deferasirox

Trade name: exjade

Small moleculeapprovedOrphan Drug ^FDAFast Track ^FDA

Approved

Nov 2, 2005

Deferasirox (marketed as Exjade, Desirox, Deferasirox) is an iron chelator. Its main use is to reduce chronic iron overload in patients who are receiving long term blood transfusions for conditions such as beta-thalassemia and other chronic anemias. It is the first oral medication approved for this purpose in the USA by FDA in November 2005. It is approved in the European Union by the European Medicines Agency (EMA) for children 6 years and older for chronic iron overload from repeated blood transfusions. Deferasirox is highly selective for iron as Fe3+. In approximately 1-year clinical trials of patients with transfusional chronic iron overload associated with beta-thalassaemia, sickle cell disease, myelodysplastic syndrome or other rare chronic anaemias, deferasiroxhad a beneficial effect on liver iron concentrations (LIC) and serum ferritin levels. Deferasirox can cause acute renal failure, fatal in some patients and requiring dialysis in others. It was showed that most fatalities occurred in patients with multiple comorbidities in advanced stages of their hematological disorders. — NCATS

Clinical trial activity

95 trials · 55 clinical orgs · 25 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jul 1, 2002 (NCT00379483)

Timeline

2000s

Jan 1, 2002
Novartis — Earliest Phase 2 Sponsor(trial)
Nov 21, 2002
Orphan Drug Designation
Jan 1, 2003
Novartis — Earliest Phase 3 Sponsor(trial)
Nov 2, 2005
Novartis — Earliest FDA Approval
Nov 2, 2005
Novartis — NDA Organization
Jan 1, 2006
Novartis — Earliest Phase 1 Sponsor(trial)

2010s

Jan 26, 2016
Actavis — Marketing Organization
Jan 26, 2016
Allergan PLC (2015) — Marketing Organization
Dec 8, 2017
Torrent Pharmaceuticals Limited — Marketing Organization
Nov 16, 2018
Zydus Discovery DMCC — Marketing Organization
Nov 20, 2019
Alembic — Marketing Organization
Nov 20, 2019
Alkem Labs Ltd — Marketing Organization
Nov 20, 2019
Bionpharma Inc — Marketing Organization
Nov 20, 2019
MSN Laboratories — Marketing Organization
Nov 20, 2019
Sun Pharmaceuticals — Marketing Organization
Nov 25, 2019
Teva — Marketing Organization
Dec 13, 2019
AbbVie — Marketing Organization
Dec 27, 2019
Amneal Pharmaceuticals — Marketing Organization
Dec 27, 2019
Jerome Stevens Pharmaceuticals — Marketing Organization
Dec 30, 2019
Piramal — Marketing Organization

2020s

Jan 3, 2020
Glenmark Pharmaceuticals — Marketing Organization
Jan 3, 2020
Ichnos — Marketing Organization
Feb 11, 2020
Cipla — Marketing Organization
Mar 9, 2021
Aucta Pharms — Marketing Organization
May 14, 2021
Annora Pharma — Marketing Organization
May 27, 2021
Celltrion — Marketing Organization
May 27, 2021
Chartwell Pharmaceuticals — Marketing Organization
Oct 16, 2023
Aurobindo Pharma — Marketing Organization
Mar 22, 2024
PHARMOBEDIENT — Marketing Organization
Apr 11, 2025
Jubilant Innovation Ltd. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

IronCHELATING AGENT
Iron chelating agent
Selective

Approval history

approvedPriority reviewAcceleratedFast trackNov 2, 2005

Chemistry & pharmacology

Loading structure…

SMILES

OC(=O)C1=CC=C(C=C1)N2N=C(N=C2C3=CC=CC=C3O)C4=CC=CC=C4O

Mol. weight: 373.3615 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Black box warning

Sources

Also known as

4-(3,5-bis-(2-hydroxyphenyl)-(1,2,4)-triazol-1-yl)benzoic acid
deferasirix
deferasirox
deferasirox
deferasirox
deferasirox
deferasirox
deferasirox
deferasirox
deferasirox
deferasirox
deferasirox
deferasirox
deferasiroxum
deferasiroxum
deferisarox
desferasirox
exjade
exjade
exjade
exjade
exjade
icl670
icl670
icl 670
icl 670
icl 670
icl-670
icl670a
icl670a
icl670a
icl670a
icl670a
icl670a
icl670a
icl 670a
icl 670a
icl 670a
icl 670a
icl-670a
icl-670a

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07023666	Phase 2	Oct 7, 2025	Inova Health System
NCT06964971	N/A	May 20, 2025	Zhejiang Chinese Medical University
NCT06784336	Phase 2	Apr 30, 2025	University of Michigan
NCT06468423	N/A	Jan 1, 2023	RESnTEC, Institute of Research
NCT05392101	Phase 2	Jul 20, 2021	University of Amsterdam
NCT03920657	Phase 2	May 31, 2019	Fondazione Italiana Diabete Onlus
NCT03637556	Phase 2	Sep 30, 2018	DisperSol Technologies LLC
NCT03387475	Phase 2	Feb 20, 2018	Novartis, University of Grenoble
NCT03372083	Phase 4	Jan 16, 2018	Novartis
NCT03203850	Phase 2	Oct 3, 2017	Novartis
NCT02993224	Phase 2	Jun 15, 2017	Novartis
NCT02943668	Phase 2	Mar 2, 2017	National Cancer Institute (NCI), University of Washington
NCT02720536	Phase 3	Aug 16, 2016	Novartis
NCT02854722	Phase 2	Aug 1, 2016	Soochow University
NCT02663752	Phase 4	May 1, 2016	Novartis
NCT02413021	Phase 1	May 1, 2016	Applied Physiology Research Center, Isfahan University, Seyyed-alshohada hospital of Isfahan
NCT02761395	N/A	Nov 1, 2015	Tanta University
NCT02435212	Phase 2	Oct 21, 2015	Novartis
NCT02474420	N/A	Jun 1, 2015	University of Toronto
NCT02069886	Phase 4	Dec 1, 2014	Novartis

Showing 20 of 95 trials

Page 1 / 5

Organizations

Research & Development (55)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Novartis	For profit	63	54	4	2002
Ain Shams University	Academic/Hospital	2	2	1	2012
American University of Beirut	Academic/Hospital	2	0	2	2004
National Cancer Institute (NCI)	Government	2	0	2	2011
Northwestern University	Academic/Hospital	2	0	1	2006
University of California, San Francisco	Academic/Hospital	2	1	2	2006
University of Paris	Academic/Hospital	2	1	1	2011
University of Pennsylvania	Academic/Hospital	2	2	2	2012
University of Southern California	Academic/Hospital	2	1	2	2006
University of Toronto	Academic/Hospital	2	2	2	2014
Aga Khan University	Academic/Hospital	1	1	1	2014
Applied Physiology Research Center	Academic/Hospital	1	0	1	2016
Association pour l'Etude des Fonctions Digestives	Academic/Hospital	1	0	1	2011
Astellas	For profit	1	0	1	2007
Ben Gurion University	Academic/Hospital	1	0	1	2007
China Medical University	Academic/Hospital	1	1	1	2007
City of Hope National Medical Center	Academic/Hospital	1	1	1	2010
Consorzio per Valutazioni Biologiche e Farmacologiche	Academic/Hospital	1	1	1	2014
Cornell University	Academic/Hospital	1	1	1	2008
Crolll Gmbh	For profit	1	1	1	2010

55 organizations

Page 1 / 3

Marketing (36)

Organization	Org type	Relationship	Date
AbbVie	For profit	MKTG	Dec 13, 2019
Actavis	For profit	MKTG	Jan 26, 2016
Alembic	For profit	MKTG	Nov 20, 2019
Alembic	For profit	SYN	Nov 20, 2019
Alkem Labs Ltd	For profit	MKTG	Nov 20, 2019
Allergan PLC (2015)	For profit	MKTG	Jan 26, 2016
Amneal Pharmaceuticals	For profit	SYN	Dec 27, 2019
Amneal Pharmaceuticals	For profit	MKTG	Dec 27, 2019
Annora Pharma	For profit	MKTG	May 14, 2021
Aucta Pharms	For profit	MKTG	Mar 9, 2021
Aurobindo Pharma	For profit	MKTG	Oct 16, 2023
Aurobindo Pharma	For profit	SYN	Sep 8, 2025
Bionpharma Inc	For profit	MKTG	Nov 20, 2019
Bionpharma Inc	For profit	SYN	Nov 20, 2019
Celltrion	For profit	MKTG	May 27, 2021
Chartwell Pharmaceuticals	For profit	MKTG	May 27, 2021
Cipla	For profit	MKTG	Feb 11, 2020
Glenmark Pharmaceuticals	For profit	MKTG	Jan 3, 2020
Glenmark Pharmaceuticals	For profit	SYN	Jan 3, 2020
Ichnos	For profit	MKTG	Jan 3, 2020
Jerome Stevens Pharmaceuticals	For profit	MKTG	Dec 27, 2019
Jubilant Innovation Ltd.	For profit	MKTG	Apr 11, 2025
MSN Laboratories	For profit	MKTG	Nov 20, 2019
MSN Laboratories	For profit	SYN	Nov 20, 2019
Novartis	For profit	SYN	Mar 30, 2015
Novartis	For profit	NDA	Nov 2, 2005
PHARMOBEDIENT	For profit	MKTG	Mar 22, 2024
Piramal	For profit	MKTG	Dec 30, 2019
Piramal	For profit	SYN	Dec 30, 2019
Sun Pharmaceuticals	For profit	MKTG	Nov 20, 2019
Teva	For profit	MKTG	Nov 25, 2019
Torrent Pharmaceuticals Limited	For profit	MKTG	Dec 8, 2017
Torrent Pharmaceuticals Limited	For profit	SYN	Nov 5, 2024
Zydus Discovery DMCC	For profit	MKTG	Nov 16, 2018
Zydus Discovery DMCC	For profit	SYN	Nov 21, 2019
Zydus Discovery DMCC	For profit	SYN	Nov 20, 2019