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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
Daprodustat is an investigational oral small molecule being developed for the treatment of anaemia, specifically anaemia associated with chronic kidney disease. It is being studied in patients with anaemia, including those on hemodialysis. It is not yet approved and remains in clinical development.
Daprodustat is an inhibitor of the prolyl hydroxylase enzymes EGLN1, EGLN2, EGLN3, and P4HTM. By inhibiting these enzymes, it interferes with the pathway that regulates erythropoietin production, which is relevant to red blood cell formation in anaemia associated with chronic kidney disease.
Daprodustat is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the drug in anaemia associated with chronic kidney disease.
Daprodustat is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 program includes a completed trial in Japanese hemodialysis-dependent patients with anaemia associated with chronic kidney disease.
Daprodustat has been studied in the Phase 3 trial NCT02969655, titled a study to evaluate efficacy and safety of Daprodustat compared to darbepoetin alfa in Japanese hemodialysis-dependent subjects with anemia associated with chronic kidney disease. That trial is completed and enrolled 271 participants in Japan.
The Phase 3 trial NCT02969655 was a randomized, double-blind, active-controlled study comparing Daprodustat with darbepoetin alfa in Japanese hemodialysis-dependent patients with anaemia associated with chronic kidney disease. It enrolled 271 participants aged 20 years and older and has been completed.