Defined by the International Continence Society (ICS) as urinary "urgency, with or without urge incontinence, usually with frequency and nocturia", overactive bladder (OAB) presents as challenging syndrome to treat. OAB is a very prevalent condition, affecting between 11.8% to 16% of the population with equal impact on women and men and growing prevalence with age. OAB is associated with a significant financial burden to both patients and the health care system with a estimated cost of US $82.6 billion in 2020. Traditionally, a stepwise approach has been taken in managing OAB; starting first with lifestyle modifications, followed by anticholinergic or beta-3-agonist medications as the second line, and lastly, intradetrusor onabotulinumtoxinA injections, percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM) as third line options. Given the limitations of this stepwise approach in patients with refractory OAB, combination therapy offers patients an increasing number of treatment options but the literature surrounding the efficacy of combination therapy is somewhat limited. A 2019 systematic review revealed there were only 32 studies in the current OAB literature that explored the role of combination therapy, and the majority of these studies examined the effect of lifestyle modifications with another intervention strategy, highlighting an untapped area of research5.
To date, there has only been a single pilot study conducted in Taiwan examining the effect of intradetrusor onabotulinumtoxinA injections with the addition of mirabegron for patients with refractory OAB. This study by Wang et al. explored the therapeutic impact of adding either an anticholinergic, solifenacin, or a beta-3 agonist, mirabegron, to intradetrusor onabotulinumtoxinA injections as compared to each other as well as patients receiving onabotulinumtoxinA alone. Ninety patients were enrolled with 30 patients allocated to the solifenacin arm, 31 to the mirabegron arm, and 29 to the control group. While the baseline data among the three arms was comparable, the percentage of OAB wet in the mirabegron plus onabotulinumtoxinA group was significantly less at 3-, 6-, 9-, and 12-month intervals than the solifenacin plus onabotulinumtoxinA and the onabotulinumtoxinA alone groups. While this pilot study reveals the potential additive benefit of a beta-3 agonist to intradetrusor onabotulinumtoxinA, no further studies have been performed to date and there are no studies regarding the additive benefit of vibegron, which has a more tolerable side effect profile and is not as limited by as many contraindications as mirabegron. If vibegron can potentiate the effect of intradetrusor onabotulinumtoxinA, this presents a new treatment strategy for OAB and could offer patients an additional line of therapy before having to pursue more invasive and costly management option of sacral neuro modulation.

Start Date01 Sep 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT06987383

/ Not yet recruitingPhase 3IIT

Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity

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 Jul 2025

Sponsor / Collaborator

Wake Forest School of Medicine

JPRN-jRCTs031240134

/ RecruitingNot ApplicableIIT

ADVISR trial: ADd-on or switch to Vibegron in patients with overactive bladder InSufficiently responding to initial 4-Week antimuscarinics: A Randomized, parallel-group, multicenter study - ADVISR trial

Start Date14 Jun 2024

Sponsor / Collaborator-

100 Clinical Results associated with Vibegron

100 Translational Medicine associated with Vibegron

100 Patents (Medical) associated with Vibegron

150

Literatures (Medical) associated with Vibegron

03 May 2025·Journal of biomolecular structure & dynamics

Unearthing the inhibitory potential of phytochemicals from Lawsonia inermis L. and some drugs against dengue virus protein NS1: an in silico approach

Article

Author: Mallick, Bidisha ; Sinha, Suchita ; Samanta, Dipu ; Roy, Debleena ; Das, Debapriya ; Ganguli, Sayak ; Banerjee, Rajat

Dengue has received the status of an epidemic and endemic disease, with countless number of infections every year. Due to the unreliability of vaccines and non-specificity of drugs, it becomes necessary to find plant-based alternatives, with less harmful side effects. Lawsonia inermis L., is the sole source of dye, Mehendi. The rich repertoire of phytochemicals makes it useful, medicinally. The main objectives of the study are to explore the anti-dengue properties of the phytochemicals from Lawsonia inermis, and to shortlist potential candidates in curing the disease. Phytochemicals from the plant, and a set of drugs were screened and docked against NS1 protein, a less explored drug target, needed for maintenance of virus life cycle. Ligand screening and docking analysis concluded gallic acid, and chlorogenic acid to be good candidates, exhibiting high binding affinity and extensive interactions with the protein. From among the shortlisted drugs, only Vibegron showed effective binding affinity with NS1 protein with zero violations to the Lipinski's Rule of 5. Molecular dynamic simulations, executed for a time period of 100 nanoseconds, reveal the performance of a ligand within a solvated system. Chlorogenic and gallic acid, formed more stable and compact complexes with protein, with stable energy parameters and strong binding affinity. This was further validated with snapshots taken every 50 nanoseconds, showing no change in binding site between the ligand and protein, within the stipulated time frame. It was interesting to see that, a phenol (chlorogenic acid), served as a better drug candidate, against the NS1 protein.

01 May 2025·UROLOGY

Comparative Efficacy and Safety of Mirabegron and Vibegron in Female Patients With Overactive Bladder: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Review

Author: Liang, Pu ; Yu, Liqian ; Xia, Bowen ; Zhang, Dongxu

OBJECTIVE:

To compare the efficacy and safety of mirabegron and vibegron in female patients with overactive bladder (OAB).

METHODS:

This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A meta-analysis of randomized controlled trials (RCTs) referred to the use of mirabegron and vibegron in female patients with OAB from PubMed, EMBASE, Cochrane Library, and Web of Science databases was performed.

RESULTS:

Three RCTs involving 371 patients were included. We found that vibegron was more effective in relieving urgency urinary incontinence in females with OAB compared to mirabegron [mean difference (MD)=0.25, 95% confidence interval (CI) 0.04 to 0.47, p=0.02]. And vibegron was similar to mirabegron in OAB symptom score (OABSS) [MD=0.22, 95% CI -0.32 to 0.76, p=0.42], urgency (MD=0.15, 95% CI -0.08 to 0.38, p=0.20), quality of life (QOL) (MD=-0.18, 95% CI -0.49 to 0.13, p=0.26), mean volume voided per micturition (MD=-6.16, 95% CI -21.50 to -9.17, p=0.43). In terms of the safety outcomes, there were no significant differences between mirabegron and control groups in terms of the total adverse events (TAEs) [odds ratio (OR)=0.75; 95% CI: 0.44 to 1.26; p=0.28], dry mouth (OR=1.01; 95% CI: 0.36 to 2.81; p=0.99), constipation (OR=0.69; 95% CI: 0.33 to 1.44; p=0.32), elevated post-void residual (PVR) (OR=0.35; 95% CI: 0.05 to 2.23; p=0.26), and dizziness (OR=1.02; 95% CI: 0.14 to 7.31; p=0.98).

CONCLUSION:

In female OAB patients, the efficacy and safety of mirabegron and vibegron were similar. Vibegron may be more effective than mirabegron in relieving urgency urinary incontinence.

01 Apr 2025·Urogynecology (Philadelphia, Pa.)

Trends in Medicare Coverage of Overactive Bladder Medications in the United States

Article

Author: Wallace, Megan B. ; Gaddam, Neha G. ; Dieter, Alexis A.

Importance:

Strong evidence demonstrates long-term cognitive decline associated with anticholinergics. While prevalent among older populations, medical management of overactive bladder (OAB) is dictated by insurance coverage rather than medical provider and patient preferences.

Objective:

The aim of this study was to assess Medicare insurance plan coverage for select OAB medications and evaluate coverage of preferred medications to medications with a greater risk of cognitive dysfunction.

Study Design:

This cross-sectional study analyzed formularies and coverage tiers across 6 U.S. insurers for the following OAB medications: oxybutynin instant-release (IR) 5 mg, oxybutynin extended-release (ER) 5 mg, tolterodine IR 1 mg, tolterodine ER 2 mg, fesoterodine ER 4 mg, darifenacin 7.5 mg, solifenacin 5 mg, trospium IR 20 mg, trospium ER 60 mg, mirabegron 25 mg, and vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, tolterodine, fesoterodine, darifenacin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, a weighted distribution based on coverage tier frequency relative to the number of plans investigated, were generated with a lower score indicating better coverage (range, 0.2–1.0).

Results:

One thousand six hundred nineteen insurance plans representing an estimated 47% of the market share were evaluated. Oxybutynin IR had the best coverage score across insurers (0.4), whereas trospium ER had the worst (0.89). Preferred medications had worse coverage versus nonpreferred medications (P < 0.001). Centene had the best overall coverage and lowest initiation cost, whereas Aetna/CVS had the best coverage and initiation cost for preferred medications.

Conclusions:

Beta-3 agonists had worse coverage across insurers nationwide. Current trends in Medicare coverage reveal a need for improved coverage of preferred OAB medications for an aging population already at risk of cognitive dysfunction.

News (Medical) associated with Vibegron

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

02 Jan 2025

·www.drugs.com

FDA Approves Gemtesa for Overactive Bladder in Men With BPH

THURSDAY, Jan. 2, 2025 -- Gemtesa (vibegron) has been approved by the U.S. Food and Drug Administration for men with overactive bladder (OAB) symptoms receiving pharmacologic therapy for benign prostatic hyperplasia (BPH), according to a press release published by Sumitomo Pharma. Gemtesa, a β 3 adrenergic receptor agonist, dosed once daily (75 mg), has been approved for men with OAB symptoms, including urinary incontinence, urgency, and urinary frequency, who are receiving pharmacologic treatment for BPH. The approval was based on results from a 24-week phase 3 study of Gemtesa versus placebo in about 1,100 men with OAB symptoms receiving pharmacologic therapy for BPH. All coprimary end points at week 12 were met, with significant reductions from baseline seen in the average number of micturition episodes per day and in the average number of daily urgency episodes with Gemtesa versus placebo. In addition, at 12 weeks, there was a reduction in instances of urge urinary incontinence episodes per day. Adverse reactions of hypertension and urinary tract infection exceeding the placebo rate occurred in ≥2 percent of patients treated with Gemtesa. "The FDA's expanded approval of Gemtesa is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH, which underscores our urgency to deliver for those affected by conditions with unmet need," Tsutomu Nakagawa, Ph.D., president and chief executive officer of Sumitomo Pharma America Inc., said in a statement. Approval of Gemtesa was granted to Sumitomo Pharma. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 3Drug ApprovalClinical Result

23 Dec 2024

·pipelinereview.com

Sumitomo Pharma America Announces U.S. FDA Approval of GEMTESA® (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

– GEMTESA ® is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH – MARLBOROUGH, MA, USA I December 23, 2024 I Sumitomo Pharma America, Inc. (SMPA) announced today that the U.S. Food and Drug Administration (FDA) has approved GEMTESA ® (vibegron), a beta-3 (β 3 ) adrenergic receptor agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH). This approval marks GEMTESA as the first and only β 3 agonist approved to treat patients living with OAB and being treated for BPH. It is currently available for prescription in the U.S. BPH is increasingly prevalent in men as they get older, and OAB symptoms, which could be associated with BPH, can often be mistaken as a natural part of aging. There are about 14 million men in the U.S. living with BPH, and up to 75% of them have clinical symptoms of OAB. 1,2 OAB symptoms may go unnoticed in men, especially if they have BPH. 3 In fact, ~80% of OAB cases in men may go undiagnosed. 4 “Millions of patients suffer from OAB along with existing BPH. OAB is a urological condition that has limited treatment options to address their symptoms and impact on their social life.” said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. “The FDA’s expanded approval of GEMTESA is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH, which underscores our urgency to deliver for those affected by conditions with unmet need.” The FDA’s approval of GEMTESA is based on results from URO-901-3005, a Phase 3 study of vibegron versus placebo over 24 weeks in approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH. The study met all co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline in the average number of micturition (urination) episodes per day and in the average number of daily urgency episodes (sudden urge to urinate that is difficult to control) compared to placebo. 5 An additional endpoint showed a reduction in instances of urge urinary incontinence episodes (unintentional loss of urine immediately after an urgent need to urinate) per day at 12 weeks. 5 Adverse reactions, exceeding placebo rate, reported in ≥2% of patients treated with GEMTESA were hypertension and urinary tract infection. 5 Please see Important Safety Information below. “The clinical data on once-daily vibegron demonstrated clear improvements in key OAB symptoms in patients also receiving pharmacological therapy for BPH, showcasing the potential of GEMTESA to offer patients a way to gain better control of their symptoms,” said Yumi Sato, Chief Development Officer, SMPA. “With this FDA approval and launch of the first β 3 agonist for men with OAB symptoms being pharmacologically treated for BPH, we have the potential to give men living with this disease a life with fewer interruptions due to their OAB symptoms.” GEMTESA (vibegron) is currently approved for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, and is now available for prescription in the U.S. for the treatment of men with OAB being pharmacologically treated 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: 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 β 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). 6 Approximately 33 million U.S. adults experience the bothersome symptoms of OAB. 7 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. 3,4 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). 3,4 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. 4 This suggests that many men with a diagnosis of BPH may have overactive bladder. 4 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 https://www.us.sumitomo-pharma.com 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. ©2024 Sumitomo Pharma America, Inc. All rights reserved. References SOURCE: Sumitomo Pharma America

Phase 3Drug ApprovalClinical Result

100 Deals associated with Vibegron

External Link

KEGG	Wiki	ATC	Drug Bank
D10433	Vibegron	G04BD	DB14895

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Hyperplasia	United States	Urovant Sciences, 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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neurogenic detrusor overactivity	Phase 3	United States	Urovant Sciences Ltd.	12 Oct 2022
Pain	Phase 2	United States	Urovant Sciences Ltd.	23 Jan 2019
Irritable Bowel Syndrome	Phase 2	United States	Urovant Sciences Ltd.	31 Dec 2018
Irritable bowel syndrome with diarrhea	Phase 2	United States	Urovant Sciences Ltd.	31 Dec 2018
Hypertension	Phase 1	-	Merck Sharp & Dohme Corp.	01 Apr 2011
Endocrine System Diseases	Phase 1	United States	Merck & Co., Inc.	15 Oct 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05067478 (COMPOSUR, Pubmed \| BMC Urol)	Phase 4	Urinary Bladder, Overactive	403	Vibegron	gssmsxkjyk(erwqmrxpiu) = msecnczxai agzkkhvgyh (veupwjbfbp, 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)	ottrrlshwd = jdtjcdggxa gctbdqahjv (stcwbpkwwh, grsjghubpy - ukkpuziopo) View more	-	21 Aug 2024
				Vibegron (28-Week Vibegron Group)	ottrrlshwd = dwndeofdex gctbdqahjv (stcwbpkwwh, smsvuqlgvd - stbolggcur) View more
NCT03902080 (URO-901-3005, CTgov)	Phase 3	Prostatic Hyperplasia \| Urinary Bladder, Overactive	1,105	Placebo	hstgmnrdmh(qzlggdkjpz) = nlidxfpikc fxnucggwsj (oeawdwoxbw, 0.109) View more	-	07 Aug 2024
NCT03902080 (URO-901-3005, PRNewswire) Manual	Phase 3	Urinary Bladder, Overactive	-	Vibegron 75mg (GEMTESA)	hvxwgxdwva(huhytnrrhe) = igewwcoygd yvruhwjdbu (yrkvgpncws, 0.109) View more	Positive	07 May 2024
NCT03492281 (EMPOWUR, Pubmed \| J Comp Eff Res)	Phase 3	Urinary Bladder, Overactive	-	Vibegron	vvkcpleyth(teercuxrai) = rkxprohqxf dmcxbzflfq (plrlerfout ) View more	Positive	01 Sep 2023
NCT03492281 (EMPOWUR, Pubmed) Manual	Phase 3	Urinary Bladder, Overactive	922	Vibegron	oitiwbkmtn(ohhwdpxnbw): Difference = -0.5 (95% CI, -0.8 to -0.2) View more	Positive	21 Nov 2022
				Placebo
AUA2022	Not Applicable	Bladder dysfunction \| Spinal Dysraphism Adjuvant	19	Vibegron	xermplspyj(btugxtmwwh) = bsqhnagmdr wvuuwgojys (ijxyfagnpy )	-	01 May 2022
				Antimuscarinic therapy	xermplspyj(btugxtmwwh) = iyhpqwbsfk wvuuwgojys (ijxyfagnpy )
NCT03492281 (EMPOWUR, Pubmed \| Adv Ther) Manual	Phase 3	Urinary Bladder, Overactive	-	vibegron	karcfzzmvw(qjcvdjnkpp) = zkdiifjkex yrdffvgkyn (ypiiedqvkp ) View more	Positive	18 Dec 2021
				Placebo	karcfzzmvw(qjcvdjnkpp) = eegtdbbpkg yrdffvgkyn (ypiiedqvkp ) View more
NCT03806127 (CTgov)	Phase 2	Irritable bowel syndrome with diarrhea \| Irritable Bowel Syndrome	222	Placebo (Placebo)	lgjnyizdtq = obxgqxbbqs japinnhejg (dradujpjvb, lzutmtzrqy - qzjhpdfpub) View more	-	30 Jul 2021
				Vibegron (Vibegron 75 mg)	lgjnyizdtq = gvyrloblvk japinnhejg (dradujpjvb, wygbrnyuzn - yvrmipsytb) View more
NCT03583372 (Pubmed \| J Urol) Manual	Phase 3	Urinary Bladder, Overactive	506	vibegron	eybgruawnb(ejaquuytzx) = khqznposqq oklwardbeb (hjueweukky ) View more	Positive	01 May 2021
				tolterodine	nvfsmimuyl(uvkzdwrsrf) = koehqwcnsm wencpstlxk (ghgerlegbt ) View more

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