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Drug ReportsMechlorethamine
Mechlorethamine
Ledaga, Valchlor (mechlorethamine) is a small molecule pharmaceutical. Mechlorethamine was first approved as Mustargen on 1982-01-01. It is used to treat hodgkin disease, malignant pleural effusion, mycosis fungoides, and neoplasm metastasis in the USA. It has been approved in Europe to treat mycosis fungoides.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Valchlor (discontinued: Mustargen)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mechlorethamine hydrochloride
Tradename
Company
Number
Date
Products
VALCHLORHelsinn Birex PharmaceuticalsN-202317 RX2013-08-23
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
valchlorNew Drug Application2024-05-17
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
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FDA Information
Mechlorethamine Hydrochloride, Valchlor, Helsinn
78720502029-07-08U-1427
78385642026-03-07DP
84503752026-03-07DP
85018182026-03-07DP
85018192026-03-07U-1427
93821912026-03-07DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01A: Alkylating agents
— L01AA: Nitrogen mustard analogues
— L01AA05: Chlormethine
HCPCS
Code
Description
J9230
Injection, mechlorethamine hydrochloride, (nitrogen mustard), 10 mg
Clinical
Clinical Trials
312 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.92845102680
Non-hodgkin lymphomaD008228—C85.9152521438
B-cell lymphomaD016393——131121426
Large b-cell lymphoma diffuseD016403—C83.3111021425
T-cell lymphomaD016399——47—1414
Germ cell and embryonal neoplasmsD009373——58—1—13
T-cell lymphoma peripheralD016411——13—149
Burkitt lymphomaD002051—C83.722—137
Aplastic anemiaD000741HP_0001915D61.913—116
BronchiolitisD001988HP_0011950——141—5
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101—C90.018324—247
LeukemiaD007938—C9515245—444
Plasma cell neoplasmsD054219——17274—140
RecurrenceD012008——20221—538
Hodgkin diseaseD006689—C8111233—334
SarcomaD012509——71210—632
NeoplasmsD009369—C8013172—231
Precursor cell lymphoblastic leukemia-lymphomaD054198——12134—330
Myeloid leukemia acuteD015470—C92.012122—226
Myeloid leukemiaD007951—C9211121—224
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelomonocytic leukemia juvenileD054429—C93.3212——115
MycosesD009181—B35-B4918——615
Mycosis fungoidesD009182—C84.018——615
Mantle-cell lymphomaD020522——78——314
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—410——113
Myeloproliferative disordersD009196—D47.166——113
B-cell chronic lymphocytic leukemiaD015451—C91.157——313
Follicular lymphomaD008224—C8247——412
Myelomonocytic leukemia chronicD015477—C93.128——111
Primary myelofibrosisD055728—D47.446——111
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rhabdoid tumorD018335——3————3
EpendymomaD004806——2————2
Barrett esophagusD001471EFO_0000280K22.72————2
Triple negative breast neoplasmsD064726——2————2
Choroid plexus neoplasmsD016545EFO_0007206—1————1
PhenylketonuriasD010661—E70.01————1
Renal insufficiencyD051437HP_0000083N191————1
HypersensitivityD006967HP_0012393T78.401————1
Neuroendocrine carcinomaD018278——1————1
Papillary thyroid cancerD000077273——1————1
Show 28 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E11————44
Diabetes mellitusD003920HP_0000819E08-E13————33
Drug-related side effects and adverse reactionsD064420—T88.7————22
DysmenorrheaD004412HP_0100607N94.6————22
Intraocular lymphomaD064090——————22
Blood circulationD001775——————22
NauseaD009325HP_0002018R11.0————11
Glucose metabolism disordersD044882——————11
Metabolic diseasesD008659EFO_0000589E88.9————11
HypertensionD006973EFO_0000537I10————11
Show 44 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMechlorethamine
INNchlormethine
Description
Mechlorethamine is a nitrogen mustard and an organochlorine compound. It has a role as an alkylating agent.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
CN(CCCl)CCCl
Identifiers
PDB—
CAS-ID51-75-2
RxCUI—
ChEMBL IDCHEMBL427
ChEBI ID28925
PubChem CID4033
DrugBankDB00888
UNII ID50D9XSG0VR (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 2,120 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,699 adverse events reported
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