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Placebo+G-CSF
Placebo+G-CSF is a Small molecule drug developed by Guangzhou Gloria Biosciences Co., Ltd.. It is currently in Phase 3 development for Neutropenia.
G-CSF stimulates the bone marrow to produce more neutrophils, a type of white blood cell.
Placebo+G-CSF, also known as filgrastim, is a protein-based treatment used in clinical trials for various conditions, including leukemia, lymphoma, oral complications, decompensated cirrhosis of the liver, and non-small cell lung cancer. It is administered as part of a treatment regimen that may include other interventions such as cyclophosphamide and palifermin.
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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 | Placebo+G-CSF |
|---|---|
| Sponsor | Guangzhou Gloria Biosciences Co., Ltd. |
| Target | G-CSF receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
G-CSF works by binding to its receptor on the surface of bone marrow cells, triggering a signaling cascade that leads to increased production of neutrophils. This can help to boost the immune system and fight off infections.
Approved indications
- Neutropenia
Common side effects
- Bone pain
- Fatigue
- Headache
- Injection site reaction
- Nausea
- Diarrhea
- Muscle pain
- Rash
- Thrombocytopenia
- Anemia
Key clinical trials
- New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (PHASE2)
- CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant (PHASE2)
- Loratadine for the Prevention of G-CSF-related Bone Pain (PHASE2)
- A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) (PHASE3)
- G-CSF in the Treatment of Toxic Epidermal Necrolysis (PHASE4)
- Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients (PHASE3)
- Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522) (PHASE3)
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:
- Placebo+G-CSF CI brief — competitive landscape report
- Placebo+G-CSF updates RSS · CI watch RSS
- Guangzhou Gloria Biosciences Co., Ltd. portfolio CI
Frequently asked questions about Placebo+G-CSF
What is Placebo+G-CSF?
How does Placebo+G-CSF work?
What is Placebo+G-CSF used for?
Who makes Placebo+G-CSF?
What development phase is Placebo+G-CSF in?
What are the side effects of Placebo+G-CSF?
What does Placebo+G-CSF target?
Related
- Target: All drugs targeting G-CSF receptor
- Manufacturer: Guangzhou Gloria Biosciences Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Neutropenia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing