Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Deferasirox dispersible · 1 trial · 1 indication
The percentage of participants with adverse events, serious adverse events and deaths was assessed.
The percentage of participants with post-baseline laboratory values meeting specified criteria for notable/extended range was assessed. The following laboratory parameters were measured: platelet count, absolute neutrophils, serum creatinine , creatinine clearance, urinary protein/urinary creatinine ratio, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Note that within data categories, creat = creatinine, cons = consecutive, ULN = upper limit of normal and urin = urinary.
| Arm | Type | Description |
|---|---|---|
| Deferasirox dispersible tablet (DFX-DT) | ACTIVE_COMPARATOR | Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose. |
| Deferasirox film-coated tablet (DFX-FCT) | EXPERIMENTAL | Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose |
| Name | Type | Description |
|---|---|---|
| Deferasirox dispersible tablet | DRUG | Deferasirox DT was provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use. |
| Defearisox film-coated tablet | DRUG | Deferasirox FCT was provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use. |
Key Inclusion Criteria: * Male and female patients aged ≥ 10 years * Patients with transfusion-dependent thalassemia and iron overload, requiring deferasirox DT at doses of ≥ 30 mg/kg/day as per the investigator's decision OR Patients with very low, low or intermediate (int) risk myelodysplastic sy...
Deferasirox dispersible is used for chronic iron overload due to transfusion-dependent anemias. It is a small molecule being developed by Novartis AG for this hematologic condition. The drug is currently in Phase 2 clinical development and is considered investigational.
Deferasirox dispersible is an iron chelator that binds to iron in the body, helping to remove excess iron that accumulates from repeated blood transfusions. This mechanism addresses chronic iron overload in patients with transfusion-dependent anemias, reducing the risk of iron-related organ damage.
Deferasirox dispersible is developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is being studied for the treatment of chronic iron overload due to transfusion-dependent anemias and is currently in Phase 2 clinical trials.
Deferasirox dispersible is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 2 study has been completed to evaluate the benefits of an improved film-coated tablet formulation of deferasirox in patients with chronic iron overload.
Deferasirox dispersible has one completed clinical trial, NCT02125877, a Phase 2 study investigating the benefits of an improved film-coated tablet formulation. The trial enrolled 173 participants with chronic iron overload due to transfusion-dependent anemias across multiple countries, including the United States, Argentina, and France.
Deferasirox dispersible refers to the dispersible tablet formulation of deferasirox, while the clinical trial NCT02125877 investigated an improved film-coated tablet formulation. Both contain the same active ingredient, deferasirox, but differ in formulation. The study aimed to compare the benefits of the film-coated tablet, which may offer improved convenience.