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	unapproved drug for use in drug shortage	2023-07-25

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

2269 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	398	538	99	16	58	938
Lymphoma	D008223	—	C85.9	272	308	36	2	38	563
Myeloid leukemia acute	D015470	—	C92.0	175	243	57	6	26	436
Myeloid leukemia	D007951	—	C92	162	238	46	5	24	405
Lymphoid leukemia	D007945	—	C91	176	213	43	7	20	390
Myelodysplastic syndromes	D009190	—	D46	123	256	25	2	29	382
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	172	187	20	5	23	345
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	117	178	36	3	15	303
Non-hodgkin lymphoma	D008228	—	C85.9	153	160	16	1	21	293
Preleukemia	D011289	—	—	91	178	14	2	19	266

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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	185	143	5	—	16	294
B-cell lymphoma	D016393	—	—	131	79	5	—	11	192
Hematologic neoplasms	D019337	—	—	78	116	3	—	19	185
Plasma cell neoplasms	D054219	—	—	92	76	9	—	15	172
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	31	108	7	—	11	139
Hodgkin disease	D006689	—	C81	44	80	3	—	13	122
Melanoma	D008545	—	—	54	63	2	—	2	103
Large b-cell lymphoma diffuse	D016403	—	C83.3	58	49	4	—	5	100
Follicular lymphoma	D008224	—	C82	38	55	12	—	5	99
Mantle-cell lymphoma	D020522	—	C83.1	41	53	9	—	6	93

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	58	26	—	—	4	71
Ovarian neoplasms	D010051	EFO_0003893	C56	45	22	—	—	—	55
T-cell lymphoma	D016399	—	—	25	32	—	—	5	55
Plasmacytoma	D010954	—	C90.3	14	30	—	—	9	49
Breast neoplasms	D001943	EFO_0003869	C50	34	25	—	—	—	46
Renal cell carcinoma	D002292	EFO_0000376	—	28	22	—	—	3	42
Hematologic diseases	D006402	EFO_0005803	D75.9	10	21	—	—	9	37
Precursor t-cell lymphoblastic leukemia-lymphoma	D054218	—	—	34	15	—	—	—	37
Non-small-cell lung carcinoma	D002289	—	—	28	15	—	—	—	35
T-cell lymphoma peripheral	D016411	—	—	17	20	—	—	4	35

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Rhabdoid tumor	D018335	—	—	4	—	—	—	—	4
Female genital neoplasms	D005833	—	—	4	—	—	—	—	4
Small cell lung carcinoma	D055752	—	—	3	—	—	—	—	3
Wilms tumor	D009396	EFO_0000212	—	3	—	—	—	—	3
Nervous system diseases	D009422	—	G00-G99	3	—	—	—	—	3
Autoimmune diseases of the nervous system	D020274	—	—	3	—	—	—	—	3
Ependymoma	D004806	—	—	2	—	—	—	—	2
Gastrointestinal stromal tumors	D046152	EFO_0000505	C49.A	2	—	—	—	—	2
Adrenocortical carcinoma	D018268	—	—	2	—	—	—	—	2
Aids-related lymphoma	D016483	EFO_1001365	—	1	—	—	—	1	2

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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
Type 1 hyper-igm immunodeficiency syndrome	D053307	—	—	—	—	—	—	1	1
Hereditary congenital and neonatal diseases and abnormalities	D009358	—	—	—	—	—	—	1	1
Primary graft dysfunction	D055031	—	—	—	—	—	—	1	1
Antiphospholipid syndrome	D016736	EFO_0002689	D68.61	—	—	—	—	1	1
Alveolar soft part sarcoma	D018234	—	—	—	—	—	—	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