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
FDA
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Clinical
Clinical Trials
753 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 3 | 6 | 1 | — | — | 8 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 5 | 1 | — | — | 7 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 2 | 6 | — | — | — | 6 |
| Leukemia | D007938 | — | C95 | 2 | 4 | — | — | — | 4 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 2 | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 2 | — | — | — | 2 |
| Preleukemia | D011289 | — | — | 2 | 2 | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | 1 | — | — | — | 1 |
| Plasmacytoma | D010954 | — | C90.3 | 1 | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 1 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | — | 1 | — | — | — | 1 |
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Indications Phases 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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Safety
Black-box Warning
Black-box warning for: Busulfan, Busulfex, Myleran
Adverse Events
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14,782 adverse events reported
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