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
Company: Amgen
Company Location: Western America
Company Founding Year: 1980
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|Anemia, Refractory, with Excess of Blasts|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 |
|---|---|---|---|---|---|---|---|---|
NCT05589896 |
PRESERVE I | P2 |
Recruiting |
Hodgkin Lymphoma|Lymphocytic Chronic B-Cell Leukemia|Chronic Myeloid Leukemia|Acute Myeloid Leukemia|Anemia, Refractory, with Excess of Blasts|Chronic Lymphoid Leukemia|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Lymphoma, B-Cell|Acute Lymphoid Leukemia|Lymphoma, Non-Hodgkin|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Leukemia|Biphenotypic Acute Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic Syndrome|T-Cell Cutaneous Lymphoma |
2026-05-31 |
12% |
2026-02-25 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2024-511520-13-00 |
RP-L301-0119 | P1 |
Active, not recruiting |
Pyruvate Kinase Deficiency |
2025-10-27 |
2025-05-02 |
Treatments |
|
NCT03188172 |
MUKnineb | P2 |
Active, not recruiting |
Multiple Myeloma |
2025-10-01 |
64% |
2024-05-15 |
|
2024-516894-57-00 |
CTX001-111 | P3 |
Active, not recruiting |
Thalassemia |
2026-02-05 |
40% |
2025-05-02 |
Treatments |
NCT05088356 |
IRB-60439 | P1 |
Recruiting |
Myeloproliferative Disorders|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myelodysplastic Syndrome|Chronic Myeloid Leukemia|Acute Myeloid Leukemia |
2027-11-01 |
50% |
2025-12-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
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 |
NCT03755804 |
cHOD17 | P2 |
Active, not recruiting |
Hodgkin Lymphoma |
2027-01-01 |
12% |
2025-09-23 |