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
- -
Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction
- First Posted Date
- 2017-05-30
- Last Posted Date
- 2017-05-30
- Lead Sponsor
- Eduardo Vargas-Baquero
- Target Recruit Count
- 78
- Registration Number
- NCT03169582
- Locations
- 🇪🇸
Hospital Nacional de Paraplejicos, Toledo, Spain
Efficacy and Tolerability Study of Avanafil in Russia
- Conditions
- Sexual Function and Fertility Disorders NEC-Erectile Dysfunction
- Interventions
- Drug: AVANAFILDrug: placebo
- First Posted Date
- 2015-07-20
- Last Posted Date
- 2016-03-17
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 189
- Registration Number
- NCT02503306
Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction
- First Posted Date
- 2015-06-22
- Last Posted Date
- 2015-06-24
- Lead Sponsor
- Pusan National University Hospital
- Target Recruit Count
- 159
- Registration Number
- NCT02477436
- Locations
- 🇰🇷
Department of Urology, Pusan National University Hospital, Busan, Korea, Republic of
Study Evaluating the Effects of Avanafil on Semen Parameters
- First Posted Date
- 2013-01-15
- Last Posted Date
- 2015-12-14
- Lead Sponsor
- VIVUS LLC
- Target Recruit Count
- 181
- Registration Number
- NCT01768676
- Locations
- 🇺🇸
Research Facility, San Antonio, Texas, United States
Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects
- First Posted Date
- 2010-03-30
- Last Posted Date
- 2011-01-07
- Lead Sponsor
- VIVUS LLC
- Target Recruit Count
- 24
- Registration Number
- NCT01095601
To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects.
- First Posted Date
- 2010-01-22
- Last Posted Date
- 2011-01-07
- Lead Sponsor
- VIVUS LLC
- Target Recruit Count
- 27
- Registration Number
- NCT01054430
A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.
- First Posted Date
- 2010-01-22
- Last Posted Date
- 2011-01-07
- Lead Sponsor
- VIVUS LLC
- Target Recruit Count
- 15
- Registration Number
- NCT01054859
To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.
- First Posted Date
- 2010-01-22
- Last Posted Date
- 2011-01-07
- Lead Sponsor
- VIVUS LLC
- Target Recruit Count
- 24
- Registration Number
- NCT01054261
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil
- First Posted Date
- 2009-05-19
- Last Posted Date
- 2010-04-23
- Lead Sponsor
- JW Pharmaceutical
- Target Recruit Count
- 208
- Registration Number
- NCT00903981
- Locations
- 🇰🇷
Chonbuk national university hospital, Chonju, Cholabukdo, Korea, Republic of
Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy
- First Posted Date
- 2009-05-07
- Last Posted Date
- 2012-10-01
- Lead Sponsor
- VIVUS LLC
- Target Recruit Count
- 298
- Registration Number
- NCT00895011
- Locations
- 🇺🇸
Research Site, Richmond, Virginia, United States
Drug Development Updates
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