Leustatin, Litak(cladribine)
Cladribine, Litak, Mavenclad (cladribine) is a small molecule pharmaceutical. Cladribine was first approved as Leustatin on 1993-02-26. It is used to treat b-cell chronic lymphocytic leukemia, hairy cell leukemia, multiple sclerosis, and non-hodgkin lymphoma in the USA. It has been approved in Europe to treat hairy cell leukemia and multiple sclerosis.
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Commercial
Trade Name
FDA
EMA
Cladribine, Mavenclad (discontinued: Cladribine, Leustatin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cladribine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MAVENCLAD | EMD Serono | N-022561 RX | 2019-03-29 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cladribine | ANDA | 2025-01-23 |
| mavenclad | New Drug Application | 2024-05-21 |
Indications
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EMA
Agency Specific
FDA
EMA
No data
ATC Codes
HCPCS
Code | Description |
|---|---|
| J9065 | Injection, cladribine, per 1 mg |
Clinical
Clinical Trials
207 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cladribine |
| INN | cladribine |
| Description | Cladribine is 2'-Deoxyadenosine in which the hydrogen at position 2 on the purine ring has been substituted by chlorine. It inhibits the synthesis and repair of DNA, particularly in lymphocytes and monocytes, and is used as an antimetabolite antineoplastic drug for the treatment of lymphoid malignancies including hairy-cell leukaemia and chronic lymphocytic leukaemia. It has a role as an antineoplastic agent and an immunosuppressive agent. It is a purine 2'-deoxyribonucleoside and an organochlorine compound. |
| Classification | Small molecule |
| Drug class | ribofuranil derivatives (pyrazofurin type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc(Cl)nc2c1ncn2[C@H]1C[C@H](O)[C@@H](CO)O1 |
Identifiers
| PDB | — |
| CAS-ID | 4291-63-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1619 |
| ChEBI ID | 567361 |
| PubChem CID | 20279 |
| DrugBank | DB00242 |
| UNII ID | 47M74X9YT5 (ChemIDplus, GSRS) |
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PubMed Central
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Additional graphs summarizing 6,029 documents
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Safety
Black-box Warning
Black-box warning for: Cladribine, Mavenclad
Adverse Events
Top Adverse Reactions
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7,158 adverse events reported
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