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G-CSF (Filgrastim)
G-CSF (Filgrastim) is a Granulocyte colony-stimulating factor (G-CSF) Small molecule drug developed by M.D. Anderson Cancer Center. It is currently in Phase 3 development for Chemotherapy-induced neutropenia in cancer patients, Severe chronic neutropenia, Mobilization of peripheral blood progenitor cells for autologous transplantation. Also known as: Neupogen, Filgrastim (brand name), Recombinant Filgrastim.
Filgrastim is a granulocyte colony-stimulating factor (G-CSF) that stimulates the bone marrow to produce and release neutrophils into the bloodstream.
Filgrastim, also known as Leucostim, is a recombinant human granulocyte colony-stimulating factor receptor agonist used to treat conditions such as neutropenia and certain types of cancer, including breast cancer and lymphoma. It works by binding to the granulocyte colony-stimulating factor receptor, a protein that stimulates the production of white blood cells.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | G-CSF (Filgrastim) |
|---|---|
| Also known as | Neupogen, Filgrastim (brand name), Recombinant Filgrastim |
| Sponsor | M.D. Anderson Cancer Center |
| Drug class | Granulocyte colony-stimulating factor (G-CSF) |
| Target | G-CSF receptor (CSF3R) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Filgrastim binds to G-CSF receptors on hematopoietic progenitor cells in the bone marrow, promoting their proliferation, differentiation, and activation. This increases circulating neutrophil counts, which helps prevent or reduce the severity and duration of chemotherapy-induced neutropenia and associated infections in cancer patients.
Approved indications
- Chemotherapy-induced neutropenia in cancer patients
- Severe chronic neutropenia
- Mobilization of peripheral blood progenitor cells for autologous transplantation
Common side effects
- Bone pain
- Headache
- Fatigue
- Fever
- Splenic rupture (rare)
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- Improving White Blood Cell Collection From Healthy Donors (PHASE4)
- A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) (PHASE2, PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer (PHASE2, PHASE3)
- A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant (PHASE1)
- Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| 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:
- G-CSF (Filgrastim) CI brief — competitive landscape report
- G-CSF (Filgrastim) updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI
Frequently asked questions about G-CSF (Filgrastim)
What is G-CSF (Filgrastim)?
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Who makes G-CSF (Filgrastim)?
Is G-CSF (Filgrastim) also known as anything else?
What drug class is G-CSF (Filgrastim) in?
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Related
- Drug class: All Granulocyte colony-stimulating factor (G-CSF) drugs
- Target: All drugs targeting G-CSF receptor (CSF3R)
- Manufacturer: M.D. Anderson Cancer Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chemotherapy-induced neutropenia in cancer patients
- Indication: Drugs for Severe chronic neutropenia
- Indication: Drugs for Mobilization of peripheral blood progenitor cells for autologous transplantation
- Also known as: Neupogen, Filgrastim (brand name), Recombinant Filgrastim
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing