This 12-week randomized, double-blind, placebo-controlled trial will test the hypothesis that Vibegron (brand name GEMTESA) can improve energy metabolism, cardiometabolic risk factors, and physical and cognitive function in middle-aged and older adults with obesity.

Start Date01 Nov 2026

Sponsor / Collaborator

Wake Forest School of Medicine

[+1]

NCT07674680

/ RecruitingEarly Phase 1IIT

Beta3-adrenergic Receptors and Cardiovascular Function in Aging Women

To determine if vascular beta3 adrenergic receptors are present and functional in aging women and can be targeted to attenuate sympathetic vasoconstriction and enhance vascular function in aging women.

Start Date31 Jul 2026

Sponsor / Collaborator

University of Missouri

JPRN-jRCT2011260024

/ RecruitingPhase 3

KRP-114V Phase III Clinical Trial -A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KRP-114V in Pediatric Patients with Overactive Bladder-

Start Date21 Jul 2026

Sponsor / Collaborator

KYORIN Pharmaceutical Co., Ltd.

100 Clinical Results associated with Vibegron

100 Translational Medicine associated with Vibegron

100 Patents (Medical) associated with Vibegron

160

Literatures (Medical) associated with Vibegron

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Clinical and economic value of onabotulinumtoxinA vs oral pharmacotherapies in overactive bladder in the United States

Article

Author: Li, Qianyi ; Brucker, Benjamin M. ; Singh, Ritu ; Dominguez, Annaliza ; Chaplin, Stephen ; Chung, Doreen E. ; Wissinger, Erika

AIMS:

To evaluate the clinical and economic value of onabotulinumtoxinA (onabotA) vs oral pharmacotherapies for adults with OAB inadequately managed with anticholinergics from a United States (US) Medicare + societal perspective over 1 year.

MATERIALS AND METHODS:

A Markov model-based 1-year cost per responder (CPR) analysis was conducted for patients achieving complete response (100% reduction in urinary incontinence episodes [i.e. complete dryness]). Comparators included onabotA and oral therapies (vibegron [brand], mirabegron 25/50 mg [brand and generic], and anticholinergics [generic]), using inputs for efficacy, costs, and healthcare resource use. The primary outcome was CPR for a complete response, with secondary outcomes including number of urinary incontinence episodes per patient and number needed to treat (NNT). Uncertainty was evaluated through one-way and probabilistic sensitivity analyses. Scenario analyses assessed results using commercial costs and longer-term effects for selected outcomes.

RESULTS:

In the base-case analysis, onabotA had the highest complete response rate (23.5%), resulting in the lowest NNT and CPR (4.3; $18,646) vs oral therapies (response 10.9-12.1%; NNT 8.3-9.2; CPR $21,941-$49,524). Scenario and sensitivity analyses were consistent with these findings and supported the base-case results.

LIMITATIONS:

Model inputs were primarily based on clinical trial data and may not fully reflect real-world practice; differences across trials may limit comparability. The stringent responder definition, use of non-US productivity estimates, 1-year time horizon, and exclusion of neuromodulation therapies may further limit generalizability and scope.

CONCLUSIONS:

OnabotA demonstrated favorable clinical and economic value relative to oral pharmacotherapies that was consistent across sensitivity and scenario analyses. About 1 in 4 patients treated with onabotA could achieve a 100% response over 1 year compared to 1 in at least 8 with oral pharmacotherapies. These findings support onabotA as a treatment option with demonstrated clinical and economic value for patients who do not achieve adequate symptom relief with oral OAB therapies.

01 Nov 2026·NEUROUROLOGY AND URODYNAMICS

β3‐Adrenoceptor Agonists for Neurogenic Lower Urinary Tract Dysfunction: Evidence and Clinical Rationale for First‐Line Therapy

Review

Author: Matta, Rano ; Fishberg, Sharon E.

ABSTRACT:

Aims:

To summarize current evidence on β3‐adrenoceptor agonists for managing neurogenic lower urinary tract dysfunction (NLUTD), focusing on their efficacy, safety, and clinical role in optimizing bladder storage and protecting upper tracts.

Methods:

Evidence from randomized controlled trials, meta‐analyses, and observational studies in spinal cord injury (SCI), multiple sclerosis (MS), and spina bifida populations was reviewed. Outcomes included bladder storage parameters, patient‐reported measures, and cardiovascular and cognitive safety profiles.

Results:

β3‐adrenoceptor agonists such as Mirabegron improve cystometric capacity, reduce detrusor pressure, and enhance quality of life. A recent individual‐patient meta‐analysis confirmed these benefits. Early data on Vibegron in SCI and spina bifida show increased bladder compliance and capacity without new safety concerns. Cardiovascular safety signals are reassuring: one randomized trial in SCI/MS and a large multinational cohort both showed no excess risk. Observational studies continue to associate antimuscarinics with cognitive adverse effects, whereas β3‐agonists demonstrate a more favorable tolerability profile.

Conclusions:

β3‐adrenoceptor agonists represent a safe, effective, and well‐tolerated first‐line option in NLUTD management. They preserve bladder safety and continence with fewer systemic side effects. OnabotulinumtoxinA remains an important escalation therapy for refractory cases but carries higher procedural and retention risks. A β3‐agonist–based strategy offers a rational, patient‐centered foundation for treatment.

08 Oct 2026·British journal of nursing (Mark Allen Publishing)

The combined medication approach for treating overactive bladder: assessing safety and efficacy

Review

Author: Henderson, Lucy ; Hughes, Ben

Research question: What is the latest evidence on the efficacy and safety of combining medications to treat overactive bladder? The problem: Overactive bladder symptoms negatively impact quality of life and, with an ageing population, overactive bladder prevalence is expected to rise. Current treatments do not adequately address all patients’ needs, with concerns about dementia risk from antimuscarinics, and not all patients wish to proceed to invasive procedures. This highlights the need for alternative pharmacological strategies. Literature review: The literature emphasises the detrimental impact of overactive bladder on patients’ daily lives and highlights safety concerns, particularly cognitive risks linked to traditional antimuscarinics. Methodology: Nine randomised controlled trials were critically appraised for methodological quality and risk of bias, with findings synthesised narratively due to study heterogeneity. Results: Explored combinations include beta-3 adrenoreceptor agonists (vibegron or mirabegron) with antimuscarinics, beta-3 adrenoreceptor agonists with phosphodiesterase 5 inhibitors, and antimuscarinics with cholinergic agonists. These combinations demonstrated improved efficacy and tolerability in treating overactive bladder while minimising side effects. Most studies report symptom improvement without increased cardiovascular risk. Conclusions: Combination therapies demonstrate superior efficacy compared to monotherapy without increasing anticholinergic burden, offering promising treatment alternatives. These findings support the expansion of new agents (vibegron) and novel pharmacological combinations in nursing practice to improve patient outcomes while considering safety profiles. However, methodological limitations such as sample bias and potential funding bias should be noted.

News (Medical) associated with Vibegron

18 May 2026

·www.biospace.com

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 pro 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 pro 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 Title Details IP15-20: Efficacy and safety of vibegron in men ≥75 years of age with symptoms of overactive bladder on pharmacotherapy for benign prostatic hyperplasia: a subgroup analysis of the COURAGE trial Poster Presentation Presenter: Dr. Sender Herschorn, MD, University of Toronto IP38-21: Testosterone suppression and recovery in patients with advanced prostate cancer treated with relugolix: an interim analysis of the OPTYX study Poster Presentation Presenter: Dr. Benjamin Lowenritt, MD, FACS, Chesapeake Urology PD26-08: Evaluating sexual function in men treated with vibegron for overactive bladder while on pharmacological therapy for benign prostatic hyperplasia: exploratory analysis from the phase 3 COURAGE trial Podium Presentation Presenter: Dr. Kenneth Peters, MD, Urology, Corewell Health William Beaumont University Hospital 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 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 Overactive bladder – symptoms and causes. Mayo Clinic. February 4, 2025. Accessed May 6, 2026. 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 GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025 Contacts For further information: SMPA CONTACT: Dave Murdoch, Sumitomo Pharma America, Inc., david.murdoch@us.sumitomo-pharma.com , +1 (774) 405-5570

Clinical ResultPhase 3Drug Approval

30 Jun 2025

·www.prnewswire.com

Sumitomo Pharma America and Former Professional Quarterback Rodney Peete Say it's Time to Go™ and Put Yourself First with Overactive Bladder Treatment Option GEMTESA®

Rodney Peete joins the Time to Go™ campaign as the newest GEMTESA Go-Getter, alongside wife Holly Robinson Peete, encouraging men and women to speak up about their overactive bladder symptoms and explore treatment options, like GEMTESA® (vibegron) MARLBOROUGH, Mass., June 30, 2025 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) today announced the expansion of its Time To Go™ campaign, introducing former professional quarterback and overactive bladder (OAB) patient Rodney Peete as its newest partner, in support of GEMTESA® (vibegron). Continue Reading Rodney Peete and Holly Robinson Peete Time To Go™ Campaign Logo Starting this month, Men's Health Month, Rodney will join his wife of 30 years and fellow OAB patient, Holly Robinson Peete, as a GEMTESA Go-Getter, or brand ambassador. Through their partnership, they'll share their personal experiences with symptom management, emphasizing the importance of openly discussing chronic conditions like OAB and their symptoms with loved ones and medical professionals. "As I got older, I started noticing I was making more frequent trips to the bathroom — I couldn't even make it through an inning of a baseball game," said Rodney Peete. "I convinced myself it was all part of aging. Through some prodding, and a whole lot of support, my wife Holly pointed out my symptoms and urged me to see a doctor. Her experience before discovering GEMTESA, a treatment option that has helped to manage her OAB symptoms, opened the door to have an honest conversation without embarrassment. That kind of support made all the difference — it turned something I was quietly dealing with into something we could manage together, with compassion, towards each other." GEMTESA is a prescription medicine for the treatment of OAB in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH), with symptoms of urge urinary incontinence, urgency, and frequency. OAB causes sudden urges to urinate that are difficult to control and can result in leakage, as well as frequent urination — usually eight or more times a day.1 Overactive bladder can disrupt everyday life with approximately 16% of men and 17% of women in the U.S. experiencing symptoms,3 which can be bothersome and disruptive. The introduction of Rodney Peete, who has both OAB and BPH, comes on the heels of SMPA's 2024 U.S. Food and Drug Administration (FDA) approval of GEMTESA for men with OAB who are also receiving pharmacological therapy for BPH, making GEMTESA the first and only beta-3 agonist approved to treat men living with OAB and being treated for BPH.4 And with 46% of men citing embarrassment as the primary barrier to being completely honest with their doctors,2 The Peetes' partnership is that much more relevant. "It's important we create a space where people feel supported and are empowered to speak openly about their symptoms and experiences with OAB," said Alana Darden Powell, Vice President of Marketing for SMPA. "Rodney represents men everywhere who are impacted by OAB but might too embarrassed or scared to talk about it. It's our hope that by welcoming him as a Go-Getter alongside Holly, we can demonstrate the importance of communication and encourage everyone to seek help when help is needed." Holly's story, as well as additional patient stories, are currently featured on the Time to Go website. Rodney's personal story and roadmap to how he's navigating his symptoms, including treatment with GEMTESA, will be available on the Time to Go website later this year. "Since starting GEMTESA my symptoms have lessened, and I've been able to get back to doing things I love with fewer interruptions and less worry about the next bathroom break," said Holly Robinson Peete, actor and activist. "My experience with OAB is what led me to recognize something was off with Rodney. I noticed changes in his habits, frequent bathrooms trips and delays before outings. I was happy to help Rodney get to the bottom of his symptoms. If there's one thing we've learned after 30 years of marriage, it's that open communication and support of your partner is paramount. I'm excited to be on this journey with him and have him join me in raising awareness for this chronic condition." People experiencing OAB symptoms are encouraged to talk to their doctor to get a diagnosis and determine the best treatment option(s) to help them manage the condition. To learn more about OAB and GEMTESA, or hear from other GEMTESA Go-Getters, visit TimeToGo.com. 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 About 33 million U.S. adults experience the bothersome symptoms of OAB.5 About GEMTESA GEMTESA®(vibegron) is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH): urge urinary incontinence: a strong need to urinate with leaking or wetting accidents urgency: the need to urinate right away frequency: urinating often It is not known if GEMTESA is safe and effective in children. IMPORTANT SAFETY INFORMATION Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA. Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA). Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. What are the possible side effects of GEMTESA? GEMTESA may cause serious side effects including: inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder. angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing. Stop using GEMTESA and tell your doctor right away. The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see accompanying full Product Information . 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.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed 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 or follow us on LinkedIn. SUMITOMO PHARMA is a 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. ©2025 Sumitomo Pharma America, Inc. All rights reserved. GEM-US-0234-25 06/25 References: Mayo Clinic. (2025, February 4). Overactive bladder – Symptoms and causes. Mayo Clinic. Mayo Clinic Cleveland Clinic. (2019, September 4). Cleveland Clinic survey: Men will do almost anything to avoid going to the doctor. Cleveland Clinic Newsroom. Stewart, W. F., Van Rooyen, J. B., Cundiff, G. W., Abrams, P., Herzog, A. R., Corey, R., Hunt, T. L., & Wein, A. J. (2003). Prevalence and burden of overactive bladder in the United States. World Journal of Urology, 20(6), 327–336. Sumitomo Pharma America, Inc. (2024, December 23). Sumitomo Pharma America announces U.S. FDA approval of GEMTESA® (vibegron) for men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia. Gomelsky, A., & Dmochowski, R. R. (2010). Update on the management of overactive bladder: Patient considerations and adherence. Open Access Journal of Urology, 3, 7–17. SOURCE Sumitomo Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

29 Apr 2025

·www.prnewswire.com

Sumitomo Pharma America Presents New Data on Vibegron at the 2025 American Urological Association Annual Meeting

– Data include results from COURAGE Phase 3 and COMPOSUR Phase 4 studies of vibegron (GEMTESA®) – MARLBOROUGH, Mass., April 29, 2025 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) presented new, positive data from the COURAGE Phase 3 open-label extension study of vibegron (GEMTESA®) in men living with overactive bladder (OAB) and receiving pharmacological therapy for benign prostatic hyperplasia (BPH). Data presented from the Phase 3 COURAGE trial (URO-901-3006) included a total of 276 men with OAB symptoms receiving pharmacological therapy for BPH who participated in the open-label extension study. The primary outcome was to evaluate the long-term safety of vibegron 75 mg, which was well tolerated for up to 52 weeks in men with symptoms of OAB who were receiving pharmacological treatment for BPH. The data reveal that the efficacy results of treatment with vibegron 75 mg a day were sustained among those receiving vibegron for 52 weeks and improved after 28 weeks of vibegron treatment for those who received placebo during the first 12 weeks of a double-blind placebo-controlled study (URO-901-3005). Sustained efficacy results in all secondary outcomes were observed, including mean daily micturitions, urgency episodes, nocturia episodes, urge urinary incontinence episodes, IPSS-Storage and volume voided per micturition. Vibegron demonstrated favorable long-term safety and efficacy, with no new safety signals compared to prior OAB studies. At the conference SMPA also shared findings from the Phase 4 COMPOSUR, real-world study of vibegron in patients with OAB, which continue to support that it was generally safe and well-tolerated, with the majority of patients satisfied with treatment and remaining on vibegron after 12 months. Most common adverse events were urinary tract infection (4.0%), headache (2.7%), dizziness (2.2%) and diarrhea (2.0%). "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 SMPA. "These data continue to reaffirm vibegron's safety and tolerability." Vibegron is approved for OAB with symptoms of urge urinary incontinence, urgency and urinary frequency in adults, and in December 2024, became the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for 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. 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). Please click here for full Prescribing Information. 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 April 2021. GEMTESA was approved on December 18, 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 β3 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).7 Approximately 33 million U.S. adults experience the bothersome symptoms of OAB.1 About Benign Prostatic Hyperplasia Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.4, 5 Even when the obstruction is alleviated by BPH treatment, unresolved symptoms of OAB may persist. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).4, 5 LUTS can be divided into storage, voiding, and postmicturition symptoms.8 More than half of men with LUTS report storage symptoms, and about a quarter report voiding symptoms.5 This suggests that many men with a diagnosis of BPH may have overactive bladder.5 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.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, 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 or follow us on LinkedIn. The Sumitomo corporate symbol mark is a 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. ©2025 Sumitomo Pharma America, Inc. All rights reserved. References 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 Deters LA. Benign Prostatic Hyperplasia (BPH). . Updated March 22, 2023. Accessed December 18, 2024 Gomelsky A, Dmochowski RR. Overactive bladder in males. Ther Adv Urol. 2009;1(4):209-221. doi:10.1177/1756287209350383 Burnett AL, Walker DR, Feng Q, et al. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: a retrospective observational study. Neurourol Urodyn. 2020;39(5):1378-1386. doi:10.1002/nau.24348 Anger JT, Goldman HB, Luo X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourol Urodyn. 2018;37(1):213-222. doi:10.1002/nau.23276 GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2024 Overactive bladder – symptoms and causes. Mayo Clinic. March 2 2024. Accessed December 18, 2024. Lepor H. Pathophysiology of lower urinary tract symptoms in the aging male population. Rev Urol. 2005;7 suppl 7(suppl 7):S3-S11. PMID: 16986059; PMCID: PMC1477625. SOURCE Sumitomo Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

100 Deals associated with Vibegron

External Link

KEGG	Wiki	ATC	Drug Bank
D10433	Vibegron	G04BD15 G04BD	DB14895

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Hyperplasia	United States	Sumitomo Pharma America, Inc.	18 Dec 2024
Overactive bladder syndrome	European Union	Pierre Fabre Médicament SAS	27 Jun 2024
Overactive bladder syndrome	Iceland	Pierre Fabre Médicament SAS	27 Jun 2024
Overactive bladder syndrome	Liechtenstein	Pierre Fabre Médicament SAS	27 Jun 2024
Overactive bladder syndrome	Norway	Pierre Fabre Médicament SAS	27 Jun 2024
Urinary Bladder, Overactive	Japan	KYORIN Pharmaceutical Co., Ltd.	21 Sep 2018
Urinary Bladder, Overactive	Japan	Kissei Pharmaceutical Co., Ltd.	21 Sep 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neurogenic detrusor overactivity	Phase 3	United States	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Belgium	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Canada	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Croatia	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Denmark	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Jordan	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Latvia	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Lithuania	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Malaysia	Urovant Sciences Ltd.	12 Oct 2022
Neurogenic detrusor overactivity	Phase 3	Philippines	Urovant Sciences Ltd.	12 Oct 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03902080 (Courage, AUA2026)	Phase 3	Urinary Bladder, Overactive	192	Vibegron 75 mg	nomnpbjqoj(sdbbkartcv) = ojxsznbqim npetxjfvkr (vtbbaowybk )	Positive	15 May 2026
				Placebo	nomnpbjqoj(sdbbkartcv) = kptsqngxcb npetxjfvkr (vtbbaowybk )
NCT03902080 (COURAGE, Pubmed \| Neurourol Urodyn)	Phase 3	Urinary Bladder, Overactive	1,104	Vibegron	spockgkjox(gjrgejrxcs) = differences between vibegron and placebo in PVR were minimal at baseline, week 12, and week 24. vlxofjvhkj (lebodqejer ) View more	Positive	09 Dec 2025
				Placebo
NCT05067478 (COMPOSUR, AUA2025)	Phase 4	Urinary Bladder, Overactive	403	Vibegron	btsgaavkxk(atrtjglrbz) = mclxmmgjvg cdamgnziec (csqjivwwpw, 24.7) View more	Positive	26 Apr 2025
COURAGE (AUA2025)	Phase 3	Urinary Bladder, Overactive	276	VibeGron 75 mg	uezdncerps(rwqxlkttlk) = egwtldgomg noyauzgobs (orxbesqapg ) View more	Positive	26 Apr 2025
				Placebo	uezdncerps(iylbiqcnyz) = joendiioiy urjogkqjii (exfzwrrepj )
NCT05067478 (COMPOSUR, Pubmed \| BMC Urol)	Phase 4	Urinary Bladder, Overactive	403	Vibegron	rpvxsnrzsz(fixbzptgyn) = zodzxrbnzo viwplzkydm (lvoinlnzgu, 69.3% - 78.0) View more	Positive	02 Apr 2025
NCT04103450 (CTgov)	Phase 3	Prostatic Hyperplasia \| Urinary Bladder, Overactive	276	Vibegron (52-Week Vibegron Group)	apnkfxbcvv = esnyuyedxu trlhnikcch (fufezhppko, nkzqnqgtvt - dbeaskuarh) View more	-	21 Aug 2024
				Vibegron (28-Week Vibegron Group)	apnkfxbcvv = xglnczybjf trlhnikcch (fufezhppko, smpkigrvob - tnouokegfx) View more
NCT03902080 (Courage \| URO-901-3005, CTgov)	Phase 3	Prostatic Hyperplasia \| Urinary Bladder, Overactive	1,105	Placebo	eaaudnpgox(iwrgbmydpb) = rhimljqdaz sjqurfkiab (kpjauuinan, 0.109) View more	-	07 Aug 2024
NCT03902080 (URO-901-3005, PRNewswire) Manual	Phase 3	Urinary Bladder, Overactive	-	VibegronVibegron 75mg (GEMTESA)	mgmywanjxn(xcoqeusalx) = remahlqzci tuwbbhtkez (buftmxuygp, 0.109) View more	Positive	07 May 2024
NCT03492281 (EMPOWUR, Pubmed \| J Comp Eff Res)	Phase 3	Urinary Bladder, Overactive	-	Vibegron	htbbtnsnmp(sgkkjcaajt) = niyyiqovor zvjvdjaoxk (qfneilcwjv ) View more	Positive	01 Sep 2023
NCT03492281 (EMPOWUR, Pubmed) Manual	Phase 3	Urinary Bladder, Overactive	922	Vibegron	furtruksdx(veqcamwxwh): Difference = -0.5 (95% CI, -0.8 to -0.2) View more	Positive	21 Nov 2022
				Placebo

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