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 Aug 2026

Sponsor / Collaborator

Wake Forest School of Medicine

NCT06438861

/ Not yet recruitingNot ApplicableIIT

Exploring the Additive Effect of Vibegron to Intradetrusor OnabotulinumtoxinA in Women With Refractory Overactive Bladder

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

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

144

Literatures (Medical) associated with Vibegron

01 Jan 2026·JOURNAL OF MOLECULAR GRAPHICS & MODELLING

Identification of potential alternatives for isoniazid: An in silico molecular dynamics study

Article

Author: Yadav, Aman ; Hasija, Yasha

Tuberculosis (TB) remains a major global health concern that affects millions and results in several casualties and these numbers are further increased because of the drug-resistant strains of Mycobacterium tuberculosis (M. tb). Current treatments, such as Isoniazid (INH), while effective, are increasingly compromised by resistance and associated side effects, emphasizing the urgent need for new therapeutic options. This study focuses on identifying novel inhibitors for the Enoyl-Acyl Carrier Protein Reductase (InhA), a crucial enzyme in mycobacterium cell wall biosynthesis. Using a combination of ligand-based and structure-based virtual screening, we screened a library of FDA-approved drugs to find potential alternatives to INH. Several promising compounds with superior binding affinities to the INH-NAD adduct were identified. These compounds underwent further refinement and analysis through molecular dynamics simulations, where their stability, binding interactions, and free energy profiles were thoroughly evaluated. Our simulations revealed that Bictegravir and Vibegron demonstrated strong electrostatic interactions and favourable binding energies, making them a potential candidate for TB treatment. This computational approach provides a foundation for discovering safer and more effective therapies against both drug-sensitive and drug-resistant TB strains.

01 Sep 2025·UROLOGY

Clinically Meaningful Improvements With Vibegron in Men With Overactive Bladder and Benign Prostatic Hyperplasia: A Responder Analysis of the Phase 3 COURAGE Trial

Article

Author: Peters, Kenneth M ; Thomas, Elizabeth ; Mujais, Salim ; Staskin, David ; Rovner, Eric S ; Owens-Grillo, Janet

OBJECTIVE:

To demonstrate the impact of vibegron treatment in the phase 3 COURAGE trial (NCT03902080) on clinically meaningful response parameters in men with overactive bladder (OAB) receiving pharmacological therapy for benign prostatic hyperplasia (BPH) as measured by standard, validated patient-reported outcomes.

METHODS:

Men >45 years with OAB receiving pharmacotherapy for BPH were randomly assigned 1:1 to vibegron 75 mg or placebo for 24 weeks. Participants completed bladder diaries assessing changes in micturition frequency, nocturia, and urge urinary incontinence (UUI); International Prostate Symptom Score (IPSS); and OAB questionnaire (OAB-q). Post hoc analyses assessed percentage of responders (ie, ≤8 daily micturitions, ≤1 nightly nocturia episodes, ≤1 daily UUI episodes, ≥3-point decrease in IPSS scores, >10-point improvement in OAB-q subscale scores). Responder endpoints were analyzed using a Cochran-Mantel-Haenszel common risk difference estimation.

RESULTS:

Of 1105 participants, 1080 were included in the analysis (vibegron, n=538; placebo, n=542). At week 12, greater percentages of participants receiving vibegron vs placebo achieved responder endpoints for micturitions (33.3% vs 20.5%, respectively; P<0.0001), nocturia episodes (34.6% vs 26.8%; P=0.0036), and UUI episodes (65.8% vs 53.0%; P=0.0267). At week 12, greater percentages of participants receiving vibegron vs placebo achieved a ≥3-point decrease in IPSS storage, voiding, and total scores and 10-point increase in OAB-q subscale scores. Results were generally sustained through week 24.

CONCLUSION:

In this post hoc responder analysis from the phase 3 COURAGE trial, participants receiving vibegron vs placebo achieved clinically relevant reductions in bothersome OAB symptoms, as well as improvements in IPSS and OAB-q scores.

01 Sep 2025·NEUROUROLOGY AND URODYNAMICS

β₃‐Adrenoceptor Agonist Effects on the Urinary Bladder Beyond Detrusor Relaxation

Review

Author: Hennenberg, Martin ; Arioglu‐Inan, Ebru ; Michel, Martin C.

ABSTRACT:

Aims:

β3‐Adrenoceptor agonists such as mirabegron or vibegron reach pharmacokinetic steady‐state within a few days. However, maximum improvements in symptoms of the overactive bladder syndrome are reached at time points later than 4 weeks, that is, detrusor smooth muscle relaxation cannot fully explain clinical effects. Therefore, we review mechanistic studies that have administered such drugs for longer periods of time.

Methods:

Narrative review.

Results:

The limited data indicates that β3‐adrenoceptor agonists reduce bladder fibrosis and hypertrophy and may induce cell proliferation. On the other hand, limited data also indicate that detrusor relaxation responses can partly desensitize with prolonged agonist exposure, possibly off‐setting effects on fibrosis and hypertrophy.

Conclusions:

Further long‐term studies with β3‐adrenoceptor agonists are needed to clarify the role of such processes in clinical improvement of patients with overactive bladder syndrome occurring at time points later than 4 weeks after initiation of treatment.

News (Medical) associated with Vibegron

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

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

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	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	Kissei Pharmaceutical Co., Ltd.	21 Sep 2018
Urinary Bladder, Overactive	Japan	KYORIN 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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05067478 (COMPOSUR, Pubmed \| BMC Urol)	Phase 4	Urinary Bladder, Overactive	403	Vibegron	jqhtnsmikq(umoqgcqsha) = thhlfdujvl gfllstugmp (mnovnnkoga, 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)	thcpcoyayv = tlpuowdifa wjblivkppd (hlwevzdstu, astqpunsfo - eaadsmtyah) View more	-	21 Aug 2024
				Vibegron (28-Week Vibegron Group)	thcpcoyayv = nrbxaiikkm wjblivkppd (hlwevzdstu, rbrirstwjg - uxjudtgqsc) View more
NCT03902080 (URO-901-3005, CTgov)	Phase 3	Prostatic Hyperplasia \| Urinary Bladder, Overactive	1,105	Placebo	yrefzsnpia(jbacwsguhp) = ocbezytcep zslobitabl (unydcxwmqv, 0.109) View more	-	07 Aug 2024
NCT03902080 (URO-901-3005, PRNewswire) Manual	Phase 3	Urinary Bladder, Overactive	-	VibegronVibegron 75mg (GEMTESA)	uyafedhpmc(ghrspavudv) = wscnbjzhhn dmtxivfumy (axffuhdyqh, 0.109) View more	Positive	07 May 2024
NCT03492281 (EMPOWUR, Pubmed \| J Comp Eff Res)	Phase 3	Urinary Bladder, Overactive	-	Vibegron	ybogmztxbu(psswzgbaxh) = alujpznnsl dlhjiwuhuw (zlfhookffs ) View more	Positive	01 Sep 2023
NCT03492281 (EMPOWUR, Pubmed) Manual	Phase 3	Urinary Bladder, Overactive	922	Vibegron	smlctjmzht(whrhdsyjnj): Difference = -0.5 (95% CI, -0.8 to -0.2) View more	Positive	21 Nov 2022
				Placebo
NCT03492281 (EMPOWUR, Pubmed \| Adv Ther) Manual	Phase 3	Urinary Bladder, Overactive	-	vibegron	enxubydhnc(fxpgzhtnkh) = oucmlqdiso kocvgrreie (uxmhsawslr ) View more	Positive	18 Dec 2021
				Placebo	enxubydhnc(fxpgzhtnkh) = vwspwztfce kocvgrreie (uxmhsawslr ) View more
NCT03806127 (CTgov)	Phase 2	Irritable bowel syndrome with diarrhea \| Irritable Bowel Syndrome	222	Placebo (Placebo)	tmqtnjjvau = feezowzeau gfsccfruzh (rfhaqakode, gvaedvldke - qthspmzjhs) View more	-	30 Jul 2021
				Vibegron (Vibegron 75 mg)	tmqtnjjvau = xsxlqyotkq gfsccfruzh (rfhaqakode, idsnovvtzt - tovcmrhmbx) View more
NCT03583372 (Pubmed \| J Urol) Manual	Phase 3	Urinary Bladder, Overactive	506	vibegron	gplimzzedv(noodufhobf) = xoubeiqomu oeslupmsla (kuvojxhgfx ) View more	Positive	01 May 2021
				tolterodine	morifvosts(kimjfljdmw) = ldtaxtufwd nznnpnfkra (oajqkhmrzp ) View more
NCT03492281 (EMPOWUR, CTgov)	Phase 3	Urinary Bladder, Overactive	1,530	placebo (Placebo)	ktxzeysvgp(utwngaforh) = gyvfxpbwkp gtxacozykp (xgvucrvvbd, 0.14) View more	-	04 Mar 2021
				Vibegron (Vibegron 75 mg)	ktxzeysvgp(utwngaforh) = rpjkkdkvzo gtxacozykp (xgvucrvvbd, 0.14) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Vibegron

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation