Myleran, Busilvex(busulfan)
Busulfan, 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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Commercial
Trade Name
FDA
EMA
Busulfan, Busulfex, Myleran (discontinued: Busulfan)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Busulfan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BUSULFEX | Otsuka | N-020954 RX | 1999-02-04 | 1 products, RLD, RS |
| MYLERAN | Waylis Therapeutics | N-009386 RX | 1982-01-01 | 1 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| polycythemia vera | — | D011087 | D45 |
| primary myelofibrosis | — | D055728 | D47.4 |
| bcr-abl positive chronic myelogenous leukemia | EFO_0000340 | D015464 | — |
Agency Specific
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Clinical
Clinical Trials
738 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 64 | 223 | 51 | 6 | 40 | 332 |
| Myelodysplastic syndromes | D009190 | — | D46 | 34 | 138 | 23 | 2 | 20 | 195 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 29 | 108 | 35 | 1 | 23 | 172 |
| Myeloid leukemia | D007951 | — | C92 | 30 | 112 | 31 | 1 | 22 | 170 |
| Lymphoma | D008223 | — | C85.9 | 35 | 121 | 8 | 2 | 16 | 162 |
| Preleukemia | D011289 | — | — | 26 | 108 | 15 | 1 | 13 | 147 |
| Multiple myeloma | D009101 | — | C90.0 | 21 | 72 | 4 | 1 | 13 | 101 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 17 | 59 | 8 | 2 | 13 | 88 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 11 | 61 | 4 | 1 | 11 | 78 |
| Lymphoid leukemia | D007945 | — | C91 | 10 | 37 | 4 | 2 | 7 | 53 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 24 | 94 | 16 | — | 15 | 131 |
| Neoplasms | D009369 | — | C80 | 24 | 52 | 2 | — | 14 | 82 |
| Hematologic neoplasms | D019337 | — | — | 21 | 55 | 3 | — | 12 | 75 |
| Plasma cell neoplasms | D054219 | — | — | 12 | 52 | 4 | — | 7 | 68 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 10 | 48 | 7 | — | 8 | 64 |
| Plasmacytoma | D010954 | — | C90.3 | 5 | 32 | 1 | — | 7 | 43 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 5 | 34 | 3 | — | 3 | 40 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 18 | 30 | 2 | — | 3 | 37 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 13 | 23 | 6 | — | 4 | 35 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 4 | 14 | 6 | — | 7 | 27 |
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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 | 10 | 51 | — | — | 4 | 60 |
| Hodgkin disease | D006689 | — | C81 | 9 | 29 | — | — | 5 | 38 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 5 | 28 | — | — | 4 | 35 |
| Primary myelofibrosis | D055728 | — | D47.4 | 5 | 15 | — | — | 4 | 23 |
| Chronic granulomatous disease | D006105 | EFO_0000338 | D71 | 10 | 9 | — | — | 2 | 14 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 3 | 11 | — | — | — | 12 |
| Mantle-cell lymphoma | D020522 | — | — | 1 | 10 | — | — | 1 | 12 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | 3 | 9 | — | — | 1 | 12 |
| Burkitt lymphoma | D002051 | — | C83.7 | 1 | 9 | — | — | 2 | 12 |
| Follicular lymphoma | D008224 | — | C82 | 1 | 9 | — | — | 1 | 11 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinoblastoma | D012175 | — | — | 4 | — | — | — | 2 | 6 |
| Primitive neuroectodermal tumors | D018242 | — | — | 2 | — | — | — | 3 | 5 |
| Neuroectodermal tumors | D017599 | — | — | 2 | — | — | — | 3 | 5 |
| Primitive neuroectodermal tumors peripheral | D018241 | — | — | 2 | — | — | — | 2 | 4 |
| Melanoma | D008545 | — | — | 3 | — | — | — | 1 | 4 |
| Rhabdomyosarcoma | D012208 | — | — | 3 | — | — | — | 1 | 4 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | — | — | — | 1 | 3 |
| Wilms tumor | D009396 | EFO_0000212 | — | 2 | — | — | — | 1 | 3 |
| Rhabdoid tumor | D018335 | — | — | 1 | — | — | — | 1 | 2 |
| Testicular neoplasms | D013736 | — | C62 | 1 | — | — | — | 1 | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 hyper-igm immunodeficiency syndrome | D053307 | — | — | — | — | — | — | 2 | 2 |
| Hyper-igm immunodeficiency syndrome | D053306 | Orphanet_101088 | D80.5 | — | — | — | — | 2 | 2 |
| Mucositis | D052016 | EFO_1001898 | — | — | — | — | — | 2 | 2 |
| Hepatoblastoma | D018197 | — | C22.2 | — | — | — | — | 1 | 1 |
| Retinal neoplasms | D019572 | — | C69.2 | — | — | — | — | 1 | 1 |
| Phenylketonurias | D010661 | — | E70.0 | — | — | — | — | 1 | 1 |
| Agammaglobulinemia | D000361 | HP_0004313 | D80.1 | — | — | — | — | 1 | 1 |
| Leukocyte-adhesion deficiency syndrome | D018370 | EFO_1001359 | — | — | — | — | — | 1 | 1 |
| Hereditary congenital and neonatal diseases and abnormalities | D009358 | — | — | — | — | — | — | 1 | 1 |
| Thrombasthenia | D013915 | — | D69.1 | — | — | — | — | 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 | — |
| ChEMBL ID | CHEMBL820 |
| ChEBI ID | 28901 |
| PubChem CID | 2478 |
| DrugBank | DB01008 |
| UNII ID | G1LN9045DK (ChemIDplus, GSRS) |
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Trends
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Safety
Black-box Warning
Black-box warning for: Busulfan, Busulfex, Myleran
Adverse Events
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13,676 adverse events reported
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