New Data from Sumitomo Pharma America at AUA 2026 Highlight Efficacy of Vibegron in Men Aged 75 and Older with Overactive Bladder and BPH

SMPA reinforces commitment to the urology community with findings from studies across overactive bladder and advanced prostate cancer portfolios

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sumitomo Pharma America, Inc. (SMPA) today announced the presentation of new data from its urology and oncology portfolios at the American Urological Association (AUA) 2026 Annual Meeting, held on May 15–18 in Washington, D.C. The presentations include a featured subgroup analysis of the phase 3 COURAGE trial evaluating vibegron in older men, along with 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.”

Safety and efficacy outcomes with vibegron are comparable in older and younger patients

Data presented includes a poster on a subgroup analysis of the placebo-controlled phase 3 COURAGE trial, which evaluated the efficacy and safety of once-daily vibegron 75 mg in men with symptoms of overactive bladder (OAB) who were also receiving pharmacologic therapy for benign prostatic hyperplasia (BPH) (stable dose of α-blocker ± 5α-reductase inhibitors). The analysis found that men ≥75 years experienced clinically meaningful reductions from baseline at week 24 in average daily number of micturitions and urgency episodes with vibegron (n=92) compared with placebo (n=100). Micturitions were –2.3 in the vibegron group compared with –1.5 in the placebo group, and urgency episodes were –3.6 in the vibegron group compared with –2.3 in the placebo group. These results were comparable to the outcomes observed in men <75 years. Vibegron was generally well tolerated in this older population, with a safety profile comparable to that observed in men <75 years.

“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 Dr. Sender Herschorn, M.D., Professor of Surgery/Urology at the University of Toronto and lead author of the poster.

Additional data presented in treatment of OAB and advanced prostate cancer

In a separate podium presentation, SMPA shared a subgroup analysis from the COURAGE trial evaluating the effect of vibegron on sexual function in men. SMPA, in a poster presentation, also shared an interim analysis of testosterone suppression and recovery from the OPTYX study, a prospective, long-term observational study of relugolix (monotherapy and combination) in a real-world setting.

Presentation Details

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

INDICATIONS AND USAGE
GEMTESA^® is a beta-3 adrenergic agonist indicated for the treatment of:

• overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
• overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS
Urinary Retention
Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema
Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS
Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

Please see full Prescribing Information.

ABOUT ORGOVYX^® (relugolix)
ORGOVYX^® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

IMPORTANT SAFETY INFORMATION
Contraindication
ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components.

Warnings and Precautions
QT/QTc Interval Prolongation: Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

Hypersensitivity: Angioedema was reported in 0.2% of patients treated with ORGOVYX in HERO. Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported post-marketing with ORGOVYX. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue ORGOVYX and promptly seek medical care. Discontinue ORGOVYX for severe hypersensitivity reactions and manage as clinically indicated.

Embryo-Fetal Toxicity: The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Laboratory Testing: Therapy with ORGOVYX results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after ORGOVYX may be affected. The therapeutic effect of ORGOVYX should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.

Adverse Reactions
Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. Serious adverse reactions in ≥0.5% of patients included myocardial infarction (0.8%), acute kidney injury (0.6%), arrhythmia (0.6%), hemorrhage (0.6%), and urinary tract infection (0.5%). Fatal adverse reactions occurred in 0.8% of patients receiving ORGOVYX including metastatic lung cancer (0.3%), myocardial infarction (0.3%), and acute kidney injury (0.2%). Fatal and non-fatal myocardial infarction and stroke were reported in 2.7% of patients receiving ORGOVYX.

Most common adverse reactions (≥10%) and laboratory abnormalities (≥15%) in patients receiving ORGOVYX were hot flush (54%), glucose increased (44%), triglycerides increased (35%), musculoskeletal pain (30%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), fatigue (26%), aspartate aminotransferase increased (18%), constipation (12%), and diarrhea (12%).

Drug Interactions
Co-administration of ORGOVYX with an oral P-gp inhibitor increases relugolix exposure, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first and separate dosing by at least 6 hours. Monitor patients for increased adverse reactions. Treatment with ORGOVYX may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required. Resume ORGOVYX after the P-gp inhibitor is discontinued. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a 360 mg loading dose on the first day and continue with 120 mg once daily.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases relugolix exposure, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended ORGOVYX dose of 120 mg once daily.

Please see full Prescribing Information for ORGOVYX.

About Sumitomo Pharma

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.) focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

The Sumitomo corporate symbol mark is a registered trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.

GEMTESA and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

ORGOVYX^® and its logo are registered trademarks of Sumitomo Pharma Co. Ltd., used under license.

©2026 Sumitomo Pharma America, Inc. All rights reserved.

References

1. Overactive bladder – symptoms and causes. Mayo Clinic. February 4, 2025. Accessed May 6, 2026. https://www.mayoclinic.org/diseases-conditions/overactive-bladder/symptoms-causes/syc-20355715
2. Gomelsky A, Dmochowski RR. Update on the management of overactive bladder: patient considerations and adherence. Open Access J Urol. 2011;3:7-17. doi:10.2147/OAJU.S7233
3. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025

For further information: SMPA CONTACT: Dave Murdoch, Sumitomo Pharma America, Inc., david.murdoch@us.sumitomo-pharma.com, +1 (774) 405-5570