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Drug ReportsClofarabine
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.
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
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
CLOLARSanofiN-021673 RX2004-12-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
clofarabineNDA authorized generic2023-12-07
clolarNew Drug Application2023-11-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lymphoid leukemia—D007945C91
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BB: Purine analogs, antimetabolites antineoplastic
— L01BB06: Clofarabine
HCPCS
Code
Description
J9027
Injection, clofarabine, 1 mg
Clinical
Clinical Trials
178 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 acuteD015470—C92.022485—267
Myelodysplastic syndromesD009190—D4621322——46
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.016283—142
LeukemiaD007938—C9524283—142
Myeloid leukemiaD007951—C92111——3
Bone marrow transplantationD016026——1—1——2
Megakaryoblastic leukemia acuteD007947—C94.21—1——2
Monocytic leukemia acuteD007948——1—1——2
Myelomonocytic leukemia acuteD015479—C92.51—1——2
Erythroblastic leukemia acuteD004915EFO_1001257C94.01—1——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.9712———15
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—39———11
Myelomonocytic leukemia chronicD015477—C93.147———10
Hodgkin diseaseD006689—C8168———10
NeoplasmsD009369—C8073——19
LymphomaD008223—C85.977———9
B-cell chronic lymphocytic leukemiaD015451—C91.155———8
Multiple myelomaD009101—C90.036———7
Hematologic neoplasmsD019337——41——15
Burkitt lymphomaD002051—C83.724———4
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloproliferative disordersD009196—D47.12————2
Lymphoproliferative disordersD008232Orphanet_2442D47.91————1
Primary myelofibrosisD055728—D47.41————1
NeutropeniaD009503—D701————1
Bone marrow diseasesD001855——1————1
Rheumatoid arthritisD001172EFO_0000685M06.91————1
Crohn diseaseD003424EFO_0000384K501————1
Autoimmune diseasesD001327HP_0002960M30-M361————1
Systemic lupus erythematosusD008180HP_0002725M321————1
Takayasu arteritisD013625EFO_1001857M31.41————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Peroxisomal disordersD018901Orphanet_44E71.5————11
Lysosomal storage diseasesD016464——————11
Sickle cell anemiaD000755EFO_0000697D57————11
ThalassemiaD013789EFO_1001996D56————11
Fanconi anemiaD005199Orphanet_84D61.09————11
MelanomaD008545——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameClofarabine
INNclofarabine
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 classantineoplastics (arabinofuranosyl derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1nc(Cl)nc2c1ncn2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1F
Identifiers
PDB—
CAS-ID123318-82-1
RxCUI—
ChEMBL IDCHEMBL1750
ChEBI ID681569
PubChem CID119182
DrugBankDB00631
UNII ID762RDY0Y2H (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PDE8A
PDE8A
Organism
Homo sapiens
Gene name
PDE8A
Gene synonyms
NCBI Gene ID
Protein name
high affinity cAMP-specific and IBMX-insensitive 3',5'-cyclic phosphodiesterase 8A
Protein synonyms
cAMP-specific cyclic nucleotide phosphodiesterase 8A
Uniprot ID
Mouse ortholog
Pde8a (18584)
high affinity cAMP-specific and IBMX-insensitive 3',5'-cyclic phosphodiesterase 8A (Q059P6)
Variants
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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4,941 adverse events reported
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