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Fludarabine · Fludara, Fludarabine Phosphate

Small molecule · Inhibitor of DNA polymerase alpha (POLA1), ribonucleotide reductase (RRM1) and DNA primase (PRIM1) · developed by Genzyme

Approved FDA, Apr 1991

20 Registered trials

What is Fludarabine?

Fludarabine is a fluorinated nucleotide antimetabolite that is dephosphorylated and then phosphorylated intracellularly to its active triphosphate, 2-fluoro-ara-ATP. The metabolite inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase, interrupting DNA synthesis. It is studied as a lymphodepleting pre-conditioning chemotherapy in lymphoma, leukemia, myelodysplastic syndrome and autoimmune conditions such as myositis and systemic sclerosis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Fludara, Fludarabine Phosphate, Oforta, CABA-201, SN301A, Fluradosa, Cyclophosphamide
Drug type: Small molecule
Targets: DNA polymerase alpha (POLA1), ribonucleotide reductase (RRM1), DNA primase (PRIM1)
Mechanism: Inhibitor of DNA polymerase alpha (POLA1), ribonucleotide reductase (RRM1) and DNA primase (PRIM1)
Pathways: DNA synthesis inhibition, deoxycytidine kinase-mediated intracellular phosphorylation
Therapy area: Oncology
Developer: Genzyme Corp
In trials of: AAPG, ACET, ALLO, ARTV, ATNM, BMY, CABA, CELU, DTIL, GERN
FDA status: Approved as Fludara, Fludarabine Phosphate, Oforta (April 18, 1991), NDA020038

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07157514	Phase 2/3	Acute Leukemia	Not yet recruiting	ATNM
NCT06319456	Phase 3	CLL/SLL	Recruiting	AAPG
NCT06154252	Phase 2/3	Idiopathic Inflammatory Myopathy	Recruiting	CABA
NCT04217278	Phase 2/3	Acute Myeloid Leukaemia	Active not recruiting	JAZZ
NCT07288073	Phase 2	Cutaneous Squamous Cell Carcinoma	Recruiting	IOVA
NCT07015242	Phase 2	Lymphoma	Recruiting	BMY
NCT06480565	Phase 1/2	Clear Cell Renal Cell Carcinoma	Active not recruiting	ACET
NCT05826535	Phase 1/2	Relapsed Non-Hodgkin Lymphoma	Recruiting	LYEL
NCT05207722	Phase 1/2	Metastatic HER2 Positive Gastroesophageal Junction Cancer	Terminated	CELU
NCT04673617	Phase 1/2	Non Hodgkin Lymphoma	Completed	ARTV
NCT04416984	Phase 1/2	Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic…	Active not recruiting	ALLO
NCT04030195	Phase 1/2	Non-Hodgkin's Lymphoma, Relapsed	Completed	DTIL
NCT04109482	Phase 1/2	Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)	Terminated	MBIO
NCT03935347	Phase 2	Metastatic Bladder Urothelial Carcinoma	Withdrawn	IOVA
NCT05618925	Phase 1	Non Hodgkin's Lymphoma Refractory/Relapsed	Recruiting	IBRX
NCT06247787	Phase 1	Recurrent Childhood Acute Myeloid Leukemia	Recruiting	GERN
NCT06152172	Phase 1	Idiopathic Inflammatory Myopathies	Active not recruiting	KYTX
NCT03994705	Phase 1	Multiple Myeloma	Terminated	RNAC
NCT06652243	Early Phase 1	Hepatocellular Carcinoma (HCC)	Recruiting	SNTI
NCT01701674	N/A	Metastatic Melanoma	Completed	IOVA

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Acute Myeloid LeukaemiaANCA Associated VasculitisAnti-Synthetase SyndromeDermatomyositisDiffuse Cutaneous Systemic SclerosisHigh-risk Myelodysplastic SyndromeIdiopathic Inflammatory MyopathiesIdiopathic Inflammatory MyopathyLarge B-cell LymphomaNon Hodgkin's Lymphoma Refractory/RelapsedNon-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaRelapsed Non-Hodgkin LymphomaSLE Nephritis

Sources

Updated Oct 11, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z