Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BAY60-4552
BAY60-4552+ Vardenafil · 3 trials · 2 indications
Area under the plasma concentration vs time curve from zero to infinity after single dose
AUC divided by dose (mg)
Maximum drug concentration in plasma after single dose administration
Cmax divided by dose (mg)
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| Arm 4 | PLACEBO_COMPARATOR | - |
| BAY60-4552, 1 mg | EXPERIMENTAL | Subjects were planned to receive 1 mg of BAY60-4552 as solution |
| BAY60-4552, 2.5 mg | EXPERIMENTAL | Subjects were planned to receive 2.5 mg of BAY60-4552 as tablet |
| BAY60-4552, 5 mg | EXPERIMENTAL | Subjects were planned to receive 5.0 mg of BAY60-4552 as tablet |
| BAY60-4552, 7.5 mg | EXPERIMENTAL | Subjects were planned to receive 7.5 mg of BAY60-4552 as tablet |
| BAY60-4552, 10 mg | EXPERIMENTAL | Subjects were planned to receive 10 mg of BAY60-4552 as tablet |
| Name | Type | Description |
|---|---|---|
| BAY60-4552 plus Vardenafil | DRUG | Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg) |
| Vardenafil | DRUG | Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg) |
| Placebo | DRUG | Treatment with 3 tablets once daily for 4 weeks (Placebo) |
| BAY60-4552 + Vardenafil | DRUG | Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil |
| BAY60-4552 | DRUG | Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg |
Inclusion Criteria: * Open-label run-in phase (first four weeks): * Written informed consent signed before any study-specific procedure * History of ED (Erectile Dysfunction) for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis su...
BAY60-4552 + Vardenafil is an investigational combination of two small molecules developed by Bayer AG. It has been studied in Phase 2 for erectile dysfunction and in Phase 1 for heart failure. The combination pairs vardenafil, a PDE5 inhibitor, with the investigational agent BAY60-4552.
BAY60-4552 + Vardenafil has been studied for erectile dysfunction, including in men not sufficiently responsive to standard PDE5 inhibitor therapy, and for chronic heart failure. Both are investigational uses; the combination is not approved for either indication.
Bayer AG develops BAY60-4552 + Vardenafil. Bayer trades on the OTC market in the United States under the ticker BAYRY. The combination is an internal Bayer program, and the company sponsored the clinical trials conducted to date.
BAY60-4552 + Vardenafil has reached Phase 2. The Phase 2 proof-of-concept study in erectile dysfunction is completed, and two Phase 1 studies, one in erectile dysfunction and one in chronic heart failure, are also completed. No trials are currently active.
Three completed trials are registered. NCT01168817 was a Phase 2 placebo-controlled proof-of-concept study in erectile dysfunction with 140 patients across seven European countries. NCT01110590 was a Phase 1 multiple dose escalation study in 37 men in Germany, and NCT00565565 was a Phase 1 single dose escalation study in 55 chronic heart failure patients.
Yes. BAY60-4552 + Vardenafil, BAY60-4552 plus Vardenafil, and BAY60-4552 all refer to the same Bayer combination program. Searches using the shorter BAY60-4552 name point to the same asset studied in erectile dysfunction and heart failure.