Clofarabine - PharmaKB

Clolar, Evoltra(clofarabine)

Clofarabine, Clolar, Evoltra, Ivozall (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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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425
immune system diseases	D007154

Trade Name

FDA

EMA

Clofarabine, Clolar (discontinued: Clofarabine)

Drug Products

FDA

EMA

New Drug Application (NDA)

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	2024-02-27
clolar	New Drug Application	2023-11-15

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
lymphoid leukemia	—	D007945	C91

Agency Specific

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EMA

No data

Patent Expiration

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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

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	55	85	13	—	3	128
Myeloid leukemia acute	D015470	—	C92.0	25	57	7	—	2	80
Myeloid leukemia	D007951	—	C92	26	53	7	—	2	76
Myelodysplastic syndromes	D009190	—	D46	25	37	3	—	—	52
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	18	34	5	—	1	50
Preleukemia	D011289	—	—	21	32	2	—	—	42
Lymphoid leukemia	D007945	—	C91	18	21	4	—	1	39
Syndrome	D013577	—	—	12	24	1	—	—	30
Lymphoma	D008223	—	C85.9	16	23	1	—	—	28
Acute disease	D000208	—	—	1	2	2	—	1	5

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-hodgkin lymphoma	D008228	—	C85.9	8	15	—	—	—	18
Hematologic neoplasms	D019337	—	—	11	8	—	—	2	17
Neoplasms	D009369	—	C80	13	7	—	—	1	17
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	4	10	—	—	—	13
Myelomonocytic leukemia juvenile	D054429	—	C93.3	5	7	—	—	—	11
Hodgkin disease	D006689	—	C81	6	8	—	—	—	10
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	6	5	—	—	—	9
Myelomonocytic leukemia chronic	D015477	—	C93.1	4	6	—	—	—	9
Recurrence	D012008	—	—	2	4	—	—	1	7
Multiple myeloma	D009101	—	C90.0	3	6	—	—	—	7

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
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
Arteritis	D001167	EFO_0009011	I77.6	1	—	—	—	—	1
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	1	—	—	—	—	1
Crohn disease	D003424	EFO_0000384	K50	1	—	—	—	—	1
Autoimmune diseases	D001327	HP_0002960	M30-M36	1	—	—	—	—	1
Systemic lupus erythematosus	D008180	HP_0002725	M32	1	—	—	—	—	1
Takayasu arteritis	D013625	EFO_1001857	M31.4	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Frailty	D000073496	—	R53.1	—	—	—	—	1	1
Peroxisomal disorders	D018901	Orphanet_44	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
Inborn errors metabolism	D008661	—	—	—	—	—	—	1	1
Immunologic deficiency syndromes	D007153	HP_0002721	D84.9	—	—	—	—	1	1
Melanoma	D008545	—	—	—	—	—	—	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