JADENU SPRINKLE (deferasirox)
JADENU SPRINKLE is indicated for the treatment of Chronic Iron Overload; Thalassemia.
How JADENU SPRINKLE Works
Deferasirox is an orally active, tridentate ligand that demonstrates high affinity and selectivity for ferric iron ($Fe^{3+}$). It binds iron in a 2:1 ratio (two molecules of deferasirox per one atom of iron), forming a stable complex that facilitates iron excretion. While highly selective for iron, it has a low affinity for zinc and copper, though variable decreases in these trace metals may occur during therapy.
Details
- Status
- Prescription
- First Approved
- 2017-05-18
- Routes
- ORAL
- Dosage Forms
- GRANULE
JADENU SPRINKLE Approval History
What JADENU SPRINKLE Treats
2 indicationsJADENU SPRINKLE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Iron Overload
- Thalassemia
JADENU SPRINKLE Boxed Warning
RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE Renal Failure Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m 2 . Measure serum creatinine in duplicate prior to ...
WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE Renal Failure Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m 2 . Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with preexisting renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation [see Dosage and Administration (2.1 , 2.4 , 2.5 ), Warnings and Precautions (5.1) , Adverse Reactions (6.1 , 6.2 )]. Hepatic Failure Deferasirox can cause hepatic injury including hepatic failure and death. Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter. Avoid use of deferasirox in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child-Pugh B) hepatic impairment [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.2 )]. Gastrointestinal Hemorrhage Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts. Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage [see Warnings and Precautions ( 5.3 )]. WARNING: RENAL FAIL
JADENU SPRINKLE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
28 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07023666 | INOVA-2023-159 | Ph 2 | recruiting | Early Screening and Treatment of Heart Complication in Sickle Cell Disease |
| NCT03387475 LODEFI | 38RC17.064 | Ph 2 | completed | Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk MDS Resistant or Relapsing After ESA Agents |
| NCT01892644 DefeHEMY | 2012/2139 | Ph 2 | withdrawn | Treatment of Iron Overload With Deferasirox (Exjade) in Hereditary Hemochromatosis and Myelodysplastic Syndrome |
| NCT00749515 results posted | 07090349 NIH/NHLBI 1 K12 HL087164-01 | Ph 4 | completed | Pilot Study for Patients With Poor Response to Deferasirox |
| NCT03920657 | FISM_IRON-MDS | Ph 2 | terminated | 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 |
| NCT01927913 | SPD602-204 FBS0701 (SSP-004184), 2013-000743-33 | Ph 2 | withdrawn | Treatment of Iron Overload Requiring Chelation Therapy |
| NCT01825512 results posted | DEEP-2 | Ph 3 | completed | Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients |
| NCT00940602 TELESTO results posted | CICL670A2302 2009-012418-38 | Ph 2 | completed | Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study |
| NCT03372083 MIMAS results posted | CICL670F2429 2016-003482-25 | Ph 4 | completed | Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis |
| NCT02943668 results posted | 9422 NCI-2016-01457, 9422 | Ph 2 | terminated | Deferasirox in Treating Patients With Very Low, Low, or Intermediate-Risk Red Blood Cell Transfusion Dependent Anemia or Myelodysplastic Syndrome |
| NCT02720536 results posted | CICL670AIC04 | Ph 3 | completed | Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation |
| NCT02341495 EXJADE results posted | 204961 | Ph 2 | terminated | Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65 |
| NCT01459718 results posted | CICL670AGR02 2009-018091-34 | Ph 2 | terminated | Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload |
| NCT01709838 THETIS results posted | CICL670E2419 2012-000650-64 | Ph 4 | completed | Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia |
| NCT01159067 results posted | 09187 NCI-2010-01428 | Ph 2 | terminated | Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload |
| NCT01273766 results posted | IRB00015287 NCI-2010-02228, CCCWFU 97710 | Ph 2 | completed | Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies |
| NCT02663752 EXPHAR results posted | CICL670ABE04 | Ph 2 | terminated | A Phase II Pilot Study to Assess the Presence of Molecular Factors Predictive for Hematologic Response in Myelodysplastic Syndrome Patients Receiving Deferasirox Therapy. |
| NCT01948817 | CICL670A2420 2013-002624-16 | Ph 2 | withdrawn | Deferasirox BID (Twice a Day) in Transfusion Dependent Thalassemia Patients With Inadequate Response to High Doses |
| NCT02069886 CENTAurus | CICL670AIT12 | Ph 4 | withdrawn | Effect of Deferasirox on Endocrine Complications in Subjects With Transfusion Dependent Thalassemia |
| NCT01724138 MACS2163 | CICL670ACN02 | Ph 4 | withdrawn | 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 |
| NCT01326845 MACS1574 results posted | CICL670A2417 2011-001077-13 | Ph 4 | terminated | Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study |
| NCT00981370 results posted | CICL670AUS30T | Ph 3 | terminated | Clinical Importance of Treating Iron Overload in Sickle Cell Disease |
| NCT00879242 | CICL670AIT07 EUDRACT Code :2008-003230-22 | Ph 2 | completed | Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec |
| NCT01250951 | CICL670ARU01 | Ph 4 | completed | This Study Will Evaluate Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndromes (MDS), Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload. |
| NCT00654589 | CICL670ADE02 | Ph 4 | completed | Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload |
| NCT00599326 results posted | CICL670A US17 IRB File Number 062007-047 | Ph 3 | completed | Pilot Trial of Deferasirox in the Treatment of Porphyria Cutanea Tarda |
| NCT00873041 THALASSA results posted | CICL670A2209 EudraCT 2007-007000-15 | Ph 2 | completed | Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study |
| NCT01335035 | CICL670AES04 EudraCT: 2008-003207-30 | Ph 4 | completed | Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JADENU SPRINKLE FDA Label Details
Indications & Usage
FDA Label (PDF)JADENU SPRINKLE is indicated for the treatment of Chronic Iron Overload; Thalassemia.
WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE Renal Failure Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Evaluate baseline renal function prior to s...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.