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Also known as ICL670
Deferasirox granule formulation · 5 trials · 5 indications
Compliance was calculated as the ratio of total count consumed to total count prescribed of deferasirox granule stick packs or dispersible tablets, where total count consumed was derived from cumulative dispensed, returned and lost/wasted counts over 24 weeks of treatment and total count prescribed was derived from cumulative prescribed count over 24 weeks of treatment.
The analysis included the comparison of means between the two treatment arms of change from baseline after 24 weeks of treatment in serum ferritin in pediatric ICT naïve participants with iron overload. The endpoint was assessed at Week 25 visit.
Safety as assessed by the number of participants with adverse event or death after the start of ICL670.
| Arm | Type | Description |
|---|---|---|
| ICL670 | EXPERIMENTAL | - |
| Deferoxamine | ACTIVE_COMPARATOR | - |
| DFX DT | ACTIVE_COMPARATOR | Participants will be administered deferasirox dispersible tablets orally once daily based on body weight for 48 weeks. |
| DFX Granule | EXPERIMENTAL | Participants will be administered deferasirox granules orally once daily in the form of stick packs based on body weight for 48 weeks. |
| ICL670 + deferoxamine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ICL670 | DRUG | - |
| deferoxamine | DRUG | - |
| Deferasirox granule formulation | DRUG | Deferasirox granules will be provided as stick packs containing 90 mg, 180 mg and 360 mg granules for oral use and will be administered based on body weight. |
| Deferasirox DT formulation | DRUG | Deferasirox DT will be provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use and will be administered based on body weight. |
| ICL670, deferoxamine | DRUG | - |
Inclusion Criteria: * Beta-thalassemia patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day * Liver iron content greater than 2 mg iron/g dw as measured by liver biopsy * Need for regular transfusions 8 or more times per year Exclusion Criteria: * Non-trans...
Deferasirox granule formulation is used for transfusion-dependent anemia, specifically to treat iron overload in pediatric patients aged 2 to under 18 years. It is a small molecule being developed by Novartis AG for this hematology indication.
Deferasirox granule formulation is an iron chelator, meaning it binds to excess iron in the body to help remove it. This mechanism is relevant for patients with transfusion-dependent anemia who accumulate iron from repeated blood transfusions.
Deferasirox granule formulation is developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The company is conducting clinical trials to evaluate this formulation in pediatric patients.
Deferasirox granule formulation is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 2 trial has been completed, involving 224 participants.
Deferasirox granule formulation has one completed Phase 2 trial, NCT02435212, titled 'Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload.' The trial enrolled 224 patients across multiple countries.
Deferasirox granule formulation is an improved formulation of deferasirox, an iron chelator. It is designed as granules, which may offer advantages over existing forms, but it is a distinct product under investigation for pediatric use.