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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
therapeuticsD013812
operative surgical proceduresD013514
Trade Name
FDA
EMA
Busulfex, Myleran (generic drugs available since 2017-03-24)
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
BUSULFEXOtsukaN-020954 RX1999-02-04
1 products, RLD, RS
MYLERANWOODWARD SPECLN-009386 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
busulfexNew Drug Application2020-03-30
myleranNew Drug Application2023-05-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bcr-abl positive chronic myelogenous leukemiaEFO_0000340D015464—
polycythemia vera—D011087D45
primary myelofibrosis—D055728D47.4
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01A: Alkylating agents
— L01AB: Alkyl sulfonate alkylating agents
— L01AB01: Busulfan
HCPCS
Code
Description
J0594
injection, busulfan, 1 mg
J8510
Busulfan; oral, 2 mg
Clinical
Clinical Trials
498 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D462910515211144
LeukemiaD007938C95269717111132
LymphomaD008223C85.92261311187
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0114341659
Myeloproliferative disordersD009196D47.182221530
Myelomonocytic leukemia juvenileD054429C93.336—1—9
Beta-thalassemiaD017086Orphanet_848D56.113—217
Lymphoid leukemiaD007945C911——113
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.0246818—7103
Multiple myelomaD009101C90.012312—443
Plasma cell neoplasmsD0542195301—741
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003406281—334
Graft vs host diseaseD006086D89.814201—527
NeuroblastomaD009447EFO_0000621995—224
Myelodysplastic-myeloproliferative diseasesD0544373191—221
NeoplasmsD009369C80861—417
Sickle cell anemiaD000755EFO_0000697D572111—315
Myelomonocytic leukemia chronicD015477C93.13111——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 lymphomaD008228C85.9935——241
Hodgkin diseaseD006689C81821——328
B-cell chronic lymphocytic leukemiaD015451C91.1419——223
Hematologic neoplasmsD019337515——421
Primary myelofibrosisD055728D47.4510——317
Biphenotypic leukemia acuteD015456C95.039———10
Severe combined immunodeficiencyD016511D81.078——210
Extranodal nk-t-cell lymphomaD054391C86.017——19
Follicular lymphomaD008224C8217——19
Mantle-cell lymphomaD020522C83.117——19
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RetinoblastomaD0121755———27
Germ cell and embryonal neoplasmsD0093734———15
MelanomaD0085453———14
RhabdomyosarcomaD0122082———13
Wilms tumorD0093962———13
Neuroectodermal tumorsD0175991———12
MedulloblastomaD0085271———12
Liver neoplasmsD008113EFO_1001513C22.02————2
Hiv infectionsD015658EFO_0000764B202————2
Renal cell carcinomaD0022921————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 tumorsD018242————33
Hemophagocytic lymphohistiocytosisD051359D76.1————33
Chediak-higashi syndromeD002609Orphanet_167D72.0————33
Immunoglobulin light-chain amyloidosisD000075363————11
Hyper-igm immunodeficiency syndromeD053306Orphanet_101088D80.5————11
HepatoblastomaD018197C22.2————11
Retinal neoplasmsD019572C69.2————11
PhenylketonuriasD010661E70.0————11
Type 1 hyper-igm immunodeficiency syndromeD053307————11
Leukocyte-adhesion deficiency syndromeD018370EFO_1001359————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBUSULFAN
INNbusulfan
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 classantineoplastics, 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-ID55-98-1
RxCUI1828
ChEMBL IDCHEMBL820
ChEBI ID28901
PubChem CID2478
DrugBankDB01008
UNII IDG1LN9045DK (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 11,601 documents
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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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