NX-1207: a novel investigational drug for the treatment of benign prostatic hyperplasia.

IMPORTANCE OF THE FIELD: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) is a common affliction among older men that can have significant impact on health-related quality of life. BPH is a progressive condition that can lead to complications including acute urinary retention (AUR) and to surgical intervention. There is an ongoing need for new, safe and effective treatments for BPH. Currently available therapies have significant safety and efficacy limitations. NX-1207 is a promising first-in-class drug currently in Phase III trials for the treatment of BPH. AREAS COVERED IN THIS REVIEW: This review provides an overview of BPH and currently approved medical treatments and drugs as described in the literature and treatment practice guidelines in the past 10 years, an outline of the results of the Phase II trials of NX-1207 and an expert opinion on the role NX-1207 may play in the treatment of men with clinical BPH. WHAT THE READER WILL GAIN: This review aims to introduce readers to NX-1207, a new treatment for BPH that is administered in an office-based procedure by transrectal intraprostatic injection under ultrasound guidance. NX-1207 has selective pro-apoptotic properties, which induces focal cell loss in prostate leading to prostate volume reduction with both short- and long-term symptomatic improvement. TAKE HOME MESSAGE: In four US clinical trials to date, NX-1207 has shown evidence of symptomatic improvement substantially better than currently approved BPH medications with no significant safety issues. Larger Phase III trials are ongoing to further confirm the efficacy, safety and tolerability for this minimally invasive, anesthetic free, clinic-based treatment for BPH.