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: THOUSAND OAKS CA 91320
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Germany, Spain, United Kingdom, United States
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: ST Elevation Myocardial Infarction|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 |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| IRB-60439 | P1 |
Recruiting |
Acute Myeloid Leukemia|Myeloproliferative Disorders|Chronic Myeloid Leukemia|Myelodysplastic Syndrome|Myelogenous, Chronic, BCR-ABL Positive Leukemia |
2025-12-01 |
57% |
2025-06-27 |
Primary Endpoints |
| RP-L301-0119 | P1 |
Active, not recruiting |
Pyruvate Kinase Deficiency |
2025-10-27 |
2025-05-02 |
Treatments |
|
| 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 |
| cHOD17 | P2 |
Recruiting |
Hodgkin Lymphoma |
2027-01-01 |
12% |
2024-11-27 |
Primary Endpoints |
| PRESERVE I | P2 |
Recruiting |
Chronic Myeloid Leukemia|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Cutaneous Lymphoma|Myelodysplastic Syndrome|Lymphocytic Chronic B-Cell Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, B-Cell|Biphenotypic Acute Leukemia|Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Lymphoma, Non-Hodgkin|T-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma |
2026-02-25 |
12% |
2025-06-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| MUKnineb | P2 |
Active, not recruiting |
Multiple Myeloma |
2025-10-01 |
64% |
2024-05-15 |
|
| CTX001-111 | P3 |
Active, not recruiting |
Thalassemia |
2026-02-05 |
2025-05-02 |
Treatments |
|
| HEAL-MI | P3 |
Not yet recruiting |
ST Elevation Myocardial Infarction |
2025-09-01 |
6% |
2023-06-02 |
Primary Endpoints|Treatments |