Drug

Avanafil

Approved · EMA

Emerging researchLate-stage development

Also known as (S)-4-(3-Chloro-4-methoxybenzylamino)-2-(2-hydroxymethylpyrrolidin-1-yl)-N-pyrimidin-2-ylmethyl-5-pyrimidinecarboxamide, Stendra, Avanafilo.

RxNorm1291301 ChEMBLCHEMBL1963681UNIIDR5S136IVO

Research papers

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Evaluation of the Clinical and Molecular Efficacy of Daily Avanafil in Egyptian Males With Erectile and Endothelial Dysfunction (Randomized Placebo-Controlled Study)

Clinical trial2019-10-10Completed · ClinicalTrials.gov

Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction: Non- Inferiority, Randomized, Crossover, Open Clinical Trial

Clinical trial2018-06-01Primary completion · ClinicalTrials.gov

Clinical Trial on Efficacy and Tolerability of Two Different Single Doses of Avanafil in Russia

Clinical trial2016-03-01Completed · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Clinical Trial of the Effect of Avanafil (STENDRA™) on Spermatogenesis in Healthy Adult Males and Adult Males With Mild Erectile Dysfunction

Clinical trial2015-12-14Results posted · ClinicalTrials.gov

A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Parallel Study to Assess the Effects of Avanafil (STENDRA™) on Multiple Parameters of Vision, Including, But Not Limited to Visual Acuity, Intraocular Pressure, Pupillometry, and Color Vision Discrimination, in Healthy Male Subjects

Clinical trial2015-03-13Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men With Erectile Dysfunction

Clinical trial2014-10-27Results posted · ClinicalTrials.gov

Approval: Spedra (EMA)

Regulatory2013-06-21EMA

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy

Clinical trial2012-10-01Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in the Treatment of Erectile Dysfunction in Diabetic Men

Clinical trial2012-08-17Results posted · ClinicalTrials.gov

An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction

Clinical trial2012-08-17Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in Subjects With Generalized Erectile Dysfunction

Clinical trial2012-07-11Results posted · ClinicalTrials.gov

A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction.

Research2012-01-16The journal of sexual medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Avanafil

Aliases & brands

(S)-4-(3-Chloro-4-methoxybenzylamino)-2-(2-hydroxymethylpyrrolidin-1-yl)-N-pyrimidin-2-ylmethyl-5-pyrimidinecarboxamideStendraAvanafilo

RxNorm CUI

1291301

ChEMBL ID

CHEMBL1963681

UNII

DR5S136IVO

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2013-06-21

Latest approval

2013-06-21

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2013-06-21Approval

Approval: Spedra (EMA)

Indication: Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.

Evidence ↗