NYPOZI (filgrastim-txid)
NYPOZI (filgrastim-txid) is a leukocyte growth factor used to manage neutropenia and reduce the risk of associated infections in several patient populations. It is indicated for patients with nonmyeloid malignancies receiving myelosuppressive or myeloablative chemotherapy, as well as those with acute myeloid leukemia or chronic forms of neutropenia. Additionally, the drug is used to mobilize hematopoietic progenitor cells for collection and to increase survival following acute exposure to myelosuppressive doses of radiation.
How NYPOZI Works
NYPOZI functions as a colony-stimulating factor that binds to specific cell surface receptors on hematopoietic cells. This binding stimulates the proliferation, differentiation, and activation of neutrophil progenitors within the bone marrow. By mimicking endogenous G-CSF, the drug specifically regulates the production of neutrophils and enhances their functional abilities, such as phagocytosis and antibody-dependent killing, with minimal effect on other cell lineages.
Details
- Status
- Prescription
- First Approved
- 2024-06-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NYPOZI Approval History
What NYPOZI Treats
7 indicationsNYPOZI is approved for 7 conditions since its original approval in 2024. 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
NYPOZI is a lower-cost alternative to Neupogen with no clinically meaningful differences. Requires prescriber approval to substitute.
NYPOZI 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 NYPOZI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NYPOZI treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
NYPOZI FDA Label Details
Indications & Usage
FDA Label (PDF)NYPOZI 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.