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Drug

Deferasirox

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Exjade, Jadenu, Deferasiroxum.

RxNorm614373ChEMBLCHEMBL550348UNIIV8G4MOF2V9
2
Research papers
1
Active clinical trials
9
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Label change: DEFERASIROX (ANDA210945)

Regulatory2024-12-17FDA

Phase II Trial Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk (MDS) Myelodysplastic Syndrome Resistant or Relapsing After ESA Agents (LODEFI)

Clinical trial2024-10-01Completed · ClinicalTrials.gov

Pilot Pharmacokinetic Study In Patients With Inadequate Response To Deferasirox (Exjade)

Clinical trial2024-02-12Results posted · ClinicalTrials.gov

The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) Study

Clinical trial2023-10-16Results posted · ClinicalTrials.gov

Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload

Clinical trial2023-09-30Completed · ClinicalTrials.gov

Low Dose Iron Chelation as TReatment of Oxidative Damage in Patients With Sickle Cell Disease: the TROS Study

Clinical trial2022-11-20Completed · ClinicalTrials.gov

Label change: DEFERASIROX (ANDA210945)

Regulatory2021-03-01FDA

Label change: DEFERASIROX (ANDA210945)

Regulatory2021-03-01FDA

Supplemental approval: DEFERASIROX (ANDA210945)

Regulatory2021-03-01FDA

Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome.

Research2012-04-30Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Deferasirox pharmacokinetics in patients with adequate versus inadequate response.

Research2009-09-01Blood

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Deferasirox
Aliases & brands
ExjadeJadenuDeferasiroxum
RxNorm CUI
614373
ChEMBL ID
CHEMBL550348
UNII
V8G4MOF2V9
Regulatory jurisdictions
fdaema

Regulatory timeline

9 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2019-09-26 → 2021-03-01)
Earliest approval
2006-08-28
Latest approval
2021-03-01
Authorities
FDA · EMA
Total events
9
fdaU.S. Food and Drug Administration· 6 events
2024-12-17Label change
Label change: DEFERASIROX (ANDA210945)
Evidence ↗
2021-03-01Supplemental approvalMulti-authority
Supplemental approval: DEFERASIROX (ANDA210945)
Evidence ↗
2021-03-01Label change
Label change: DEFERASIROX (ANDA210945)
Evidence ↗
emaEuropean Medicines Agency· 3 events
2020-01-09ApprovalMulti-authority
Approval: Deferasirox Accord (EMA)
Indication: Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta… Show full indication

Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. Deferasirox Accord is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.

Evidence ↗
2019-09-26ApprovalMulti-authority
Approval: Deferasirox Mylan (EMA)
Indication: Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta… Show full indication

Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion dependent thalassaemia syndromes aged 10 years and older.

Evidence ↗
2006-08-28Approval
Approval: Exjade (EMA)
Indication: Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia… Show full indication

Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older. Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged two to five years; in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged two years and older; in patients with other anaemias aged two years and older. Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

67 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
67
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
29
Late-stage (III+)
46
Completed
20
Discontinued
PHASE DISTRIBUTIONn = 67
Phase 15Phase 1 / 23Phase 230Phase 2 / 31Phase 39Phase 415Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Single-arm Interventional Phase IV, Post-authorisation Study Evaluating the Safety of Pediatric Patients With Transfusional Hemosiderosis Treated With Deferasirox Crushed Film Coated Tablets

CompletedPH IVNovartis Pharmaceuticalsn=442019

An Open Label, Multi-center, Efficacy and Safety Study of Deferasirox in Iron Overloaded Patients With Non-transfusion Dependent Thalassemia

CompletedPH IVNovartis Pharmaceuticalsn=1342019

A Multicenter, Open-label, Single Arm, Interventional Phase IV Study, to Evaluate the Effect of Deferasirox on Endocrine Complications in Subjects With Transfusion Dependent Thalassemia

WithdrawnPH IVNovartis Pharmaceuticals2018

An Open Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of Deferasirox Administered to Chinese Patients With β-thalassemia Major Aged From 2 to Less Than 6 Years Old

WithdrawnPH IVNovartis Pharmaceuticals2014

A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.

TerminatedPH IVNovartis Pharmaceuticalsn=122012

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase II Trial Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk (MDS) Myelodysplastic Syndrome Resistant or Relapsing After ESA Agents (LODEFI)

CompletedPH IIUniversity Hospital, Grenoblen=392024

Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload

CompletedN/ARESnTEC, Institute of Researchn=1422023

Low Dose Iron Chelation as TReatment of Oxidative Damage in Patients With Sickle Cell Disease: the TROS Study

CompletedPH IIAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)n=122022

A Multi-Center, Open-Label, Two-Period Cross-Over, Patient-Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Iron Chelating Activity of DST-0509 (Deferasirox) Tablets in Thalassemia Patients With Inadequate Response to Standard Chelation Therapy

CompletedPH IIDisperSol Technologies, LLCn=252021

A Single-arm Interventional Phase IV, Post-authorisation Study Evaluating the Safety of Pediatric Patients With Transfusional Hemosiderosis Treated With Deferasirox Crushed Film Coated Tablets

CompletedPH IVNovartis Pharmaceuticalsn=442019

Open-label, Multicenter, Single Arm, Phase III Study to Collect Additional Safety and Efficacy Data With Deferasirox Film-coated Tablets in Patients Completing Study CICL670F2201

CompletedPH IIINovartis Pharmaceuticalsn=532019

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092012
Most influential

Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012 · 132 cites

Deferasirox pharmacokinetics in patients with adequate versus inadequate response.

Blood · 2009 · 69 cites
Recent papers

Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012 · 132 cites

Deferasirox pharmacokinetics in patients with adequate versus inadequate response.

Blood · 2009 · 69 cites
Journals, researchers & institutions
Top journals
  • Blood1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Paley C2
  • Baer MR1
  • Bergmann AK1
  • Besa E1
  • Braunstein J1
  • Chirnomas D1
  • Esposito J1
  • Feigert J1
Leading institutions
free-text, unnormalised
  • Children's Hospital Boston1
  • H. Lee Moffitt Cancer Center and Research Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.