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AVANAFIL · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Avanafil dose 1 | EXPERIMENTAL | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
| Avanafil dose 2 | EXPERIMENTAL | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
| Placebo | PLACEBO_COMPARATOR | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
| Name | Type | Description |
|---|---|---|
| AVANAFIL | DRUG | Pharmaceutical form:tablets Route of administration: oral |
| placebo | DRUG | Pharmaceutical form:tablets Route of administration: oral |
Inclusion criteria: * Male subjects, age ≥18 years. * Minimum 6-month history of mild to severe erectile dysfunction prior to the enrollment into the study. * Subject is in a monogamous, heterosexual relationship for at least 3 months prior to the enrollment into the study. * Subject agrees to make...
AVANAFIL is being developed for erectile dysfunction, a sexual function and fertility disorder. It is a small molecule PDE5A inhibitor studied in adult men aged 18 years and older. Development is in Phase 3, and the drug is investigational rather than approved.
AVANAFIL targets PDE5A, also known as phosphodiesterase type 5A, and acts as an inhibitor of that enzyme. By inhibiting PDE5A, the drug belongs to the PDE5 inhibitor class of small molecules used in the erectile dysfunction therapeutic area.
AVANAFIL is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical development program for this PDE5A inhibitor in erectile dysfunction.
AVANAFIL is in Phase 3 clinical development. It is an investigational drug and has not been established as approved. The program includes one completed Phase 3 trial, with no active trials currently listed.
AVANAFIL has been studied in a completed Phase 3 trial, NCT02503306, titled Efficacy and Tolerability Study of Avanafil in Russia. That randomized, double-blind, placebo-controlled trial enrolled 189 male participants aged 18 years and older in Russia.
AVANAFIL is the drug name used for this PDE5A inhibitor program developed by Sanofi. It is a small molecule in the PDE5 inhibitor class, studied for erectile dysfunction, and is identified in chemical databases under the ChEMBL identifier CHEMBL1963681.