Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Udenafil · 1 trial · 2 indications
AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).
| Arm | Type | Description |
|---|---|---|
| Udenafil 150 mg + Udenafil 150 mg | EXPERIMENTAL | Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. |
| Udenafil 150 mg + Placebo | EXPERIMENTAL | Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. |
| Placebo + Udenafil 150 mg | EXPERIMENTAL | Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. |
| Placebo + Placebo | PLACEBO_COMPARATOR | Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. |
| Name | Type | Description |
|---|---|---|
| Udenafil | DRUG | Udenafil tablets |
| Placebo | DRUG | Placebo tablets |
Inclusion Criteria: 1. Sign a letter of informed consent prior to performing any procedure. 2. Male 3. Clinically healthy 4. Age between 18 and 55 years old. 5. Body Mass Index (BMI) between 18.5 and 24.9. 6. Capability and disposition to attend clinical intervention period Exclusion Criteria: 1....
Udenafil is a small molecule drug being developed by Takeda Pharmaceutical Company Limited for erectile dysfunction. It is a phosphodiesterase 5 (PDE5) inhibitor and is currently in Phase 1 clinical development. It has been studied in a completed Phase 1 trial in healthy adult male volunteers.
Udenafil is being developed for the treatment of erectile dysfunction. Its clinical program has focused on this indication, and the completed Phase 1 study enrolled healthy adult male volunteers in Mexico. It remains investigational and is not yet an approved treatment.
Udenafil targets PDE5A, the phosphodiesterase 5 enzyme. It acts as an inhibitor of this target, which is the same mechanism class used by other PDE5 inhibitor drugs. This target activity underlies its development for erectile dysfunction.
Udenafil is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor associated with the clinical development program for this PDE5A inhibitor in erectile dysfunction.
Udenafil is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication based on the available development information.
Udenafil has been studied in one completed Phase 1 trial, NCT01967264, titled Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults. The trial enrolled 83 healthy male volunteers aged 18 years and older in Mexico and used a randomized, double-blind, placebo-controlled design.