Clolar, Evoltra(clofarabine)
Clolar, Evoltra (clofarabine) is a small molecule pharmaceutical. Clofarabine was first approved as Clolar on 2004-12-28. It is used to treat lymphoid leukemia in the USA. It has been approved in Europe to treat precursor cell lymphoblastic leukemia-lymphoma. The pharmaceutical is active against ribonucleoside-diphosphate reductase subunit M2. In addition, it is known to target ribonucleoside-diphosphate reductase large subunit and high affinity cAMP-specific and IBMX-insensitive 3',5'-cyclic phosphodiesterase 8A.
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Drugs Approved for Childhood Cancers
Commercial
Trade Name
FDA
EMA
Clolar (generic drugs available since 2017-05-09)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clofarabine
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
CLOLAR | Sanofi | N-021673 RX | 2004-12-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
clofarabine | ANDA | 2023-02-15 |
clolar | New Drug Application | 2020-10-15 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
J9027 | Injection, clofarabine, 1 mg |
Clinical
Clinical Trials
163 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 |
---|---|---|---|---|---|---|---|---|---|
Myeloid leukemia acute | D015470 | C92.0 | 21 | 46 | 4 | — | 1 | 63 | |
Myelodysplastic syndromes | D009190 | D46 | 20 | 31 | 2 | — | — | 45 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 16 | 28 | 3 | — | — | 41 | |
Leukemia | D007938 | C95 | 22 | 26 | 3 | — | — | 39 | |
Myeloid leukemia | D007951 | C92 | 1 | 1 | 1 | — | — | 3 | |
Megakaryoblastic leukemia acute | D007947 | C94.2 | 1 | — | 1 | — | — | 2 | |
Monocytic leukemia acute | D007948 | 1 | — | 1 | — | — | 2 | ||
Myelomonocytic leukemia acute | D015479 | C92.5 | 1 | — | 1 | — | — | 2 | |
Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | 1 | — | 1 | — | — | 2 |
Stem cell transplantation | D033581 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Non-hodgkin lymphoma | D008228 | C85.9 | 7 | 12 | — | — | — | 15 | |
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 2 | 8 | — | — | — | 10 | |
Myelomonocytic leukemia chronic | D015477 | C93.1 | 4 | 7 | — | — | — | 10 | |
Hodgkin disease | D006689 | C81 | 5 | 7 | — | — | — | 9 | |
Neoplasms | D009369 | C80 | 6 | 2 | — | — | 1 | 8 | |
B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 5 | 5 | — | — | — | 8 | |
Lymphoma | D008223 | C85.9 | 5 | 5 | — | — | — | 7 | |
Multiple myeloma | D009101 | C90.0 | 2 | 5 | — | — | — | 6 | |
Hematologic neoplasms | D019337 | 4 | 1 | — | — | 1 | 5 | ||
Burkitt lymphoma | D002051 | C83.7 | 2 | 4 | — | — | — | 4 |
Show 37 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Myeloproliferative disorders | D009196 | D47.1 | 2 | — | — | — | — | 2 | |
Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | — | — | — | — | 1 |
Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
Neutropenia | D009503 | D70 | 1 | — | — | — | — | 1 | |
Bone marrow diseases | D001855 | 1 | — | — | — | — | 1 | ||
Bone marrow transplantation | D016026 | 1 | — | — | — | — | 1 | ||
Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | — | — | — | 1 |
Crohn disease | D003424 | EFO_0000384 | K50 | 1 | — | — | — | — | 1 |
Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 1 | — | — | — | — | 1 |
Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Peroxisomal disorders | D018901 | EFO_0010956 | E71.5 | — | — | — | — | 1 | 1 |
Lysosomal storage diseases | D016464 | — | — | — | — | 1 | 1 | ||
Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 1 | 1 |
Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 1 | 1 |
Fanconi anemia | D005199 | Orphanet_84 | D61.09 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | CLOFARABINE |
INN | clofarabine |
Description | Clofarabine is a purine nucleoside analogue consisting of a 6-amino-2-chloropurin-9-yl group attached to the 1beta position of 2'-deoxy-2'-fluoro-D-arabinofuranose. It is metabolized intracellularly to the active 5'-triphosphate metabolite, which inhibits DNA synthesisis and so stops the growth of cancer cells. Clofarabine is used as an antimetabolite antineoplastic agent in the treatment of relapsed or refractory acute lymphoblastic leukaemia. It has a role as an antineoplastic agent and an antimetabolite. It is an organofluorine compound and a member of adenosines. |
Classification | Small molecule |
Drug class | antineoplastics (arabinofuranosyl derivatives) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Nc1nc(Cl)nc2c1ncn2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1F |
Identifiers
PDB | 7CWA |
CAS-ID | 123318-82-1 |
RxCUI | 44151 |
ChEMBL ID | CHEMBL1750 |
ChEBI ID | 681569 |
PubChem CID | 119182 |
DrugBank | DB00631 |
UNII ID | 762RDY0Y2H (ChemIDplus, GSRS) |
Target
Agency Approved
RRM2
RRM2
Organism
Homo sapiens
Gene name
RRM2
Gene synonyms
RR2
NCBI Gene ID
Protein name
ribonucleoside-diphosphate reductase subunit M2
Protein synonyms
ribonucleotide reductase M2 polypeptide, Ribonucleotide reductase small chain, Ribonucleotide reductase small subunit, uncharacterized protein C2orf48
Uniprot ID
Mouse ortholog
Rrm2 (20135)
ribonucleoside-diphosphate reductase subunit M2 (Q542E2)
Alternate
RRM1
RRM1
PDE8A
PDE8A
Organism
Homo sapiens
Gene name
RRM1
Gene synonyms
RR1
NCBI Gene ID
Protein name
ribonucleoside-diphosphate reductase large subunit
Protein synonyms
Ribonucleoside-diphosphate reductase subunit M1, Ribonucleotide reductase large subunit, ribonucleotide reductase M1 polypeptide, ribonucleotide reductase, R1 subunit
Uniprot ID
Mouse ortholog
Rrm1 (20133)
ribonucleoside-diphosphate reductase large subunit (Q91YM8)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,006 adverse events reported
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