Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Molidustat (BAY85-3934)
Molidustat · 10 trials · 3 indications
Responder is defined as meeting all of the following criteria: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment
Cmax: maximum drug concentration in plasma after single dose administration
AUC: area under the plasma concentration vs time curve from zero to infinity
Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight
Systolic, diastolic, mean blood pressure
Maximum observed drug concentration in measured matrix after single dose administration
Cmax divided by dose
Area under the concentration vs time curve from zero to infinity after single dose
AUC divided by dose
Stroke volume, heart rate, cardiac index, cardiac output, and total peripheral resistance
| Arm | Type | Description |
|---|---|---|
| Molidustat group | EXPERIMENTAL | Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo. |
| Darbepoetin alfa group | ACTIVE_COMPARATOR | Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa. |
| Molidustat (BAY85-3934) | EXPERIMENTAL | Molidustat group |
| Darbepoetin alfa | ACTIVE_COMPARATOR | Darbepoetin alfa group |
| BAY85-3934 | EXPERIMENTAL | - |
| Darbepoetin | ACTIVE_COMPARATOR | - |
| Epoetin alfa/beta | ACTIVE_COMPARATOR | - |
| Molidustat (BAY 85-3934)(25mg) | EXPERIMENTAL | Starting dose of 25 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily. |
| Molidustat (BAY 85-3934)(50mg) | EXPERIMENTAL | Starting dose of 50 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily. |
| Molidustat (BAY 85-3934) (75mg) | EXPERIMENTAL | Starting dose of 75 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily., |
| Molidustat (BAY 85-3934) (150mg) | EXPERIMENTAL | Starting dose of 150 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, 150 and 200 mg once daily |
| Arm 1 | EXPERIMENTAL | Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively) |
| Arm 2 | EXPERIMENTAL | Single oral dose of 75 mg molidustat (fasted) in subjects on peritoneal dialysis (after start of peritoneal dialysis intervall and, optionally, after the start of a peritoneal dialysis-free intervall,respectively) |
| Arm 3 | EXPERIMENTAL | Single oral dose of 75 mg molidustat (fasted) in healthy subjects |
| Molidustat, 80 mg | EXPERIMENTAL | Subjects received a single oral dose of 80 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. |
| Molidustat, 120 mg | EXPERIMENTAL | Subjects received a single oral dose of 120 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. |
| Molidustat, 40 mg | EXPERIMENTAL | Subjects received a single oral dose of 40 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. This is an optional dose escalation step. |
| Molidustat, 160 mg | EXPERIMENTAL | Subjects received a single oral dose of 160 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. This is an optional dose escalation step. |
| Name | Type | Description |
|---|---|---|
| Molidustat (BAY85-3934) | DRUG | Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD). |
| Darbepoetin alfa | DRUG | Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection. |
| Placebo of Molidustat (BAY85-3934) | DRUG | Matching placebo of Molidustat. |
| Placebo of Darbepoetin alfa | DRUG | Matching placebo of Darbepoetin alfa. |
| Darbepoetin | BIOLOGICAL | Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months. |
| Epoetin alfa/beta | BIOLOGICAL | Subjects will continue with the same treatment they were receiving in the parent study (16208). Epoetin alfa / beta will be administered as intravenous (IV) or subcutaneous (SC) injections per individual subject regimen according to the local label. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits,dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose.Total treatment time is up to 36 months. |
| Molidustat (BAY 85-3934) | DRUG | Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets |
| Molidustat(BAY85-3934) | DRUG | Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis |
| Placebo | DRUG | Single oral dose of matching placebo will be given in each treatment arm |
Inclusion Criteria: * Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization * Body weight (after dialy...
| 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 |
Molidustat is an investigational oral small molecule being studied for the treatment of anemia associated with chronic kidney disease and renal insufficiency. Development has focused on correcting and maintaining renal anemia in both dialysis and non-dialysis patients. It is not yet approved and remains in Phase 3 clinical development.
Molidustat targets the EGLN3, EGLN2, and EGLN1 enzymes and acts as an inhibitor of this target class. By inhibiting these enzymes, it is designed to stimulate erythropoiesis, the production of red blood cells, offering an oral alternative approach to managing renal anemia in chronic kidney disease patients.
Molidustat is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer has sponsored the Phase 3 clinical program evaluating the drug in renal anemia associated with chronic kidney disease and renal insufficiency.
Molidustat is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Eight trials have been completed, including four Phase 3 studies in Japan, and there are currently no active trials. The program has enrolled a total of 1,086 participants.
Molidustat has been evaluated in completed Phase 3 trials including NCT03543657 for maintenance treatment of renal anemia in dialysis subjects, NCT03418168 in peritoneal dialysis subjects, NCT03351166 for correction of renal anemia in dialysis subjects, and NCT03350347 for maintenance treatment in non-dialysis subjects. All were conducted in Japan.
Yes, Molidustat is also known as BAY85-3934 or BAY 85-3934. These are alternative names for the same investigational compound developed by Bayer AG for anemia associated with chronic kidney disease. Searches using any of these names refer to the same Phase 3 drug candidate.