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Motixafortide+G-CSF
Motixafortide+G-CSF is a CXCR4 antagonist Small molecule drug developed by Guangzhou Gloria Biosciences Co., Ltd.. It is currently in Phase 3 development for Hematopoietic stem cell mobilization in patients with multiple myeloma or lymphoma undergoing autologous stem cell transplantation. Also known as: BL-8040+G-CSF.
Motixafortide is a CXCR4 antagonist that mobilizes hematopoietic stem cells from bone marrow into peripheral blood, used in combination with G-CSF (granulocyte-colony stimulating factor) to enhance stem cell mobilization for transplantation.
Motixafortide is a CXCR4 antagonist that mobilizes hematopoietic stem cells from bone marrow into peripheral blood, used in combination with G-CSF (granulocyte-colony stimulating factor) to enhance stem cell mobilization for transplantation. Used for Hematopoietic stem cell mobilization in patients with multiple myeloma or lymphoma undergoing autologous stem cell transplantation.
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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 | Motixafortide+G-CSF |
|---|---|
| Also known as | BL-8040+G-CSF |
| Sponsor | Guangzhou Gloria Biosciences Co., Ltd. |
| Drug class | CXCR4 antagonist |
| Target | CXCR4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Motixafortide blocks the CXCR4 chemokine receptor on hematopoietic stem cells, disrupting their retention in the bone marrow microenvironment. When combined with G-CSF, which stimulates stem cell proliferation and mobilization, this dual mechanism significantly increases the number of CD34+ cells available for collection in autologous stem cell transplantation procedures. This combination improves mobilization efficiency, particularly in patients who are poor mobilizers.
Approved indications
- Hematopoietic stem cell mobilization in patients with multiple myeloma or lymphoma undergoing autologous stem cell transplantation
Common side effects
- Bone pain
- Fatigue
- Headache
- Nausea
- Splenomegaly
Key clinical trials
- Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial (PHASE4)
- Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients (PHASE3)
- A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization (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:
- Motixafortide+G-CSF CI brief — competitive landscape report
- Motixafortide+G-CSF updates RSS · CI watch RSS
- Guangzhou Gloria Biosciences Co., Ltd. portfolio CI
Frequently asked questions about Motixafortide+G-CSF
What is Motixafortide+G-CSF?
How does Motixafortide+G-CSF work?
What is Motixafortide+G-CSF used for?
Who makes Motixafortide+G-CSF?
Is Motixafortide+G-CSF also known as anything else?
What drug class is Motixafortide+G-CSF in?
What development phase is Motixafortide+G-CSF in?
What are the side effects of Motixafortide+G-CSF?
What does Motixafortide+G-CSF target?
Related
- Drug class: All CXCR4 antagonist drugs
- Target: All drugs targeting CXCR4
- Manufacturer: Guangzhou Gloria Biosciences Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hematopoietic stem cell mobilization in patients with multiple myeloma or lymphoma undergoing autologous stem cell transplantation
- Also known as: BL-8040+G-CSF
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing