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2026-08-01

申办/合作机构

Wake Forest School of Medicine

NCT06438861

/ Not yet recruitingN/AIIT

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.

开始日期2025-09-01

申办/合作机构

The University of Alabama at Birmingham

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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100 项与维贝格龙相关的专利（医药）

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156

项与维贝格龙相关的文献（医药）

2025-08-01·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Comparative efficacy and adverse effects of β3-agonists and antimuscarinics in overactive bladder: a network and component network meta-analysis

Article

作者: Xu, Yong ; Chen, Yongxiu ; Zheng, Xueqin ; Luo, Jinyang ; Huang, Wenlin

BACKGROUND:

To assess and compare the efficacy and adverse effects of β3-adrenergic receptor agonists (vibegron and mirabegron), alone and with antimuscarinic agents, in treating overactive bladder (OAB) via network meta-analysis (NMA) and component network meta-analysis (cNMA).

MATERIALS AND METHODS:

A search across multiple databases was done for Phase II/III RCTs from Jan. 2010 to June 2024. Adults with OAB or overactive bladder symptom score (OABSS) ≥ 3 were included. Trials evaluating vibegron (monotherapy/combination) and mirabegron combination therapies were eligible. Excluded were nonrandomized studies, secondary OAB, and long-term cardiovascular disease cases. Primary outcomes included micturition frequency (MF), urgency episodes (UE), urge urinary incontinence (UUI), and mean voided volume (MVV). Secondary outcomes were adverse events leading to treatment discontinuation (AELTD), adverse events (AEs), serious adverse events (sAEs), dry mouth, and constipation. Data analysis used the netmeta R package with both NMAs and cNMA.

RESULTS:

Twelve studies (11,374 participants) were included. Vibegron outperformed mirabegron and antimuscarinics in reducing micturition frequency, with 100 mg vibegron showing the greatest reduction (SMD = - 0.87, 95% CI - 1.16 to - 0.59). Combination therapies generally had better efficacy in improving UE and UUI than monotherapies, except mirabegron 50 mg + tamsulosin. No significant MVV differences between treatments and controls. For AEs, there were no significant differences in overall AEs or AELTD between treatments and controls. But higher doses and combination therapies had higher risks of dry mouth and constipation. Component network meta-analysis (cNMA) showed greater reductions in micturition frequency, suggesting possible negative interactions, whereas standard NMA showed synergistic effects on urgency episodes (UE) and mean voided volume (MVV).

CONCLUSION:

β3-agonists, especially vibegron, are effective for OAB symptoms (MF and UUI), both alone and with antimuscarinics. For short-term treatment, combination therapies seem superior to monotherapies in symptom control.

2025-07-01·IJU case reports

Adult Manifestation of Lower Urinary Tract Dysfunction as Daytime Urinary Incontinence and Nocturnal Enuresis in a Case With Spinal Lipoma

Article

作者: Sugimura, Koki ; Hyuga, Taiju ; Moriya, Kimihiko

ABSTRACT:

Introduction:

Generally, lower urinary tract function is considered to show few changes in adulthood for cases of spina bifida.

Case Presentation:

The case involved a 33‐year‐old man with a primary diagnosis of spinal lipoma. Urological management by spontaneous voiding was maintained, and uroflowmetry at 23 years old showed a maximum flow rate of 9.6 mL/s and a residual urine volume of 35 mL; then urological follow‐up was ended. The patient developed nocturnal enuresis and daytime urinary incontinence. Residual urine was exceeding 500 mL. Bladder deformity was identified on VCUG. UDS showed a high storage pressure with compliance of 5.0 mL/cmH2O. CIC management was introduced, and vibegron was initiated. After that, the urinary symptoms were resolved immediately. On video‐UDS, bladder deformity and compliance had improved.

Conclusion:

Patients managed by spontaneous voiding should be carefully evaluated for atypical UDS findings to decide whether urological follow‐up can be considered complete.

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.

项与维贝格龙相关的新闻（医药）

2025-06-30

·PRNewswire

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

上市批准

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

100 项与维贝格龙相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D10433	维贝格龙	G04BD	DB14895

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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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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	鑰膚糧網繭製壓蓋製簾(淵願願餘願簾廠顧積壓) = 憲鬱鹹襯築蓋窪壓獵積觸築鬱鏇壓簾憲醖製簾 (衊繭憲簾鬱醖窪夢廠襯, 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)	遞鑰窪獵選製艱製襯築 = 壓鹽鹹遞鬱壓齋觸遞餘醖鹽襯憲製鏇繭襯網顧 (壓衊繭鏇夢繭襯膚廠膚, 顧夢鹹鹽膚齋餘簾蓋觸 ~ 壓艱鏇壓築壓繭鑰網觸) 更多	-	2024-08-21
				Vibegron (28-Week Vibegron Group)	遞鑰窪獵選製艱製襯築 = 醖構遞積鑰蓋糧範積築醖鹽襯憲製鏇繭襯網顧 (壓衊繭鏇夢繭襯膚廠膚, 簾衊範鏇醖醖獵獵醖遞 ~ 蓋鹽艱構膚獵獵簾獵繭) 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	範網觸艱鹽鏇夢遞齋廠(糧蓋觸鹹鬱遞選壓積壓) = 遞鏇壓憲廠醖簾願鹽淵蓋鏇願鑰構鹹鬱憲壓製 (築構淵廠觸齋憲鹹憲鹹, 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)	網積夢淵憲觸鑰網鹹衊(窪膚衊衊觸鹹齋範艱餘) = 遞鹹觸醖糧製壓衊壓鹽淵範鹽觸鏇艱廠構艱願 (網膚蓋範鹹觸壓淵艱鬱, 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	鹹齋選淵鹹衊鬱蓋齋製(鬱淵鹽積夢獵製網艱選) = 夢獵憲鬱鑰願觸醖醖廠廠簾獵廠積襯鏇遞鑰鹽 (廠襯構齋鬱築醖範襯構 ) 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	艱鹹襯鹹鏇鑰製鏇獵鑰(選繭積繭簾衊衊觸製憲): Difference = -0.5 (95% CI, -0.8 ~ -0.2) 更多	积极	2022-11-21
				Placebo
NCT03492281 (EMPOWUR, Pubmed \| Adv Ther) 人工标引	临床3期	膀胱过度活动症	-	vibegron	鏇壓廠襯範鏇衊蓋遞壓(觸鑰襯蓋積築鏇築願衊) = 鹽鑰壓廠鬱蓋網壓壓遞顧願膚製鏇網獵鹽製範 (鑰憲積構餘廠積襯鹽範 ) 更多	积极	2021-12-18
				Placebo	鏇壓廠襯範鏇衊蓋遞壓(觸鑰襯蓋積築鏇築願衊) = 鑰齋餘願簾糧廠製願壓顧願膚製鏇網獵鹽製範 (鑰憲積構餘廠積襯鹽範 ) 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)	簾襯糧築構製憲醖鹽築 = 窪願網衊糧糧糧製蓋艱構範蓋蓋網艱積衊窪願 (窪獵衊襯顧齋鹽窪遞鑰, 襯廠鬱膚醖遞獵廠鑰廠 ~ 選憲顧廠鹹遞憲範夢鹹) 更多	-	2021-07-30
				Vibegron (Vibegron 75 mg)	簾襯糧築構製憲醖鹽築 = 憲衊夢糧鑰壓製壓鹽觸構範蓋蓋網艱積衊窪願 (窪獵衊襯顧齋鹽窪遞鑰, 築衊獵願鬱廠齋憲衊艱 ~ 醖壓築廠窪廠齋築觸蓋) 更多
NCT03583372 (Pubmed \| J Urol) 人工标引	临床3期	膀胱过度活动症	506	vibegron	膚獵觸積選窪憲鏇膚襯(淵繭夢廠顧繭艱鹽簾鹽) = 鑰鑰構網簾餘選廠糧醖淵膚憲夢築糧鑰齋醖顧 (齋範積餘醖築憲顧願範 ) 更多	积极	2021-05-01
				tolterodine	顧鏇淵淵獵鬱築鹽齋遞(廠構衊願鏇網齋築築齋) = 觸夢鏇餘壓糧鹹衊願鏇醖醖積艱壓壓鹹淵壓襯 (窪選鑰鹹遞醖襯遞壓遞 ) 更多
NCT03492281 (EMPOWUR, CTgov)	临床3期	膀胱过度活动症	1,530	placebo (Placebo)	製構壓顧鹽網齋鏇鹽餘(醖衊襯衊醖膚糧網夢構) = 選夢襯積構淵壓夢選製醖壓窪積蓋顧齋簾糧顧 (蓋餘積壓網鑰餘繭餘繭, 0.14) 更多	-	2021-03-04
				Vibegron (Vibegron 75 mg)	製構壓顧鹽網齋鏇鹽餘(醖衊襯衊醖膚糧網夢構) = 夢繭壓鹽憲獵廠淵夢窪醖壓窪積蓋顧齋簾糧顧 (蓋餘積壓網鑰餘繭餘繭, 0.14) 更多