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Busilvex
Busilvex is a Small molecule drug developed by medac GmbH. It is currently in Phase 2 development for Allogeneic bone marrow transplantation, Autologous hematopoietic stem-cell transplantation for Ewing's sarcoma family of tumors, Malignant lymphoma.
Busulfan is a chemotherapy drug used since 1959, classified as a cell cycle non-specific alkylating antineoplastic agent. It is being studied in clinical trials for various conditions, including Transfusion Dependent Beta-Thalassemia, Immunologic Deficiency Syndromes, and Graft Versus Host Disease, among others.
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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.
| 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 | Busilvex |
|---|---|
| Sponsor | medac GmbH |
| Target | Matrix metalloproteinase-9 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Approved indications
- Allogeneic bone marrow transplantation
- Autologous hematopoietic stem-cell transplantation for Ewing's sarcoma family of tumors
- Malignant lymphoma
- Neuroblastoma
- Philadelphia Chromosome Positive Chronic Myelocytic Leukemia
Common side effects
- Fever
- Headache
- Nausea
- Stomatitis
- Vomiting
- Anorexia
- Diarrhea
- Abdominal Pain
- Insomnia
- Anxiety
- Hypomagnesemia
- Hyperglycemia
Key clinical trials
- Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies (PHASE2)
- Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease (PHASE1, PHASE2)
- Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID) (PHASE1, PHASE2)
- Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency (PHASE2)
- Base Editing Hematopoietic Stem Cell and T Cell Gene Therapy for CD40L-HyperIgM Syndrome: Single Patient Study (PHASE1, PHASE2)
- Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists (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:
- Busilvex CI brief — competitive landscape report
- Busilvex updates RSS · CI watch RSS
- medac GmbH portfolio CI
Frequently asked questions about Busilvex
What is Busilvex?
What is Busilvex used for?
Who makes Busilvex?
What development phase is Busilvex in?
What are the side effects of Busilvex?
What does Busilvex target?
Related
- Target: All drugs targeting Matrix metalloproteinase-9
- Manufacturer: medac GmbH — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Allogeneic bone marrow transplantation
- Indication: Drugs for Autologous hematopoietic stem-cell transplantation for Ewing's sarcoma family of tumors
- Indication: Drugs for Malignant lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing