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.

Download report

Favorite

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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

Mock data
Subscribe for the real data

Commercial

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

Hide discontinued

Labels

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

2228 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	395	535	97	16	58	931
Lymphoma	D008223	—	C85.9	272	306	35	2	37	560
Myeloid leukemia acute	D015470	—	C92.0	174	241	56	6	26	432
Myeloid leukemia	D007951	—	C92	161	237	45	5	24	402
Lymphoid leukemia	D007945	—	C91	174	213	43	8	20	389
Myelodysplastic syndromes	D009190	—	D46	123	253	24	2	29	379
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	170	185	19	5	22	340
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	117	178	36	3	15	303
Non-hodgkin lymphoma	D008228	—	C85.9	152	159	15	1	20	290
Preleukemia	D011289	—	—	91	177	14	2	19	265

Show 11 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	181	141	5	—	16	288
B-cell lymphoma	D016393	—	—	130	79	5	—	11	191
Hematologic neoplasms	D019337	—	—	76	114	3	—	19	182
Plasma cell neoplasms	D054219	—	—	90	76	9	—	15	170
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	31	107	7	—	11	138
Hodgkin disease	D006689	—	C81	44	80	3	—	13	122
Melanoma	D008545	—	—	53	63	1	—	2	101
Large b-cell lymphoma diffuse	D016403	—	C83.3	58	49	4	—	5	100
Follicular lymphoma	D008224	—	C82	38	54	12	—	5	98
Mantle-cell lymphoma	D020522	—	—	41	53	9	—	6	93

Show 47 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	57	26	—	—	4	70
T-cell lymphoma	D016399	—	—	24	32	—	—	5	54
Ovarian neoplasms	D010051	EFO_0003893	C56	43	22	—	—	—	53
Plasmacytoma	D010954	—	C90.3	14	30	—	—	9	49
Breast neoplasms	D001943	EFO_0003869	C50	34	25	—	—	—	46
Renal cell carcinoma	D002292	EFO_0000376	—	27	22	—	—	3	41
Precursor t-cell lymphoblastic leukemia-lymphoma	D054218	—	—	34	15	—	—	—	37
Biphenotypic leukemia acute	D015456	—	C95.0	18	21	—	—	—	35
Hematologic diseases	D006402	EFO_0005803	D75.9	8	21	—	—	9	35
T-cell lymphoma peripheral	D016411	—	—	17	20	—	—	4	35

Show 273 more

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

Show 53 more

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

Epidemiology

Epidemiological information for investigational and approved indications

View more details

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