MED2005 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED").

MED2005 can be applied by the user or his sexual partner in a manner consistent with sexual foreplay.

DermaSys®, our proprietary transdermal drug delivery technology platform, enables the active compound to be delivered rapidly and effectively through the skin 2. This targeted local application and absorption translates into a fast onset of action (within 5-10 minutes in 69.5% of all intercourse attempts1).

Recent clinical studies

Study code Study type Study design Doses Completed Conclusions
FM53 Phase 2a Placebo-controlled, double blind, home use, crossover design 0.2% GTN September 2016
  • Met its primary endpoint of superior improvement in erectile function compared to placebo (IIEF-EF score)
  • MED2005 showed superior sexual experience compared to placebo (other IIEF domains)
  • MED2005 was well tolerated compared with other topically applied gels or PDE5 inhibitors.
FM58 PK Open-label, randomised, six-period, reference replicate, crossover study 0.2%, 0.4%, 0.6%, 0.8% GTN April 2018
  • Clear dose proportionality for the DermaSys® topical gel.

FM57 Phase 3 Multicentre, randomised, double blind, placebo controlled, home use, parallel group 0.2%, 0.4%, 0.6%, GTN Ongoing – Headline results expected end 2019
  • Study ongoing
  • Endpoints – Efficacy and safety of MED2005 in a larger patient sample and at higher doses using the EF-IIEF and SEP questionnaires

MED2005 Mode of Action

MED2005's active compound is Glyceryl Trinitrate ("GTN"). The GTN in MED2005 is absorbed into the penile blood system and is converted to nitric oxide, which has the effect of relaxing muscles surrounding the corpus cavernosa and dilating the penile arteries. This allows the corpus cavernosa to engorge with blood and, following sexual stimulation, an erection occurs.


Application of gel with active GTN

Combination of solvents including volatile solvents

Seconds later

Volatile solvents evaporate, leaving the remaining solvent supersaturated with active GTN.
As evidenced by pharmacokinetic data 2 supersaturation drives GTN rapidly through the tissue

Minutes later

Absorption into corpus cavernosum, with erection in around 5-10 minutes 1

GTN rapidly enters the systemic circulation

MED2005 Mechanism of Action

MED2005’s active compound, glyceryl trinitrate (GTN) promotes vasodilation through local absorption into penile vasculature,  minimising systemic uptake. MED2005 stimulates production of NO which leads to smooth muscle relaxation and ultimately penile erection as shown on the diagram below.

Natural NO production


Endothelial cells

Targeted treatment to drive additional NO where it is needed




PDE5i: PDE5 inhibition

Oral treatment with systemic absorption. Primarily selective for PDE5

cGMP-specific phos-phodiesterase type 5

Soluble guanylyl cyclase


Smooth muscle relaxation

Penile erection


  • Nitric Oxide
  • Guanosine Monophosphate
  • Cyclic Guanosine Monophosphate
  • Guanosine Triphosphate
  • Nonadrenergic, Noncholinergic

PK data for MED2005 compared with leading oral PDE5is

Not a comparative study - PDE5i data taken from open access studies.

Comparative dual axis pharmacokinetic graph comparing MED2005 (0.6%) vs Viagra (100mg) and Cialis (20mg) over 4hrs.


Data derived from multiple studies - illustrative purposes only

Clinical data demonstrating efficacy and safety profile

MED2005 is supported by  efficacy and safety data from a range of studies including a Phase 2a study, with the European Phase 3 study ongoing.

FM53 - Phase 2a Efficacy and safety trial

The Phase 2a clinical efficacy study met its primary endpoint. The study showed statistically significant benefit over placebo using the internationally accepted IIEF-EF trial endpoints including benefits to improve erectile function, intercourse satisfaction, orgasmic function and overall satisfaction.

An onset of action  within 5 minutes in 44.2% of intercourse attempts and within 10 minutes in 69.5% of attempts was reported. No treatment-related serious adverse events or serious adverse reactions recorded and there were no drop-outs from the study owing to side-effects.  The data was published in February 2018 in the peer-reviewed Journal of Sexual Medicine. The study results give us great confidence in the future development of the product.

FM58 – Pharmacokinetic (PK) trial

FM58 demonstrated an increase in GTN concentration corresponds to an increase in systemic availability. This supports the Company's strong belief that the higher dose forms of MED2005 could improve efficacy, including in the more severe cases of ED. MED2005 showed rapid rates of absorption and was first detected in blood plasma in 4-5 minutes, reaching peak levels in the bloodstream within 10-12 minutes for all doses.

The results from these studies enable Futura to file under the 505(b)2 regulatory pathway in the US, once the Phase 3 programme is successfully completed.

The positive data from this study indicates a new innovation with the potential to be a first line therapy in erectile dysfunction."

"MED2005 has the potential to meet the needs of primary care providers and of patients."

Professor David Ralph

Consultant Urologist

St Peter's Andrology Centre & Institute of Urology, UCLH, London

Past President of the European Society of Sexual Medicine

European Phase 3 study ongoing (FM57)

The first Phase 3 trial is a dose ranging, multicentre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically applied GTN MED2005 (study registered on This study has completed recruitment of approximately 1,000 patients at European centres with mild, moderate or severe ED and compares the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2005 against that of placebo using IIEF-EF clinical endpoints. The trial is being conducted throughout Central and Eastern Europe with a three-month study period for each patient. After patients complete this first phase, they are invited to enter the open label extension study (“OLE”) to assess safety primarily, in compliance with international guidelines, at the highest dose (0.6% GTN) up to the required number of patients. We anticipate headline efficacy results of the double-blind phase on the first Phase 3 by end of December 2019.

The second Phase 3 study (FM59) will start sequentially, will be confirmatory and include a cohort of US patients. The study will be a placebo controlled, parallel group study and will likely compare the efficacy of two GTN doses of MED2005, shown to be optimal in the first Phase 3 trial, in around 700 patients.

FM57 Clinical trial design

Subjects pre-screening


Treatment period 1
n = 1,000

MED2005 0.2%
25% of patients

MED2005 0.4%
25% of patients

MED2005 0.6%
25% of patients

25% of patients

Open Label

MED2005 0.6%
N = 300 patients
6 months use

MED2005 0.6%
N = 100 patients
12 months use


Follow-up visit

The study is being conducted in nine countries across approximately 60 sites.
(Bulgaria, Latvia, Russia, Ukraine, Slovakia, Hungary, Czech Republic, Poland, Georgia)

Clear path to regulatory approval

The development and regulatory strategy for MED2005 has been finalised. The FDA, MEB and MHRA have signaled their broad approval of the planned development programme, which apart from the recently completed PK study detailed above requires two Phase 3 studies, one of which FM57 is under way as detailed above. The Netherlands is likely to be the reference member state for any EU regulatory filing for MED2005 following Brexit.

Indicative timetable

  • If data meets qualifying criteria for EU single study pathway then EU submission Q2 2020 otherwise Q4 2020 at same time as FDA submission
  • Regulatory and ethics submissions expected in H2 2019 to allow patient enrolment to commence H1 2020
  • The US Food and Drug Administration, the Medicines and Healthcare products Regulatory Agency and the Medicines Evaluation Board respectively
  1. Ralph DJ Topical GTN in the treatment of erectile dysfunction. J Sex Med 2018
  2. Futura Medical FM58 PK Study; Data on file.