Drug · Small Molecule

Fludarabine

CI-DRUG-00000249Explore in graph →NCIt C1094 CHEMBL1568 CIViC Phase 3

Regulatory

Approvals (11)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory11 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as FLUDARABINE PHOSPHATE INJECTION, USP (DIN 02438577) under ATC L01BB05 FLUDARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 25, 2022	health-canada-dpd
CA Health Canada	—	Marketed in Canada as FLUDARABINE PHOSPHATE INJECTION (DIN 02351722) under ATC L01BB05 FLUDARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Aug 3, 2017	Apr 11, 2011	health-canada-dpd
CA Health Canada	—	Marketed in Canada as FLUDARABINE PHOSPHATE FOR INJECTION USP (DIN 02293846) under ATC L01BB05 FLUDARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Market

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	390	229	90	1,309	11	CA, US	Sep 24, 2002	1994-01
Leukemia	Approved	Phase 4	149	80	58	653	1	US	Apr 28, 2004	1994-10
Non-Hodgkin Lymphoma	Phase4	Phase 4	91	50	24	335	0	—	—	1994-01
Multiple Myeloma	Phase4	Phase 4	25	11	10	151	0	—

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
IKZF1 Deletion1
Cytarabine + Daunorubicin

Clinical trials

Trials with this intervention (1,319)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1,301–1,319 of 1,319 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00346359	Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer	completed	Phase 2	40	Fred Hutchinson Cancer CenterOTHER	1	May 14, 2010	clinicaltrials
NCT00005802	Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia

Molecule

Record

Kind: Small Molecule
UNII: 1X9VK9O1SC
Aliases: 2-f-araa, 2-Fluoro-9-beta-arabinofuranosyladenine, 2-fluoro ara-a, 2-Fluorovidarabine, 9-Beta-D-arabinofuranosyl-2-fluoro-9H-purin-6-amine, 9-Beta-D-arabinofuranosyl-2-fluoroadenine, AJ-FLUDARABINE, FLUDARA, Fludarabina, Fludarabine, Fludarabine Phosphate, FLUDARABINE PHOSPHATE, Fludarabine Phosphate Sodium, Fluradosa, NSC-118218, NSC-118218H

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (21)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01BB05	FLUDARABINE
DIN (Health Canada)	01989537	FLUDARA
DIN (Health Canada)	02246226