% were 75 and older.”
US prescribing information · 93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies and its mechanism of action [ see Clinical Pharmacology ( 12.1 )] , sorafenib may cause fetal harm when administered to a pregnant woman.”
US prescribing information · 93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of sorafenib or its metabolites in human milk, or its effects on the breast-fed child or on milk production.”
US prescribing information · 93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6 · read 2026-08-30
On people with reduced kidney function, the label states: “No dose adjustment is necessary for patients with mild, moderate or severe renal impairment who are not on dialysis.”
US prescribing information · 93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
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 (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
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.
Sorafenib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 7380 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
21 products list this as an active ingredient in the United States drug directory. 21 of them contain it and nothing else.
FDA National Drug Code directory · 43598-458 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 43598-458 · read 2026-08-29
The regulator's established pharmacologic class for it is kinase inhibitor [epc] and protein kinase inhibitors [moa].
FDA National Drug Code directory · 43598-458 · read 2026-08-29
7 published labels name it as an active ingredient. 7 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 68aa4b7f-3f13-4e73-b572-aa6c11a8429c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 68aa4b7f-3f13-4e73-b572-aa6c11a8429c · read 2026-08-29
sorafenib is oral at 3 DOSAGE FORMS AND STRENGTHS Sorafenib tablets USP, 200 mg are light yellow to yellow colour, round, biconvex, film-coated tablets debossed with ‘I’ on one side and plain on the other side and free from physical defects., recorded as fda label in effect 2024-12-02 in the United States.
US prescribing information · 93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Sorafenib studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Sorafenib are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
How many documents were read
8 documents were read for this substance.
RNAWiki source record
8 of them state the same halfLife, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
9ZOQ3TZI87
CAS registry number
284461-73-0
PubChem compound
216239
ChEMBL
CHEMBL1336
ChEBI
50924
WHO international nonproprietary name list entry
8234
RxNorm concept
495881
EMA substance identifier
100000091433
DrugBank
DB00398
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 unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
7 approved applications cover products containing this substance. The earliest was NDA021923, approved 20051201 to BAYER HLTHCARE.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 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.
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Recorded evidence blocks (13)
Q2
What did Sorafenib's largest trial (4103 people) and its longest (22 years) measure?
4103 people in Sorafenib's largest registered study, 22 years in its longest registered window, measuring Median survival. ClinicalTrials.gov · 2026-09-01
343 phase2, 201 phase1, 91 phase3, 39 na or unstated, 20 na, 10 phase4, 3 early phase1; NCT00265798; 2027-03-31; no ageing endpoint recorded. Last human test completed 2026, NCT04039607.
Interpretation These counts include studies where Sorafenib was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
343
phase1
201
phase3
91
na or unstated
39
na
20
phase4
10
2 more recorded rows
early phase1
3
Last recorded human testNCT04039607
2026-07-09
recorded 2026-09-01 · last checked 2026-09-04
Q3
From C. elegans to human: where has Sorafenib shown lifespan?
terminated; "Negative sorafenib results from ESCAPE trial and safety concerns of regimen"
NCT00452387
terminated; "Early stopping rule"
NCT00496756
terminated; "Low accrual rate"
NCT00510289
terminated; "Early closure of study due to poor response"
NCT00525161
terminated; "Slow accrual and loss of funding"
14 further recorded trials
NCT00526799
terminated; "Study closed to accrual due unfavorable interim analysis"
NCT00543335
terminated; "Lack of Accrual."
NCT00547443
withdrawn; "Withdrawn as the sponsor has stopped the drug for NSCLC population"
NCT00557830
terminated; "The study was closed to enrollment when it became clear that enrollment was too slow to complete the full enrollment target within the time frame allowed."
NCT00573755
terminated; "lack of participant accrual"
NCT00576056
terminated; "Bayer Healthcare is no supplying the study drug"
NCT00589550
terminated; "low accrual"
NCT00595985
terminated; "low response rate, no evidence of PFS or OS improved."
NCT00607438
terminated; "Low accrual"
NCT00619242
terminated; "Low accrual"
NCT00622466
terminated; "Study sponsor requested that the study be permanently closed by letter."
NCT00627835
withdrawn; "Site decided not to open this study"
NCT00632541
terminated; "Significant Toxicities Experienced"
NCT00687674
terminated; "Due to study design (and toxicity), this trial closed to accrual prior to opening the phase II portion."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Sorafenib used sorafenib (200 or 400mg bid) and taxotere iv — over how long?
"Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate"; n 38; "Objective Response Rate"; 2027-03-31
NCT00494182
"Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer"; n 48; "Objective overall response rate"; 2026-12-31
NCT01187199
"Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer"; n 278; "Maximum Tolerated Dose (MTD)"; 2026-04-30
NCT01303341
"Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma"; n 35; "Maximum-tolerated dose of sorafenib tosylate and riluzole in patients with all types of solid tumors"; 2026-09-17
NCT01840592
"Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib"; n 30; "overall survival"; 2027-04
NCT01861314
"Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia"; n 15; "BETD of bortezomib, sorafenib tosylate, and decitabine using National Cancer Institute Common Terminology Criteria for Adverse Events version 4"; 2027-03-19
14 further recorded trials
NCT01871766
"Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy"; n 115; "Event-free survival (intermediate risk arm)"; 2030-06
NCT02029001
"Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment"; n 900; "Induction Progression-Free Rate after induction treatment"; 2028-10
NCT02143726
"Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer"; n 35; "Progression Free Survival"; 2028-08-06
NCT02185560
"Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib"; n 453; "Number of participants with Adverse drug reaction as a measure of safety and tolerability."; 2026-09-30
NCT02298348
"Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma"; n 18; "The maximum tolerated dose of sorafenib given twice each day when given in combination with cyclophosphamide/topotecan for 5 days"; 2026-12
NCT02559778
"Pediatric Precision Laboratory Advanced Neuroblastoma Therapy"; n 500; "Number of days from start of therapy to date of first relapse"; 2035-09
NCT03017326
"Paediatric Hepatic International Tumour Trial"; n 450; "Event-free survival (EFS)"; 2027-12
NCT03132454
"Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia"; n 32; "Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT)"; 2027-12-31
NCT03164057
"A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia"; n 206; "Proportion of evaluable patients who tolerate five days of single agent DMTi before a standard chemotherapy combination"; 2027-06
NCT03247088
"Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant"; n 74; "Maximum tolerated dose (MTD) as defined by toxicity (Phase I)"; 2027-12-31
NCT03298451
"Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma"; n 1324; "Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg"; 2027-12-31
NCT03533582
"Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery"; n 537; "Event-free survival (EFS)"; 2027-03-31
NCT03755791
"Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy"; n 837; "Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population"; 2026-07-31
NCT03899428
"Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC"; n 30; "Time to decline to ≥ 2 log10 IU/mL of serum HBsAg"; 2025-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Sorafenib could settle lifespan?
NCT03755791 measures Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population, reading out 2026-07-31.
12 open trials; n 837; "Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy"
Show the evidence
Trial
NCT03755791
"Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy"; n 837; "Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population"; 2026-07-31
NCT04770896
"A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab"; n 557; "Overall Survival (OS)"; 2026-10-14
NCT04344158
"A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)"; n 648; "Overall survival (OS)"; 2026-12
NCT03533582
"Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery"; n 537; "Event-free survival (EFS)"; 2027-03-31
NCT01840592
"Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib"; n 30; "overall survival"; 2027-04
NCT03017326
"Paediatric Hepatic International Tumour Trial"; n 450; "Event-free survival (EFS)"; 2027-12
6 further recorded trials
NCT03298451
"Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma"; n 1324; "Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg"; 2027-12-31
NCT06532084
"Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen"; n 88; "Event-free survival"; 2028-05
NCT02143726
"Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer"; n 35; "Progression Free Survival"; 2028-08-06
NCT07463651
"MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib"; n 594; "Measurable residual disease recurrence-free survival (MRD-RFS)"; 2030-03-31
NCT01871766
"Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy"; n 115; "Event-free survival (intermediate risk arm)"; 2030-06
NCT07787429
"Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma"; n 40; "Event-Free Survival (EFS)"; 2033-07-31
Q10
Which 209 trials of Sorafenib posted no result?
Posted no result
209 of 209 completed trials
Registrations
NCT00661180, NCT00657254, NCT00119639, NCT00661375, NCT00079612 and NCT00255658, and 203 more
Completion dates
oldest 2005-02; newest 2024-07
Show the evidence
Trial
NCT00661180
2005-02
NCT00657254
2005-06
NCT00119639
2005-12
NCT00661375
2006-03
NCT00079612
2007-01
NCT00255658
2007-04
14 further recorded trials
NCT00259129
2008-03
NCT00609401
2008-05
NCT00606866
2008-06
NCT00111020
2008-10
NCT00445042
2008-10
NCT00498836
2008-10
NCT00492986
2008-11
NCT00456716
2008-12
NCT00496301
2008-12
NCT00478374
2009-01
NCT00619541
2009-01
NCT00619996
2009-01
NCT00606125
2009-02
NCT00464919
2009-03
Q11
At the median, Sorafenib's trials enrolled 44 people — anything larger?
Median enrolment
44
Largest enrolment
4103
Registered trials counted
630
Q12
What do 7380 spontaneous reports say about Sorafenib — 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.
Sorafenib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 7380 reaction mentions were counted: diarrhoea 1363; palmar-plantar erythrodysaesthesia syndrome 1212; hepatocellular carcinoma 841; fatigue 806. open-targets-adr · CHEMBL1200485 · 2026-06-24
Show the evidence
diarrhoea
1363
palmar-plantar erythrodysaesthesia syndrome
1212
hepatocellular carcinoma
841
fatigue
806
rash
694
hypertension
596
4 more recorded rows
decreased appetite
556
pyrexia
486
asthenia
440
hepatic function abnormal
386
recorded 2026-06-24 · last checked 2026-09-04
Q13
Sorafenib and CYP3A4, CYP2C19 and CYP2D6: shared by which compounds?
CYP3A4, CYP2C19 and CYP2D6 appear in Sorafenib's recorded interaction sentences, 17 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Sorafenib did not increase CYP1A2 and CYP3A4 activities, suggesting that sorafenib is unlikely to induce CYP1A2 or CYP3A4 in humans.
CYP2B6pharmacokinetics
In Vitro Studies Sorafenib competitively inhibited CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in vitro .
CYP2C19
pharmacokinetics
Effect of Sorafenib on Other Drugs : Sorafenib 400 mg twice daily for 28 days did not increase the systemic exposure of concomitantly administered midazolam (CYP3A4 substrate), dextromethorphan (CYP2D6 substrate), and omeprazole (CYP2C19 substrate) [see Clinical Pharmacology ( 12.3 )].
pharmacokinetics
However, sorafenib 400 mg twice daily for 28 days with substrates of CYP3A4, CYP2D6 and CYP2C19 did not increase the systemic exposure of these substrates [see Drug Interactions ( 7.3 )] .
pharmacokinetics
In Vitro Studies Sorafenib competitively inhibited CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in vitro .
CYP2C8pharmacokinetics
In Vitro Studies Sorafenib competitively inhibited CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in vitro .
CYP2C9pharmacokinetics
In Vitro Studies Sorafenib competitively inhibited CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in vitro .
CYP2D6
pharmacokinetics
Effect of Sorafenib on Other Drugs : Sorafenib 400 mg twice daily for 28 days did not increase the systemic exposure of concomitantly administered midazolam (CYP3A4 substrate), dextromethorphan (CYP2D6 substrate), and omeprazole (CYP2C19 substrate) [see Clinical Pharmacology ( 12.3 )].
pharmacokinetics
However, sorafenib 400 mg twice daily for 28 days with substrates of CYP3A4, CYP2D6 and CYP2C19 did not increase the systemic exposure of these substrates [see Drug Interactions ( 7.3 )] .
pharmacokinetics
In Vitro Studies Sorafenib competitively inhibited CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in vitro .
CYP3A4
pharmacokinetics
Metabolism Sorafenib undergoes oxidative metabolism by hepatic CYP3A4, as well as glucuronidation by UGT1A9.
pharmacokinetics
Drug Interactions Studies Effect of Strong CYP3A4 Inhibitors on Sorafenib: Ketoconazole, a strong inhibitor of CYP3A4 and P-glycoprotein, administered at a dose of 400 mg once daily for 7 days did not alter the mean AUC of a single oral dose of sorafenib 50 mg in healthy subjects.
pharmacokinetics
Effect of Sorafenib on Other Drugs : Sorafenib 400 mg twice daily for 28 days did not increase the systemic exposure of concomitantly administered midazolam (CYP3A4 substrate), dextromethorphan (CYP2D6 substrate), and omeprazole (CYP2C19 substrate) [see Clinical Pharmacology ( 12.3 )].
pharmacokinetics
However, sorafenib 400 mg twice daily for 28 days with substrates of CYP3A4, CYP2D6 and CYP2C19 did not increase the systemic exposure of these substrates [see Drug Interactions ( 7.3 )] .
pharmacokinetics
Effect of Strong CYP3A4 Inducers on Sorafenib: Concomitant use of sorafenib with rifampin administered at a dose of 600 mg once daily for 5 days with a single oral dose of sorafenib 400 mg in healthy volunteers resulted in a 37% decrease in the mean AUC of sorafenib.
pharmacokinetics
Sorafenib did not increase CYP1A2 and CYP3A4 activities, suggesting that sorafenib is unlikely to induce CYP1A2 or CYP3A4 in humans.
1 more recorded row
CYP3A4pharmacokinetics
In Vitro Studies Sorafenib competitively inhibited CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in vitro .
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Sorafenib and autophagy?
"To elucidate the specific mechanism by which LAS inhibits autophagy in HCC cells and investigate its impact on the sensitivity of HCC cells to sorafenib." — where Sorafenib and autophagy appear together. Europe PMC · pathway abstract search · 2026-03-31
"To elucidate the specific mechanism by which LAS inhibits autophagy in HCC cells and investigate its impact on the sensitivity of HCC cells to sorafenib."
PMID 41308386
"Moreover, it enhanced the sensitivity of HCC cells to sorafenib by inhibiting sorafenib-induced autophagy in vitro and in vivo."
sirtuinPMID 38466472
"Sirtuin 1 (SIRT1), is a nicotinamide adenosine dinucleotide (NAD)-dependent histone deacetylases that regulates various metabolic and oncogenic events such as cell survival, apoptosis, autophagy, tumourigenesis, metastasis and drug resistance in various cancers, but its role in HCC, particularly in sorafenib resistance is underexplored."
autophagyPMID 38466472
"Sirtuin 1 (SIRT1), is a nicotinamide adenosine dinucleotide (NAD)-dependent histone deacetylases that regulates various metabolic and oncogenic events such as cell survival, apoptosis, autophagy, tumourigenesis, metastasis and drug resistance in various cancers, but its role in HCC, particularly in sorafenib resistance is underexplored."
NAD+PMID 38466472
"Sirtuin 1 (SIRT1), is a nicotinamide adenosine dinucleotide (NAD)-dependent histone deacetylases that regulates various metabolic and oncogenic events such as cell survival, apoptosis, autophagy, tumourigenesis, metastasis and drug resistance in various cancers, but its role in HCC, particularly in sorafenib resistance is underexplored."
sirtuin
PMID 38466472
"Western blot analysis showed increased SIRT1, altered autophagy pathway and activated NF-ĸβ signalling in sorafenib-resistant cells."
PMID 42079338
"TOPK also contributes to resistance to anti-cancer agents such as doxorubicin, gefitinib, oxaliplatin, and sorafenib through its influence on activator protein-1, phosphatase and tensin homolog, sirtuin 1 (SIRT1), p53, and additional downstream effectors."
mTOR
PMID 41632344
"Through triggering the Akt/mTOR signaling pathway, CCDC137 encourages sorafenib resistance in HCC cells, potentially offering a treatment approach to combat sorafenib resistance in HCC cells."
PMID 40533744
"CBD interacts with the endocannabinoid system (ECS), inhibits oncogenic signaling (PI3K/AKT/mTOR), and enhances chemotherapeutic efficacy (sorafenib, cabozantinib)."
PMID 40950667
"Sorafenib can inhibit the proliferation and migration of pNENs by down-regulating the mTOR pathway."
AMPK
PMID 38360276
"Low-dose sorafenib has been reported to activate AMPK through inducing mitochondrial uncoupling without detectable toxicities."
PMID 38360276
"AMPK activation has been the approach for extending lifespan, therefore, we investigated the effect of sorafenib on lifespan and physical activity of C. elegans and the underlying mechanisms."
PMID 38360276
"Sorafenib activated AMPK through inducing mitochondrial uncoupling in C. elegans."
NAD+
PMID 31430957
"Resistance to sorafenib develops frequently and could be mediated by the nicotinamide adenine dinucleotide (NAD)-dependent deacetylase sirtuin (SIRT)1."
PMID 31430957
"We aimed to test whether sorafenib efficacy is influenced by cellular NAD levels and NAD-dependent SIRT1 function."
recorded 2026-03-31 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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