Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Deferasirox dispersible tablet
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 to treat chronic iron overload caused by transfusion-dependent anemias. It is a small molecule therapy in the hematology area, developed by Novartis AG under the ticker NVS. The dispersible tablet form is designed to be mixed in liquid before it is taken.
Deferasirox dispersible is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor behind the clinical program studying this dispersible tablet formulation for chronic iron overload due to transfusion-dependent anemias.
Deferasirox dispersible is in Phase 2 clinical development. It is an investigational formulation and is not described as approved. The program includes one completed Phase 2 trial, and no trials are currently listed as active.
Deferasirox dispersible has been studied in one completed Phase 2 trial, NCT02125877, titled a Phase II study to investigate the benefits of an improved deferasirox formulation as a film-coated tablet. That trial enrolled 173 participants with chronic iron overload due to transfusion-dependent anemias across the United States, Europe, the Middle East, Asia, and Mexico.
Yes, deferasirox dispersible and deferasirox dispersible tablet refer to the same product. The dispersible tablet is the formulation name, and it is the form studied in the Phase 2 program for chronic iron overload due to transfusion-dependent anemias.
The Phase 2 trial NCT02125877 was a randomized, active-controlled study of 173 participants, and it was not double-blind. It enrolled patients aged 10 years and older of any sex, excluded healthy volunteers, and was completed across sites in the United States, Argentina, Austria, France, Germany, Greece, Italy, Lebanon, Malaysia, Mexico, Russia, Saudi Arabia, Spain, Thailand, the United Arab Emirates, and the United Kingdom.