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 Apr 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

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-

NCT06417177

/ RecruitingEarly Phase 1IIT

Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.

Start Date03 Jun 2024

Sponsor / Collaborator

University of Missouri

100 Clinical Results associated with Vibegron

100 Translational Medicine associated with Vibegron

100 Patents (Medical) associated with Vibegron

118

Literatures (Medical) associated with Vibegron

01 Jan 2025·LUTS: Lower Urinary Tract Symptoms

Comparison of the 3‐Year Continuation Rate and Discontinuation Factors Between Vibegron and Mirabegron in Patients With Overactive Bladder: A Retrospective Follow‐Up Study in a Rehabilitation Hospital in Japan

Article

Author: Sengoku, Atsushi ; Yanagiuchi, Akihiro ; Nomi, Masashi ; Mukai, Shigeto

ABSTRACTObjectivesThe objective of this study is to compare the 3‐year continuation rate and discontinuation factors between vibegron and mirabegron in patients with overactive bladder in a rehabilitation hospital in Japan.MethodsThe 3‐year continuation rate of the target drugs and reasons for discontinuation as well as patients' backgrounds and adverse effects were evaluated retrospectively from the medical records between September 2018 and December 2020. After selecting patients according to our inclusion and exclusion criteria, 136 cases taking mirabegron and 82 taking vibegron were adjusted for intergroup variability by propensity score matching. We performed Cox proportional hazards regression for the 3‐year continuation rate and Fine‐Gray proportional hazards regression for the 3‐year cumulative incidence of discontinuation events. Subgroup analysis was also performed.ResultsApproximately 70% of the patients analyzed had neurogenic overactive bladder. The 3‐year continuation rate was 65.2% in vibegron and 30.3% in mirabegron, and the hazard ratio was 0.41 (95% confidence interval: 0.25–0.68, p < 0.001) as for an incidence of discontinuation events of vibegron against mirabegron. The incidence of discontinuation due to inadequate efficacy was 22.7% in vibegron and 47.0% in mirabegron, and similarly the hazard ratio was 0.43 (95% confidence interval: 0.23–0.80, p < 0.01). In the subgroup analysis, vibegron continued significantly more than mirabegron for the 3‐year continuation rate in non‐neurogenic overactive bladder (p < 0.001), in spontaneous voiding (p < 0.001), in anticholinergic combination (p = 0.0017), in female (p < 0.001), and in 70 years or older (p = 0.0028). Additionally, a significant interaction was observed regarding the methods of emptying urine (p = 0.0066).ConclusionsVibegron was superior to mirabegron in the 3‐year continuation rate of administration with a fewer discontinuation due to inadequate efficacy in a patient population with relatively high rates of neurogenic overactive bladder.

01 Jan 2025·International Journal of Geriatric Psychiatry

Risks of Dementia Associated With Anticholinergic Medication Compared to Beta‐3 Agonist Among Older Patients With Overactive Bladder in Japan: The LIFE Study

Article

Author: Gon, Yasufumi ; Fukuda, Haruhisa ; Komukai, Sho ; Komatsu, Masayo ; Zha, Ling ; Kitamura, Tetsuhisa ; Murata, Fumiko ; Kiyohara, Kosuke ; Maeda, Megumi ; Shimomura, Yoshimitsu ; Kimura, Yasuyoshi ; Okita, Yuki

ABSTRACTObjectivesAnticholinergic drugs can cause cognitive impairment. The risk of dementia associated with anticholinergics compared to beta‐3 agonists (mirabegron and vibegron) has not been extensively investigated in the super‐aging society of Japan. This study evaluated the association between the dementia risk and anticholinergics compared to beta‐3 agonists in older adults with overactive bladder in Japan.MethodsThis study had 1,493,202 participants from the Longevity Improvement & Fair Evidence Study, which includes claim data in Japan from 2014 to 2022. The participants included 13,448 anticholinergic drug users and 24,669 beta‐3 agonist users diagnosed with overactive bladder and aged ≥ 65 years. The Cox proportional hazards regression model was used to calculate hazard ratios and 95% confidence intervals being adjusted for confounding variables to evaluate the impact of anticholinergic drugs compared to beta‐3 agonists prescribed at index date to patients with overactive bladder.ResultsAmong the beta‐3 agonist and anticholinergic drug users, the mean (standard deviation) age was 78.9 (6.7) and 78.8 (7.0) years, and the percentage of men was 47.2% and 39.7%, respectively. In the beta‐3 agonist group, 2130 participants were newly diagnosed with dementia during the 51,605 person‐years of follow‐up from the index date, whereas in the anticholinergic drug group, 1826 participants were diagnosed during the 34,929 person‐years of follow‐up. In the Cox proportional hazard regression model, there was an increased risk of dementia in the anticholinergic drug group compared to the beta‐3 agonist group (adjusted hazard ratio [aHR] = 1.22; 95% confidence interval [CI], 1.15–1.30). The increased risk remained identical when Inverse Probability Weighting (IPW) model was used for the analysis (aHR = 1.19; 95% CI, 1.11–1.28).ConclusionsCompared to beta‐3 agonists, anticholinergic drugs are associated with an increased risk of dementia in older adults with overactive bladder, in Japan. These findings suggest that beta‐3 agonists may have a lower risk of dementia than anticholinergics and have potential to be a good alternative opinion for older people with OAB, which warrants further study.

01 Dec 2024·Journal of Urology

Letter: Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial

Letter

Author: Yu, Ting ; Li, Jun ; Shan, Dan ; Yang, Yu ; Chen, Dong

News (Medical) associated with Vibegron

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

23 Dec 2024

·www.prnewswire.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, Mass., Dec. 23, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) announced today that the U.S. Food and Drug Administration (FDA) has approved GEMTESA® (vibegron), a beta-3 (β3) 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 β3 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 β3 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: 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).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 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 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. 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 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

Phase 3Clinical ResultDrug Approval

100 Deals associated with Vibegron

External Link

KEGG	Wiki	ATC	Drug Bank
D10433	Vibegron	G04BD	DB14895

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Prostatic Hyperplasia	US	Urovant Sciences, Inc.	18 Dec 2024
Overactive bladder syndrome	LI	Pierre Fabre Médicament SAS	27 Jun 2024
Overactive bladder syndrome	NO	Pierre Fabre Médicament SAS	27 Jun 2024
Overactive bladder syndrome	IS	Pierre Fabre Médicament SAS	27 Jun 2024
Overactive bladder syndrome	EU	Pierre Fabre Médicament SAS	27 Jun 2024
Urinary Bladder, Overactive	JP	KYORIN Pharmaceutical Co., Ltd.	21 Sep 2018
Urinary Bladder, Overactive	JP	Kissei Pharmaceutical Co., Ltd.	21 Sep 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Urinary Bladder, Overactive	NDA/BLA	EU	Pierre Fabre SA	22 May 2023
Neurogenic detrusor overactivity	Phase 3	US	Urovant Sciences Ltd.	12 Oct 2022
Prostatic Hyperplasia	Phase 3	PL	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	HU	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	BE	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	PT	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	CA	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	LT	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	ES	Urovant Sciences Ltd.	26 Mar 2019
Irritable Bowel Syndrome	Preclinical	US	Urovant Sciences Ltd.	31 Dec 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04103450 (CTgov)	Phase 3	Prostatic Hyperplasia \| Urinary Bladder, Overactive	276	Vibegron (52-Week Vibegron Group)	tdzbrogxjg(dedinhyrie) = pgxyibghml ixwlavvfhv (khmybpiovy, rskddeaegu - hfbuezmsgs) View more	-	21 Aug 2024
				Vibegron (28-Week Vibegron Group)	tdzbrogxjg(dedinhyrie) = vnxfvonibc ixwlavvfhv (khmybpiovy, vmnlwxnrcj - rblqfswunp) View more
NCT03902080 (URO-901-3005, CTgov)	Phase 3	Prostatic Hyperplasia \| Urinary Bladder, Overactive	1,105	Placebo	mdmcohalqq(fwiaqbrqsz) = yjqbvqmpek hxwkomkmco (byaerzjazr, tlqhctqbyw - tefekmnurh) View more	-	07 Aug 2024
NCT03902080 (URO-901-3005, PRNewswire) Manual	Phase 3	Urinary Bladder, Overactive	-	Vibegron 75mg (GEMTESA)	hyujytnkhq(hvtrdenzyv) = mzpblocsda aduivqwazv (dwjuuykjcr, 0.109) View more	Positive	07 May 2024
NCT03492281 (EMPOWUR, Pubmed \| J Comp Eff Res)	Phase 3	Urinary Bladder, Overactive	-	Vibegron	(keakumniws) = lwzmfodzzc vvxzsgbrhb (ltbwfjcjqf ) View more	Positive	01 Sep 2023
NCT03492281 (EMPOWUR, Pubmed) Manual	Phase 3	Urinary Bladder, Overactive	922	Vibegron	(ucmqbdagyo): 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	dbuthyotrk(tqvnnyiwae) = pqvrkzpgzb qzvbdfhjgl (eqmdbmwowq )	-	01 May 2022
				Antimuscarinic therapy	dbuthyotrk(tqvnnyiwae) = yhxwcflrkk qzvbdfhjgl (eqmdbmwowq )
NCT03492281 (EMPOWUR, Pubmed \| Adv Ther) Manual	Phase 3	Urinary Bladder, Overactive	-	vibegron	(oqenempdsx) = hsmkyovmsg stpgrtwawg (ajrcgjumks ) View more	Positive	18 Dec 2021
				Placebo	(oqenempdsx) = dgivcndcuh stpgrtwawg (ajrcgjumks ) View more
NCT03806127 (CTgov)	Phase 2	Irritable Bowel Syndrome	222	Placebo (Placebo)	kjmmlbgmpe(xjcbldostq) = ybzidsewyz tuxxycpabk (tlzvjzulai, vfknqhcruc - wpszxdxyky) View more	-	30 Jul 2021
				Vibegron (Vibegron 75 mg)	kjmmlbgmpe(xjcbldostq) = muttwkraqd tuxxycpabk (tlzvjzulai, lrmzvkelmz - syucyfofyk) View more
NCT03583372 (Pubmed \| J Urol) Manual	Phase 3	Urinary Bladder, Overactive	506	vibegron	(sivcvvebdn) = lwdaxlzblx myrktjvnji (xfktmqxice ) View more	Positive	01 May 2021
				tolterodine	(ornfctkowv) = msnwmuueya wqslbjhcny (grneamacuj ) View more
NCT03492281 (EMPOWUR, CTgov)	Phase 3	Urinary Bladder, Overactive	1,530	placebo (Placebo)	tugselpoee(nftjusalud) = khcplovxja kaqbshpxnc (idozhidpix, kqrlmsgsja - hxmtloqcpd) View more	-	04 Mar 2021
				Vibegron (Vibegron 75 mg)	tugselpoee(nftjusalud) = dtbojdltfh kaqbshpxnc (idozhidpix, bmnixznmoa - kdxlqdevrm) View more

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Vibegron

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