MedPath

Avanafil

Generic Name
Avanafil
Brand Names
Spedra, Stendra
Drug Type
Small Molecule
Chemical Formula
C23H26ClN7O3
CAS Number
330784-47-9
Unique Ingredient Identifier
DR5S136IVO
Background

Avanafil is a phosphodiesterase-5 (PDE5) inhibitor used in the treatment of erectile dysfunction. In comparison with other drugs of the same class, it shows greater selectivity for PDE5 over PDE6 than both sildenafil and vardenafil but less selectivity than tadalafil, suggesting a relatively lower risk of visual disturbances associated with off-target PDE6 inhibition.

It first received FDA approval on April 27, 2012, with subsequent EMA approval in June 2013.

Indication

Avanafil is indicated for the treatment of erectile dysfunction.

Associated Conditions
Erectile Dysfunction
Associated Therapies
-

Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction

Phase 3
Completed
Conditions
Erectile Dysfunction
Interventions
First Posted Date
2009-03-02
Last Posted Date
2012-08-17
Lead Sponsor
VIVUS LLC
Target Recruit Count
712
Registration Number
NCT00853606
Locations
🇺🇸

Research Site, Spring, Texas, United States

Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)

Phase 3
Completed
Conditions
Erectile Dysfunction
Interventions
Drug: placebo
Drug: avanafil
First Posted Date
2008-12-17
Last Posted Date
2012-08-17
Lead Sponsor
VIVUS LLC
Target Recruit Count
390
Registration Number
NCT00809471
Locations
🇺🇸

Research Site, Spring, Texas, United States

Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED

Phase 3
Completed
Conditions
Erectile Dysfunction
Interventions
Drug: placebo
Drug: avanafil
First Posted Date
2008-11-13
Last Posted Date
2012-07-11
Lead Sponsor
VIVUS LLC
Target Recruit Count
646
Registration Number
NCT00790751
Locations
🇺🇸

Research Site, Spring, Texas, United States

To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil

Phase 1
Completed
Conditions
Erectile Dysfunction
Interventions
First Posted Date
2008-10-09
Last Posted Date
2009-12-02
Lead Sponsor
VIVUS LLC
Target Recruit Count
44
Registration Number
NCT00770042
Locations
🇺🇸

Research Site, Lincoln, Nebraska, United States

A Thorough EKG Safety Study of TA-1790 (Avanafil)

Phase 1
Completed
Conditions
Erectile Dysfunction
Interventions
First Posted Date
2008-10-08
Last Posted Date
2011-01-07
Lead Sponsor
VIVUS LLC
Target Recruit Count
57
Registration Number
NCT00769041
Locations
🇺🇸

Covance Phase 1 Clinical Unit, Madison, Wisconsin, United States

© Copyright 2025. All Rights Reserved by MedPath