Last reviewed · How we verify
BAY60-4552 plus Vardenafil
BAY60-4552 activates soluble guanylate cyclase to increase cGMP levels, while vardenafil inhibits phosphodiesterase-5 to prevent cGMP degradation, synergistically enhancing vasodilation and improving erectile function.
BAY60-4552 activates soluble guanylate cyclase to increase cGMP levels, while vardenafil inhibits phosphodiesterase-5 to prevent cGMP degradation, synergistically enhancing vasodilation and improving erectile function. Used for Erectile dysfunction, Pulmonary hypertension.
At a glance
| Generic name | BAY60-4552 plus Vardenafil |
|---|---|
| Sponsor | Bayer |
| Drug class | Soluble guanylate cyclase activator + phosphodiesterase-5 inhibitor combination |
| Target | Soluble guanylate cyclase (sGC) and phosphodiesterase-5 (PDE-5) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Mechanism of action
BAY60-4552 is a soluble guanylate cyclase activator that directly stimulates the enzyme to produce cyclic GMP (cGMP), a key signaling molecule in vascular smooth muscle relaxation. Vardenafil is a phosphodiesterase-5 (PDE-5) inhibitor that prevents the breakdown of cGMP. Together, this combination provides dual pathway enhancement of cGMP signaling, potentially offering greater efficacy than either agent alone in conditions characterized by impaired nitric oxide-cGMP signaling.
Approved indications
- Erectile dysfunction
- Pulmonary hypertension
Common side effects
- Headache
- Flushing
- Dyspepsia
- Hypotension
Key clinical trials
- Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors (PHASE2)
- Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552 (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BAY60-4552 plus Vardenafil CI brief — competitive landscape report
- BAY60-4552 plus Vardenafil updates RSS · CI watch RSS
- Bayer portfolio CI