Evidence Hub

A systematic review of regulatory approved drugs and pharmacological interventions for erectile dysfunction

Rajasekhar AT, Un-Nabi SS, Kaliyamoorthy S, Anusha D, S N

The Journal of pharmacy and pharmacology, 2026

Abstract

OBJECTIVES: Erectile dysfunction (ED), or impotence, means having trouble getting or keeping an erection. The National Institutes of Health (NIH) says ED can happen to men at any age, but it's more common as men get older. This review looks at PDE5 inhibitor drugs approved by health authorities to treat ED. We carefully studied available research and clinical data to understand these drugs, how they work, how well they help, their safety, and their role in managing ED.

METHODS: A literature-based study was conducted using PubMed, ScienceDirect, and regulatory documents (FDA, EMA) from 2015-2025. Search terms included "PDE5 inhibitors," "erectile dysfunction," and "ED pharmacological interventions." Secondary data from peer-reviewed clinical trials, meta-analyses, and pharmacokinetic studies were synthesized and analyzed.

KEY FINDINGS: PDE5 inhibitors significantly improve erectile function compared with placebo across diverse patient populations. While overall efficacy among approved agents is broadly comparable, differences in onset of action, duration, and pharmacokinetic characteristics allow treatment individualization. Adverse events are generally mild, transient, and dose-related, with a favourable benefit-risk profile when prescribed in accordance with contraindications and cardiovascular risk assessment. Alternative therapies are effective in PDE5 inhibitor non-responders. Formulation innovations, including chewable dosage forms, may enhance adherence.

CONCLUSION: In…

How strong is the evidence?

Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

Read the paper

Related studies

Go deeper in Evidence Hub

Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.

Open this study Sign up free