Last reviewed · How we verify
Pegylated G-CSF
Pegylated G-CSF is a Growth factor Small molecule drug developed by Australasian Gastro-Intestinal Trials Group. It is currently in Phase 3 development for Reducing the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy, Reducing the incidence of infection in patients with acute myeloid leukemia. Also known as: Neulasta, Neulasta®), Pegfilgrastim, Pegfilgrastim 6 mg.
Pegylated G-CSF stimulates the production of white blood cells, specifically neutrophils, to help the body fight infection.
Pegylated G-CSF is used to treat conditions such as lymphoma, leukemia, and chemotherapy-induced neutropenia. It works by facilitating the transfer of carbon monoxide or oxygen, although its exact modality is unknown.
-
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 | Pegylated G-CSF |
|---|---|
| Also known as | Neulasta, Neulasta®), Pegfilgrastim, Pegfilgrastim 6 mg |
| Sponsor | Australasian Gastro-Intestinal Trials Group |
| Drug class | Growth factor |
| Target | G-CSF receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This is achieved by mimicking the action of the natural hormone G-CSF, which is responsible for regulating the production of neutrophils in the bone marrow. By increasing the production of neutrophils, pegylated G-CSF helps to reduce the risk of infection in patients undergoing chemotherapy or other treatments that suppress the immune system.
Approved indications
- Reducing the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy
- Reducing the incidence of infection in patients with acute myeloid leukemia
Common side effects
- Bone pain
- Fatigue
- Headache
- Nausea
- Injection site reaction
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- 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)
- Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma (PHASE2)
- Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (PHASE2)
- Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection
- A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (PHASE2)
- Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas (PHASE1, 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:
- Pegylated G-CSF CI brief — competitive landscape report
- Pegylated G-CSF updates RSS · CI watch RSS
- Australasian Gastro-Intestinal Trials Group portfolio CI
Frequently asked questions about Pegylated G-CSF
What is Pegylated G-CSF?
How does Pegylated G-CSF work?
What is Pegylated G-CSF used for?
Who makes Pegylated G-CSF?
Is Pegylated G-CSF also known as anything else?
What drug class is Pegylated G-CSF in?
What development phase is Pegylated G-CSF in?
What are the side effects of Pegylated G-CSF?
What does Pegylated G-CSF target?
Related
- Drug class: All Growth factor drugs
- Target: All drugs targeting G-CSF receptor
- Manufacturer: Australasian Gastro-Intestinal Trials Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Reducing the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy
- Indication: Drugs for Reducing the incidence of infection in patients with acute myeloid leukemia
- Also known as: Neulasta, Neulasta®), Pegfilgrastim, Pegfilgrastim 6 mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing