GRANIX (tbo-filgrastim)
Granix (tbo-filgrastim) is a leukocyte growth factor indicated for use in adult and pediatric patients aged one month and older. It is used to reduce the duration of severe neutropenia in patients with non-myeloid malignancies who are undergoing treatment with myelosuppressive anticancer drugs. These chemotherapy regimens are typically associated with a clinically significant incidence of febrile neutropenia. The drug serves a supportive role in oncology by managing white blood cell counts during cancer treatment.
How GRANIX Works
Tbo-filgrastim is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. The drug works by binding to G-CSF receptors, which triggers the proliferation of neutrophils. This process stimulates differentiation commitment and functional activation of these cells, ultimately increasing both the count and activity of neutrophils in the body.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-08-29
- Patent Cliff
- 2024
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GRANIX Approval History
What GRANIX Treats
3 indicationsGRANIX is approved for 3 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neutropenia
- Febrile Neutropenia
- Non-Myeloid Malignancies
GRANIX 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 GRANIX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GRANIX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to GRANIX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03317899 results posted | 17D.404 JT 10928 | Ph 2 | completed | Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma |
| NCT03029000 GRANIX results posted | TV44688-ONC-30054 | Ph 3 | terminated | Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants |
| NCT02190721 results posted | XM02-ONC-201 2014-001772-55 | Ph 2 | completed | A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement |
| NCT02112045 results posted | 201405057 | Ph 2 | terminated | A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation |
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.
GRANIX FDA Label Details
Indications & Usage
FDA Label (PDF)GRANIX is indicated for the treatment of Neutropenia; Febrile Neutropenia; Non-Myeloid Malignancies.
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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