Chlorambucil
Leukeran (chlorambucil) is a small molecule pharmaceutical. Chlorambucil was first approved as Leukeran on 1982-01-01. It is used to treat b-cell chronic lymphocytic leukemia, breast neoplasms, choriocarcinoma, hodgkin disease, and non-hodgkin lymphoma amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Leukeran
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Chlorambucil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LEUKERAN | Waylis Therapeutics | N-010669 RX | 1982-01-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| leukeran | New Drug Application | 2023-05-15 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| S0172 | Chlorambucil, oral, 2 mg |
Clinical
Clinical Trials
64 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 5 | 10 | 22 | 2 | 5 | 42 |
| Leukemia | D007938 | — | C95 | 5 | 10 | 21 | 2 | 4 | 40 |
| Lymphoid leukemia | D007945 | — | C91 | 5 | 10 | 21 | 2 | 3 | 39 |
| Uveitis | D014605 | HP_0000554 | H20.9 | — | — | — | 1 | 1 | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 1 | 4 | 12 | — | 2 | 19 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 2 | 1 | — | — | 4 |
| Mantle-cell lymphoma | D020522 | — | — | 1 | 2 | 1 | — | — | 4 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 1 | 2 | — | — | 3 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | 1 | — | — | 2 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | — | — | 2 | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
| Glomerulonephritis | D005921 | HP_0000099 | N05 | — | — | 1 | — | — | 1 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic neoplasms | D014571 | — | C64-C68 | — | 1 | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | — | 1 | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | — | 1 | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Chlorambucil |
| INN | chlorambucil |
| Description | Chlorambucil is a monocarboxylic acid that is butanoic acid substituted at position 4 by a 4-[bis(2-chloroethyl)amino]phenyl group. A chemotherapy drug that can be used in combination with the antibody obinutuzumab for the treatment of chronic lymphocytic leukemia. It has a role as an alkylating agent, a carcinogenic agent, an antineoplastic agent, an immunosuppressive agent and a drug allergen. It is a nitrogen mustard, an organochlorine compound, an aromatic amine, a tertiary amino compound and a monocarboxylic acid. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)CCCc1ccc(N(CCCl)CCCl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 305-03-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL515 |
| ChEBI ID | 28830 |
| PubChem CID | 2708 |
| DrugBank | DB00291 |
| UNII ID | 18D0SL7309 (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Chlorambucil
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PubMed Central
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Additional graphs summarizing 9,262 documents
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Safety
Black-box Warning
Black-box warning for: Leukeran
Adverse Events
Top Adverse Reactions
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3,553 adverse events reported
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