Deferasirox
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | JADENU SPRINKLE | — | 2018-05-11 – 2020-07-23 | fda.gov ↗ |
| Label expansion | US (FDA) | JADENU | — | 2019-07-26 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | EXJADE | — | 2013-01-23 – 2019-07-24 | fda.gov ↗ |
| Approved | EU (EMA) | Exjade | — | 2006-08-28 | europa.eu ↗ |
| Approved | US (FDA) | EXJADE | — | 2005-11-02 | fda.gov ↗ |
Trials 83 · started per year
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials | ||||||
| Phase 2 | NCT07292259 Background | Jan 2024 → Dec 2025 | beta-thalassemia major | Pakistan Blood and Marrow Transplant (PBMT) Group | Completed | No outcome recorded |
| Phase 2 | NCT03637556 Comparator | Aug 2019 → Jun 2021 | beta-thalassemia major | DisperSol Technologies, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01927913 Comparator | Nov 2014 → Oct 2015 | beta thalassemia, disorder of iron metabolism and transport, hemosiderosis | Shire | Withdrawn | No outcome recorded |
| Phase 2 | NCT02125877 Comparator | Jul 2014 → Feb 2016 | disorder of iron metabolism and transport | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01892644 Comparator | May 2013 → Jan 2017 | hereditary hemochromatosis, myelodysplastic syndrome | Haukeland University Hospital | Withdrawn | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02065492 Background | Feb 2014 → Oct 2015 | thalassemia | Aga Khan University | Completed | No outcome recorded |
| Phase 2/3 | NCT01511848 Comparator | Feb 2012 → Feb 2013 | beta-thalassemia major, hemosiderosis, sickle cell disease | Ain Shams University | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07157722 Comparator | Aug → Dec 2025 overdue | beta thalassemia | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT01825512 Comparator | Mar 2014 → Sep 2017 | disorder of iron metabolism and transport | Consorzio per Valutazioni Biologiche e Farmacologiche | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02761395 Background | Nov 2015 → May 2017 | beta-thalassemia major | Tanta University | Unknown | No outcome recorded |
| — | NCT02474420 Background | Jun 2015 → Jun 2017 | beta thalassemia, disorder of iron metabolism and transport | Kevin H.M. Kuo, MD, MSc, FRCPC | Unknown | No outcome recorded |
| — | NCT01349699 Comparator | Feb → May 2010 | anemia, autoinflammatory syndrome | Radboud University Medical Center | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-03-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of a Generic Version of EXJADE® (deferasirox) Tablets For Oral Suspension in the United States tevapharm.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 101 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Deferasirox | “Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100” NCT06784336 ↗83“This will comprise of standard chelation drugs (Deferasirox or Deferoxamine or Combination of Deferoxamine and Deferiprone).” NCT02065492 ↗ “Patients will also continue the iron chelation therapy (Deferasirox, Deferiprone or Deferoxamine) in case of iron overload.” NCT07292259 ↗ “oral iron chelator Deferasirox -Exjade” NCT00452660 ↗ |
| Known as | Deferasirox dispersible tablet | “Deferasirox dispersible tablet (DFX-DT)” NCT02125877 ↗ |
| Known as | Deferasirox film-coated tablet | “Deferasirox film-coated tablet (DFX-FCT)” NCT02125877 ↗ |
| Known as | Deferasirox, (Exjade) | “Deferasirox, (Exjade)” NCT00901199 ↗ |
| Known as | DFX | “Comparison of safety, efficacy, compliance, treatment satisfaction, and quality of life (QoL) of two regimens: deferiprone (DFP) and deferoxamine (DFO) versus DFP and...” PMID 25600572 ↗ Mar 20155“Deferasirox (DFX) monotherapy is effective for reducing myocardial and liver iron concentrations (LIC), although some patients may require intensive chelation for a limited duration.” PMID 25934475 ↗ May 2015 “combined therapy with deferasirox (DFX, 20-30 mg/kg daily) and deferoxamine (DFO, 35-50mg/kg on 3-7 days/week)” PMID 23151373 ↗ Nov 2012 “Deferasirox DFX, DT” NCT01868477 ↗ “Deferasirox (DFX)” NCT06468423 ↗ “DFX(Deferasirox)” NCT02198508 ↗ |
| Known as | DFX-DT | “Deferasirox dispersible tablet (DFX-DT)” NCT02125877 ↗ |
| Known as | DFX-FCT | “Deferasirox film-coated tablet (DFX-FCT)” NCT02125877 ↗ |
| Known as | Exjade | “Background Following a clinical evaluation of deferasirox (Exjade) it was concluded that, in addition to baseline body iron burden, ongoing transfusional iron intake should be...” PMID 19951979 ↗ Nov 20098“The THALASSA (assessment of Exjade(®) in non-transfusion-dependent THALASSemiA patients) study assessed the efficacy and safety of deferasirox in iron-overloaded NTDT patients” PMID 25212456 ↗ Sep 2014 “Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100” NCT06784336 ↗ “Patient-reported outcomes of once-daily oral deferasirox (Exjade) in iron-overloaded patients with beta-thalassemia” PMID 20424435 ↗ Apr 2010 “Exjade® (deferasirox, ICL670)” NCT02233504 ↗ |
| Known as | ICL670 | “The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called...” NCT00600938 ↗16“Open Label, Multicenter Study to Evaluate Safety/Tolerability and Efficacy of Deferasirox (ICL670) in Myelodysplastic Syndrome Patients With Chronic Transfusional Hemosiderosis.” NCT00469560 ↗ “Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload” NCT00901199 ↗ “An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload” NCT00171210 ↗ “Drug: Deferasirox will be orally administered at a dose of 20 mg/kg once daily at evening for 5 days. Other Name: ICL670” NCT01511848 ↗ “An Open Label Trial Evaluating Cardiac T2* in Beta-thalassemia Patients on Deferasirox (ICL670) Treatment for 18 Months” NCT00447694 ↗ “Deferasirox (Exjade, ICL670) is an oral chelator with high iron-binding potency and selectivity.” NCT00171301 ↗ “Exjade® (deferasirox, ICL670)” NCT02233504 ↗ “Deferasirox (ICL670)” NCT00631163 ↗ “Deferasirox (ICL670)” NCT00395629 ↗ “Deferasirox (ICL670)” NCT00110617 ↗ |
| Known as | Jadenu | “Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100” NCT06784336 ↗2“JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.” NCT07157722 ↗ |
| Known as | osveral | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01369719 ↗ |
| Route | Oral | “The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is as effective and as safe as deferoxamine in preventing accumulation of iron in the...” NCT00061750 ↗ |