Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daprodustat small · 1 trial · 1 indication
The mean hemoglobin during the Evaluation Period was estimated by a statistical model.
| Arm | Type | Description |
|---|---|---|
| Daprodustat | EXPERIMENTAL | Subjects will receive oral daprodustat once daily and intravenous (IV) darbepoetin alfa placebo once weekly for 52 weeks |
| Darbepoetin alfa | ACTIVE_COMPARATOR | Subjects will receive IV darbepoetin alfa once weekly and oral daprodustat placebo once daily for 52 weeks |
| Name | Type | Description |
|---|---|---|
| Daprodustat small | DRUG | Available as 7.0 millimeter (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of daprodustat as active ingredient |
| Daprodustat small placebo | DRUG | Available as 7.0 mm round, standard biconvex, white film coated tablets containing no daprodustat |
| Daprodustat large | DRUG | Available as 9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of daprodustat as active ingredient |
| Daprodustat large placebo | DRUG | Available as 9.0 mm round, standard biconvex, white film coated tablets containing no daprodustat |
| Darbepoetin alfa | DRUG | Available as 0.5 mL plastic prefilled syringes (PFS) for IV injection each containing 10, 15, 20, 30, 40 or 60 mcg of darbepoetin alfa in a clear and colorless solution. |
| Darbepoetin alfa placebo | DRUG | Available as 0.5 mL plastic PFS for IV injection containing no darbepoetin alfa in a clear and colorless solution. |
Inclusion Criteria * Age (informed consent): \>=20 years of age * Dialysis: On HD or hemodiafiltration (HDF) given three times weekly for at least 12 weeks prior to screening * ESAs: Use of one and the same ESA for 10 weeks prior to screening * ESA dose: Darbepoetin alfa 10 to 60 μg per week, epoet...
Daprodustat small is an investigational small molecule being developed for the treatment of anaemia. It is being studied in patients with anaemia associated with chronic kidney disease, specifically in a Phase 3 clinical trial. The drug is not yet approved and remains in clinical development.
Daprodustat small is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of anaemia.
Daprodustat small is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for the treatment of anaemia associated with chronic kidney disease.
Daprodustat small has one completed Phase 3 clinical trial registered as NCT02969655. This randomized, double-blind, active-controlled study evaluated the efficacy and safety of daprodustat compared to darbepoetin alfa in Japanese hemodialysis-dependent subjects with anemia associated with chronic kidney disease. The trial enrolled 271 participants.
Daprodustat small is not FDA approved. It is an investigational drug currently in clinical development, having completed a Phase 3 trial. The drug has not received regulatory approval and remains under investigation for the treatment of anaemia associated with chronic kidney disease.