Product Description
Filgrastim injection products (Granix, Neupogen, Nivestym, Zarxio) are used to decrease the chance of infection in people who have non myeloid cancer (cancer that does not involve the bone marrow) and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils. (Sourced from: https://medlineplus.gov/druginfo/meds/a692033.html)
Mechanisms of Action: G-CSF
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous, Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Amgen
Company Location: Western America
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Germany, Spain, United Kingdom, United States
Active Clinical Trial Count: 7
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Thalassemia
Phase 2: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Biphenotypic Acute Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Hodgkin Lymphoma|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma|Myelodysplastic Syndrome|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Cutaneous Lymphoma|T-Cell Leukemia
Phase 1: Healthy Volunteers|Myeloproliferative Disorders|Pyruvate Kinase Deficiency
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03755804 |
cHOD17 | P2 |
Active, not recruiting |
Hodgkin Lymphoma |
2027-01-01 |
2% |
2025-09-23 |
|
2024-511520-13-00 |
RP-L301-0119 | P1 |
Active, not recruiting |
Pyruvate Kinase Deficiency |
2025-10-27 |
2025-05-02 |
Treatments |
|
2024-516894-57-00 |
CTX001-111 | P3 |
Active, not recruiting |
Thalassemia |
2026-02-05 |
40% |
2025-05-02 |
Treatments |
NCT05088356 |
IRB-60439 | P1 |
Recruiting |
Acute Myeloid Leukemia|Chronic Myeloid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloproliferative Disorders|Myelodysplastic Syndrome |
2027-11-01 |
50% |
2025-12-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05589896 |
PRESERVE I | P2 |
Recruiting |
Chronic Myeloid Leukemia|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic Syndrome|T-Cell Cutaneous Lymphoma|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, Non-Hodgkin|Lymphoma, B-Cell|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Chronic Lymphoid Leukemia|T-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Biphenotypic Acute Leukemia|Acute Myeloid Leukemia |
2026-02-25 |
12% |
2025-06-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT03188172 |
MUKnineb | P2 |
Active, not recruiting |
Multiple Myeloma |
2025-10-01 |
64% |
2024-05-15 |
|
NCT04958772 |
LATIM | P1 |
Not yet recruiting |
Healthy Volunteers |
2025-04-30 |
50% |
2024-08-17 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |