MARLBOROUGH, Mass. — Sumitomo Pharma America presented new data from its urology and oncology portfolios at the American Urological Association 2026 Annual Meeting, including findings on vibegron in older men with overactive bladder and benign prostatic hyperplasia.
The Marlborough-based company said the presentations included a subgroup analysis from the Phase III COURAGE trial evaluating once-daily vibegron 75 mg in men with symptoms of overactive bladder who were also receiving pharmacologic therapy for benign prostatic hyperplasia. The company also presented real-world evidence from the OPTYX study of relugolix in advanced prostate cancer.
“Our presence at AUA 2026 underscores our deep-rooted commitment to advancing scientific understanding for patients managing complex urologic conditions,” said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. “By focusing on patient populations at particular risk, such as men over 75 with overactive bladder and on pharmacologic treatment for benign prostatic hyperplasia, and those navigating the complexities of advanced prostate cancer, we aim to provide clinicians with the robust data they need to make informed, patient-centered treatment decisions.”
In the COURAGE subgroup analysis, men age 75 and older who received vibegron had clinically meaningful reductions from baseline at week 24 in average daily micturitions and urgency episodes compared with placebo. Micturitions declined by 2.3 in the vibegron group, compared with 1.5 in the placebo group. Urgency episodes declined by 3.6 in the vibegron group, compared with 2.3 in the placebo group.
Sumitomo Pharma America said those results were comparable to outcomes seen in men younger than 75. The company said vibegron was generally well tolerated in the older population, with a safety profile comparable to that observed in younger patients.
“Older men often face the dual challenge of managing OAB symptoms while on existing therapies for BPH. These findings are encouraging as they demonstrate that vibegron can provide meaningful symptomatic relief in this specific, often harder-to-treat population, with a safety profile comparable to that of younger patients,” said Sender Herschorn, M.D., professor of surgery and urology at the University of Toronto and lead author of the poster.
The company also presented a separate subgroup analysis from COURAGE evaluating the effect of vibegron on sexual function in men. Another poster presentation included an interim analysis from OPTYX, a prospective, long-term observational study evaluating testosterone suppression and recovery in patients with advanced prostate cancer treated with relugolix in a real-world setting.
GEMTESA, the brand name for vibegron, is approved in the U.S. for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency in adults. It was also approved in December 2024 for overactive bladder symptoms in adult males receiving pharmacological therapy for benign prostatic hyperplasia.
The drug works by selectively targeting beta-3 adrenergic receptors to reduce overactive bladder symptoms by relaxing the bladder detrusor muscle and increasing bladder capacity. Sumitomo Pharma America said about 33 million U.S. adults experience symptoms of overactive bladder.
