Fludarabine - PharmaKB

Fludarabine phosphate

Fludarabine (fludarabine phosphate) is a small molecule pharmaceutical. Fludarabine phosphate was first approved as Fludara on 1991-04-18. It is used to treat b-cell chronic lymphocytic leukemia and non-hodgkin lymphoma in the USA.

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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Fludarabine (discontinued: Fludara, Fludarabine, Oforta)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Fludarabine phosphate

Tradename	Company	Number	Date	Products
FLUDARA	Sanofi	N-020038 DISCN	1991-04-18	1 products, RLD
FLUDARABINE PHOSPHATE	Sandoz	N-022137 DISCN	2007-09-21	1 products, RLD
OFORTA	Sanofi	N-022273 DISCN	2008-12-18	1 products

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FDA

EMA

Brand Name	Status	Last Update
fludarabine	ANDA	2024-10-14
fludarabine phosphate	ANDA	2026-09-20

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
non-hodgkin lymphoma	—	D008228	C85.9
b-cell chronic lymphocytic leukemia	—	D015451	C91.1

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

— L01BB05: Fludarabine

HCPCS

Code	Description
J8562	Fludarabine phosphate, oral, 10 mg
J9185	Injection, fludarabine phosphate, 50 mg

Clinical

Clinical Trials

2635 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	292	406	72	13	50	701
Myeloid leukemia acute	D015470	—	C92.0	208	292	59	6	32	510
Lymphoma	D008223	—	C85.9	227	245	22	3	36	449
Myelodysplastic syndromes	D009190	—	D46	134	276	27	2	31	411
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	186	214	18	5	28	381
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	122	193	37	3	19	326
Non-hodgkin lymphoma	D008228	—	C85.9	164	171	14	1	23	310
Multiple myeloma	D009101	—	C90.0	139	147	13	1	28	291
Lymphoid leukemia	D007945	—	C91	113	135	28	7	14	251
Myeloid leukemia	D007951	—	C92	89	140	32	3	14	234

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	174	108	4	—	15	249
Hodgkin disease	D006689	—	C81	54	97	3	—	16	148
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	33	115	6	—	11	146
Follicular lymphoma	D008224	—	C82	50	69	14	—	8	126
Mantle-cell lymphoma	D020522	—	C83.1	49	68	9	—	9	118
Melanoma	D008545	—	—	61	68	1	—	2	110
Burkitt lymphoma	D002051	—	C83.7	33	41	3	—	8	77
Myelomonocytic leukemia chronic	D015477	—	C93.1	26	47	2	—	8	71
Anemia	D000740	EFO_0004272	D64.9	22	49	9	—	10	71
Aplastic anemia	D000741	—	D61.9	12	48	6	—	17	71

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ovarian neoplasms	D010051	EFO_0003893	C56	54	30	—	—	—	65
Systemic lupus erythematosus	D008180	EFO_0002690	M32	50	13	—	—	4	57
T-cell lymphoma	D016399	—	—	26	33	—	—	3	52
Breast neoplasms	D001943	EFO_0003869	C50	38	27	—	—	—	49
Carcinoma	D002277	—	C80.0	39	16	—	—	3	48
Renal cell carcinoma	D002292	EFO_0000376	—	31	21	—	—	3	45
Myelomonocytic leukemia juvenile	D054429	—	C93.3	13	30	—	—	6	45
Myeloid leukemia accelerated phase	D015465	—	—	9	33	—	—	5	42
Non-small-cell lung carcinoma	D002289	—	—	34	16	—	—	—	41
Pancreatic neoplasms	D010190	EFO_0003860	C25	37	20	—	—	1	41

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Autoimmune diseases of the nervous system	D020274	—	—	7	—	—	—	—	7
Rhabdoid tumor	D018335	—	—	5	—	—	—	—	5
Iga glomerulonephritis	D005922	EFO_0004194	—	5	—	—	—	—	5
Female genital neoplasms	D005833	—	—	4	—	—	—	—	4
Medulloblastoma	D008527	—	—	3	—	—	—	—	3
Ependymoma	D004806	—	—	3	—	—	—	—	3
Wilms tumor	D009396	EFO_0000212	—	3	—	—	—	—	3
Cytokine release syndrome	D000080424	—	D89.83	3	—	—	—	—	3
Nervous system diseases	D009422	—	G00-G99	3	—	—	—	—	3
Alveolar soft part sarcoma	D018234	—	—	3	—	—	—	—	3

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Abnormal karyotype	D059786	—	—	—	—	—	—	1	1
Hemoglobin c disease	D006445	—	D58.2	—	—	—	—	1	1
Mucositis	D052016	EFO_1001898	—	—	—	—	—	1	1
Hereditary congenital and neonatal diseases and abnormalities	D009358	—	—	—	—	—	—	1	1
Monoclonal gammopathy of undetermined significance	D008998	EFO_1000836	D47.2	—	—	—	—	1	1
Primary graft dysfunction	D055031	—	—	—	—	—	—	1	1
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Fludarabine phosphate
INN	fludarabine
Description	(2R,3S,4S,5R)-2-(6-amino-2-fluoro-9-purinyl)-5-(hydroxymethyl)oxolane-3,4-diol is a purine nucleoside.
Classification	Small molecule
Drug class	antineoplastics (arabinofuranosyl derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Nc1nc(F)nc2c1ncn2[C@@H]1O[C@H](COP(=O)(O)O)[C@@H](O)[C@@H]1O