Filgrastim
Trade name: neupogen
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
Earliest trial started Oct 1, 1998 (NCT00464217)
Timeline
1990s
2000s
2010s
- Aug 29, 2012
Sicor — Marketing Organization
- Aug 29, 2012
Teva — NDA Secondary Org
- Jun 4, 2018
Mylan — Marketing Organization
- Jun 4, 2018
Biocon Limited — NDA Secondary Org
- Jul 20, 2018
Hospira — Marketing Organization
- Jul 20, 2018
Pfizer — NDA Secondary Org
- Nov 2, 2018
Coherus BioSciences — Marketing Organization
- Nov 2, 2018
Coherus BioSciences — NDA Secondary Org
- Nov 4, 2019
Sandoz — Marketing Organization
- Nov 4, 2019
Novartis — NDA Secondary Org
2020s
- Feb 25, 2022
Kashiv BioSciences, LLC — Marketing Organization
- Feb 25, 2022
Kashiv BioSciences, LLC — NDA Secondary Org
- Sep 1, 2022
Fresenius — Marketing Organization
- Sep 1, 2022
Fresenius — NDA Secondary Org
- Jun 28, 2024
Tanvex BioPharma — Marketing Organization
- Nov 28, 2025
Lupin — Marketing Organization
Indications
Approved for
Studied for
- Acute-On-Chronic Liver Failure · Phase 2
- Adenocarcinoma of Lung · Phase 2
- Adolescent · Phase 2
- Allografts · Phase 3
- Alzheimer Disease · Phase 2
- Amyloidosis · Phase 1
- Anaplasia · Phase 2
- Anemia · Phase 2
- Anemia, Aplastic · Phase 2
- Anemia, Refractory · Phase 2
- Anemia, Sickle Cell · Phase 1/Phase 2
- Antibiotic Prophylaxis · Phase 4
- Ascites · Phase 1/Phase 2
- Astrocytoma · Phase 1
- Autoimmune Diseases · Phase 3
- beta-Thalassemia · Phase 1/Phase 2
- Bile Duct Neoplasms · Phase 2
- Biliary Atresia · Phase 2
- Biomarkers · Phase 1
- Blood Platelet Disorders · Phase 1
- Bone Marrow Diseases · Phase 4
- Bone Marrow Failure Disorders · Phase 2
- Bone Neoplasms · Phase 2
- Brain Neoplasms · Phase 2
- Breast Neoplasms · Phase 4
- Breast Neoplasms, Male · Phase 2
- Bronchiectasis · Phase 1
- Burkitt Lymphoma · Phase 2
- Carcinoma, Embryonal · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 4
- Carcinoma, Ovarian Epithelial · Phase 3
- Carcinoma, Renal Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 3
- Central Nervous System Neoplasms · Phase 1
- Chemoradiotherapy · Phase 2
- Chemotherapy, Adjuvant · Phase 4
- Chemotherapy-Induced Febrile Neutropenia · Phase 4
- Child · Phase 2
- Cholangiocarcinoma · Phase 2
- Choriocarcinoma · Phase 3
- Choroid Plexus Neoplasms · Phase 1
- Chronic Limb-Threatening Ischemia · Phase 1/Phase 2
- Colonic Neoplasms · Phase 4
- Colony-Stimulating Factors · Phase 3
- Colorectal Neoplasms · Phase 3
- Congenital Bone Marrow Failure Syndromes · Phase 2
- Coronary Artery Disease · Phase 1
- Cost-Benefit Analysis · Phase 4
- Cost of Illness · Phase 3
- COVID-19 · Phase 2
- Crohn Disease · Phase 2
- Cystic Fibrosis · Phase 2
- Desmoplastic Small Round Cell Tumor · Phase 1/Phase 2
- Diabetes Mellitus · Phase 1/Phase 2
- Diabetes Mellitus, Type 1 · Phase 2
- Diabetic Neuropathies · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drug Therapy · Phase 3
- Dyskeratosis Congenita · Phase 2
- Embryonic Development · Phase 4
- Embryo Transfer · Phase 4
- Endodermal Sinus Tumor · Phase 3
- Endometrial Neoplasms · Phase 3
- Endometriosis · Phase 2
- End Stage Liver Disease · Phase 1/Phase 2
- Enterocolitis, Necrotizing · Phase 1/Phase 2
- Ependymoma · Phase 1
- Esophageal Neoplasms · Phase 3
- Esophageal Squamous Cell Carcinoma · Phase 3
- Fallopian Tube Neoplasms · Phase 2
- Fanconi Anemia · Phase 2
- Febrile Neutropenia · Phase 4
- Feeding and Eating Disorders · Phase 1/Phase 2
- Fertilization in Vitro · Phase 4
- Fever · Phase 3
- Filgrastim · Phase 4
- Gastrointestinal Neoplasms · Phase 2
- General Surgery · Phase 3
- Gene Rearrangement · Phase 1
- Genital Neoplasms, Female · Phase 4
- Geriatrics · Phase 2
- Germinoma · Phase 3
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Gliosarcoma · Phase 2
- Granulocyte Colony-Stimulating Factor · Phase 4
- Granuloma · Phase 1/Phase 2
- Granulomatous Disease, Chronic · Phase 1/Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 3
- Hemangiosarcoma · Phase 1
- Hematologic Neoplasms · Phase 4
- Hematology · Phase 2
- Hematopoietic Stem Cell Mobilization · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 4
- Hemoglobinuria, Paroxysmal · Phase 2
- Hepatitis, Alcoholic · Phase 4
- Hepatoblastoma · Phase 1
- Hodgkin Disease · Phase 4
- Hypoglycemia · Phase 1/Phase 2
- Idiopathic Pulmonary Fibrosis · Phase 1/Phase 2
- Immune Checkpoint Inhibitors · Phase 2
- Immunity, Humoral · Phase 1
- Induction Chemotherapy · Phase 3
- Infections · Phase 1
- Infertility · Phase 4
- Infertility, Female · Phase 4
- Leiomyosarcoma · Phase 3
- Lenograstim · Phase 4
- Leucogenenol · Phase 3
- Leukemia · Phase 4
- Leukemia, Biphenotypic, Acute · Phase 1/Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 3
- Leukemia, Lymphoid · Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Leukemia, Monocytic, Acute · Phase 2/Phase 3
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 3
- Leukemia, Myeloid · Phase 2
- Leukemia, Myeloid, Acute · Phase 4
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 2
- Leukemia, Myeloid, Chronic-Phase · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 2
- Leukemia, Myelomonocytic, Juvenile · Phase 2
- Leukemia, Prolymphocytic · Phase 2
- Leukemia, Promyelocytic, Acute · Phase 1
- Liver Cirrhosis · Phase 3
- Liver Cirrhosis, Alcoholic · Phase 2
- Lung Diseases · Phase 3
- Lung Neoplasms · Phase 4
- Lymphoma · Phase 4
- Lymphoma, AIDS-Related · Phase 1
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Anaplastic · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 3
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 4
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 2
- Lymphoma, T-Cell · Phase 2
- Lymphoma, T-Cell, Cutaneous · Phase 1
- Lymphoma, T-Cell, Peripheral · Phase 1
- Lymphopenia · Phase 2
- Malnutrition · Phase 3
- Medulloblastoma · Phase 2
- Melanoma · Phase 2/Phase 3
- Meningioma · Phase 1
- Multiple Myeloma · Phase 4
- Multiple Sclerosis, Relapsing-Remitting · Phase 3
- Muscular Diseases · Phase 1
- Musculoskeletal Diseases · Phase 1
- Mutation · Phase 2
- Myasthenia Gravis · Phase 1
- Mycobacterium Infections, Nontuberculous · Phase 2
- Myelodysplastic-Myeloproliferative Diseases · Phase 2
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 3
- Myocardial Infarction · Phase 2
- Myocardial Ischemia · Phase 2
- Nasopharyngeal Carcinoma · Phase 3
- Neoadjuvant Therapy · Phase 2
- Neoplasm Metastasis · Phase 1
- Neoplasms · Phase 4
- Neoplasms by Histologic Type · Phase 1
- Neoplasms, Germ Cell and Embryonal · Phase 3
- Neoplasms, Neuroepithelial · Phase 1
- Neuroblastoma · Phase 1
- Neuroectodermal Tumors, Primitive · Phase 1
- Neuromyelitis Optica · Phase 2/Phase 3
- Neutropenia · Phase 4
- Oligodendroglioma · Phase 1
- Osteosarcoma · Phase 1/Phase 2
- Ovarian Diseases · Phase 4
- Ovarian Neoplasms · Phase 4
- Pain · Phase 1/Phase 2
- Pancreatic Neoplasms · Phase 3
- Papillomaviridae · Phase 2
- Paraganglioma · Phase 1
- Patient Participation · Phase 3
- Peripheral Blood Stem Cell Transplantation · Phase 2
- Pharmacokinetics · Phase 1
- Pharmacology, Clinical · Phase 1
- Pinealoma · Phase 1
- Plasma · Phase 3
- Postmenopause · Phase 1
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 3
- Pre-Eclampsia · Phase 1
- Primary Immunodeficiency Diseases · Phase 1/Phase 2
- Primary Myelofibrosis · Phase 3
- Progression-Free Survival · Phase 3
- Prostatic Neoplasms · Phase 4
- Prostatic Neoplasms, Castration-Resistant · Phase 1
- Prostheses and Implants · Phase 2
- Pulmonary Alveolar Proteinosis · Phase 1
- Pulmonary Disease, Chronic Obstructive · Phase 1/Phase 2
- Quality of Life · Phase 3
- Radiotherapy · Phase 2
- Rare Diseases · Phase 2/Phase 3
- Receptors, Antigen, T-Cell, alpha-beta · Phase 2
- Rectal Neoplasms · Phase 3
- Respiratory Distress Syndrome · Phase 1
- Retinoblastoma · Phase 2
- Rhabdoid Tumor · Phase 1
- Rhabdomyosarcoma · Phase 2
- Sarcoma · Phase 3
- Sarcoma, Clear Cell · Phase 1
- Sarcoma, Ewing · Phase 2
- Scleroderma, Systemic · Phase 3
- Seminoma · Phase 3
- Severe Acute Respiratory Syndrome · Phase 2
- Severe Combined Immunodeficiency · Phase 1/Phase 2
- Small Cell Lung Carcinoma · Phase 3
- Spine · Phase 3
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- ST Elevation Myocardial Infarction · Phase 3
- Stem Cells · Phase 1
- Stevens-Johnson Syndrome · Phase 2/Phase 3
- Stiff-Person Syndrome · Phase 1/Phase 2
- Stomach Neoplasms · Phase 2
- Telomere · Phase 2
- Teratoma · Phase 3
- Testicular Neoplasms · Phase 2
- Therapeutic Equivalency · Phase 1
- Thoracic Neoplasms · Phase 2
- Thrombocytopenia · Phase 2
- T-Lymphocytopenia, Idiopathic CD4-Positive · Phase 2
- Transplants · Phase 2
- Triple Negative Breast Neoplasms · Phase 3
- Ureteral Neoplasms · Phase 3
- Urethral Neoplasms · Phase 3
- Urinary Bladder Neoplasms · Phase 3
- Uterine Cervical Neoplasms · Phase 4
- Uterine Neoplasms · Phase 3
- Vasculitis · Phase 1
- Wilms Tumor · Phase 2
- X-Linked Combined Immunodeficiency Diseases · Phase 1/Phase 2
Mechanism of action
CSF3R agonist
- Granulocyte colony-stimulating factorSupplementation
CSF3 supplementation
Approval history
- approvedJan 31, 2002
Chemistry & pharmacology
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
- NCATSPVI5M0M1GW ↗
- WikipediaMolgramostim ↗
- ChEMBLCHEMBL4594230 ↗
- ChEMBLCHEMBL2109134 ↗
- ChEMBLCHEMBL2109128 ↗
- ChEMBLCHEMBL2105765 ↗
- ChEMBLCHEMBL1201568 ↗
- ChEMBLCHEMBL1201567 ↗
- WikipediaPegfilgrastim ↗
- WikipediaLenograstim ↗
- WikipediaFilgrastim ↗
- ChEMBLCHEMBL5314921 ↗
- NCATS3A58010674 ↗
- ChEMBLCHEMBL5095279 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07283705 | Phase 2 | May 18, 2026 | Bristol-Myers Squibb, University of Texas at Houston |
| NCT07020533 | Phase 1 | May 8, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07224100 | Phase 2 | May 1, 2026 | Takeda, University of Washington |
| NCT07278856 | Phase 1 | Apr 27, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07255404 | Phase 2 | Dec 31, 2025 | Biontech, Bristol-Myers Squibb |
| NCT07257419 | Phase 1 | Dec 31, 2025 | St. Jude Children's Hospital |
| NCT07052370 | Phase 1 | Dec 31, 2025 | St. Jude Children's Hospital |
| NCT07059611 | Phase 2 | Nov 8, 2025 | Replimune Inc., University of Pennsylvania |
| NCT07044544 | Phase 1 | Oct 31, 2025 | University of Alabama, Birmingham |
| NCT07012044 | Phase 1 | Oct 31, 2025 | National Cancer Institute (NCI) |
| NCT07021989 | Phase 2 | Oct 31, 2025 | Gateway for Cancer Research, University of California, San Francisco |
| NCT07114861 | Phase 1/Phase 2 (Phase 2) | Oct 22, 2025 | — |
| NCT07166601 | Phase 1 | Oct 10, 2025 | Merck KGaA, Merck Serono |
| NCT07044453 | Phase 2/Phase 3 (Phase 3) | Sep 30, 2025 | Rouen Normandy University |
| NCT06942039 | Early Phase 1 (Phase 1) | Sep 30, 2025 | C17 Council |
| NCT07046078 | Phase 2 | Sep 26, 2025 | University of Washington |
| NCT07101445 | Phase 4 | Sep 24, 2025 | Emory University, Gamida Cell, National Cancer Institute (NCI) |
| NCT06928662 | Phase 1/Phase 2 (Phase 2) | Sep 23, 2025 | University of Washington |
| NCT06890039 | Phase 2 | Sep 1, 2025 | Assistance Publique - Hôpitaux de Paris, European Foundation for Study of Chronic Liver Failure, Humboldt University, Leiden University, University of Leipzig, University of London, Yaqrit Ltd |
| NCT07155629 | Phase 3 | Sep 1, 2025 | University of Helsinki, University of Oulu |
Organizations
Research & Development (476)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 88 | 28 | 5 | 1999 |
| University of Texas at Houston | Academic/Hospital | 38 | 33 | 3 | 2002 |
| Amgen | For profit | 37 | 17 | 5 | 2000 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 20 | 10 | 5 | 2006 |
| University of Washington | Academic/Hospital | 20 | 19 | 3 | 2004 |
| Peking University | Academic/Hospital | 18 | 9 | 5 | 2006 |
| Sun Yat-Sen University | Academic/Hospital | 17 | 11 | 5 | 2016 |
| St. Jude Children's Hospital | Academic/Hospital | 15 | 15 | 2 | 2002 |
| Cornell University | Academic/Hospital | 14 | 9 | 4 | 2003 |
| Northwestern University | Academic/Hospital | 12 | 11 | 3 | 2002 |
| Harvard University | Academic/Hospital | 11 | 8 | 3 | 2003 |
| People's Liberation Army of China | Government | 11 | 7 | 4 | 2006 |
| Shijiazhuang Pharma Group (CSPC) | For profit | 11 | 10 | 2 | 2013 |
| Soochow University | Academic/Hospital | 11 | 11 | 3 | 2018 |
| Sanofi | For profit | 10 | 3 | 3 | 2006 |
| Washington University in St. Louis | Academic/Hospital | 10 | 9 | 3 | 2006 |
| Zhejiang University | Academic/Hospital | 10 | 5 | 2 | 2006 |
| City of Hope National Medical Center | Academic/Hospital | 9 | 6 | 2 | 2006 |
| Gynecologic Oncology Group | Academic/Hospital | 9 | 8 | 3 | 2000 |
| Mayo Clinic | Academic/Hospital | 9 | 5 | 3 | 2004 |
Marketing (19)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amgen | For profit | MKTG | Jan 31, 2002 |
| Amgen | For profit | IND | — |
| Amgen | For profit | NDA | Feb 20, 1991 |
| Biocon Limited | For profit | NDA2 | Jun 4, 2018 |
| Coherus BioSciences | For profit | MKTG | Nov 2, 2018 |
| Coherus BioSciences | For profit | NDA2 | Nov 2, 2018 |
| Fresenius | For profit | MKTG | Sep 1, 2022 |
| Fresenius | For profit | NDA2 | Sep 1, 2022 |
| Hospira | For profit | MKTG | Jul 20, 2018 |
| Kashiv BioSciences, LLC | For profit | MKTG | Feb 25, 2022 |
| Kashiv BioSciences, LLC | For profit | NDA2 | Feb 25, 2022 |
| Lupin | For profit | MKTG | Nov 28, 2025 |
| Mylan | For profit | MKTG | Jun 4, 2018 |
| Novartis | For profit | NDA2 | Nov 4, 2019 |
| Pfizer | For profit | NDA2 | Jul 20, 2018 |
| Sandoz | For profit | MKTG | Nov 4, 2019 |
| Sicor | For profit | MKTG | Aug 29, 2012 |
| Tanvex BioPharma | For profit | MKTG | Jun 28, 2024 |
| Teva | For profit | NDA2 | Aug 29, 2012 |