Filgrastim: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Filgrastim appears in the FDA drug-label database. Marketed as RELEUKO.
- Drug class
- Leukocyte Growth Factor (FDA established pharmacologic class)
FDA-approved use
RELEUKO is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever. ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT). ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia. ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. — Amgen, Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-02-27 |
| Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit — Teva Pharmaceuticals USA, Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-01-10 |
| Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. — Amgen, Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-02-27 |
Phase breakdown
Conditions being studied
Recruiting trials involving Filgrastim
- Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease
- Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
- Stem Cell Transplantation in Crohn's Disease
- Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
Common questions
Is Filgrastim FDA-approved?
Yes, marketed as RELEUKO.
How many recruiting trials involve Filgrastim?
4 recruiting trials across 12 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.