This page shows what was measured, who it was measured in, and what that does not settle.
What Pegfilgrastim does in the body
The chain reduces removal by the kidneys, so neutrophil-mediated clearance becomes the main route.
Pegfilgrastim is the same protein as filgrastim with a long, inert polymer chain attached to one end. While the neutrophil count is low, clearance is slower. As the count recovers, clearance increases, allowing one dose to provide support through a chemotherapy cycle.
Why people take it. One injection per chemotherapy cycle instead of a daily white cell injection
What happened in people
Bone pain incidence, severity and duration not significantly different from daily filgrastim
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
NEULASTA (pegfilgrastim) injection — US prescribing information, DailyMed (https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fdfe5d72-6b80-435a-afa4-c… · a recorded source, not a stored snapshot
Duration of grade 4 neutropenia in cycle 1 versus daily filgrastim
✓ The study showed what it set out to show
Who was studied
Green 2003 non-inferiority registration trial
How many people
157
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Non-inferiority met (1.8 versus 1.6 days in cycle 1)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The comparator was an active drug rather than placebo, so this trial establishes equivalence to filgrastim and says nothing about benefit over no treatment.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection: prefilled syringe, single-dose vial, or prefilled syringe with an on-body injector
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
NEULASTA (pegfilgrastim) injection — US prescribing information, DailyMed (https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fdfe5d72-6b80-435a-afa4-c… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 2 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 it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Pegfilgrastim
What a person takes: Subcutaneous injection: prefilled syringe, single-dose vial, or prefilled syringe with an on-body injector.
The measurement behind this step
Clear, colourless, preservative-free solution at pH 4.0. The 6 mg/0.6 mL prefilled syringe carries no graduation marks and delivers its entire contents. The on-body injector is applied on the day of chemotherapy and delivers the dose approximately 27 hours later, removing a return clinic visit.
Getting in
One subcutaneous injection the day after chemotherapy
A single 6 mg injection given about 24 hours after the chemotherapy finishes, either by syringe or by an adhesive on-body device that delivers it later that day.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Fixed 6 mg dose, not weight-adjusted, because clearance is receptor-mediated and therefore self-scaling rather than proportional to body size.
The polymer chain makes the molecule behave as though it were far larger than it is, so the kidney can no longer filter it out of the blood.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The 20 kDa mPEG raises the hydrodynamic radius well above the glomerular filtration cutoff. Total molecular weight is approximately 39 kDa but the hydrated PEG behaves like a much larger protein.
From here the mechanism is identical to filgrastim: it docks on the receptors of immature neutrophils in the marrow.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
N-terminal PEGylation is site-selected precisely because the N-terminus is not part of the receptor-binding interface, so 2:2 G-CSFR complex formation and JAK-STAT signalling are preserved.
The only way the body removes this drug is by the very cells it is making. While your count is low, it stays. As the count comes back, it disappears.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Neutrophil-mediated receptor internalisation and degradation is the dominant clearance pathway. Serum concentration therefore stays high through the nadir and falls sharply as the neutrophil count recovers, producing self-regulating exposure without therapeutic drug monitoring.
Immature cells are pushed to finish maturing and the marrow releases its stored neutrophils earlier than it otherwise would.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
STAT3-driven granulocytic proliferation plus proteolytic cleavage of the marrow CXCL12-CXCR4 retention axis by neutrophil elastase, releasing the mature reserve into circulation.
The end result is the same recovery as fourteen daily injections, and against no treatment at all, febrile neutropenia falls from about one in six patients to about one in a hundred.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Grade 4 neutropenia duration 1.8 days versus 1.6 days for daily filgrastim; febrile neutropenia 1% versus 17% against placebo, with hospitalisation falling from 14% to 1%.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
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.
Patients on chemotherapy regimens carrying a clinically significant risk of febrile neutropenia. It is also the only G-CSF product with an indication for acute radiation syndrome.
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 ZIEXTENZO for chemotherapy-induced neutropenia and hematopoietic subsyndrome of acute radiation syndrome have been established in pediatric patients aged newborn and older.”
US prescribing information · 7dada041-6528-4acf-809c-62d271538c9a · read 2026-08-30
On older people, the label states: “Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over.”
US prescribing information · 7dada041-6528-4acf-809c-62d271538c9a · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Although available data with pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products.”
US prescribing information · 7dada041-6528-4acf-809c-62d271538c9a · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 7dada041-6528-4acf-809c-62d271538c9a · read 2026-08-30
Where the result stopped carrying
On-body injector failures generated a dedicated Warnings and Precautions section requiring patients to report suspected non-delivery
The acrylic adhesive on the injector causes significant reactions in acrylate-sensitive patients
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 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 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
Given by a clinician
❝ 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
Subcutaneous injection: prefilled syringe, single-dose vial, or prefilled syringe with an on-body injector
✎ 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.
No source is stored against this line.
What is in the pack
0. 6 mL prefilled syringe carries no graduation marks and delivers its entire contents. The on-body injector is applied on the day of chemotherapy and delivers the dose approximately 27 hours later, removing a return clinic visit.
✎ 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◇Read from sources, not yet reviewed
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.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Fatal splenic rupture, acute respiratory distress syndrome, serious allergic reactions including anaphylaxis, fatal sickle cell crises, glomerulonephritis, capillary leak syndrome, thrombocytopenia, leucocytosis, cutaneous vasculitis and aortitis are labelled risks. The label requires monitoring for myelodysplastic syndrome and acute myeloid leukaemia in breast and lung cancer patients receiving it with chemotherapy or radiotherapy.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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
Subcutaneous injection: prefilled syringe, single-dose vial, or prefilled syringe with an on-body injector
✎ 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
0. 6 mL prefilled syringe carries no graduation marks and delivers its entire contents. The on-body injector is applied on the day of chemotherapy and delivers the dose approximately 27 hours later, removing a return clinic visit.
✎ 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 which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
16 products list this as an active ingredient in the United States drug directory. 16 of them contain it and nothing else.
FDA National Drug Code directory · 70114-130 · read 2026-08-29
They are sold as injection, injection, solution, liquid and solution, taken subcutaneous.
FDA National Drug Code directory · 70114-130 · read 2026-08-29
The regulator's established pharmacologic class for it is granulocyte colony-stimulating factor [cs], granulocyte-macrophage colony-stimulating factor [cs] and increased myeloid cell production [pe].
FDA National Drug Code directory · 70114-130 · read 2026-08-29
10 published labels name it as an active ingredient. 10 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 7dada041-6528-4acf-809c-62d271538c9a · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 7dada041-6528-4acf-809c-62d271538c9a · read 2026-08-29
ZIEXTENZO is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS ZIEXTENZO is a clear, colorless to slightly yellowish, preservative-free solution available as: • Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only., recorded as fda label in effect 2026-05-14 in the United States.
US prescribing information · 7dada041-6528-4acf-809c-62d271538c9a · 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 Pegfilgrastim 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
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That once-per-cycle dosing improves survival relative to daily filgrastim — no trial has tested it
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the radiation indication rests on human evidence; it was granted under the Animal Rule
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That an on-body injector is equivalent to a supervised injection; the label has a device-failure warning section
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
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 Pegfilgrastim 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.
Every line above can be traced to the study named beside it. Follow the link and read it.
Against placebo: febrile neutropenia fell from 17% to 1%
In plain words
In 928 breast cancer patients on docetaxel, one injection per cycle reduced fevers with low white counts from about one in six patients to about one in a hundred.
What was measured
Febrile neutropenia 1% versus 17% (p < 0.001) in 928 patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Multicentre, double-blind, placebo-controlled phase III trial. Patients received placebo (n = 465) or pegfilgrastim 6 mg subcutaneously on day 2 of each 21-day cycle of docetaxel 100 mg/m2. Febrile neutropenia occurred in 1% versus 17% (p < 0.001), febrile-neutropenia-related hospitalisation in 1% versus 14% (p < 0.001), and intravenous anti-infective use in 2% versus 10% (p < 0.001).
Written into the record, not signed off as a reviewed claim
One injection matched fourteen: the non-inferiority registration trial
In plain words
A single fixed 6 mg dose performed the same as daily filgrastim injections on every efficacy measure across four chemotherapy cycles.
What was measured
Grade 4 neutropenia duration 1.8 versus 1.6 days in cycle 1
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, multicentre phase III study, 157 patients on doxorubicin 60 mg/m2 and docetaxel 75 mg/m2. Mean duration of grade 4 neutropenia in cycle 1 was 1.8 days with pegfilgrastim and 1.6 days with daily filgrastim. Results in cycles 2 to 4 were consistent. Febrile neutropenia trended lower with pegfilgrastim across all cycles, 13% versus 20%. Safety and tolerability were comparable.
Written into the record, not signed off as a reviewed claim
Approved on a surrogate, not on survival
In plain words
The endpoint that got this drug licensed was how many days the white count stayed critically low, compared with a drug that was already on the market. No trial has shown it makes people live longer than daily filgrastim.
What was measured
That once-per-cycle dosing produces better patient outcomes rather than better adherence to the same effect
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The pivotal comparison was non-inferiority in duration of grade 4 neutropenia against daily filgrastim, in 157 and 310 patients respectively. Duration of severe neutropenia is a laboratory surrogate; the placebo-controlled trial then measured febrile neutropenia, which is a clinical event, but neither design was powered for survival. The convenience advantage of one injection per cycle is real and measurable; a survival advantage over daily filgrastim has never been demonstrated because no trial has looked for one.
Written into the record, not signed off as a reviewed claim
The on-body injector has its own warning section
In plain words
The device designed to remove the clinic visit can fail to deliver the dose, and the label tells patients to report it if they suspect it has.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Section 5.12 of the US prescribing information, Potential Device Failures, instructs that patients be told to notify their healthcare provider if they suspect the on-body injector may not have performed as intended, so that the need for a replacement dose can be assessed. Section 5.4 separately warns that the acrylic adhesive used by the injector can cause significant reactions in patients sensitive to acrylates. A delivery system introduced to improve adherence therefore introduced a failure mode that the daily syringe did not have.
Source
NEULASTA US prescribing information, Warnings and Precautions sections 5.4 and 5.12
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Biosimilar entry from 2018 was the price event, not a new trial
In plain words
What changed the economics of this drug was not new evidence about whether it works. It was four biosimilars arriving after the patents ran out.
What was measured
First two US pegfilgrastim biosimilar approvals: 4 June 2018 and 2 November 2018
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Fulphila (pegfilgrastim-jmdb, BLA 761075) was approved 4 June 2018 and Udenyca (pegfilgrastim-cbqv, BLA 761039) on 2 November 2018, followed by further entrants. Pegfilgrastim became one of the first US biologic markets with meaningful multi-source competition, and the clinical question the biosimilar programmes answered was analytical and pharmacodynamic comparability rather than a fresh outcome trial. Nothing about the underlying evidence for the molecule changed; the price did.
Source
Drugs@FDA, BLA 761075 (Fulphila) and BLA 761039 (Udenyca)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
A radiation indication granted without a human efficacy trial
In plain words
The indication for radiation sickness could not ethically be tested in people, so it was granted on animal data under a specific regulatory rule.
What was measured
That the haematopoietic syndrome of acute radiation syndrome responds to G-CSF in humans the way it does in irradiated animals
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Pegfilgrastim carries an indication to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Efficacy studies in humans cannot be ethically or feasibly conducted, so this indication rests on the FDA Animal Rule pathway and on the mechanistic continuity with chemotherapy-induced neutropenia. It is a legitimate regulatory decision and it is also, by construction, an indication with no human efficacy evidence behind it.
Source
NEULASTA US prescribing information, Indications and Usage
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
2 documents were read for this substance.
RNAWiki source record
2 of them state the same halfLife, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
3A58010674
RxNorm concept
727539
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.
✓ 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.
Withdrawn in United States, 2026, for "Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment." (openFDA drug enforcement Class I recall)
What the approval register records
1 approved application covers products containing this substance. The earliest was BLA125031, approved 20020131 to AMGEN.
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.
How close this is to real life — 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.
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.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
Filgrastim with a 20 kDa polyethylene glycol chain on its N-terminal methionine, which makes neutrophils themselves the main route of clearance; one 6 mg injection per cycle matched fourteen days of filgrastim, and against placebo it cut febrile neutropenia from 17% to 1%.
Recorded evidence blocks (10)
Q2
On the Pegfilgrastim label: indicated for what?
"Neulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.…": indications and usage on Pegfilgrastim's label. DailyMed label · fdfe5d72-6b80-435a-afa4-c5d74dd852ce · 2026-08-10
Q3
277 registered trials of Pegfilgrastim — at which phases?
Registered studies posting no result
170 of 277
277 registered studies of Pegfilgrastim: 158 phase2, 71 phase1, 51 phase3, 11 phase4, 10 na, 5 na or unstated, 2 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
15 to 80 hours; The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection.
recorded 2026-08-10 · last checked 2026-09-04
Q7
Which running trial of Pegfilgrastim could settle lifespan?
NCT01933932 measures Progression-Free Survival (PFS), reading out 2026-12-31.
10 open trials; n 510; "Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC"
Show the evidence
Trial
NCT01933932
"Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC"; n 510; "Progression-Free Survival (PFS)"; 2026-12-31
NCT04759586
"Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma"; n 244; "Progression-free survival (PFS)"; 2026-12-31
NCT00070564
"S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer"; n 3294; "Disease-free Survival"; 2027-01
NCT03907488
"Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma"; n 994; "Progression Free Survival (PFS)"; 2027-03-28
NCT04628767
"Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer"; n 131; "Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)"; 2027-09-30
NCT00433420
"Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer"; n 2000; "Disease-free survival"; 2027-12
4 further recorded trials
NCT06188676
"Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL"; n 100; "Progression-free survival (PFS)"; 2029-04-01
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
NCT04685616
"Brentuximab Vedotin in Early Stage Hodgkin Lymphoma"; n 1042; "Progression free survival (PFS)"; 2032-09
NCT05535166
"Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma"; n 130; "Progression free survival of SHH-2 infant (0-2.99 years) and young child (3-4.99 years) medulloblastoma patients treated with systemic HD-MTX-based chemotherapy only."; 2035-07
Q8
Which 83 trials of Pegfilgrastim posted no result?
Posted no result
83 of 83 completed trials
Registrations
NCT00004192, NCT00117897, NCT00117910, NCT00035594, NCT00115206 and NCT00114764, and 77 more
Completion dates
oldest 2001-03-16; newest 2024-05-01
Show the evidence
Trial
NCT00004192
2001-03-16
NCT00117897
2004-02
NCT00117910
2004-05
NCT00035594
2004-06
NCT00115206
2004-07
NCT00114764
2004-08
14 further recorded trials
NCT00066092
2004-10
NCT00117442
2004-12
NCT00277160
2005-01
NCT00115193
2005-08
NCT00283621
2006-04-12
NCT00074178
2006-07
NCT00035620
2007-04
NCT00067639
2007-04
NCT00146562
2007-05
NCT00217503
2007-06
NCT00310089
2007-07
NCT00431080
2007-10
NCT02782845
2007-10
NCT00261313
2007-12
Q9
At the median, Pegfilgrastim's trials enrolled 55 people — anything larger?
Median enrolment
55
Largest enrolment
4400
Registered trials counted
267
Q10
What do 33027 spontaneous reports say about Pegfilgrastim — 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.
Pegfilgrastim appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 33027 reaction mentions were counted: wrong technique in product usage process 7895; unintentional medical device removal 6546; device adhesion issue 5355; device use error 4867. FAERS via Open Targets · CHEMBL1201568 · 2026-06-24
Show the evidence
wrong technique in product usage process
7895
unintentional medical device removal
6546
device adhesion issue
5355
device use error
4867
febrile neutropenia
2367
bone pain
1743
4 more recorded rows
neutropenia
1657
application site haemorrhage
1049
application site pain
792
occupational exposure to product
756
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Pegfilgrastim's label not list?
2 label terms; 10 reported and unlisted; fdfe5d72-6b80-435a-afa4-c5d74dd852ce
Show the evidence
application site haemorrhage
count not stated
application site pain
count not stated
bone pain
count not stated
device adhesion issue
count not stated
device use error
count not stated
febrile neutropenia
count not stated
4 more recorded rows
neutropenia
count not stated
occupational exposure to product
count not stated
unintentional medical device removal
count not stated
wrong technique in product usage process
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Where it is registered
Where it’s registered
Withdrawn in United States, 2026, for "Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment." (openFDA drug enforcement Class I recall)
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work · openFDA enforcement — US Government work
✗ 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: 7 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
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.