Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY60-4552+ Vardenafil · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| Arm 4 | PLACEBO_COMPARATOR | - |
| 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 |
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 is an investigational small molecule being developed for heart failure and erectile dysfunction. It is being studied in patients with chronic heart failure and in men with erectile dysfunction, including those not sufficiently responsive to standard PDE5 inhibitor therapy. The drug is in clinical development and is not approved.
BAY60-4552 is being developed by Bayer AG, a German pharmaceutical company. Bayer AG trades on the OTC market under the ticker BAYRY. The company is conducting clinical trials of BAY60-4552 in cardiovascular and erectile dysfunction indications.
BAY60-4552 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and one Phase 2 proof-of-concept study has also been completed. The drug remains investigational and has not received regulatory approval.
BAY60-4552 has been studied in three completed clinical trials. NCT00565565 was a single-dose escalation study in chronic heart failure patients. NCT01110590 was a multiple-dose study of vardenafil and BAY60-4552 in erectile dysfunction. NCT01168817 was a Phase 2 proof-of-concept study combining BAY60-4552 with vardenafil for erectile dysfunction.
BAY60-4552 is a small molecule being studied for its effects in cardiovascular and erectile dysfunction conditions. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated in combination with vardenafil, a PDE5 inhibitor, for erectile dysfunction.
No, BAY60-4552 is not the same as vardenafil. BAY60-4552 is a separate investigational drug being studied alone and in combination with vardenafil. Clinical trials have evaluated BAY60-4552 both as a single agent and in combination with vardenafil for erectile dysfunction.