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Sargramostim

  • Vaccine
  • Given by a clinician
  • 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 Sargramostim does in the body

LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).

From the FDA-approved label: Sargramostim (GM-CSF) belongs to a group of growth factors termed colony-stimulating factors which support survival, clonal expansion, and differentiation of hematopoietic progenitor cells. GM-CSF induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways which include neutrophils, monocytes/macrophages and myeloid-derived dendritic cells. GM-CSF is also capable of activating mature granulocytes and macrophages. GM-CSF is a multilineage factor and, in addition to dose-dependent effects on the myelomonocytic lineage, can promote the proliferation of megakaryocytic and erythroid progenitors.

Why people take it. LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).

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 · 5TAA004E22 · 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 181 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.

100% healing time of the wound surface

The study did not show it

Who was studied
NCT01785784
How many people
2510
Study design
Phase 4
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. Intravenous

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

Invasive Disease-Free Survival (iDFS)

The study did not show it

Who was studied
NCT03498716
How many people
2199
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. Intravenous

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

Overall Survival

The study did not show it

Who was studied
NCT00002514
How many people
1929
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. Intravenous

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

Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)

The study did not show it

Who was studied
NCT03970837
How many people
1764
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. Intravenous

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

Percentage of Participants Achieving 20 Percentage (%) Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo

The study did not show it

Who was studied
NCT03980483
How many people
1537
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. Intravenous

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

Event-Free Survival (EFS)

The study did not show it

Who was studied
NCT00026312
How many people
1449
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. Intravenous

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.

  • LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).

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 LEUKINE have been established in pediatric patients 2 years of age and older for autologous peripheral blood progenitor cells and bone marrow transplantation, allogeneic bone marrow transplantation, and treatment of delayed neutrophil recovery or graft failure.”

    US prescribing information · bb9a3820-f31a-4dd9-bef4-97094c01a398 · read 2026-08-30

  • On older people, the label states: “Clinical studies of LEUKINE did not include a sufficient numbers of subject aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · bb9a3820-f31a-4dd9-bef4-97094c01a398 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP contain 0.9% benzyl alcohol, which has been associated with gasping syndrome in neonates and infants.”

    US prescribing information · bb9a3820-f31a-4dd9-bef4-97094c01a398 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of LEUKINE in human milk, the effects on the breastfed child, or the effects on milk production.”

    US prescribing information · bb9a3820-f31a-4dd9-bef4-97094c01a398 · 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

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

Intravenous

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 vial, injection, powder, lyophilized, for solution, given by the intravenous, subcutaneous 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

Intravenous

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 · 71837-5843 · read 2026-08-29

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

    FDA National Drug Code directory · 71837-5843 · 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 · 71837-5843 · 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 · bb9a3820-f31a-4dd9-bef4-97094c01a398 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · bb9a3820-f31a-4dd9-bef4-97094c01a398 · read 2026-08-29

  • Leukine is intravenous at 3 DOSAGE FORMS AND STRENGTHS For injection: 250 mcg of sargramostim as a white lyophilized powder in a single-dose vial for reconstitution For injection (lyophilized powder): 250 mcg of sargramostim in single-dose vial…, recorded as fda label in effect 2024-12-06 in the United States.

    US prescribing information · bb9a3820-f31a-4dd9-bef4-97094c01a398 · 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 Sargramostim 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 Sargramostim 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)
5TAA004E22
RxNorm concept
208083

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: S1, 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.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA103362, approved 19910305 to BERLEX LABS.

    Drugs@FDA application register · BLA103362 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA103362 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20230901.

    FDA National Drug Code directory · 71837-5843 · 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 (9)

On the Sargramostim label: indicated for what?

"LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the…": indications and usage on Sargramostim's label. DailyMed label · bb9a3820-f31a-4dd9-bef4-97094c01a398 · 2024-12-06

393 registered trials of Sargramostim — at which phases?

Registered studies posting no result
280 of 393

393 registered studies of Sargramostim: 254 phase2, 121 phase1, 38 phase3, 11 na, 4 phase4, 2 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

67 with a PubMed record

Show the evidence
  • phase2
    254
  • phase1
    121
  • phase3
    38
  • na
    11
  • phase4
    4
  • early phase1
    2
8 more recorded rows
  • completed
    276
  • terminated
    45
  • unknown
    22
  • withdrawn
    16
  • recruiting
    15
  • active not recruiting
    12
  • suspended
    4
  • not yet recruiting
    3

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

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

safety (2), futility/efficacy (3), accrual/recruitment (20), funding/business (5), sponsor decision unspecified (4) and other (15): Sargramostim's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"No recruitment"; 49 of 393 registered studies

Show the evidence

Trial

  • NCT00002664
    withdrawn; "No recruitment"
  • NCT00002778
    terminated; "subject accrual and data analysis is completed."
  • NCT00003567
    terminated; "slow accrual"
  • NCT00005787
    terminated; "Per PI due to poor/inadequate accrual."
  • NCT00005987
    terminated; "Withdrawn because treatment guidelines changed"
  • NCT00006113
    terminated; "Lack of efficacy"
14 further recorded trials
  • NCT00006478
    terminated; "Genitope suspend drug development by decision made by the FDA March 6, 2008."
  • NCT00012246
    terminated; "Administratively Terminated"
  • NCT00014560
    terminated; "Medarex (supplier of BsAb) stopped study due to toxicities experienced at other sites on unrelated trials halting manufacturing of BsAb"
  • NCT00022230
    withdrawn; "PI left Institution"
  • NCT00023634
    terminated; "lack of accrual"
  • NCT00027911
    terminated; "Departure of PI"
  • NCT00048893
    terminated; "The study was closed to accrual due to very poor enrollment."
  • NCT00089115
    terminated; "Withdrawn as company has shut down and filed for bankruptcy"
  • NCT00104819
    terminated; "Withdrawn as company has shut down and filed for bankruptcy"
  • NCT00176280
    withdrawn; "Slow accrual"
  • NCT00308087
    terminated; "Terminated by sponsor due to low enrollment; see details below"
  • NCT00313482
    terminated; "Low accrual"
  • NCT00415857
    terminated; "Vaccine sponsor ceased operations."
  • NCT00446173
    withdrawn; "Terminated due to low accrual."

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

Sargramostim's half-life is 1.4 h — which schedules were studied?

1.4 h, the half-life Sargramostim's label states: "Elimination LEUKINE administered SC to healthy adult volunteers, GM-CSF had a terminal elimination half-life of 1.4 h." DailyMed label · bb9a3820-f31a-4dd9-bef4-97094c01a398 · 2024-12-06

bioavailability 75 %.

Show the evidence
  • half life pharmacokinetics
    1.4 h; Elimination LEUKINE administered SC to healthy adult volunteers, GM-CSF had a terminal elimination half-life of 1.4 h.
  • bioavailability pharmacokinetics
    75 %; The absolute bioavailability with the SC route, when compared to the IV route, was 75%.
  • metabolism pharmacokinetics
    Specific metabolism studies were not conducted, because LEUKINE is a protein and is expected to degrade to small peptides and individual amino acids.

recorded 2024-12-06 · last checked 2026-09-04

Which running trial of Sargramostim could settle lifespan?

NCT03012100 measures Disease-free Survival, reading out 2026-07-31.

7 open trials; n 280; "Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer"

Show the evidence

Trial

  • NCT03012100
    "Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer"; n 280; "Disease-free Survival"; 2026-07-31
  • NCT02455557
    "SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma"; n 66; "Progression-free Survival (PFS)"; 2026-09-02
  • NCT01134614
    "Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery"; n 245; "Overall Survival"; 2027-03-19
  • NCT05344209
    "Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer"; n 138; "Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) as determined by Blinded Independent Central Review (BICR)"; 2027-07-01
  • NCT05794659
    "Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer"; n 98; "Progression-Free Survival (PFS)"; 2027-11-15
  • NCT03126916
    "Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)"; n 750; "Event free survival (EFS) (Arm A, B, D, and E)"; 2030-09-30
  • 1 further recorded trial NCT02339571
    "A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma"; n 600; "Overall survival"; 2033-06-30

Which 147 trials of Sargramostim posted no result?

Posted no result
147 of 147 completed trials
Registrations
NCT00000711, NCT00000689, NCT00002461, NCT00000989, NCT00000694 and NCT00000681, and 141 more
Completion dates
oldest 1990-05; newest 2023-02
Show the evidence

Trial

  • NCT00000711
    1990-05
  • NCT00000689
    1991-03
  • NCT00002461
    1991-07
  • NCT00000989
    1992-07
  • NCT00000694
    1992-08
  • NCT00000681
    1993-10
14 further recorded trials
  • NCT00000658
    1996-02
  • NCT00003315
    1997-12
  • NCT00003185
    1998-07
  • NCT00001090
    1999-10
  • NCT00003408
    2000-03
  • NCT00003003
    2000-08
  • NCT00000896
    2000-10
  • NCT00003269
    2001-01
  • NCT00004162
    2001-01
  • NCT00005023
    2001-01
  • NCT00003362
    2001-02
  • NCT00004184
    2001-06
  • NCT00006240
    2001-08
  • NCT00005948
    2001-10

At the median, Sargramostim's trials enrolled 37.5 people — anything larger?

Median enrolment
37.5
Largest enrolment
1929
Registered trials counted
342

What do 350 spontaneous reports say about Sargramostim — 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.

Sargramostim appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 350 reaction mentions were counted: pyrexia 66; dyspnoea 58; hypotension 52; hyperhidrosis 33. FAERS via Open Targets · CHEMBL1201670 · 2026-06-24

Show the evidence
  • pyrexia
    66
  • dyspnoea
    58
  • hypotension
    52
  • hyperhidrosis
    33
  • chills
    32
  • syncope
    31
4 more recorded rows
  • chest pain
    25
  • bone pain
    20
  • device related bacteraemia
    17
  • flushing
    16

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

Which 10 reactions does Sargramostim's label not list?

bone pain, chest pain and chills and 7 more reported for Sargramostim, absent from its label. FAERS via Open Targets · CHEMBL1201670 · 2026-06-24

2 label terms; 10 reported and unlisted; bb9a3820-f31a-4dd9-bef4-97094c01a398

Show the evidence
  • bone pain
    count not stated
  • chest pain
    count not stated
  • chills
    count not stated
  • device related bacteraemia
    count not stated
  • dyspnoea
    count not stated
  • flushing
    count not stated
4 more recorded rows
  • hyperhidrosis
    count not stated
  • hypotension
    count not stated
  • pyrexia
    count not stated
  • syncope
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201670
CAS number
123774-72-1
RxCUI
69634
Development code
B1 61.012, B1-61012, RHU GM-CSF
Also called
Granulocyte-macrophage colony-stimulating factor sargramostim, Sargramostim rdna, allogeneic gm-csf-secreting breast cancer vaccine, gm-csf, granulocyte macrophage colony stimulating factor, recombinant granulocyte-macrophage colony-stimulating factor, recombinant human gm-csf, rhgm-csf, rhugm-csf, GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR SARGRAMOSTIM [MI], SARGRAMOSTIM [JAN], SARGRAMOSTIM [MART.]
Trade name
Leukine, Imreplys
Sources (5)

Sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 5 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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