Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR407899 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1 |
| Sequence 2 | EXPERIMENTAL | Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2 |
| Sequence 3 | EXPERIMENTAL | Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo |
| Sequence 4 | EXPERIMENTAL | Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil |
| Name | Type | Description |
|---|---|---|
| SAR407899 | DRUG | Oral administration |
| Placebo | DRUG | Oral administration |
| Sildenafil | DRUG | Oral administration |
Inclusion Criteria: * male with mild to moderate erectile dysfunction for at least 6 months * written informed consent Exclusion Criteria: * diabetes mellitus * orthostatic hypotension * hypogonadal testosterone level The above information is not intended to contain all considerations relevant t...
SAR407899 is an investigational small molecule being studied for the treatment of erectile dysfunction. It was evaluated in a Phase 2 clinical trial in men with mild to moderate erectile dysfunction. It is not an approved therapy and remains in clinical development.
SAR407899 targets ROCK2 and ROCK1, two isoforms of Rho-associated protein kinase. It acts as an inhibitor of these enzymes. ROCK inhibition is the mechanism under investigation for its effects in erectile dysfunction.
SAR407899 is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the clinical research conducted on this compound.
SAR407899 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.
SAR407899 was studied in a single Phase 2 trial, NCT00914277, titled SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction. The trial was completed, enrolled 24 male participants aged 18 years and older, and was randomized, double-blind, and controlled. It was conducted in France.