ZIEXTENZO (pegfilgrastim-bmez)
Ziextenzo is a leukocyte growth factor indicated to decrease the incidence of infection, manifested as febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. It is also approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation, a condition known as Hematopoietic Subsyndrome of Acute Radiation Syndrome. The drug is not intended for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
How ZIEXTENZO Works
Ziextenzo is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors. This binding process stimulates the proliferation, differentiation, and commitment of these cells. Additionally, the mechanism triggers the functional activation of end cells to support the patient's immune response.
Details
- Status
- Prescription
- First Approved
- 2019-11-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZIEXTENZO Approval History
What ZIEXTENZO Treats
2 indicationsZIEXTENZO is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Radiation Syndrome
ZIEXTENZO is a lower-cost alternative to Neulasta with no clinically meaningful differences. Requires prescriber approval to substitute.
ZIEXTENZO 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.
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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.
ZIEXTENZO FDA Label Details
Indications & Usage
FDA Label (PDF)ZIEXTENZO is indicated for the treatment of Febrile 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.