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busulfan (Busilvex ®)
busulfan (Busilvex ®) is a Alkylating agent Small molecule drug developed by PETHEMA Foundation. It is currently in Phase 3 development for Chronic myeloid leukemia, Acute myeloid leukemia.
Busulfan is an alkylating agent that interferes with DNA replication, leading to cell death.
Busulfan is an alkylating agent that interferes with DNA replication, leading to cell death. Used for Chronic myeloid leukemia, Acute myeloid leukemia.
At a glance
| Generic name | busulfan (Busilvex ®) |
|---|---|
| Sponsor | PETHEMA Foundation |
| Drug class | Alkylating agent |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Busulfan works by adding an alkyl group to the DNA of cancer cells, which damages the cells' ability to replicate. This leads to cell death and ultimately, tumor shrinkage. Busulfan is particularly effective against hematological malignancies.
Approved indications
- Chronic myeloid leukemia
- Acute myeloid leukemia
Common side effects
- Bone marrow suppression
- Nausea and vomiting
- Diarrhea
- Fatigue
- Hair loss
Key clinical trials
- HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide (PHASE2)
- High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly (PHASE2)
- Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma (PHASE2)
- Conditioning SCID Infants Diagnosed Early (PHASE2)
- Autologous Gene Therapy for Artemis-Deficient SCID (PHASE1, PHASE2)
- HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis (PHASE2)
- Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT (PHASE2)
- Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes (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:
- busulfan (Busilvex ®) CI brief — competitive landscape report
- busulfan (Busilvex ®) updates RSS · CI watch RSS
- PETHEMA Foundation portfolio CI
Frequently asked questions about busulfan (Busilvex ®)
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Related
- Drug class: All Alkylating agent drugs
- Manufacturer: PETHEMA Foundation — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic myeloid leukemia
- Indication: Drugs for Acute myeloid leukemia
- Compare: busulfan (Busilvex ®) vs similar drugs
- Pricing: busulfan (Busilvex ®) cost, discount & access