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A New Drug Treatment for Erectile Dysfunction?


Since the release of Viagra in 1998, PDE5 inhibitors have been the front-line drug therapy for erectile dysfunction. Type 5 phosphodiesterase (PDE5) inhibitors, which include sildenafil, tadalafil, vardenafil, and avanafil, allow about 65% of men with erectile dysfunction to achieve an erectile.

A new drug, pudafensine (iped2015), is currently being tested in clinical trials. It is the first oral medication which is based on an entirely different principle, and it is targeted specifically at men who do not respond to PDE5 inhibitors. According to the developer, Initiator Pharma, “Pudafensine strengthens the natural erection response by having a dual-action, both a central effect initiating erection and a peripheral effect potentiating erection through smooth muscle relaxation.”

“Pudafensine has demonstrated positive results from its Phase IIb clinical trial with pudafensine (IP2015) for the treatment of erectile dysfunction (ED). The study data analysis has demonstrated statistically significant and clinically relevant efficacy in ED-related endpoints and no observations of critical adverse events.”

Early results have been promising, but drugs that are in clinical trials are still years away from general availability.

REDEYE Equity Research issued a report1 on Initiator Pharma in August, 2023, stating that “We believe that Initiator Pharma’s most advanced program, pudafensine (IPED2015), is wellpositioned to fundamentally change the treatment paradigm for erectile dysfunction (ED). Its
active pharmaceutical ingredient (API), IP2015, has a unique dual-action mechanism –
strengthening both the sexual drive of patients and increasing penile blood flow – which
distinguishes it from its competitors and provides it with a broader reach.”

We have reached out to Initiator Pharma for details of further clinical trials and have received no response.

Related Reading

Oral Medications for Erectile Dysfunction: Viagra, Cialis, and Levitra Compared


  1. “Initiator Pharma.” REDEYE Equity Research. August 25, 2023.

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