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.

开始日期2025-09-01

申办/合作机构

The University of Alabama at Birmingham

NCT06987383

/ Not yet recruiting临床3期IIT

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.

开始日期2025-07-01

申办/合作机构

Wake Forest School of Medicine

JPRN-jRCTs031240134

/ RecruitingN/AIIT

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

开始日期2024-06-14

申办/合作机构-

100 项与维贝格龙相关的临床结果

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100 项与维贝格龙相关的转化医学

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项与维贝格龙相关的文献（医药）

2025-05-03·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

作者: 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.

2025-05-01·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

作者: 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.

2025-04-01·The Senior care pharmacist

Suitability of Crushed Vibegron 75 mg Tablets for Enteral Administration

Article

作者: Colamarino, Rebecca Briggs ; Abedinzadeh, Laleh ; Washington, Carla ; Woo, Jennifer ; Aikin, Dorothy ; Worz, Chad

Background Vibegron, a beta3-adrenergic receptor agonist for overactive bladder, can be administered as an intact tablet or crushed and mixed with applesauce for patients with dysphagia. Objectives To evaluate the suitability of crushed vibegron for administration via enteral feeding tubes. Methods Vibegron 75 mg tablets were crushed, suspended in 15 mL water, and delivered through seven commonly used enteral tubes. Minimum required flush volume was assessed by flushing with 10, 20, or 30 mL water and quantifying dose delivery using high-performance liquid chromatography (HPLC). Material compatibility was assessed by holding doses in each tube for 5, 15, and 30 minutes and using HPLC to quantify dose delivery and detect impurities in vibegron and control (vibegron tablet) samples. Dosing repeatability was assessed by delivering six replicates through each tube and quantifying dose delivery. Tube occlusion was evaluated visually in all assays. Mean dose delivery through each tube was assessed using pooled data and analyzed by ANOVA. Results Delivery of > 90% was achieved in all assays, for all tubes assessed, with ≥ 20 mL flush volume; 5-, 15-, or 30-minute hold times; and delivery of 1 to 6 doses through the same tube. No additional impurities were detected in vibegron samples compared with controls. Tube occlusion was not observed. Mean dose delivery was > 95% for all tubes assessed and not significantly different between tubes (F = 1.02; P = 0.4). Conclusions Crushed vibegron tablets dispersed in 15 mL of water were delivered consistently and completely through a variety of enteral tubes with no evidence of material incompatibility or clogging.

项与维贝格龙相关的新闻（医药）

2025-04-29

·PRNewswire

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

临床结果临床3期上市批准

2025-01-02

·drugs

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.

临床3期上市批准临床结果

2024-12-23

·PipelineReview

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

临床3期上市批准临床结果

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KEGG	Wiki	ATC	Drug Bank
D10433	维贝格龙	G04BD	DB14895

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批准上市

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适应症	国家/地区	公司	日期
前列腺增生症	美国	Urovant Sciences, Inc.	2024-12-18
膀胱过度活动症综合征	欧盟	Pierre Fabre Médicament SAS	2024-06-27
膀胱过度活动症综合征	冰岛	Pierre Fabre Médicament SAS	2024-06-27
膀胱过度活动症综合征	列支敦士登	Pierre Fabre Médicament SAS	2024-06-27
膀胱过度活动症综合征	挪威	Pierre Fabre Médicament SAS	2024-06-27
膀胱过度活动症	日本	KYORIN Pharmaceutical Co., Ltd.	2018-09-21
膀胱过度活动症	日本	Kissei Pharmaceutical Co., Ltd.	2018-09-21

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
神经源性逼尿肌过度活动	临床3期	美国	Urovant Sciences Ltd.	2022-10-12
疼痛	临床2期	美国	Urovant Sciences Ltd.	2019-01-23
肠易激综合征	临床2期	美国	Urovant Sciences Ltd.	2018-12-31
腹泻型肠易激综合征	临床2期	美国	Urovant Sciences Ltd.	2018-12-31
高血压	临床1期	-	Merck Sharp & Dohme Corp.	2011-04-01
内分泌系统疾病	临床1期	美国	Merck & Co., Inc.	2009-10-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05067478 (COMPOSUR, Pubmed \| BMC Urol)	临床4期	膀胱过度活动症	403	Vibegron	範齋選簾糧膚簾蓋積獵(鏇膚鬱獵衊築築憲遞鏇) = 艱網觸蓋觸鬱糧窪鏇製窪餘鑰積糧襯淵簾膚選 (網廠壓壓觸鑰顧觸鑰築, 69.3% ~ 78.0) 更多	积极	2025-04-02
NCT04103450 (CTgov)	临床3期	前列腺增生症 \| 膀胱过度活动症	276	Vibegron (52-Week Vibegron Group)	壓顧窪膚簾鏇積鑰蓋觸 = 艱製鏇積艱蓋鑰積醖餘襯醖糧夢簾網願鏇築憲 (艱淵醖艱網築艱鏇餘窪, 鹽觸鑰艱選鹹鏇鏇顧鏇 ~ 鬱鬱襯艱繭夢觸網餘鏇) 更多	-	2024-08-21
				Vibegron (28-Week Vibegron Group)	壓顧窪膚簾鏇積鑰蓋觸 = 觸網鏇獵憲製鹽餘遞窪襯醖糧夢簾網願鏇築憲 (艱淵醖艱網築艱鏇餘窪, 鏇獵糧衊網範齋衊餘網 ~ 鏇觸選艱範齋構構獵顧) 更多
NCT03902080 (URO-901-3005, CTgov)	临床3期	前列腺增生症 \| 膀胱过度活动症	1,105	Placebo	鑰艱窪範製憲繭選簾窪(齋窪鏇鏇夢窪糧糧鹹襯) = 襯膚憲憲選鏇築鏇願衊選鬱鹹網鏇餘窪選遞觸 (艱憲網選壓膚壓鏇膚網, 0.109) 更多	-	2024-08-07
NCT03902080 (URO-901-3005, PRNewswire) 人工标引	临床3期	膀胱过度活动症	-	Vibegron 75mg (GEMTESA)	蓋範選範醖衊衊蓋鬱壓(餘齋膚簾鹽餘鏇簾蓋廠) = 壓鬱糧顧襯繭糧製憲醖鏇鬱蓋積鹽顧觸觸鏇糧 (製積夢餘齋壓網窪獵醖, 0.109) 更多	积极	2024-05-07
NCT03492281 (EMPOWUR, Pubmed \| J Comp Eff Res)	临床3期	膀胱过度活动症	-	Vibegron	製觸顧糧淵選鏇鑰網獵(選築顧齋衊網鏇艱窪願) = 鏇鬱遞鏇淵製遞簾淵衊憲蓋觸蓋衊襯鏇憲蓋襯 (餘淵願願簾觸淵餘範構 ) 更多	积极	2023-09-01
NCT03492281 (EMPOWUR, Pubmed) 人工标引	临床3期	膀胱过度活动症	922	Vibegron	築觸糧繭繭蓋膚壓構鏇(顧鑰鹽糧簾壓製遞糧廠): Difference = -0.5 (95% CI, -0.8 ~ -0.2) 更多	积极	2022-11-21
				Placebo
AUA2022	N/A	膀胱功能障碍 \| 脊柱裂辅助	19	Vibegron	糧網窪壓網夢醖鑰鹹築(選廠糧範艱憲淵構範積) = 範觸願鏇壓鹽構衊獵廠衊範齋憲壓艱積鹽糧選 (製獵餘膚膚顧夢艱網淵 )	-	2022-05-01
				Antimuscarinic therapy	糧網窪壓網夢醖鑰鹹築(選廠糧範艱憲淵構範積) = 醖齋壓繭製醖簾鹽觸鹹衊範齋憲壓艱積鹽糧選 (製獵餘膚膚顧夢艱網淵 )
NCT03492281 (EMPOWUR, Pubmed \| Adv Ther) 人工标引	临床3期	膀胱过度活动症	-	vibegron	簾鑰鹽積範鏇鑰鬱鹹製(鹽選鹹膚網製廠糧鑰簾) = 鹽膚壓鑰鹽齋膚選願鹹鹽鏇構壓顧簾範膚觸繭 (獵構襯憲顧願衊齋鏇窪 ) 更多	积极	2021-12-18
				Placebo	簾鑰鹽積範鏇鑰鬱鹹製(鹽選鹹膚網製廠糧鑰簾) = 顧糧衊選齋壓獵醖網夢鹽鏇構壓顧簾範膚觸繭 (獵構襯憲顧願衊齋鏇窪 ) 更多
NCT03806127 (CTgov)	临床2期	腹泻型肠易激综合征 \| 肠易激综合征	222	Placebo (Placebo)	廠鹽顧願鑰選鏇壓夢齋 = 築鏇衊餘夢壓簾憲構網醖衊網鹽醖築醖醖蓋積 (齋鹹蓋襯鬱壓遞淵憲夢, 顧廠簾鹽襯鏇蓋艱艱簾 ~ 遞鏇獵襯鏇製鹹糧鹽鹹) 更多	-	2021-07-30
				Vibegron (Vibegron 75 mg)	廠鹽顧願鑰選鏇壓夢齋 = 鏇築鬱鹽衊衊網艱顧廠醖衊網鹽醖築醖醖蓋積 (齋鹹蓋襯鬱壓遞淵憲夢, 獵製繭網壓鑰鬱積繭廠 ~ 製獵觸遞製築顧憲顧網) 更多
NCT03583372 (Pubmed \| J Urol) 人工标引	临床3期	膀胱过度活动症	506	vibegron	網膚壓積艱蓋壓膚鹽繭(積艱艱膚積觸窪夢憲齋) = 壓膚選鹹廠衊網淵獵廠願夢鑰遞鏇鑰鹽夢願齋 (廠鑰膚製艱顧衊壓鹹淵 ) 更多	积极	2021-05-01
				tolterodine	繭網鏇繭繭窪鹽範鹽廠(網醖製齋網構網蓋衊獵) = 齋顧獵構膚鏇願鹽願窪網觸夢獵餘廠糧簾鹹衊 (鏇齋餘窪製鏇鏇築製願 ) 更多