Leustatin, Litak(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
Mavenclad (generic drugs available since 2000-02-28, discontinued: 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 |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cladribine | ANDA | 2023-04-19 |
| mavenclad | New Drug Application | 2019-04-10 |
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J9065 | Injection, cladribine, per 1 mg |
Clinical
Clinical Trials
107 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 2 | 4 | 7 | 5 | 19 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | 3 | 1 | 2 | 1 | 7 | |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 3 | 1 | — | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 14 | 23 | 4 | — | 1 | 35 | |
| Leukemia | D007938 | C95 | 3 | 7 | 1 | — | — | 11 | |
| Hairy cell leukemia | D007943 | C91.4 | — | 4 | 1 | — | — | 4 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | 3 | 1 | — | — | 4 | |
| Langerhans-cell histiocytosis | D006646 | C96.6 | — | 2 | 1 | — | — | 2 | |
| Systemic mastocytosis | D034721 | C96.21 | — | 1 | 1 | — | — | 1 | |
| Myeloid leukemia | D007951 | C92 | — | 1 | 1 | — | — | 1 | |
| T-cell lymphoma peripheral | D016411 | C84.9 | — | — | 1 | — | — | 1 | |
| Monocytic leukemia acute | D007948 | — | 1 | 1 | — | — | 1 | ||
| T-cell lymphoma | D016399 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | 5 | 9 | — | — | — | 11 | |
| Lymphoma | D008223 | C85.9 | 3 | 4 | — | — | — | 7 | |
| Eyelid neoplasms | D005142 | EFO_1000934 | 2 | 3 | — | — | — | 5 | |
| Biphenotypic leukemia acute | D015456 | C95.0 | 4 | 4 | — | — | — | 5 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | 2 | — | — | — | 3 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 1 | 1 | — | — | — | 2 | |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | 1 | — | — | 1 | 2 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | — | 2 | — | — | — | 2 | |
| Graft vs host disease | D006086 | D89.81 | 1 | 1 | — | — | — | 2 | |
| Hodgkin disease | D006689 | C81 | — | 1 | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 1 | 1 |
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 | 44157 |
| ChEMBL ID | CHEMBL1619 |
| ChEBI ID | 567361 |
| PubChem CID | 20279 |
| DrugBank | DB00242 |
| UNII ID | 47M74X9YT5 (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 4,656 documents
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Safety
Black-box Warning
Black-box warning for: Mavenclad
Adverse Events
Top Adverse Reactions
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45,148 adverse events reported
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