TheraRadar
Data updated: May 26, 2026

CLOFARABINE

Nucleic Acid Synthesis Inhibitors
Oncology Approved 2017-05-09

CLOFARABINE is indicated for the treatment of Acute Lymphoblastic Leukemia.

Source: FDA Label • PHARMOBEDIENT • Nucleoside Metabolic Inhibitor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How CLOFARABINE Works

Clofarabine is intracellularly metabolized to its active 5’-triphosphate metabolite, which inhibits DNA synthesis through two primary mechanisms: the reduction of cellular deoxynucleotide triphosphate pools via inhibition of ribonucleotide reductase, and the termination of DNA chain elongation through competitive inhibition of DNA polymerases. Additionally, the drug disrupts mitochondrial membrane integrity, triggering the release of pro-apoptotic factors (cytochrome C and apoptosis-inducing factor) to induce programmed cell death in both proliferating and quiescent cancer cells.

Source: FDA Label
10
Indications
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2017-05-09
Routes
INTRAVENOUS, INJECTION
Dosage Forms
SOLUTION, INJECTABLE

Companies

PHARMOBEDIENT Dr. Reddy's NOVAST LABS EUGIA PHARMA ABON PHARMS LLC ZYDUS PHARMS USA INC SCINOPHARM TAIWAN MEITHEAL AMNEAL GLAND Pfizer MSN ACCORD HLTHCARE
Active Ingredient: CLOFARABINE

CLOFARABINE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
25 FDA actions from 2017 to 2025
Jan 2025 ORIGINAL
Update
Aug 2023 SUPPL
Label · Labeling
Apr 2023 SUPPL
Label · Labeling

What CLOFARABINE Treats

1 indications

CLOFARABINE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acute Lymphoblastic Leukemia
Source: FDA Label

CLOFARABINE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

2

Same target(s) AND same indication — head-to-head.

NELARABINE
AMNEAL
2021 2 indic.
ARRANON
Novartis
2005 2 indic.

MoA expansion candidates

7

Same target(s), different indications — where else is this mechanism being explored?

INLEXZO
Johnson &
2025 2 indic.
AVGEMSI
AVYXA HOLDINGS
2025 4 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

IMKELDI
SHORLA ONCOLOGY
2024 7 indic.
PHYRAGO
HANDA THERAP
2023 2 indic.
Unlock 13 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in CLOFARABINE's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CLOFARABINE treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to CLOFARABINE

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1 shared
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Shared indications:
Acute Lymphoblastic Leukemia
BESPONSA
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Acute Lymphoblastic Leukemia
BLINCYTO
BLINATUMOMAB
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Clinical Trial Registry

91 trials
Trial Sponsor ID Phase Status Title
NCT07566377 26-168 Ph 2 recruiting Cord Blood Transplantation in Children and Young Adults With Blood Cancer
NCT02727803 2015-0313 NCI-2016-00584, 2015-0313 Ph 2 recruiting Personalized NK Cell Therapy in CBT
NCT02883049 results posted NCI-2011-03797 NCI-2011-03797, S12-01254 Ph 3 active not recruiting Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT01279096 Vandevol 2009-010826-20 2008_40/0905 Ph 1 completed Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia
NCT04644016 20-480 Ph 2 recruiting Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders
NCT02425904 results posted 15-005 Ph 2 active not recruiting Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders
NCT03136146 2016-0211 NCI-2018-01198, 2016-0211 Ph 2 recruiting Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
NCT05917405 FLUCLORIC RC22_0524 Ph 2 recruiting Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
NCT06252870 CY-MET-RIC RC23_0286 Ph 2 recruiting Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation
NCT04994808 RG1121616 NCI-2021-07474, 10598 Ph 2 active not recruiting Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia
NCT03117751 TOT17 NCI-2017-00582 Ph 2, Ph 3 active not recruiting Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma
NCT01885689 results posted 13130 NCI-2013-01193 Ph 2 active not recruiting Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
NCT07156435 VyClo ITCC-092 2020-000142-34, 2023-508050-26 Ph 1 recruiting Vyxeos® With Clofarabine for Pediatric AML
NCT07034053 CLOFARABINE_UC Ph 1, Ph 2 recruiting Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma
NCT06986382 78920 Ph 1, Ph 2 not yet recruiting Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease
NCT03615105 results posted 18-224 Ph 2 terminated Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors
NCT01701986 results posted 2012-0506 NCI-2012-02055, 2012-0506 Ph 1, Ph 2 completed Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
NCT02085408 results posted E2906 NCI-2011-01992, CDR0000659585 Ph 3 completed Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01228331 CDR0000686545 2009-012758-18 Ph 2, Ph 3 completed Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL
NCT05569512 22-063 Ph 1 terminated Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML
NCT02135874 results posted 2013-0073 NCI-2014-02322, 2013-0073 Ph 2 completed Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
NCT02441803 results posted 2014-0358 NCI-2015-00849 Ph 2 completed Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)
NCT01041508 results posted T2008-005 IND 101588 Ph 1 completed Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.
NCT04220008 2018-0988 NCI-2019-08496, 2018-0988 Ph 2 withdrawn Vorinostat and Combination Chemotherapy Before Donor Stem Cell Transplantation for the Treatment of Relapsed Aggressive B-cell or T-cell Non-Hodgkin Lymphoma
NCT00697684 07-384 Ph 1 completed Reduced Intensity Conditioning With Clofarabine, Antithymocyte Globulin (ATG), Total Lymphoid Irradiation (TLI) Followed by Allogeneic Stem Cell Transplant
NCT03096782 results posted 2016-0051 NCI-2018-01236, 2016-0051 Ph 2 completed Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma
NCT04002115 results posted 18-011 Ph 2 terminated Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML
NCT00644189 results posted 07-401 Ph 1, Ph 2 completed Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
NCT01842672 MITCL NYMC 542 L 10, 819 Ph 1, Ph 2 completed Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia
NCT01700946 results posted ALLR18 NCI-2012-00587 Ph 2 completed Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
NCT01119066 results posted 10-050 Ph 2 completed HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies
NCT03263767 CYRIC RC16_0435 Ph 2 terminated Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC
NCT01451515 results posted NHL16 NCI-2012-00496 Ph 2 completed NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
NCT02083250 2012-0999 NCI-2014-01982, 2012-0999 Ph 1 completed Fludarabine Phosphate, Clofarabine, and Busulfan With Vorinostat in Treating Patients With Acute Leukemia in Remission or Relapse Undergoing Donor Stem Cell Transplant
NCT01471444 results posted 2011-0628 NCI-2012-00038 Ph 3 completed Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
NCT01158885 results posted T2009-002 Ph 2 terminated Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia
NCT00703820 results posted AML08 R01CA138744, R01CA115422 Ph 3 completed Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
NCT03615144 results posted 17-596 Ph 2 terminated TCR Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors
NCT00983528 results posted 090331 Ph 1, Ph 2 terminated Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT01252667 results posted 2430.00 NCI-2010-02247, 2430.00 Ph 2 completed Clofarabine and Low-Dose Total-Body Irradiation in Treating Patients With Acute Myeloid Leukemia Undergoing Donor Peripheral Blood Stem Cell Transplant
NCT00857389 results posted 2008-0363 NCI-2012-01630 Ph 2 completed Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies
NCT02349178 results posted Bridging Ph 2 terminated Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT
NCT01596699 results posted 110819 NCI-2012-00800 Ph 2 terminated Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation
NCT01289457 results posted 2010-0788 NCI-2011-00251 Ph 1, Ph 2 completed Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome
NCT01629511 results posted 2012-0249 NCI-2018-01798, 2012-0249 Ph 1, Ph 2 terminated Allogeneic Stem Cell Transplant for CLL
NCT00939653 results posted T2007-002 Ph 2 terminated T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)
NCT01629082 120146 12-H-0146 Ph 1 completed Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
NCT00691652 results posted CDR0000597410 P30CA069533, OHSU-HEM-07156-L Ph 1, Ph 2 terminated Clofarabine and Rituximab in Treating Patients With Relapsed Non-Hodgkin Lymphoma
NCT01160354 results posted 2009-0536 NCI-2012-01786 Ph 1, Ph 2 terminated Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)
NCT00882076 PSHCI 08-096 Ph 1 terminated Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias

Showing 50 of 91 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CLOFARABINE FDA Label Details

Indications & Usage

FDA Label (PDF)

CLOFARABINE is indicated for the treatment of Acute Lymphoblastic Leukemia.

Looking for the branded version?

CLOLAR

Full clinical data, patents, trials, and competitive landscape for clofarabine.

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Data Sources

FDA Approval: ANDA208860 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.