CDEK
← All drugs Report issue

sargramostim

Trade name: leukine

Recombinant proteinapprovedCOVID-19Orphan Drug FDA

Approved

Feb 20, 1991

Colony-stimulating factors (CSFs) are secreted glycoproteins that bind to receptor proteins on the surfaces of committed progenitors in the bone marrow, thereby activating intracellular signaling pathways that can cause the cells to proliferate and differentiate into a specific kind of blood cell. — Wikipedia

Clinical trial activity

1,637 trials · 672 clinical orgs · 5 marketing orgs

Phase 1
463
Phase 2
1160
Phase 3
242
Phase 4
47

Earliest trial started Nov 1, 1986 (NCT01324063)

Timeline

1980s

  1. Jan 1, 1986

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1988

    Earliest Phase 2 Sponsor(trial)

1990s

  1. May 3, 1990

    Orphan Drug Designation

  2. Jan 1, 1991

    Earliest Phase 1 Sponsor(trial)

  3. Feb 20, 1991

    Earliest FDA Approval

  4. Feb 20, 1991

    Amgen — Marketing Organization

  5. Feb 20, 1991

    Amgen — NDA Secondary Org

  6. Mar 5, 1991

    Schering AG — First NDA Organization

  7. Mar 5, 1991

    Schering AG — Marketing Organization

  8. Mar 5, 1991

    Schering AG — NDA Organization

  9. Mar 5, 1991

    Partner Therapeutics, Inc. — NDA Secondary Org

2010s

  1. Mar 6, 2015

    Sandoz — Marketing Organization

  2. Mar 6, 2015

    Novartis — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFeb 20, 1991

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • accofil
  • apvac1 vaccine
  • b1 61.012
  • bi 61.012
  • bm-csf
  • colony-stimulating factor
  • colony-stimulating factor 2 (human clone phg25 protein moiety), 23-l-leucine-
  • combination of fosfomycin, metronidazole and rhgm-csf (administered together intraperitoneally) and three days of antibiotics p.o.
  • filgrastim
  • filgrastim
  • filgrastim
  • filgrastim
  • filgrastim
  • filgrastim
  • filgrastim
  • filgrastim
  • filgrastim
  • filgrastim-sndz
  • filgrastim-sndz
  • filgrastim-sndz
  • filgrastim-sndz
  • filgrastim-sndz
  • g-csf
  • g-csf
  • g-csf)
  • gmc-89-107
  • gmcsf
  • gm-csf
  • gm-csf
  • gm-csf
  • granulocyte colony stimulating factor
  • granulocyte colony stimulating factor
  • leukine
  • leukine
  • leukine
  • leukine
  • leukine
  • neupogen
  • neupogen
  • neupogen
  • neupogen
  • neupogen 30
  • neupogen 48
  • nivestim
  • nivestim
  • nivestim
  • nivestim
  • nivestim
  • prokine
  • regramostim
  • rg-csf
  • rg-csf
  • rhg-csf
  • rhgm-csf
  • rhgm-csf
  • rhu gm-csf
  • r-methug-csf
  • r-methug-csf
  • r-methug-csf
  • sargramostim
  • sargramostim
  • sargramostim
  • sargramostim
  • sargramostim
  • sargramostim
  • sargramostim
  • sargramostim
  • sargramostim
  • sargramostim (genetical recombination)
  • tbo-filgrastim
  • uv1 synthetic peptide vaccine
  • zarxio
  • zarzio

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07169617Phase 2Feb 25, 2026National Cancer Institute (NCI), Northwestern University
NCT07078604Phase 2Dec 1, 2025Kuni Foundation, University of Washington
NCT07085338Phase 2Nov 10, 2025St. Jude Children's Hospital
NCT06989333Phase 2Jul 1, 2025Huazhong University of Science and Technology
NCT07027748Phase 1Jun 27, 2025Harvard University, Y-Mabs, Inc
NCT06799026Phase 1Jan 31, 2025Harvard University, Pfizer
NCT07305675N/AJan 1, 2025Jiao Tong University
NCT06514898Phase 1Dec 31, 2024Georgetown University, University of Florida
NCT06202066Phase 2Dec 15, 2024State University of New York, Buffalo
NCT06450041Phase 2Nov 30, 2024National Cancer Institute (NCI), Ohio State University, United Therapeutics
NCT06626516Phase 1/Phase 2 (Phase 2)Oct 31, 2024Thomas Jefferson University
NCT06651853Phase 2Oct 21, 2024Xiamen University
NCT06254326Phase 1Sep 19, 2024University of Florida
NCT06528496Phase 2Jul 22, 2024Memorial Sloan-Kettering Cancer Center
NCT06345599Phase 1/Phase 2 (Phase 2)May 1, 2024Soochow University
NCT05284214Phase 2Jan 31, 2024Partner Therapeutics, Inc.
NCT05717140Phase 1Dec 31, 2023Mayo Clinic
NCT05794659Phase 2Nov 15, 2023Aston Sci. Co., Ltd.
NCT06472739Phase 2Sep 15, 2023Sun Yat-Sen University
NCT05771584Phase 2Jul 4, 2023Aston Sci. Co., Ltd.
Showing 20 of 1,637 trials
Page 1 / 82

Organizations

Research & Development (672)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government67822741988
University of Texas at HoustonAcademic/Hospital1078941993
Cornell UniversityAcademic/Hospital917751991
University of WashingtonAcademic/Hospital705741994
Johns Hopkins UniversityAcademic/Hospital453241994
Mayo ClinicAcademic/Hospital401851993
National Institutes of Health (NIH)Government381051998
GenzymeFor profit372352003
University of California, San FranciscoAcademic/Hospital371941994
University of MinnesotaAcademic/Hospital363341998
Eastern Cooperative Oncology GroupAcademic/Hospital342331993
Harvard UniversityAcademic/Hospital332331996
AmgenFor profit311241999
Southwest Oncology GroupAcademic/Hospital302041994
National Institute of Allergy and Infectious Diseases (NIAID)Government262541999
St. Jude Children's HospitalAcademic/Hospital262231996
BayerFor profit24032002
City of Hope National Medical CenterAcademic/Hospital242041994
Case Western Reserve UniversityAcademic/Hospital232041996
State University of New York, BuffaloAcademic/Hospital221741995
672 organizations
Page 1 / 34

Marketing (7)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGFeb 20, 1991
AmgenFor profitNDA2Feb 20, 1991
NovartisFor profitNDA2Mar 6, 2015
Partner Therapeutics, Inc.For profitNDA2Mar 5, 1991
SandozFor profitMKTGMar 6, 2015
Schering AGFor profitMKTGMar 5, 1991
Schering AGFor profitNDAMar 5, 1991