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G-CSF and plerixafor
G-CSF and plerixafor is a Growth factor Small molecule drug developed by Genzyme, a Sanofi Company. It is currently in Phase 2 development for Autologous hematopoietic stem cell mobilization. Also known as: Mozobil, AMD3100.
Stimulates the production of neutrophils by binding to the G-CSF receptor
Stimulates the production of neutrophils by binding to the G-CSF receptor Used for Autologous hematopoietic stem cell mobilization.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies. -
Big-pharma sponsor
+3.0pp
Genzyme, a Sanofi Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 and plerixafor |
|---|---|
| Also known as | Mozobil, AMD3100 |
| Sponsor | Genzyme, a Sanofi Company |
| Drug class | Growth factor |
| Target | G-CSF receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
G-CSF stimulates the bone marrow to produce more neutrophils, which are a type of white blood cell. Plerixafor is a CXCR4 antagonist that mobilizes stem cells from the bone marrow into the bloodstream.
Approved indications
- Autologous hematopoietic stem cell mobilization
Common side effects
- Bone pain
- Nausea
- Headache
Key clinical trials
- Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models (PHASE2)
- Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (PHASE1, PHASE2)
- Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia (PHASE1, PHASE2)
- CHRONO-MOBILIZE: Chronotherapy of G-CSF for CD34+ Mobilization in Healthy Donors (NA)
- Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma (PHASE2)
- Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy (PHASE1, PHASE2)
- Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML (PHASE1, PHASE2)
- Protocol Title: Safety and Feasibility of Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis in Participants With RUNX1 Familial Platelet Disorder (PHASE1)
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 and plerixafor CI brief — competitive landscape report
- G-CSF and plerixafor updates RSS · CI watch RSS
- Genzyme, a Sanofi Company portfolio CI
Frequently asked questions about G-CSF and plerixafor
What is G-CSF and plerixafor?
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What is G-CSF and plerixafor used for?
Who makes G-CSF and plerixafor?
Is G-CSF and plerixafor also known as anything else?
What drug class is G-CSF and plerixafor in?
What development phase is G-CSF and plerixafor in?
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What does G-CSF and plerixafor target?
Related
- Drug class: All Growth factor drugs
- Target: All drugs targeting G-CSF receptor
- Manufacturer: Genzyme, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Autologous hematopoietic stem cell mobilization
- Also known as: Mozobil, AMD3100
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing