Results from a 52-week open-label extension of the Phase 3 COURAGE trial demonstrate that vibegron (GEMTESA®) provides sustained safety and efficacy for men with overactive bladder (OAB) who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH).
The findings, presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada, showed that vibegron 75 mg once daily maintained its beneficial effects on OAB symptoms throughout the extended treatment period with a favorable safety profile.
Extended Study Confirms Long-Term Benefits
The open-label extension enrolled 276 men who had completed the original 24-week randomized, placebo-controlled COURAGE trial. Participants continued on a stable dose of BPH treatment with an α-blocker with or without a 5-α-reductase inhibitor throughout the study.
"Previously reported data from COURAGE indicated that vibegron yielded significant, clinically meaningful improvements in OAB symptoms and was generally safe and well tolerated with adverse event rates similar to placebo," explained Dr. David R. Staskin, director of the Center for Male and Female Pelvic Health and associate professor of urology at Tufts University, Boston, who presented the findings.
The extension study was designed to evaluate both the long-term safety of vibegron and the durability of its therapeutic effects. Patients who had received vibegron in the original COURAGE study continued the same regimen for an additional 28 weeks, while those previously on placebo were switched to vibegron 75 mg once daily.
Safety Profile Remains Consistent
The overall incidence of adverse events during the extension period was 29.6%, compared to 35.9% observed during the double-blind treatment period of the original COURAGE trial. Only 7 patients (4.9%) experienced treatment-related adverse events during the extension.
The most common adverse events included hypertension (6.3%), COVID-19 (5.6%), and increased hepatic enzyme (2.1%). Six patients (4.2%) discontinued treatment due to adverse events, with two cases of urinary retention leading to discontinuation, though neither was considered related to vibegron.
"Changes in vital signs, including systolic and diastolic blood pressure and heart rate, were minimal, transient, and not considered clinically relevant," the investigators reported. "No new safety signals were identified in participants who received 24 weeks of placebo in the COURAGE trial followed by 28 weeks of vibegron treatment."
Sustained Efficacy Across Multiple Endpoints
The efficacy improvements observed in the original COURAGE trial were generally maintained throughout the extension period across all measured endpoints. These included reductions in daily micturitions, urgency episodes, nocturia episodes, and urge urinary incontinence episodes, as well as improvements in International Prostate Symptom Score (IPSS) storage scores and volume voided per micturition.
Notably, patients who switched from placebo to vibegron for the extension period also showed improvements in these efficacy outcomes after 28 weeks of active treatment.
Addressing an Unmet Clinical Need
The management of OAB symptoms in men with BPH presents a significant clinical challenge. Many men treated for BPH continue to experience persistent OAB symptoms even after the obstruction is addressed. According to clinical data, about 60% of men with BPH are treated for lower urinary tract symptoms (LUTS), with more than half reporting storage symptoms characteristic of OAB.
In December 2024, vibegron became the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH. This approval was based in part on the positive results from the COURAGE trial.
Mechanism of Action
Vibegron works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through relaxation of the bladder detrusor muscle, which increases bladder capacity. This mechanism differs from antimuscarinic agents, which have traditionally been used to treat OAB but may have limitations in men with BPH due to the risk of urinary retention.
Additional Real-World Evidence
At the same conference, Sumitomo Pharma America also presented findings from the Phase 4 COMPOSUR real-world study of vibegron in patients with OAB. These results further supported the safety and tolerability profile of vibegron, with the majority of patients reporting satisfaction with treatment and continuing therapy after 12 months.
"SMPA remains committed to advancing scientific innovation that helps the lives of the millions of patients suffering from OAB and receiving pharmacological therapy for BPH," said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of Sumitomo Pharma America. "These data continue to reaffirm vibegron's safety and tolerability."
Clinical Implications
The positive long-term data from the COURAGE extension study provide clinicians with valuable information regarding the sustained efficacy and safety of vibegron for treating OAB symptoms in men with BPH. This is particularly important given the high prevalence of concurrent OAB and BPH in aging men and the challenges of managing both conditions simultaneously.
For the estimated 33 million adults in the United States who experience bothersome symptoms of OAB, including the significant subset of men also affected by BPH, these findings offer evidence supporting vibegron as a treatment option that maintains its benefits over an extended period without introducing new safety concerns.
