Sumitomo Pharma America Presents AUA 2026 Data Showing Vibegron Benefits in Older Men With Overactive Bladder and BPH
Sumitomo Pharma America presented new clinical and real-world evidence from its urology and oncology portfolios at the American Urological Association 2026 Annual Meeting, highlighting updated findings related to overactive bladder treatment and advanced prostate cancer management. The data presentations, delivered during the meeting held in Washington from May 15 through May 18, focused on patient populations with complex treatment needs, including older men with overactive bladder symptoms and patients receiving therapy for advanced prostate cancer.
Among the key highlights were subgroup analyses from the Phase 3 COURAGE trial evaluating vibegron in elderly male patients with overactive bladder who were already receiving treatment for benign prostatic hyperplasia, as well as interim real-world findings from the OPTYX observational study evaluating relugolix in prostate cancer care.
The company said the new presentations reinforce its broader commitment to advancing evidence-based treatment strategies in urologic diseases and improving physician understanding of how therapies perform in populations that are often underrepresented in clinical research.
According to Tsutomu Nakagawa, President and Chief Executive Officer of Sumitomo Pharma America, the company’s participation at AUA 2026 reflects its continued focus on generating clinically meaningful evidence for patients facing complex urologic conditions.
Nakagawa stated that the company is particularly focused on supporting clinicians who manage high-risk or medically challenging patient groups, including men older than 75 years with overactive bladder who are also receiving pharmacologic therapy for benign prostatic hyperplasia, as well as individuals navigating treatment decisions in advanced prostate cancer.
He emphasized that the goal of the company’s research efforts is to provide physicians with robust clinical and real-world data that can help guide individualized, patient-centered treatment strategies.
One of the most prominent presentations involved a subgroup analysis from the placebo-controlled Phase 3 COURAGE study evaluating once-daily vibegron 75 mg in men experiencing symptoms of overactive bladder while concurrently receiving pharmacologic therapy for benign prostatic hyperplasia, commonly referred to as BPH.
Overactive bladder is a chronic urologic condition characterized by urinary urgency, increased urinary frequency, nocturia, and, in some patients, urge urinary incontinence. The condition can significantly impair quality of life, particularly among older adults. Benign prostatic hyperplasia, meanwhile, is a common age-related enlargement of the prostate gland that can also contribute to urinary symptoms.
Managing both conditions simultaneously can be particularly challenging in elderly men because symptoms may overlap and certain medications can increase the risk of side effects or treatment complications.
The COURAGE subgroup analysis focused specifically on men aged 75 years and older. Participants in the study were already receiving stable treatment regimens consisting of alpha-blockers with or without 5-alpha-reductase inhibitors for management of BPH symptoms.
According to the findings presented at the meeting, older men treated with vibegron experienced clinically meaningful improvements in several key urinary symptom measures over a 24-week treatment period.
Among men aged 75 years and older, patients receiving vibegron demonstrated reductions from baseline in average daily micturitions and urgency episodes compared with placebo-treated patients. The analysis included 92 patients treated with vibegron and 100 patients receiving placebo.
Specifically, the average reduction in daily micturitions was 2.3 episodes in the vibegron group compared with 1.5 episodes in the placebo group. Similarly, urgency episodes declined by 3.6 episodes in the vibegron group compared with 2.3 episodes in the placebo group.
Investigators noted that the magnitude of improvement observed in elderly patients was generally comparable to outcomes seen among younger men enrolled in the broader COURAGE trial population.
The therapy was also reported to be generally well tolerated in older patients, with a safety profile similar to that observed in men younger than 75 years of age.
Lead poster author Sender Herschorn, Professor of Surgery and Urology at the University of Toronto, said older men frequently face the difficult challenge of managing persistent overactive bladder symptoms while already receiving ongoing treatment for benign prostatic hyperplasia.
Herschorn explained that the subgroup findings are encouraging because they suggest vibegron may offer meaningful symptom relief in a patient population often considered more difficult to treat due to age-related factors, comorbidities, and concurrent medication use.
He also noted that the safety findings were important because tolerability concerns can significantly influence treatment selection in elderly populations, particularly when patients are already taking multiple medications.
In addition to the primary subgroup analysis, Sumitomo Pharma America also presented exploratory findings examining the effect of vibegron on sexual function in men enrolled in the COURAGE study.
That analysis was delivered during a podium presentation led by Kenneth Peters of Corewell Health William Beaumont University Hospital.
Sexual function represents an important consideration in the treatment of urinary disorders among male patients, especially those receiving medications for benign prostatic hyperplasia. Certain therapies used to treat urinary symptoms can potentially affect erectile function, libido, or overall sexual health, making evaluation of these outcomes clinically relevant.
While detailed efficacy findings from the sexual function analysis were not fully outlined in the announcement, the presentation reflects growing attention within urology toward understanding broader quality-of-life outcomes associated with treatment interventions.
The company also highlighted oncology-focused data presented at the meeting involving relugolix, a therapy used in advanced prostate cancer management.
In a separate poster presentation, Sumitomo Pharma America shared interim findings from the OPTYX study, a prospective long-term observational investigation evaluating testosterone suppression and recovery among patients with advanced prostate cancer treated with relugolix either as monotherapy or in combination regimens.
The OPTYX study is designed to provide real-world evidence regarding treatment patterns and hormonal response dynamics in clinical practice settings outside the constraints of randomized clinical trials.
Testosterone suppression remains a cornerstone of advanced prostate cancer management because androgen signaling plays a central role in driving prostate tumor growth. Effective androgen deprivation therapy seeks to reduce testosterone levels to castrate ranges in order to slow disease progression.
However, recovery of testosterone levels following treatment interruption or completion is also an important clinical consideration because prolonged suppression can contribute to side effects including fatigue, metabolic changes, cardiovascular risk, osteoporosis, and diminished quality of life.
The interim OPTYX analysis was presented by Benjamin Lowentritt of Chesapeake Urology.
Real-world observational studies such as OPTYX are increasingly important in oncology because they help clinicians better understand how therapies perform across diverse patient populations encountered in routine practice. These studies can also provide insights into long-term safety, treatment adherence, and recovery patterns that may not be fully captured in shorter randomized trials.
The broader set of presentations at AUA 2026 underscores Sumitomo Pharma America’s continued investment in both urologic and oncology research, particularly in areas where patients may face overlapping comorbidities or complex treatment considerations.
The company’s research focus reflects larger trends within modern urology, where clinicians increasingly seek therapies capable of improving symptom control while minimizing adverse effects and preserving overall quality of life.
Older men with overactive bladder and benign prostatic hyperplasia often represent medically complex populations requiring individualized treatment strategies. Similarly, patients with advanced prostate cancer may experience substantial treatment burdens related not only to cancer progression but also to the hormonal effects of long-term androgen suppression.
By generating subgroup analyses and real-world evidence in these settings, pharmaceutical companies aim to support more personalized approaches to care that account for age, comorbidity profiles, treatment goals, and functional outcomes.
The presentations also demonstrate the growing role of observational research and exploratory quality-of-life analyses alongside traditional randomized clinical trial endpoints. As healthcare providers increasingly emphasize patient-centered care, measures such as symptom burden, sexual health, and treatment tolerability have become more prominent components of therapeutic evaluation.
With ongoing studies continuing across both its urology and oncology portfolios, Sumitomo Pharma America appears focused on expanding the evidence base supporting its therapies while addressing clinically relevant questions faced by physicians managing complex urinary and prostate cancer conditions in everyday practice.
About GEMTESA® (vibegron)
In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since December 2020. GEMTESA was approved in December 2024, for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). GEMTESA works by selectively targeting beta-3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity.
About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).1 Approximately 33 million U.S. adults experience the bothersome symptoms of OAB.2
