This page shows what was measured, who it was measured in, and what that does not settle.
What Trifluridine does in the body
Inclusion of tipiracil increases trifluridine exposure by inhibiting its metabolism by thymidine phosphorylase.
471). Following uptake into cancer cells, trifluridine is incorporated into DNA, interferes with DNA synthesis and inhibits cell proliferation. Trifluridine/tipiracil demonstrated anti-tumor activity against KRAS wild-type and mutant human colorectal cancer xenografts in mice.
Why people take it. Primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2
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 · RMW9V5RW38 · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
No statement of the main limit is recorded.
The four opening statements run to 74 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.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
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.
The time to recurrence (TTR)
✗ The study did not show it
Who was studied
NCT06197425
How many people
1660
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
Arm 1, 2 and 3: Overall Survival
✗ The study did not show it
Who was studied
NCT07549412
How many people
1020
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Phase 1a (All cohorts except Cohort D-4, D-5 and D-9) : Percentage of participants who experience a Dose Limiting Toxicity (DLT)
✗ The study did not show it
Who was studied
NCT04999761
How many people
917
Study design
Phase 1
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
Incidence of Adverse Events [safety and tolerability]
✗ The study did not show it
Who was studied
NCT03306394
How many people
907
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Progression-free Survival (PFS)
✗ The study did not show it
Who was studied
NCT03869892
How many people
856
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
✗ The study did not show it
Who was studied
NCT01607957
How many people
800
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.7 registered measures of this kind. 3 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 healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
■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.
peak plasma concentration
area under the plasma concentration versus time curve 0 t
area under the plasma concentration versus time curve 0
Meaningful
Things that change how a life goes, not only a number.
progression free survival
16 week progression free survival rate
overall survival
progression free survival at 6 months
global cohort overall survival
china cohort overall survival
progression free survival rate
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 (12)
experiencing a dose limiting toxicity
maximum tolerated dose
immune related overall response rate
objective response rate
overall response rate
frequency of dose limiting toxicities
pathologic complete response
treatment emergent adverse events
dose limiting toxicities
incidence of adverse events
disease control rate
safety/tolerability
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
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.
Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
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: “Safety and effectiveness in pediatric patients below six years of age have not been established.”
US prescribing information · abc1d07f-91ee-4421-bc9b-457d0ed41f4c · read 2026-08-30
On older people, the label states: “No overall differences in safety or effectiveness have been observed between elderly and younger patients.”
US prescribing information · abc1d07f-91ee-4421-bc9b-457d0ed41f4c · read 2026-08-30
On people who are pregnant, the label states: “Teratogenic Effects: Trifluridine was not teratogenic at doses up to 5 mg/kg/day (23 times the estimated human exposure) when given subcutaneously to rats and rabbits.”
US prescribing information · abc1d07f-91ee-4421-bc9b-457d0ed41f4c · read 2026-08-30
On people who are breastfeeding, the label states: “It is unlikely that trifluridine is excreted in human milk after ophthalmic instillation of trifluridine because of the relatively small dosage (5mg/day), its dilution in body fluids and its extremely short half-life (approximately 12 minutes).”
US prescribing information · abc1d07f-91ee-4421-bc9b-457d0ed41f4c · 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, S4.
No source is stored against this line.
What is in the pack
Sold as tablet, solution/drops, tablet, film coated, solution, given by the oral, ophthalmic 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.
Trifluridine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3100 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
fatigue — 553 reaction mentions
disease progression — 532 reaction mentions
nausea — 486 reaction mentions
diarrhoea — 432 reaction mentions
vomiting — 255 reaction mentions
decreased appetite — 247 reaction mentions
white blood cell count decreased — 158 reaction mentions
abdominal pain — 149 reaction mentions
neutropenia — 145 reaction mentions
anaemia — 143 reaction mentions
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
8 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 · 64842-1025 · read 2026-08-29
They are sold as powder, solution and tablet, film coated, taken ophthalmic and oral.
FDA National Drug Code directory · 64842-1025 · read 2026-08-29
The regulator's established pharmacologic class for it is nucleic acid synthesis inhibitors [moa], nucleoside analog antiviral [epc] and nucleoside analog [ext].
FDA National Drug Code directory · 64842-1025 · read 2026-08-29
2 published labels name 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 · abc1d07f-91ee-4421-bc9b-457d0ed41f4c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · abc1d07f-91ee-4421-bc9b-457d0ed41f4c · read 2026-08-29
Trifluridine is ophthalmic at HOW SUPPLIED: Trifluridine Ophthalmic Solution, 1% in a 7.5 mL fill packaged in a natural plastic bottle with a natural plastic flat tip and a white plastic closure. 7.5mL- NDC 61314-044-75 Store under refrigeration 2-8…, recorded as fda label in effect 2024-08-01 in the United States.
US prescribing information · abc1d07f-91ee-4421-bc9b-457d0ed41f4c · read 2026-08-30
Recorded price in US: 23.46254 USD per one millilitre, for the one priced product, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
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 Trifluridine 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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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.
How fast does the body clear it?
The sources RNAWiki checked hold nothing for this field.
Why it matters. Without this, nothing on this page can say how long anything lasts.
What would answer it
A stored source that records 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 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 Trifluridine 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.
Where else this substance is registered
FDA substance identifier (UNII)
RMW9V5RW38
RxNorm concept
313477
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, 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 NDA018299, approved 19800410 to MONARCH PHARMS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 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.
The path through the body — 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 (10)
Q2
What did Trifluridine's largest trial (769 people) and its longest (11 years) measure?
769 people in Trifluridine's largest registered study, 11 years in its longest registered window, measuring Peak Plasma Concentration (Cmax). ClinicalTrials.gov · 2026-09-01
39 phase2, 20 phase1, 9 phase3, 4 na, 3 na or unstated; NCT05007132; 2032-12; no ageing endpoint recorded. Last human test completed 2026, NCT05198934.
Interpretation These counts include studies where Trifluridine 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
39
phase1
20
phase3
9
na
4
na or unstated
3
Last recorded human testNCT05198934
2026-04-14
recorded 2026-09-01 · last checked 2026-09-04
Q3
Trifluridine was tested only in human — what did it show?
accrual/recruitment (1), funding/business (2), sponsor decision unspecified (3) and other (4): Trifluridine's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Principal investigator left the institution"; 10 of 67 registered studies
Show the evidence
Trial
NCT02654639
terminated; "Principal investigator left the institution"
NCT02921737
terminated; "insufficient time to accrue sufficient subjects before end of funding"
NCT03717038
withdrawn; "Study was withdrawn due to administrative reasons"
NCT04046887
terminated; "Unable to proceed due to Neulasta difficulties and other complications."
NCT04073615
terminated; "Phase 2 portion of the study was not performed due to redirection of the rivoceranib development plan by the Sponsor."
NCT04076761
terminated; "Lack of Funding"
4 further recorded trials
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."
NCT04854434
terminated; "Sponsor decision"
NCT04894123
terminated; "Recruitment failure"
NCT05356897
withdrawn; "no sites were regulatory ready and the SC took the study to a different group."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Which of 16 week progression free survival rate, area under the plasma concentration versus time curve 0 and area under the plasma concentration versus time curve 0 t did Trifluridine's trials measure?
16 week progression free survival rate, area under the plasma concentration versus time curve 0 and area under the plasma concentration versus time curve 0 t lead 22 outcome terms across Trifluridine's trials. ClinicalTrials.gov · 2026-09-01
immune related overall response rate, objective response rate, 16 week progression free survival rate, overall survival, overall response rate and progression free survival at 6 months follow.
Show the evidence
experiencing a dose limiting toxicity
1
progression free survival
1
maximum tolerated dose
1
immune related overall response rate
1
objective response rate
1
16 week progression free survival rate
1
14 more recorded rows
overall survival
1
overall response rate
1
progression free survival at 6 months
1
frequency of dose limiting toxicities
1
pathologic complete response
1
treatment emergent adverse events
1
dose limiting toxicities
1
incidence of adverse events
1
disease control rate
1
global cohort overall survival
1
china cohort overall survival
1
safety/tolerability
1
progression free survival rate
1
peak plasma concentration
1
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of Trifluridine's 18 ongoing trials reports first?
Incidence of adverse events of trifluridine/tipiracil hydrochloride combination agent TAS-102 in combination with nanoliposomal irinotecan; Early change in circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) as a predictor of radiographic progression (Arm II-SOC); latest 2032-12
Show the evidence
Trial
NCT03368963
"TAS102 in Combination With NAL-IRI in Advanced GI Cancers"; n 64; "Incidence of adverse events of trifluridine/tipiracil hydrochloride combination agent TAS-102 in combination with nanoliposomal irinotecan"; 2025-11-28
NCT03844620
"Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer"; n 100; "Early change in circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) as a predictor of radiographic progression (Arm II-SOC)"; 2028-08-31
NCT04166604
"LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy"; n 176; "Rate of patients free of trifluridine/tipiracil dose reduction or postponement of cycles of > 7 days at 6 months or at progression or death or stop of treatment for another cause than neutropenia if observed in 6 months."; 2025-11
NCT04294264
"TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer"; n 50; "Overall response rate"; 2026-03-27
NCT04511039
"Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer"; n 45; "Incidence of Adverse Events"; 2029-04-01
NCT04660760
"Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer"; n 116; "Progression-free survival"; 2026-05-31
12 further recorded trials
NCT04701476
"TATE and Pembrolizumab (MK3475) in mCRC and NSCLC"; n 110; "Overall Survival for the mCRC cohort"; 2027-09-30
NCT04920032
"Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas"; n 22; "Percentage of ctDNA positivity in treatment cohort after 6 cycles or at least 3 months of adjuvant treatment"; 2028-01-21
NCT05007132
"Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer"; n 153; "Objective response rate"; 2032-12
NCT05343013
"TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy"; n 25; "To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy."; 2027-05-15
NCT05476796
"Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer"; n 118; "Progression free-survival"; 2026-12
NCT05919264
"FOG-001 in Locally Advanced or Metastatic Solid Tumors"; n 619; "During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0"; 2027-08-31
NCT05927857
"Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer ."; n 45; "To determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE)"; 2028-12-31
NCT06195111
"A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)"; n 200; "PFS (Progression-free survival)"; 2027-12-31
NCT06245356
"Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer"; n 73; "Treatment specific safety"; 2028-10-21
NCT06856837
"- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases"; n 140; "To evaluate the efficacy of Fruquintinib in combination with the PD-1 inhibitor Tislelizumab in MSS/pMMR metastatic colorectal cancer without liver metastases."; 2029-12-31
NCT07071844
"BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients"; n 162; "The occurrence of at least one grade 3-4 neutropenia"; 2029-12
NCT07280377
"A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab"; n 122; "Overall Response Rate (ORR) for Cohort 1, 2, 4, and 5"; 2028-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which running trial of Trifluridine could settle lifespan?
NCT04660760 measures Progression-free survival, reading out 2026-05-31.
4 open trials; n 116; "Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer"
Show the evidence
Trial
NCT04660760
"Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer"; n 116; "Progression-free survival"; 2026-05-31
NCT05476796
"Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer"; n 118; "Progression free-survival"; 2026-12
NCT04701476
"TATE and Pembrolizumab (MK3475) in mCRC and NSCLC"; n 110; "Overall Survival for the mCRC cohort"; 2027-09-30
NCT06195111
"A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)"; n 200; "PFS (Progression-free survival)"; 2027-12-31
Q8
Which 14 trials of Trifluridine posted no result?
Posted no result
14 of 14 completed trials
Registrations
NCT00000635, NCT01867866, NCT03305913, NCT03799731, NCT03297710 and NCT02602327, and 8 more
Completion dates
oldest 1992-04; newest 2023-07-21
Show the evidence
Trial
NCT00000635
1992-04
NCT01867866
2016-06
NCT03305913
2019-04-26
NCT03799731
2021-02-10
NCT03297710
2021-04-30
NCT02602327
2021-08-31
8 further recorded trials
NCT03616574
2022-03-01
NCT04517747
2023-01-20
NCT06031376
2023-03-31
NCT05869097
2023-04-30
NCT05130060
2023-06-11
NCT07492173
2023-06-25
NCT03317119
2023-07-14
NCT04808791
2023-07-21
Q9
At the median, Trifluridine's trials enrolled 44 people — anything larger?
Median enrolment
44
Largest enrolment
769
Registered trials counted
67
Q10
What do 3100 spontaneous reports say about Trifluridine — 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.
Trifluridine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3100 reaction mentions were counted: fatigue 553; disease progression 532; nausea 486; diarrhoea 432. open-targets-adr · CHEMBL1129 · 2026-06-24
Show the evidence
fatigue
553
disease progression
532
nausea
486
diarrhoea
432
vomiting
255
decreased appetite
247
4 more recorded rows
white blood cell count decreased
158
abdominal pain
149
neutropenia
145
anaemia
143
recorded 2026-06-24 · last checked 2026-09-04
Q11
What is recorded about Trifluridine and autophagy?
"Exploiting this metabolic vulnerability, we found that acquired resistance to autophagy inhibition promotes increased salvage and therefore sensitivity to pyrimidine analogues, including gemcitabine and trifluridine/tipiracil leading to combinatory effects with autophagy inhibitors and pyrimidine analogs." — where Trifluridine and autophagy appear together. Europe PMC · pathway abstract search · 2025-06-01
autophagy, mTOR, NAD+; PMID 35462092, 39353941
Show the evidence
autophagy
"Exploiting this metabolic vulnerability, we found that acquired resistance to autophagy inhibition promotes increased salvage and therefore sensitivity to pyrimidine analogues, including gemcitabine and trifluridine/tipiracil leading to combinatory effects with autophagy inhibitors and pyrimidine analogs."
mTORPMID 35462092
"In addition, also trifluridine induced cellular senescence by inhibiting autophagy and was closely related to the activation of the mTOR signaling pathway, therefore, we believe that trifluridine may be an effective mTOR activator."
autophagyPMID 35462092
"In addition, also trifluridine induced cellular senescence by inhibiting autophagy and was closely related to the activation of the mTOR signaling pathway, therefore, we believe that trifluridine may be an effective mTOR activator."
NAD+PMID 39353941
"Using high-throughput screening on VSMCs differentiated from iPSCs from HGPS patients, we identified a new compound, trifluridine able to increase NAD<sup>+</sup> levels through decrease of PARP-1 activity."
recorded 2025-06-01 · last checked 2026-09-04
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