Men's Health Istanbul

Science — Explained

Simenafil: a new ED pill in clinical trials

A new pill from the same family as Viagra and Cialis is working its way through clinical trials. Here is where it stands.

By Men's Health Istanbul Editorial Team2 min read

Phase 1 Phase 2 Phase 3 Approval
Illustration: Men's Health Istanbul

Editorial

Editorial processWritten by the Men's Health Istanbul editorial team, based on the published sources listed below.

Published

Updated

The short answer

Simenafil is an experimental PDE5 inhibitor, the same drug family as sildenafil and tadalafil. Phase 2 trials suggest it improves erections compared with placebo. It is still in clinical trials and is not an approved treatment.

Key takeaways

  • In a phase 2 trial of 255 men, simenafil improved erectile function compared with placebo.
  • Most side effects were mild to moderate, and they became more common at higher doses.
  • A further phase 2 study was published in September 2026. Larger phase 3 trials are the next step.

What is simenafil?

Simenafil belongs to the PDE5 inhibitor family, the group of medicines that includes sildenafil (Viagra) and tadalafil (Cialis). These drugs help the blood vessels in the penis relax so that blood can flow in during arousal.

What the trials found

In a multicentre phase 2 trial, 255 men with ED for at least three months took placebo or simenafil (5, 10 or 20 mg) when needed, for eight weeks. Men taking simenafil had better erectile function scores than those on placebo. Side effects were mostly mild to moderate and fitted what you would expect from this drug family; they were reported more often as the dose went up. In September 2026, results from another randomised, double-blind, placebo-controlled phase 2 study were published.

What we still don't know

Simenafil has not been compared head to head with existing ED pills, and it has not been studied specifically in groups such as men with diabetes. The researchers say larger and longer phase 3 trials are needed.

The bottom line

Promising, but not yet a treatment you can get. Existing ED pills work for many men, and if they don't work for you, there are other effective options. A urologist can help you find out why.

Questions men also ask

Is simenafil better than Viagra?

We don't know. It has not been compared directly with existing pills.

When will it be available?

Only if phase 3 trials succeed and regulators approve it. There is no confirmed date.

Sources & further reading

  1. UroToday Efficacy and safety of simenafil in men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group phase 2 trial (abstract) (opens in a new tab)
  2. UroToday Latest erectile dysfunction research (includes the 14 Sep 2026 phase II crossover study) (opens in a new tab) (2026)

Concerned about something you've read?

Ask one of our specialists privately. There is no obligation, and no question is too awkward.

Ask the UrologistGet a confidential medical opinion

This article summarises published research for general information. Some treatments mentioned are experimental and not approved. It is not medical advice; please speak to your doctor before starting or changing any treatment. Read our editorial policy and medical review policy.

From the clinic

Related clinical guides

Our clinical guides explain diagnosis and treatment in more detail.

Keep reading

Related stories

Ask the Urologist

Concerned about something you've read?

Ask one of our specialists privately. No question is too awkward.

Come for an answer. Stay for the conversation.

The Man Cave Briefing

Men's health worth knowing about. No spam. No awkward marketing.

  • The week's biggest men's health story
  • New research, explained
  • One question answered by a doctor
  • One conversation worth having

We only ask for your email address. Please do not send us any health information here.