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Palifermin

  • Biologic
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Palifermin does in the body

Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support.

From the FDA-approved label: KGF is an endogenous protein in the fibroblast growth factor (FGF) family that binds to the KGF receptor. Binding of KGF to its receptor has been reported to result in proliferation, differentiation, and migration of epithelial cells. The KGF receptor, one of four receptors in the FGF family, has been reported to be present on epithelial cells in many tissues examined including the tongue, buccal mucosa, esophagus, stomach, intestine, salivary gland, lung, liver, pancreas, kidney, bladder, mammary gland, skin (hair follicles and sebaceous gland), and the lens of the eye. The KGF receptor has been reported to not be present on cells of the hematopoietic lineage.

Why people take it. Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support.

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 protein.

    FDA substance registry · QMS40680K6 · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 193 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Graft-versus-host disease-free, relapse-free survival (GRFS)

The study did not show it

Who was studied
NCT06859424
How many people
358
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Maximum Severity of Oral Mucositis (World Health Organization (WHO) Grades 0/1, 2, 3, or 4)

The study did not show it

Who was studied
NCT00434161
How many people
281
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. Injection

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)

The study did not show it

Who was studied
NCT00131638
How many people
241
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. Injection

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Number of Participants With Severe (Grade 3 or 4) Oral Mucositis

The study did not show it

Who was studied
NCT00101582
How many people
188
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. Injection

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)

The study did not show it

Who was studied
NCT00189488
How many people
155
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Injection

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan

The study did not show it

Who was studied
NCT00410982
How many people
145
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. Injection

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

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

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

Who was studied

People similar to this profile were included.

  • Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients.

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: “Three age groups were studied: ages 1 to 2 (n=9), ages 3 to 11 (n=9), and ages 12 to 16 (n=9); 56% were male, 26% were Caucasian, 63% Hispanic; 81% ALL, 19% AML.”

    US prescribing information · 426f6e64-2c20-4a61-6d65-7320426f6e64 · read 2026-08-30

  • On older people, the label states: “Clinical studies of Kepivance did not include sufficient numbers of subjects aged 65 years and older to determine whether they responded differently from younger subjects [see Clinical Pharmacology ( 12.3 )].”

    US prescribing information · 426f6e64-2c20-4a61-6d65-7320426f6e64 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings in animal studies, Kepivance may cause fetal harm when administered to pregnant women.”

    US prescribing information · 426f6e64-2c20-4a61-6d65-7320426f6e64 · read 2026-08-30

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

    US prescribing information · 426f6e64-2c20-4a61-6d65-7320426f6e64 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

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

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Injection

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: S4.

No source is stored against this line.

What is in the pack

Sold as injectable, injection, powder, lyophilized, for solution, given by the injection, intravenous route.

Source-linked record

Where this came from

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

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

No source is stored against this line.

Where it is registered

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

Counted from records

Where this came from

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

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

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

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

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

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

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Injection

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

  • 1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.

    FDA National Drug Code directory · 66658-113 · read 2026-08-29

  • They are sold as injection, powder, lyophilized, for solution, taken intravenous.

    FDA National Drug Code directory · 66658-113 · read 2026-08-29

  • The regulator's established pharmacologic class for it is fibroblast growth factor 7 [cs], increased epithelial proliferation [pe] and mucocutaneous epithelial cell growth factor [epc].

    FDA National Drug Code directory · 66658-113 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 426f6e64-2c20-4a61-6d65-7320426f6e64 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 426f6e64-2c20-4a61-6d65-7320426f6e64 · read 2026-08-29

  • KEPIVANCE is intravenous at 3 DOSAGE FORMS AND STRENGTHS For injection: 5.16 mg lyophilized powder in single-dose vials., recorded as fda label in effect 2025-12-17 in the United States.

    US prescribing information · 426f6e64-2c20-4a61-6d65-7320426f6e64 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Palifermin studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

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.

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 Palifermin are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
QMS40680K6
RxNorm concept
2643434

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S4.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

  1. Withdrawn, in European Union; no reason is published (EMA Medicine.csv)

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA125103, approved 20041215 to BIOVITRUM AB.

    Drugs@FDA application register · BLA125103 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA125103 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20230804.

    FDA National Drug Code directory · 66658-113 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

On the Palifermin label: indicated for what?

"Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. Kepivance is indicated as supportive care for…": indications and usage on Palifermin's label. DailyMed label · 426f6e64-2c20-4a61-6d65-7320426f6e64 · 2025-12-17

53 registered trials of Palifermin — at which phases?

Registered studies posting no result
34 of 53

53 registered studies of Palifermin: 31 phase2, 24 phase1, 7 phase3, 2 early phase1, 2 na or unstated, 1 na, 1 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

40 with a PubMed record

Show the evidence
  • phase2
    31
  • phase1
    24
  • phase3
    7
  • early phase1
    2
  • na or unstated
    2
  • na
    1
9 more recorded rows
  • phase4
    1
  • completed
    25
  • terminated
    9
  • withdrawn
    7
  • recruiting
    4
  • active not recruiting
    3
  • not yet recruiting
    2
  • unknown
    2
  • enrolling by invitation
    1

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

13 of Palifermin's trials stopped: futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?

futility/efficacy (1), accrual/recruitment (3), funding/business (1), sponsor decision unspecified (2) and other (6): Palifermin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Due to positive preliminary results from other palifermin studies."; 13 of 53 registered studies

Show the evidence

Trial

  • NCT00360971
    terminated; "Due to positive preliminary results from other palifermin studies."
  • NCT00540332
    withdrawn; "The 20070201 study was terminated based on evaluation of Palifermin solid tumor data."
  • NCT00593554
    terminated; "Slow accrual"
  • NCT00610818
    terminated; "We did not see any effect of Palifermin on benign or malignant tumor growth"
  • NCT00728585
    withdrawn; "Withdrawn"
  • NCT01712945
    terminated; "interim anlaysis failed: palifermin does not promote thymopoeisis after alemtuzumab"
7 further recorded trials
  • NCT01746173
    terminated; "Slow accrual and futility"
  • NCT02037347
    terminated; "Low enrollment numbers precluded completion of the study during a reasonable amount of time."
  • NCT02589145
    terminated; "Closed due to very slow accrual"
  • NCT02653196
    terminated; "The Principal Investigator left the institution."
  • NCT02961816
    withdrawn; "Lack of funding"
  • NCT03100877
    withdrawn; "Feasibility Issues"
  • NCT03531281
    withdrawn; "Administratively withdrawn"

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

Palifermin's half-life is 4.5 hours — which schedules were studied?

4.5 hours, the half-life Palifermin's label states: "The elimination half-life was similar between healthy subjects and cancer patients (average 4.5 hours with a range of 3.3 to 5.7 hours)." DailyMed label · 426f6e64-2c20-4a61-6d65-7320426f6e64 · 2025-12-17

Show the evidence
  • half life pharmacokinetics
    4.5 hours; The elimination half-life was similar between healthy subjects and cancer patients (average 4.5 hours with a range of 3.3 to 5.7 hours).

recorded 2025-12-17 · last checked 2026-09-04

Which running trial of Palifermin could settle lifespan?

NCT07582172 measures Leukemia-free survival, reading out 2029-04-05.

1 open trial; n 35; "Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With…"

Show the evidence
  • Trial NCT07582172
    "Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome"; n 35; "Leukemia-free survival"; 2029-04-05

Which 10 trials of Palifermin posted no result?

Posted no result
10 of 10 completed trials
Registrations
NCT00004132, NCT00361348, NCT00352703, NCT00004061, NCT00701688 and NCT00410982, and 4 more
Completion dates
oldest 2004-05; newest 2016-07
Show the evidence

Trial

  • NCT00004132
    2004-05
  • NCT00361348
    2006-07
  • NCT00352703
    2007-05
  • NCT00004061
    2009-12
  • NCT00701688
    2012-02
  • NCT00410982
    2012-09
4 further recorded trials
  • NCT00482846
    2012-09
  • NCT00393822
    2014-03
  • NCT01421173
    2015-09
  • NCT00131638
    2016-07

At the median, Palifermin's trials enrolled 27 people — anything larger?

Median enrolment
27
Largest enrolment
281
Registered trials counted
51

What do 174 spontaneous reports say about Palifermin — 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.

Palifermin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 174 reaction mentions were counted: rash 33; mucosal inflammation 29; erythema 22; oedema peripheral 16. FAERS via Open Targets · CHEMBL1201821 · 2026-06-24

Show the evidence
  • rash
    33
  • mucosal inflammation
    29
  • erythema
    22
  • oedema peripheral
    16
  • pruritus
    14
  • face oedema
    13
4 more recorded rows
  • skin exfoliation
    12
  • tongue disorder
    12
  • neutropenia
    12
  • stomatitis
    11

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

Which 10 reactions does Palifermin's label not list?

erythema, face oedema and mucosal inflammation and 7 more reported for Palifermin, absent from its label. FAERS via Open Targets · CHEMBL1201821 · 2026-06-24

2 label terms; 10 reported and unlisted; 426f6e64-2c20-4a61-6d65-7320426f6e64

Show the evidence
  • erythema
    count not stated
  • face oedema
    count not stated
  • mucosal inflammation
    count not stated
  • neutropenia
    count not stated
  • oedema peripheral
    count not stated
  • pruritus
    count not stated
4 more recorded rows
  • rash
    count not stated
  • skin exfoliation
    count not stated
  • stomatitis
    count not stated
  • tongue disorder
    count not stated

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

Where do the label and the trials disagree about Palifermin?

"withdrawn" against "approved": withdrawal status vs register status for Palifermin.

EMA_MEDICINE_REGISTER, Drugs@FDA; 1 recorded pair

Show the evidence
  • EMA_MEDICINE_REGISTER EMEA/H/C/000609
    withdrawn; 2026-09-04
  • Drugs@FDA BLA125103
    approved; 2026-08-28
Where it is registered

Where it’s registered

Withdrawn, in European Union; no reason is published (EMA Medicine.csv)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201821
CAS number
162394-19-6
RxCUI
196319
Also called
PALIFERMIN [MI], Palifermina, Palifermine, keratinocyte growth factor, recombinant human keratinocyte growth factor, rhukgf, 24-163 FIBROBLAST GROWTH FACTOR 7 (HUMAN), PALIFERMIN [EMA EPAR], PALIFERMIN [MART.], PALIFERMIN [USAN], PALIFERMIN [VANDF], Palifermin [WHO-DD]
Trade name
Kepivance
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · EMA medicine register · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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