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Drug ReportsBusulfan
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
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
therapeuticsD013812
operative surgical proceduresD013514
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
BUSULFEXOtsukaN-020954 RX1999-02-04
1 products, RLD, RS
MYLERANWaylis TherapeuticsN-009386 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
busulfanANDA2024-06-27
busulfexNew Drug Application2023-12-14
myleranNew Drug Application2025-01-08
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
759 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C955019342538284
Myelodysplastic syndromesD009190—D463714123221199
Myeloid leukemia acuteD015470—C92.03512334129195
LymphomaD008223—C85.9311128218152
Myeloid leukemiaD007951—C92177924119121
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.019697219105
Multiple myelomaD009101—C90.021734114103
Myeloproliferative disordersD009196—D47.11062411279
Hematologic neoplasmsD019337——1749311270
Plasma cell neoplasmsD054219——135141768
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PreleukemiaD011289——16769—1099
SyndromeD013577——136511—1288
NeoplasmsD009369—C8020413—1571
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—12516—968
Myelodysplastic-myeloproliferative diseasesD054437——5332—439
Sickle cell anemiaD000755EFO_0000697D5713246—436
Myelomonocytic leukemia chronicD015477—C93.16223—432
Large b-cell lymphoma diffuseD016403—C83.36203—531
PlasmacytomaD010954—C90.32231—429
Hematologic diseasesD006402EFO_0005803D75.96156—629
Show 71 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.91358——872
Hodgkin diseaseD006689—C811337——952
B-cell chronic lymphocytic leukemiaD015451—C91.1937——850
Primary myelofibrosisD055728—D47.4723——634
Mantle-cell lymphomaD020522—C83.1415——523
Follicular lymphomaD008224—C82414——522
Myeloid leukemia accelerated phaseD015465——417——322
Burkitt lymphomaD002051—C83.7314——622
B-cell lymphoma marginal zoneD018442—C88.4412——520
Congenital abnormalitiesD000013EFO_0003915Q89.9413——419
Show 121 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RetinoblastomaD012175——4———26
Neuroectodermal tumorsD017599——2———35
Primitive neuroectodermal tumorsD018242——1———34
Renal cell carcinomaD002292EFO_0000376—3———14
MelanomaD008545——3———14
RhabdomyosarcomaD012208——3———14
Wilms tumorD009396EFO_0000212—3———14
Testicular neoplasmsD013736—C621———23
Liver neoplasmsD008113EFO_1001513C22.03————3
Rhabdoid tumorD018335——2———13
Show 29 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 1 hyper-igm immunodeficiency syndromeD053307——————22
Hyper-igm immunodeficiency syndromeD053306Orphanet_101088D80.5————22
MucositisD052016EFO_1001898—————22
Ovarian epithelial carcinomaD000077216——————11
Retinal neoplasmsD019572—C69.2————11
PhenylketonuriasD010661—E70.0————11
AgammaglobulinemiaD000361—D80.1————11
Leukocyte-adhesion deficiency syndromeD018370EFO_1001359—————11
Hereditary congenital and neonatal diseases and abnormalitiesD009358——————11
Monoclonal gammopathy of undetermined significanceD008998EFO_1000836D47.2————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)
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Structure (InChI/SMILES or Protein Sequence)
CS(=O)(=O)OCCCCOS(C)(=O)=O
Identifiers
PDB—
CAS-ID55-98-1
RxCUI—
ChEMBL IDCHEMBL820
ChEBI ID28901
PubChem CID2478
DrugBankDB01008
UNII IDG1LN9045DK (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,725 documents
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Safety
Black-box Warning
Black-box warning for: Busulfan, Busulfex, Myleran
Adverse Events
Top Adverse Reactions
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15,614 adverse events reported
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