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F-627
F-627 is a long-acting granulocyte colony-stimulating factor (G-CSF) analog that stimulates neutrophil production and mobilization.
F-627 is a long-acting granulocyte colony-stimulating factor (G-CSF) analog that stimulates neutrophil production and mobilization. Used for Chemotherapy-induced neutropenia (CIN) in patients with cancer receiving myelosuppressive chemotherapy.
At a glance
| Generic name | F-627 |
|---|---|
| Also known as | Recombinant Human Granulocyte Colony Stimulating Factor (rh G-CSF) Fc fusion protein, Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein |
| Sponsor | EVIVE Biotechnology |
| Drug class | G-CSF receptor agonist |
| Target | G-CSF receptor (CSF3R) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
F-627 is a pegylated G-CSF receptor agonist designed to provide sustained neutrophil support with less frequent dosing than conventional G-CSF. It binds to and activates the G-CSF receptor on hematopoietic progenitor cells, promoting their differentiation and proliferation into mature neutrophils, thereby reducing chemotherapy-induced neutropenia and related infections.
Approved indications
- Chemotherapy-induced neutropenia (CIN) in patients with cancer receiving myelosuppressive chemotherapy
Common side effects
- Bone pain
- Headache
- Fatigue
- Injection site reactions
Key clinical trials
- Study to Compare the Efficacy and Safety of F-627 and GRAN® (PHASE3)
- Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (PHASE1)
- Bemalenograstim Alfa for the Prevention in Patients With Colorectal Cancer/Pancreatic Cancer (PHASE2)
- Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (PHASE3)
- Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (PHASE3)
- A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (PHASE1, PHASE2)
- Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (PHASE2)
- A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy. (PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |