FDA updates in urology: January 2026

Welcome to Urology Times’® monthly FDA update! The year began with a couple of notable regulatory updates, including fast track designation for a novel platform that can deliver enzalutamide (Xtandi) directly into prostate tissue as well as FDA clearance for a new kidney stone device.

Stay informed with our FDA recap, delivered during the first week of each new month. To stay even more informed on the latest from Urology Times, subscribe to our newsletters!

FDA News in Urology from January 2026

1. FDA grants fast track designation to Enolen for localized prostate cancer

On January 8, 2026, Alessa Therapeutics announced that the FDA had granted fast track designation to Enolen for the treatment of low- to intermediate-risk localized prostate cancer. This designation is based on preclinical data supporting sustained local delivery of enzalutamide via antiandrogen-eluting implants with high intraprostatic drug concentrations and minimal systemic exposure. Enolen is currently being evaluated in a phase 1 trial, with initial readouts planned in 2026.

2. FDA grants 510(k) clearance to Break Wave lithotripsy device for kidney stones

On January 21, 2026, SonoMotion announced FDA 510(k) clearance for the Break Wave lithotripsy device for the treatment of patients with kidney stones. This approval was supported by data from the pivotal SOUND trial, which demonstrated the safety and efficacy of the noninvasive, anesthesia-free, low-pressure focused ultrasound system in patients with upper urinary tract stones. Break Wave can be used in conjunction with SonoMotion’s previously cleared Stone Clear device to fragment stones and facilitate post-procedural fragment clearance.