Myleran, Busilvex(busulfan)
Busilvex, Busulfex, Myleran (busulfan) is a small molecule pharmaceutical. Busulfan was first approved as Myleran on 1982-01-01. It is used to treat BCR-ABL positive chronic myelogenous leukemia, polycythemia vera, and primary myelofibrosis in the USA. It has been approved in Europe to treat hematopoietic stem cell transplantation.
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Busulfex, Myleran (generic drugs available since 2017-03-24)
Drug Products
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Agency Specific
FDA
EMA
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Patent Expiration
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Clinical
Clinical Trials
498 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | 29 | 105 | 15 | 2 | 11 | 144 | |
| Leukemia | D007938 | C95 | 26 | 97 | 17 | 1 | 11 | 132 | |
| Lymphoma | D008223 | C85.9 | 22 | 61 | 3 | 1 | 11 | 87 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 11 | 43 | 4 | 1 | 6 | 59 | |
| Myeloproliferative disorders | D009196 | D47.1 | 8 | 22 | 2 | 1 | 5 | 30 | |
| Myelomonocytic leukemia juvenile | D054429 | C93.3 | 3 | 6 | — | 1 | — | 9 | |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | 1 | 3 | — | 2 | 1 | 7 |
| Lymphoid leukemia | D007945 | C91 | 1 | — | — | 1 | 1 | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 24 | 68 | 18 | — | 7 | 103 | |
| Multiple myeloma | D009101 | C90.0 | 12 | 31 | 2 | — | 4 | 43 | |
| Plasma cell neoplasms | D054219 | 5 | 30 | 1 | — | 7 | 41 | ||
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 6 | 28 | 1 | — | 3 | 34 | |
| Graft vs host disease | D006086 | D89.81 | 4 | 20 | 1 | — | 5 | 27 | |
| Neuroblastoma | D009447 | EFO_0000621 | 9 | 9 | 5 | — | 2 | 24 | |
| Myelodysplastic-myeloproliferative diseases | D054437 | 3 | 19 | 1 | — | 2 | 21 | ||
| Neoplasms | D009369 | C80 | 8 | 6 | 1 | — | 4 | 17 | |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | 11 | 1 | — | 3 | 15 |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 3 | 11 | 1 | — | — | 14 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | C85.9 | 9 | 35 | — | — | 2 | 41 | |
| Hodgkin disease | D006689 | C81 | 8 | 21 | — | — | 3 | 28 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 4 | 19 | — | — | 2 | 23 | |
| Hematologic neoplasms | D019337 | 5 | 15 | — | — | 4 | 21 | ||
| Primary myelofibrosis | D055728 | D47.4 | 5 | 10 | — | — | 3 | 17 | |
| Biphenotypic leukemia acute | D015456 | C95.0 | 3 | 9 | — | — | — | 10 | |
| Severe combined immunodeficiency | D016511 | D81.0 | 7 | 8 | — | — | 2 | 10 | |
| Extranodal nk-t-cell lymphoma | D054391 | C86.0 | 1 | 7 | — | — | 1 | 9 | |
| Follicular lymphoma | D008224 | C82 | 1 | 7 | — | — | 1 | 9 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 1 | 7 | — | — | 1 | 9 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinoblastoma | D012175 | 5 | — | — | — | 2 | 7 | ||
| Germ cell and embryonal neoplasms | D009373 | 4 | — | — | — | 1 | 5 | ||
| Melanoma | D008545 | 3 | — | — | — | 1 | 4 | ||
| Rhabdomyosarcoma | D012208 | 2 | — | — | — | 1 | 3 | ||
| Wilms tumor | D009396 | 2 | — | — | — | 1 | 3 | ||
| Neuroectodermal tumors | D017599 | 1 | — | — | — | 1 | 2 | ||
| Medulloblastoma | D008527 | 1 | — | — | — | 1 | 2 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | — | — | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | — | — | — | 2 |
| Renal cell carcinoma | D002292 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primitive neuroectodermal tumors | D018242 | — | — | — | — | 3 | 3 | ||
| Hemophagocytic lymphohistiocytosis | D051359 | D76.1 | — | — | — | — | 3 | 3 | |
| Chediak-higashi syndrome | D002609 | Orphanet_167 | D72.0 | — | — | — | — | 3 | 3 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | 1 | 1 | ||
| Hyper-igm immunodeficiency syndrome | D053306 | Orphanet_101088 | D80.5 | — | — | — | — | 1 | 1 |
| Hepatoblastoma | D018197 | C22.2 | — | — | — | — | 1 | 1 | |
| Retinal neoplasms | D019572 | C69.2 | — | — | — | — | 1 | 1 | |
| Phenylketonurias | D010661 | E70.0 | — | — | — | — | 1 | 1 | |
| Type 1 hyper-igm immunodeficiency syndrome | D053307 | — | — | — | — | 1 | 1 | ||
| Leukocyte-adhesion deficiency syndrome | D018370 | EFO_1001359 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | BUSULFAN |
| INN | busulfan |
| Description | Busulfan is a methanesulfonate ester that is butane-1,4-diol in which the hydrogens of the hydroxy groups are replaced by methanesulfonyl groups. An alkylating antineoplastic agent, it is used for the treatment of chronic myeloid leukemia (although it has been largely replaced by newer drugs). It is also used as an insect sterilant. It has a role as an insect sterilant, an antineoplastic agent, a teratogenic agent, a carcinogenic agent and an alkylating agent. It is functionally related to a butane-1,4-diol. |
| Classification | Small molecule |
| Drug class | antineoplastics, alkylating agents (methane sulfonate derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CS(=O)(=O)OCCCCOS(C)(=O)=O |
Identifiers
| PDB | — |
| CAS-ID | 55-98-1 |
| RxCUI | 1828 |
| ChEMBL ID | CHEMBL820 |
| ChEBI ID | 28901 |
| PubChem CID | 2478 |
| DrugBank | DB01008 |
| UNII ID | G1LN9045DK (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Busulfex, Myleran
Adverse Events
Top Adverse Reactions
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50,643 adverse events reported
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