IP2018 is a monoamine reuptake inhibitor for the treatment of psychogenic erectile dysfunction (mainly caused by anxiety and depression) primarily targeting the serotonin followed by the dopamine system. IP2018 is different from IPED2015 for organic erectile dysfunction (mainly caused by diabetes and age), primarily targeting the dopamine system. The company intends to position IP2018 as a daily treatment for patients suffering from depression and sexual dysfunction and/or as a supplement to treat erectile dysfunction in patients with medically induced sexual dysfunction. IP2018 is targeting a clear unmet medical need.

IP2018 raises mainly serotonin followed by dopamine levels in the brain, and in its preclinical trials, Initiator has shown that IP2018 has an effect on both depression and erectile function, which is a clear differentiation from other antidepressants on the market today. IP2018 has demonstrated an excellent safety profile in a single dose study and the proof of mechanism PET study, confirming the safety and the mechanism of action of our extensive package of preclinical data.

Clinical status

IP2018 is being evaluated in a Phase 2a clinical trial conducted on 24 patients at the MAC Phase I unit in Manchester, UK. The Phase 2a trial is a randomized, double-blind, placebo-controlled, 3-way crossover trial studying the efficacy and safety of IP2018 in young, depressed, erectile dysfunction patients. The primary objective of this study is to investigate the effects of IP2018 on penile rigidity and tumescence using a visual sexual stimulation test. If the outcome is positive, it will be followed up with further clinical safety trials on multiple dosage parameters.