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 |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cladribine | ANDA | 2024-10-10 |
| mavenclad | New Drug Application | 2024-05-21 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J9065 | Injection, cladribine, per 1 mg |
Clinical
Clinical Trials
199 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 30 | 65 | 12 | 1 | 8 | 97 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 3 | 8 | 10 | 19 | 40 |
| Sclerosis | D012598 | — | — | 2 | 3 | 8 | 9 | 16 | 36 |
| Lymphoma | D008223 | — | C85.9 | 5 | 10 | 3 | 1 | 3 | 22 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 6 | 2 | 1 | 4 | 14 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 2 | 4 | 1 | 2 | 5 | 13 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | — | 4 | 3 | 5 | 12 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 23 | 46 | 10 | — | 6 | 71 |
| Myeloid leukemia | D007951 | — | C92 | 21 | 40 | 8 | — | 6 | 62 |
| Myelodysplastic syndromes | D009190 | — | D46 | 12 | 22 | 2 | — | 2 | 30 |
| Preleukemia | D011289 | — | — | 11 | 18 | 2 | — | — | 23 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 4 | 1 | — | 2 | 9 |
| Hairy cell leukemia | D007943 | — | C91.4 | — | 7 | 2 | — | — | 8 |
| Mantle-cell lymphoma | D020522 | — | — | 2 | 3 | 1 | — | 1 | 7 |
| Acute disease | D000208 | — | — | 3 | 1 | 1 | — | 1 | 6 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | 2 | 3 | — | — | 3 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | 1 | 2 | — | — | 3 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 8 | 13 | — | — | 1 | 16 |
| Neoplasms | D009369 | — | C80 | 5 | 9 | — | — | — | 12 |
| Recurrence | D012008 | — | — | 5 | 6 | — | — | 1 | 9 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | 5 | — | — | 2 | 8 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 3 | 5 | — | — | — | 7 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 3 | 5 | — | — | — | 7 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 2 | 4 | — | — | 1 | 6 |
| Eyelid neoplasms | D005142 | EFO_1000934 | — | 2 | 3 | — | — | — | 5 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 4 | 4 | — | — | — | 5 |
| Blast crisis | D001752 | — | — | 1 | 4 | — | — | — | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | 2 | 3 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Nervous system neoplasms | D009423 | — | — | 1 | — | — | — | — | 1 |
| Precancerous conditions | D011230 | — | — | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | — | — | — | — | 1 |
| Plasmacytoma | D010954 | — | C90.3 | 1 | — | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aplastic anemia | D000741 | HP_0001915 | D61.9 | — | — | — | — | 2 | 2 |
| Paroxysmal hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | — | — | — | 2 | 2 |
| Hemoglobinuria | D006456 | — | R82.3 | — | — | — | — | 2 | 2 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 2 | 2 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 2 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | — | — | — | 1 | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | — | — | 1 | 1 |
| Sarcoma | D012509 | — | — | — | — | — | — | 1 | 1 |
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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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Safety
Black-box Warning
Black-box warning for: Cladribine, Mavenclad
Adverse Events
Top Adverse Reactions
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6,537 adverse events reported
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