Deferasirox

Overview

Deferasirox is an iron chelator and the first oral medication FDA approved for chronic iron overload in patients receiving long term blood transfusions.

Background

Deferasirox is an iron chelator and the first oral medication FDA approved for chronic iron overload in patients receiving long term blood transfusions.

Indication

For the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Associated Conditions

Chronic Iron Overload

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Early Screening and Treatment of Heart Complication in Sickle Cell Disease	2025/06/17	NCT07023666	Phase 2	Not yet recruiting	Inova Health Care Services
Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload	2024/06/21	NCT06468423	Not Applicable	Completed	RESnTEC, Institute of Research
Low Dose Iron Chelation as TReatment of Oxidative Damage in Sickle Cell Disease	2022/05/26	NCT05392101	Phase 2	Completed	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Risk Factors and Measures to Prevent Liver and Pancreas Complications in Pediatric Patients After HSCT	2020/06/09	NCT04423237	N/A	Completed	University of Pisa
Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Overload in Lower Risk MDS	2019/04/19	NCT03920657	Phase 2	Terminated	Fondazione Italiana Sindromi Mielodisplastiche-ETS
Study of the Outcome of Patients With Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Receiving Iron Chelation Therapy After Allogeneic Hematopoietic Stem Cell Transplantation	2018/09/06	NCT03659084	N/A	UNKNOWN	Hospices Civils de Lyon
Pilot Study to Assess the Safety, PK and Iron Chelating Activity of DST-0509 (Deferasirox) in Thalassemia Patients Refractory to Chelation	2018/08/20	NCT03637556	Phase 2	Completed	DisperSol Technologies, LLC
Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk MDS Resistant or Relapsing After ESA Agents	2018/01/02	NCT03387475	Phase 2	Completed	University Hospital, Grenoble
Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis	2017/12/13	NCT03372083	Phase 4	Completed	Novartis Pharmaceuticals
Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH)	2017/06/29	NCT03203850	Phase 2	Terminated	Novartis Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Deferasirox	Actavis Pharma, Inc.	45963-456	ORAL	500 mg in 1 1	8/31/2021
DEFERASIROX	Sun Pharmaceutical Industries, Inc.	57664-769	ORAL	180 mg in 1 1	12/12/2022
Deferasirox	Actavis Pharma, Inc.	0591-4730	ORAL	90 mg in 1 1	1/17/2024
DEFERASIROX	Alembic Pharmaceuticals Limited	46708-412	ORAL	360 mg in 1 1	1/30/2023
deferasirox	Sun Pharmaceutical Industries, Inc.	62756-570	ORAL	500 mg in 1 1	12/26/2023
Deferasirox	Dr. Reddy's Laboratories Inc	43598-855	ORAL	125 mg in 1 1	12/30/2020
deferasirox	Zydus Pharmaceuticals USA Inc.	70710-1276	ORAL	180 mg in 1 1	7/24/2023
deferasirox	Amneal Pharmaceuticals NY LLC	69238-1702	ORAL	90 mg in 1 1	12/29/2023
DEFERASIROX	Aurobindo Pharma Limited	59651-410	ORAL	90 mg in 1 1	11/15/2023
Deferasirox	Dr. Reddy's Laboratories Inc	43598-854	ORAL	500 mg in 1 1	12/30/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Exjade	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	8/28/2006
Deferasirox Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	1/9/2020
Deferasirox Mylan	Mylan Pharmaceuticals Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Ireland	Authorised	9/26/2019
Deferasirox Mylan	Mylan Pharmaceuticals Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Ireland	Authorised	9/26/2019
Exjade	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	8/28/2006
Deferasirox Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	1/9/2020

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
JADENU FILM COATED TABLET 360MG	Novartis Pharma Stein AG, Novartis Pharma Produktions GmbH (primary and secondary packager), SANDOZ S.R.L	SIN15215P	TABLET, FILM COATED	360.00mg	4/18/2017
JADENU FILM COATED TABLET 90MG	Novartis Pharma Stein AG, Novartis Pharma Produktions GmbH (primary and secondary packager), SANDOZ S.R.L	SIN15213P	TABLET, FILM COATED	90mg	4/18/2017
FERASIRO FILM COATED TABLET 360MG	MSN Laboratories Private Limited	SIN17087P	TABLET, FILM COATED	360.00mg	9/19/2024
FERASIRO FILM COATED TABLET 90MG	MSN Laboratories Private Limited	SIN17088P	TABLET, FILM COATED	90.00mg	9/19/2024
DESROXIA FILM-COATED TABLETS 360MG	PharOS MT Ltd	SIN17173P	TABLET, FILM COATED	360.00 mg	2/6/2025
DESROXIA FILM-COATED TABLETS 90MG	PharOS MT Ltd	SIN17174P	TABLET, FILM COATED	90.00 mg	2/6/2025

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Deferasirox Tablets	江苏豪森药业集团有限公司	国药准字H20223301	化学药品	片剂	5/10/2022
Deferasirox Tablets	MSN LABORATORIES PRIVATE LIMITED	国药准字HJ20240001	化学药品	片剂	1/9/2024
Deferasirox Tablets	江苏豪森药业集团有限公司	国药准字H20223302	化学药品	片剂	5/10/2022
Deferasirox Granules	MSN LABORATORIES PRIVATE LIMITED	国药准字HJ20240039	化学药品	颗粒剂	6/11/2024
Deferasirox Granules	MSN LABORATORIES PRIVATE LIMITED	国药准字HJ20240038	化学药品	颗粒剂	6/11/2024
Deferasirox Dispersible Tablets	中美华世通生物医药科技（武汉）股份有限公司	国药准字H20244694	化学药品	片剂	8/20/2024
Deferasirox Dispersible Tablets	MSN LABORATORIES PRIVATE LIMITED	国药准字HJ20210080	化学药品	片剂	12/14/2021
Deferasirox Dispersible Tablets	MSN LABORATORIES PRIVATE LIMITED	国药准字HJ20210081	化学药品	片剂	12/14/2021
Deferasirox Dispersible Tablets	石家庄四药有限公司	国药准字H20249708	化学药品	片剂	12/6/2024
Deferasirox Dispersible Tablets	MSN LABORATORIES PRIVATE LIMITED	国药准字HJ20210082	化学药品	片剂	12/14/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
JADENU TABLETS 90MG	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	10/31/2016
JADENU TABLETS 90MG	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	11/27/2023

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
JADENU deferasirox 180 mg film-coated tablet blister pack	286761	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	3/15/2018
DESIROX deferasirox 360 mg tablet blister pack	338145	Cipla Australia Pty Ltd	Medicine	A	4/21/2021
EFERAS deferasirox 180 mg film coated tablet blister pack	331685	Alphapharm Pty Ltd	Medicine	A	3/12/2021
PHARMACOR DEFERASIROX deferasirox 125 mg dispersible tablet bottle pack	302061	Pharmacor Pty Ltd	Medicine	A	9/9/2020
PHARMACOR DEFERASIROX deferasirox 500 mg dispersible tablet blister pack	302067	Pharmacor Pty Ltd	Medicine	A	9/9/2020
JADENU deferasirox 360 mg film-coated tablet blister pack	293497	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	3/15/2018
JADENU deferasirox 90 mg film-coated tablet blister pack	286751	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	3/15/2018
Deferasirox Lupin deferasirox 360 mg film coated tablet blister pack	341234	Southern Cross Pharma Pty Ltd	Medicine	A	8/6/2021
Deferasirox TLB deferasirox 90 mg film coated tablet blister pack	341232	Southern Cross Pharma Pty Ltd	Medicine	A	8/6/2021
Deferasirox Sandoz deferasirox 360 mg film-coated tablet blister pack	362235	Sandoz Pty Ltd	Medicine	A	5/28/2021

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