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tbo-filgrastim
tbo-filgrastim is a Leukocyte Growth Factor [EPC] Small molecule drug developed by Teva Branded Pharmaceutical Products R&D, Inc.. It is currently in discontinued development. Also known as: Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Granix, XM02.
12.1 Mechanism of Action Tbo-filgrastim is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity.
Tbo-filgrastim, also known as Leucostim, is a medication used to treat various conditions, including low neutrophil count, which may occur due to HIV/AIDS, chemotherapy, radiation poisoning, or unknown causes. It works by acting as a granulocyte colony-stimulating factor receptor agonist, stimulating the production of white blood cells.
At a glance
| Generic name | tbo-filgrastim |
|---|---|
| Also known as | Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Granix, XM02 |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Drug class | Leukocyte Growth Factor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | discontinued |
Mechanism of action
1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1 )
Approved indications
Common side effects
Key clinical trials
- Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy (Phase 3)
- A PHASE II STUDY OF NEOADJUVANT CHEMOTHERAPY AND RADIATION THERAPY IN THE MANAGEMENT OF HIGH-RISK, HIGH-GRADE, SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND BODY WALL (Phase 2)
- Evaluation of the Relationship Between Immunologic Recovery After Highly Active Antiretroviral Therapy and the Ability to Mobilize CD34+ Stem Cells Following G-CSF Administration (NA)
- A Proof of Concept Pilot Study of the Addition of Venetoclax to Standard Remission Induction Chemotherapy Fludarabine or Cladrabine, Cytarabine, and Granulocyte Colony Stimulating Factor (G-CSF) (FLAG (Phase 2)
- Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate Risk Rhabdomyosarcoma (Phase 3)
- Non-interventional, Prospective, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Healthy Unrelated Stem Cell Donors Undergoing Peripheral Blood Progenitor Cell Mobilization (N/A)
- Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas (Phase 2)
- Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years (Phase 2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- tbo-filgrastim CI brief — competitive landscape report
- tbo-filgrastim updates RSS · CI watch RSS
- Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI
Frequently asked questions about tbo-filgrastim
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Related
- Drug class: All Leukocyte Growth Factor [EPC] drugs
- Manufacturer: Teva Branded Pharmaceutical Products R&D, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Also known as: Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Granix, XM02
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing