Clofarabine

Overview

Clofarabine is a purine nucleoside antimetabolite that is being studied in the treatment of cancer. It is marketed as Clolar in the U.S. and Canada, or Evoltra in Europe, Australia, and New Zealand. Clofarabine is used in paediatrics to treat a type of leukaemia called relapsed or refractory acute lymphoblastic leukaemia (ALL), only after at least two other types of treatment have failed. It is not known if the drug extends life expectancy. Its potential use in acute myeloid leukaemia (AML) and juvenile myelomonocytic leukaemia (JMML) has been investigated.

Indication

For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphocytic (lymphoblastic) leukemia after at least two prior regimens. It is designated as an orphan drug by the FDA for this use.

Associated Conditions

Refractory Acute Lymphoblastic Leukemia (ALL)
Refractory Acute Myeloid Leukemia (AML)
Relapsed Acute Lymphoblastic Leukemia (ALL)
Refractory Langerhans cell histiocytosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma	2025/06/24	NCT07034053	Phase 1	Recruiting	Ekaterina Laukhtina
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	2025/05/23	NCT06986382	Phase 1	Not yet recruiting	Stanford University
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	2024/02/12	NCT06252870	Phase 2	Recruiting	Nantes University Hospital
Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT	2023/06/23	NCT05917405	Phase 2	Recruiting	Nantes University Hospital
Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML	2022/10/06	NCT05569512	Phase 1	Terminated	Malika Kapadia
Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia	2021/08/06	NCT04994808	Phase 2	Recruiting	Fred Hutchinson Cancer Center
Bisantrene Combination for Resistant AML	2021/08/04	NCT04989335	Phase 2	Recruiting	Sheba Medical Center
Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders	2020/11/25	NCT04644016	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center
Vorinostat and Combination Chemotherapy Before Donor Stem Cell Transplantation for the Treatment of Relapsed Aggressive B-cell or T-cell Non-Hodgkin Lymphoma	2020/01/07	NCT04220008	Phase 2	Withdrawn	M.D. Anderson Cancer Center
Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML	2019/06/28	NCT04002115	Phase 2	Terminated	Milton S. Hershey Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Clolar	Sanofi-Aventis U.S. LLC	0024-5860	INTRAVENOUS	1 mg in 1 mL	7/31/2022
Clofarabine	Amneal Pharmaceuticals LLC	70121-1236	INTRAVENOUS	1 mg in 1 mL	12/23/2023
CLOFARABINE	Accord Healthcare Inc.	16729-431	INTRAVENOUS	1 mg in 1 mL	2/25/2019
Clofarabine	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1746	INTRAVENOUS	1 mg in 1 mL	12/7/2023
clofarabine	Mylan Institutional LLC	67457-546	INTRAVENOUS	1 mg in 1 mL	3/24/2020
Clofarabine	Dr.Reddy's Laboratories Inc	43598-309	INTRAVENOUS	1 mg in 1 mL	7/27/2022
Clofarabine	Gland Pharma Limited	68083-386	INTRAVENOUS	1 mg in 1 mL	11/22/2022
CLOFARABINE	Eugia US LLC	55150-326	INTRAVENOUS	1 mg in 1 mL	1/21/2020
CLOFARABINE	Fosun Pharma USA Inc.	72266-108	INTRAVENOUS	1 mg in 1 mL	2/15/2023
Clofarabine	Meitheal Pharmaceuticals Inc.	71288-128	INTRAVENOUS	1 mg in 1 mL	10/23/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Evoltra	Sanofi B.V.,Paasheuvelweg 25,1105 BP Amsterdam,Netherlands	Authorised	5/29/2006

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Evoltra Concentrate Solution for Infusion 1mg/ml	Teva-Pharmachemie B.V. (PCH)	SIN14026P	SOLUTION, CONCENTRATE	1mg/ml	10/6/2011

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
CLOFACORD CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/20ML	N/A	Jacobson Marketing Limited	N/A	N/A	3/26/2025

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EVOLTRA clofarabine 20 mg/20 mL concentrated solution for infusion vial	154991	Sanofi-Aventis Australia Pty Ltd	Medicine	A	10/13/2009

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CLOLAR	sanofi-aventis canada inc	02330407	Solution - Intravenous	1 MG / ML	2/10/2010

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
IVOZALL 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Orphelia Pharma	1191396001	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CLOFARABINA ZENTIVA 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Zentiva K.S.	83299	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CLOFARABINA ACCORD 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Accord Healthcare S.L.U.	84596	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CLOFARABINA TEVA 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Teva Pharma S.L.U.	82208	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
EVOLTRA 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Sanofi B.V.	06334002	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CLOFARABINA ARISTO 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Aristo Pharma Iberia S.L.	82174	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CLOFARABINA KOANAA 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Koanaa Healthcare Gmbh	84707	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CLOFARABINA BIOORGANICS 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Bioorganics B.V.	82636	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
EVOLTRA 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Sanofi B.V.	06334005	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CLOFARABINA AUROVITAS 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Aurovitas Spain, S.A.U.	86158	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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