Filgrastim

Trade name: neupogen

Recombinant proteinapproved

Approved

Jan 31, 2002

Molgramostim is a recombinant granulocyte macrophage colony-stimulating factor which functions as an immunostimulator. — Wikipedia

Clinical trial activity

631 trials · 476 clinical orgs · 14 marketing orgs

Phase 1
183
Phase 2
398
Phase 3
112
Phase 4
43

Earliest trial started Oct 1, 1998 (NCT00464217)

Timeline

1990s

  1. Feb 20, 1991

    Amgen — First NDA Organization

  2. Feb 20, 1991

    Amgen — NDA Organization

  3. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  3. Jan 31, 2002

    Earliest FDA Approval

  4. Jan 31, 2002

    Amgen — Marketing Organization

2010s

  1. Aug 29, 2012

    Sicor — Marketing Organization

  2. Aug 29, 2012

    Teva — NDA Secondary Org

  3. Jun 4, 2018

    Mylan — Marketing Organization

  4. Jun 4, 2018

    Biocon Limited — NDA Secondary Org

  5. Jul 20, 2018

    Hospira — Marketing Organization

  6. Jul 20, 2018

    Pfizer — NDA Secondary Org

  7. Nov 2, 2018

    Coherus BioSciences — Marketing Organization

  8. Nov 2, 2018

    Coherus BioSciences — NDA Secondary Org

  9. Nov 4, 2019

    Sandoz — Marketing Organization

  10. Nov 4, 2019

    Novartis — NDA Secondary Org

2020s

  1. Feb 25, 2022

    Kashiv BioSciences, LLC — Marketing Organization

  2. Feb 25, 2022

    Kashiv BioSciences, LLC — NDA Secondary Org

  3. Sep 1, 2022

    Fresenius — Marketing Organization

  4. Sep 1, 2022

    Fresenius — NDA Secondary Org

  5. Jun 28, 2024

    Tanvex BioPharma — Marketing Organization

  6. Nov 28, 2025

    Lupin — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedJan 31, 2002

Chemistry & pharmacology

Loading structure…

SMILES

COCCOC(=O)NCC(=O)N[C@@H]1[C@@H](O)C[C@@](OC[C@H]2O[C@H](O[C@H](C)[C@H](N)C(=O)O)[C@H](NC(=O)C)[C@@H](O)[C@H]2O)(O[C@H]1[C@H](O)[C@H](O)CO)C(=O)O
Mol. weight
730.67 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
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

  • da-3030
  • da-3031
  • euprotin
  • filgrastim
  • filgrastim-aafi
  • gcpgc
  • g-csf (cho cell derived)
  • g-gsf
  • glycosylated recombinant g-csf
  • glycosylated recombinant granulocyte colony stimulating factor
  • gramal
  • granix
  • granocyte
  • granocyte
  • granocyte-13
  • granocyte-34
  • granulocyte colony stimulating factor 3 (cho cell derived)
  • granulocyte colony-stimulating factor lenograstim
  • granulocyte colony-stimulating factor pegfilgrastim
  • la-ep2006
  • lenograstim
  • lenograstim
  • lenograstim
  • lenograstim
  • lenograstim
  • lenograstim, component 1
  • lenograstim, component 2
  • lenograstim (genetical recombination)
  • lenograstim rdna
  • leucomax
  • leucomax
  • lipegfilgrastim
  • lipegfilgrastim
  • lipegfilgrastim
  • lipegfilgrastim
  • lipegfilgrastim
  • lipegfilgrastim
  • lipegfilgrastim
  • lonquek
  • lonquex
  • lonquex
  • mielogen
  • molgramostim
  • molgramostim
  • molgramostim
  • molgramostim
  • monocyte cells
  • myeloid growth factor
  • n-(3-hydroxypropyl)methionylcolony-stimulating factor (human), 1-ether with alpha-methyl-omega-hydroxypoly(oxyethylene)
  • neugranin
  • neulast
  • neulasta
  • neulasta
  • neulasta
  • neulasta
  • neulasta
  • neulasta
  • neulasta sureclick
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • pegfilgrastim
  • peg-filgrastim
  • peg-filgrastim
  • pegfilgrastim-cbqv
  • pegfilgrastim-jmdb
  • peg-g-csf
  • peg-rmethug-csf
  • peg sd-01
  • pegylated filgrastim
  • pegylated g-csf
  • pegylated recombinant human g-csf
  • pegylated rhg-csf
  • pegylate g-csf
  • ristempa
  • sch-39300
  • sd-01-filgrastim
  • sd-01, polyethylene glycol-conjugated filgrastim
  • tbo-filgrastim
  • tbo-filgrastim
  • tbo-filgrastim
  • tevagastrim
  • tripegfilgrastim
  • xm22
  • xm22
  • xm22
  • xm22
  • ypeg-rhg-csf

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07283705Phase 2May 18, 2026Bristol-Myers Squibb, University of Texas at Houston
NCT07020533Phase 1May 8, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07224100Phase 2May 1, 2026Takeda, University of Washington
NCT07278856Phase 1Apr 27, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07255404Phase 2Dec 31, 2025Biontech, Bristol-Myers Squibb
NCT07257419Phase 1Dec 31, 2025St. Jude Children's Hospital
NCT07052370Phase 1Dec 31, 2025St. Jude Children's Hospital
NCT07059611Phase 2Nov 8, 2025Replimune Inc., University of Pennsylvania
NCT07044544Phase 1Oct 31, 2025University of Alabama, Birmingham
NCT07012044Phase 1Oct 31, 2025National Cancer Institute (NCI)
NCT07021989Phase 2Oct 31, 2025Gateway for Cancer Research, University of California, San Francisco
NCT07114861Phase 1/Phase 2 (Phase 2)Oct 22, 2025
NCT07166601Phase 1Oct 10, 2025Merck KGaA, Merck Serono
NCT07044453Phase 2/Phase 3 (Phase 3)Sep 30, 2025Rouen Normandy University
NCT06942039Early Phase 1 (Phase 1)Sep 30, 2025C17 Council
NCT07046078Phase 2Sep 26, 2025University of Washington
NCT07101445Phase 4Sep 24, 2025Emory University, Gamida Cell, National Cancer Institute (NCI)
NCT06928662Phase 1/Phase 2 (Phase 2)Sep 23, 2025University of Washington
NCT06890039Phase 2Sep 1, 2025Assistance Publique - Hôpitaux de Paris, European Foundation for Study of Chronic Liver Failure, Humboldt University, Leiden University, University of Leipzig, University of London, Yaqrit Ltd
NCT07155629Phase 3Sep 1, 2025University of Helsinki, University of Oulu
Showing 20 of 631 trials
Page 1 / 32

Organizations

Research & Development (476)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government882851999
University of Texas at HoustonAcademic/Hospital383332002
AmgenFor profit371752000
Chinese Academy of Medical SciencesAcademic/Hospital201052006
University of WashingtonAcademic/Hospital201932004
Peking UniversityAcademic/Hospital18952006
Sun Yat-Sen UniversityAcademic/Hospital171152016
St. Jude Children's HospitalAcademic/Hospital151522002
Cornell UniversityAcademic/Hospital14942003
Northwestern UniversityAcademic/Hospital121132002
Harvard UniversityAcademic/Hospital11832003
People's Liberation Army of ChinaGovernment11742006
Shijiazhuang Pharma Group (CSPC)For profit111022013
Soochow UniversityAcademic/Hospital111132018
SanofiFor profit10332006
Washington University in St. LouisAcademic/Hospital10932006
Zhejiang UniversityAcademic/Hospital10522006
City of Hope National Medical CenterAcademic/Hospital9622006
Gynecologic Oncology GroupAcademic/Hospital9832000
Mayo ClinicAcademic/Hospital9532004
476 organizations
Page 1 / 24

Marketing (19)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGJan 31, 2002
AmgenFor profitIND
AmgenFor profitNDAFeb 20, 1991
Biocon LimitedFor profitNDA2Jun 4, 2018
Coherus BioSciencesFor profitMKTGNov 2, 2018
Coherus BioSciencesFor profitNDA2Nov 2, 2018
FreseniusFor profitMKTGSep 1, 2022
FreseniusFor profitNDA2Sep 1, 2022
HospiraFor profitMKTGJul 20, 2018
Kashiv BioSciences, LLCFor profitMKTGFeb 25, 2022
Kashiv BioSciences, LLCFor profitNDA2Feb 25, 2022
LupinFor profitMKTGNov 28, 2025
MylanFor profitMKTGJun 4, 2018
NovartisFor profitNDA2Nov 4, 2019
PfizerFor profitNDA2Jul 20, 2018
SandozFor profitMKTGNov 4, 2019
SicorFor profitMKTGAug 29, 2012
Tanvex BioPharmaFor profitMKTGJun 28, 2024
TevaFor profitNDA2Aug 29, 2012