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Mustargen, Ledaga(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 Application2021-03-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hodgkin disease—D006689C81
malignant pleural effusion—D016066J91.0
mycosis fungoides—D009182C84.0
neoplasm metastasisEFO_0009708D009362—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
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
38 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.9—44——8
Neonatal sepsisD000071074HP_0040187——1——1
Infant mortalityD007226——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mycosis fungoidesD009182C84.0—5——27
T-cell lymphoma cutaneousD016410C84.A—2——13
Healthy volunteers/patients—11——23
Non-hodgkin lymphomaD008228C85.912——13
Hodgkin diseaseD006689C81—2———2
Cerebral hemorrhageD002543—1———1
Chronic renal insufficiencyD051436N1811———1
Myelodysplastic syndromesD009190D46—1———1
Myeloid leukemia acuteD015470C92.0—1———1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0—1———1
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Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E11————22
Glucose metabolism disordersD044882————11
Anorexia nervosaD000856EFO_0004215F50.0————11
Chronic periodontitisD055113EFO_0006343K05.3————11
Follicular lymphomaD008224C82————11
Large-cell lymphoma anaplasticD017728C84.6————11
Lymphomatoid papulosisD017731C86.6————11
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—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN(CCCl)CCCl
Identifiers
PDB—
CAS-ID51-75-2
RxCUI6674
ChEMBL IDCHEMBL427
ChEBI ID28925
PubChem CID4033
DrugBankDB00888
UNII ID50D9XSG0VR (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:
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Additional graphs summarizing 1,894 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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249 adverse events reported
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