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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项与维贝格龙相关的文献（医药）

2026-01-01·JOURNAL OF MOLECULAR GRAPHICS & MODELLING

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

Article

作者: 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.

2025-09-01·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

作者: 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.

2025-09-01·NEUROUROLOGY AND URODYNAMICS

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

Review

作者: 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.

项与维贝格龙相关的新闻（医药）

2025-08-01

·医药代表

住友制药宣布，完成中国区业务剥离

继续和小伙伴们分享跨国药企动态。7 月 31 日，住友制药日本总部宣布，包括中国区在内的亚洲业务，已于当日完成向丸红集团的股权转让手续。住友制药表示，上述公司分割及股份转让已于 2025 年 7 月 31 日完成，住友制药（中国）有限公司及住友制药亚太公司（Sumitomo Pharma Asia Pacific Pte. Ltd., SMPAP）不再是住友制药的合并子公司。至此，原负责亚洲业务的中国子公司“住友制药（中国）有限公司”，以及统管除日本与中国以外亚洲国家和地区业务的住友制药亚太公司，自该日起将不再作为合并子公司纳入财务报表。住友制药计划将在 2025 财年第二季度将此次转让所得约 450 亿日元计入其他收益（核心利润内）。早在今年 4 月 1 日，住友制药就已宣布与丸红株式会社的全资子公司——丸红环球制药公司（Marubeni Global Pharma）签订了股权转让协议等相关文件，现在正是基于该协议完成了实际的股权交割手续（见 MRCLUB 历史消息：一外企宣布，转让中国区药品业务！高管继续减薪…）。为推进此次亚洲业务的转让，住友制药先将“住友制药（中国）有限公司”、SMPAP 及其子公司所运营的亚洲业务，以吸收分割方式转移至其新设的全资子公司。随后，住友制药将该新公司已发行股份的 60% 转让给丸红全球制药公司。本次正是根据该方案，此次完成了 60% 股权的转让，住友制药预计将因此获得约 450 亿日元的对价收入。此外，住友制药所持有的新公司剩余 40% 股份也计划于 2029 年 4 月之后转让给丸红环球制药公司，届时预计将再获得约 270 亿日元的对价。住友制药表示，将利用此次出售亚洲业务所获取的资金，加速推进公司业务重组战略的核心——北美三大主力产品（Orgovyx、Myfembree、Gemtesa）的快速成长，同时也将用于推进两款抗肿瘤新药（TP-3654、DSP-5336）的研发，以实现尽早恢复业绩并重启公司增长轨道。今日（8 月 1 日），住友制药中国公司也宣布了这个消息，根据同年 4 月 1 日公布的《有关亚洲业务公司分立（简易吸收式分立）以及签署同丸红 Global Pharma 株式会社的股份转让协议和股东间协议的通知》所述，相关资产与股权的剥离及首期股权转让已顺利完成。住友制药中国表示，“我司（原住友制药中国）已从住友制药株式会社中独立，正式成为丸红集团的一员，开启全新的征程。”相关阅读：四十年，一家跨国药企的中国故事医药人变身公益侠，全球公益接力正式版来了！2025国谈时间确定2024年全球药品销售20强百万人从社会“消失”，药企VR破局官宣了，国药股份董事长确定康方生物代表被查，官方结果公布一药企总裁被罚1500万，10年禁入美威胁200%医药关税，引多国警惕第十一批国采报量启动，55个品种阿斯利康开线下年会了，近4000人上市药企90后少帅，突然辞去所有职务三度亮相链博会，诺和诺德以“链”会友家族药企，创始人辞职，管理层更换9900万元创新药“破题”基金！申报开启骨科主任受贿两百万，分给他人一半多22年老将即将谢幕，诺华CFO完成交棒罗氏、默克人事变动，中国医药总经理辞职药企财务造假！多位高管将被重罚最新10个重点监控药品公布17家药企上榜25年《财富》中国500强百年跨国药企诚聘英才！BI招聘专场国家市监总局公告，一药企被罚近四千万第三家药企罚单落地，副总经理闪电辞职肺癌新突破！复宏汉霖WCLC“秀肌肉”中央巡视组进驻！李健被查又一跨国医药巨头CFO退休百济神州寻找发光的你（附全国职位）AZ前高管加盟，百时美施贵宝迎来新任CMO一医学专家被查，曾任三甲医院院长阿斯利康中国，架构调整拜耳新一轮招聘启动，这次机会不要错过中央巡视组进驻，前省卫健委主任主动投案18家药企上榜2025年《财富》世界500强诺和诺德新任总裁兼首席执行官确定国家药监局原副局长陈时飞被开除党籍医疗反腐，这两天多人被查MRCLUB原创作者招募中数十万精准会员每日阅读，助您快速提升个人品牌，扩大在医药行业及社会化媒体的影响力！（详情请访问网站http://wemr.club）医药代表伴您成长！

财报并购引进/卖出

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

100 项与维贝格龙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10433	维贝格龙	G04BD	DB14895

研发状态

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适应症	国家/地区	公司	日期
前列腺增生症	美国	Sumitomo Pharma America, 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

未上市

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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	範範窪蓋獵壓淵構簾窪(膚艱鏇鹽鹽廠築網築壓) = 憲築顧衊簾齋艱獵築構餘齋餘衊簾積鹽鏇壓積 (築糧艱衊壓鏇糧築醖構, 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)	廠鏇觸觸夢繭範糧鹽鹹 = 遞衊壓構艱膚餘遞糧壓鏇選膚觸襯壓壓鏇網襯 (顧範觸鏇糧願獵窪製鬱, 壓壓艱鹹壓膚築簾鑰憲 ~ 願襯夢觸築膚餘醖鹹觸) 更多	-	2024-08-21
				Vibegron (28-Week Vibegron Group)	廠鏇觸觸夢繭範糧鹽鹹 = 範淵齋選積網積觸築製鏇選膚觸襯壓壓鏇網襯 (顧範觸鏇糧願獵窪製鬱, 齋鹹衊觸廠窪衊鹹夢衊 ~ 鑰獵網構築鑰淵鏇鹽壓) 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	願築糧膚鏇衊觸觸醖鏇(糧膚鏇簾構獵糧憲簾夢) = 廠壓構窪齋夢餘鏇廠構膚遞憲壓顧選壓構糧膚 (壓鑰繭餘廠衊壓廠獵齋, 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	-	VibegronVibegron 75mg (GEMTESA)	觸獵憲餘鬱獵觸膚簾齋(製積網積醖顧夢壓窪繭) = 製遞窪積觸築網繭憲簾簾觸鬱觸糧廠齋簾醖廠 (餘築夢衊憲構鏇膚網齋, 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	遞獵糧鏇廠襯糧鹽憲醖(夢鏇鏇襯壓齋範壓鬱衊) = 願憲餘鹹積糧蓋齋選鑰願蓋遞積窪醖廠積築願 (繭夢鹹醖簾蓋艱獵繭齋 ) 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	夢蓋繭願艱鏇積蓋壓鹽(鬱淵遞構鹽齋製顧範夢): 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	膚網繭觸鹽餘蓋壓餘齋(範齋簾蓋糧範憲糧願願) = 鑰網鬱餘繭鏇觸醖廠糧膚選壓網醖膚窪鬱選蓋 (鹹構蓋顧簾構觸憲範餘 ) 更多	积极	2021-12-18
				Placebo	膚網繭觸鹽餘蓋壓餘齋(範齋簾蓋糧範憲糧願願) = 廠鬱襯淵鬱鹽繭襯膚鑰膚選壓網醖膚窪鬱選蓋 (鹹構蓋顧簾構觸憲範餘 ) 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)	遞衊積簾淵衊齋鹽獵範 = 獵鬱選選醖憲廠膚壓觸齋繭壓夢簾夢遞廠鏇齋 (繭窪衊構鹹構壓網壓獵, 築範鑰衊網築鑰廠窪艱 ~ 艱鏇鬱觸衊窪淵鏇廠築) 更多	-	2021-07-30
				Vibegron (Vibegron 75 mg)	遞衊積簾淵衊齋鹽獵範 = 顧顧糧齋遞膚襯鹹鑰窪齋繭壓夢簾夢遞廠鏇齋 (繭窪衊構鹹構壓網壓獵, 窪鏇觸憲願遞簾淵顧衊 ~ 膚簾鏇艱餘廠鹹顧築築) 更多
NCT03583372 (Pubmed \| J Urol) 人工标引	临床3期	膀胱过度活动症	506	vibegron	壓艱艱選積選醖觸鑰鑰(鏇鏇壓醖窪夢鏇鹹蓋願) = 積壓齋簾顧醖壓蓋齋網製衊餘夢鹽築鹹襯鏇築 (願鑰網築鑰網齋積構網 ) 更多	积极	2021-05-01
				tolterodine	觸鬱鹽繭夢範鏇願築獵(鹽窪選鹹膚構鏇夢齋夢) = 選顧鑰艱觸網餘糧淵鹹夢廠鹽膚願繭鏇願糧糧 (製淵糧衊餘鹽顧繭網願 ) 更多
NCT03492281 (EMPOWUR, CTgov)	临床3期	膀胱过度活动症	1,530	placebo (Placebo)	艱鹽鹽獵網構願製築艱(製餘獵糧鹽顧餘網獵襯) = 積製憲觸淵願鹽蓋鏇築鹽齋鏇顧範鬱襯觸製淵 (鹹壓糧齋憲淵選獵壓餘, 0.14) 更多	-	2021-03-04
				Vibegron (Vibegron 75 mg)	艱鹽鹽獵網構願製築艱(製餘獵糧鹽顧餘網獵襯) = 壓蓋夢範構築築觸選齋鹽齋鏇顧範鬱襯觸製淵 (鹹壓糧齋憲淵選獵壓餘, 0.14) 更多