ZARXIO (filgrastim-sndz)
Zarxio is a leukocyte growth factor used to reduce the risk of infection and clinical complications in patients with various forms of neutropenia. It is indicated for patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy or undergoing bone marrow transplantation, as well as those with acute myeloid leukemia. The drug also serves to mobilize hematopoietic progenitor cells for collection and to improve survival in patients experiencing acute exposure to myelosuppressive doses of radiation.
How ZARXIO Works
Zarxio functions as a colony-stimulating factor that binds to specific receptors on hematopoietic cells to stimulate the production and activation of neutrophils. By regulating bone marrow activity, the drug promotes the proliferation and differentiation of neutrophil progenitors into functional white blood cells. This process enhances the immune system's end-cell functions, including phagocytic ability and antibody-dependent killing, while having minimal effect on other cell lineages.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-03-06
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZARXIO Approval History
What ZARXIO Treats
7 indicationsZARXIO is approved for 7 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Myeloid Leukemia
- Neutropenia
- Congenital Neutropenia
- Cyclic Neutropenia
- Idiopathic Neutropenia
- Acute Radiation Syndrome
ZARXIO is a lower-cost alternative to Neupogen with no clinically meaningful differences. Requires prescriber approval to substitute.
ZARXIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZARXIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZARXIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZARXIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03856216 results posted | 2018-0860 NCI-2019-00531, 2018-0860 | Ph 2 | terminated | Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation |
| NCT04022239 | 2018-0972 NCI-2019-03900, 2018-0972 | Ph 1, Ph 2 | recruiting | Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant |
| NCT05032183 results posted | 2021-0545 NCI-2021-08859, 2021-0545 | Ph 1, Ph 2 | terminated | Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| NCT03417284 results posted | 2017-0399 NCI-2018-00906, 2017-0399 | Ph 1, Ph 2 | completed | Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation |
| NCT03096782 results posted | 2016-0051 NCI-2018-01236, 2016-0051 | Ph 2 | completed | Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma |
| NCT01946152 results posted | 2013-0018 NCI-2014-01270, NCI-2014-00159 | Ph 1, Ph 2 | terminated | Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma |
| NCT01787474 | 2012-0079 NCI-2014-00883, NCI-2014-00841 | Ph 1 | completed | Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZARXIO FDA Label Details
Indications & Usage
FDA Label (PDF)ZARXIO is indicated for the treatment of Febrile Neutropenia; Acute Myeloid Leukemia; Neutropenia; Congenital Neutropenia; Cyclic Neutropenia; Idiopathic Neutropenia; Acute Radiation Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment