Sustained Therapeutics – Presents Positive Phase 2 Data for ST-01 in Podium Presentation at the American Urological Association 2026 Annual Meeting

Why It Matters

The results validate a non‑opioid, office‑based therapy for CSCP, a condition affecting millions and lacking effective long‑term treatments. Successful Phase 3 progression could reshape urologic pain management and reduce reliance on opioids and surgery.

Key Takeaways

• ST-01 70 mg/mL achieved 67% pain‑response vs 26% control
• 83% of ST-01 patients met clinical response versus 32% control
• Phase 2 enrolled 63 men across eight Canadian sites
• Crossover patients showed >80% response after switching to ST‑01
• Company targets Phase 3 to address 5 million North American CSCP patients

Pulse Analysis

Chronic scrotal content pain (CSCP) remains a largely overlooked urologic condition, impacting an estimated five million men in North America. Current therapeutic options range from oral analgesics and opioids to invasive surgeries, each with limited durability and significant side‑effect profiles. A non‑opioid, localized treatment that can be administered in an office setting promises to fill a critical gap, improving patient quality of life while mitigating the broader opioid crisis that continues to strain healthcare resources.

In the recent Phase 2 trial, Sustained Therapeutics evaluated repeat monthly dosing of ST‑01, a proprietary lidocaine polymer solution, in 63 men across eight Canadian sites. The 70 mg/mL formulation produced statistically significant improvements: 67% of participants achieved a ≥2‑point pain reduction versus 26% in the lidocaine control arm, and 83% met clinical response thresholds compared with 32% of controls. The study also reported that patients who crossed over from standard care to ST‑01 experienced over an 80% response rate, underscoring the therapy’s robust efficacy and tolerability. These outcomes suggest that ST‑01 can deliver durable analgesia without the systemic exposure associated with oral opioids.

Looking ahead, Sustained Therapeutics plans to advance ST‑01 into Phase 3 trials, targeting the broader CSCP population and potentially expanding into chronic pelvic pain, which affects roughly 13 million North Americans. The company’s sustained‑release platform could also be leveraged for other urologic indications, positioning it as a versatile asset in a market hungry for innovative, low‑risk pain solutions. Successful commercialization would not only generate significant revenue—given the high prevalence of CSCP—but also set a new standard for non‑surgical, non‑opioid pain management in urology.