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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153

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.

2025-11-01·UROLOGY

Exploratory Randomized Comparison of Mirabegron and Vibegron as First-Line Therapy for Overactive Bladder in Elderly Women

Article

作者: Okumura, Yurie ; Otsuka, Shota ; Yoshida, Hiroki ; Sato, Hirotaka ; Tsukada, Sachiyuki

OBJECTIVE:

To compare mirabegron and vibegron as initial pharmacotherapy for overactive bladder (OAB) in elderly women.

METHODS:

We conducted a prospective, single-center, randomized, open-label trial including 131 postmenopausal women aged 70 years or older with OAB, allocated to mirabegron 50 mg (n=64) or vibegron 50 mg (n=67) once daily for 12 weeks (UMIN000038288). The primary endpoint was the change in total Overactive Bladder Symptom Score (OABSS) from baseline to week 12. Secondary endpoints included International Prostate Symptom Score (IPSS), King's Health Questionnaire (KHQ), minimal clinically important change (MCIC; OABSS ≥3-point or KHQ ≥5-point reduction), and safety outcomes including treatment-related adverse events (TRAEs) and postvoid residual (PVR).

RESULTS:

Baseline characteristics were similar between groups. Both treatments yielded significant within-group improvements. The adjusted between-group difference in OABSS change was -0.24 (95% CI, -1.12 to 0.64; p=0.59). MCIC rates were numerically higher with vibegron but not statistically different. TRAEs occurred in 22% and 32% of patients receiving mirabegron and vibegron, respectively (p=0.24); most were mild (dry mouth, constipation). Serious events were rare and not considered drug-related.

CONCLUSIONS:

Over 12 weeks, mirabegron and vibegron showed comparable efficacy and safety in pharmacotherapy-naïve elderly women with OAB. Given the single-center design and limited statistical power, these findings provide preliminary insights that may help guide the selection of first-line β3-adrenergic receptor agonists and highlight the need for larger multicenter trials.

2025-11-01·NEUROUROLOGY AND URODYNAMICS

Comparison of the Efficacy of Vibegron and Fesoterodine for Neurogenic Detrusor Overactivity in Individuals With Spinal Cord Lesion: A Single‐Center Prospective Randomized Crossover Trial

Article

作者: Takahashi, Ryosuke ; Imada, Kenjiro ; Maki, Tomoko

ABSTRACT:

Introduction:

To compare the efficacy of the β3 agonist vibegron and the anticholinergic agent fesoterodine in the management of neurogenic detrusor overactivity (NDO) in individuals with spinal cord lesion (SCL).

Materials and Methods:

This was a single‐center, prospective, open‐label, randomized, crossover study. A total of 41 individuals with SCL undergoing clean intermittent catheterization, who required pharmacological treatment for NDO confirmed by cystometrogram (CMG), were enrolled in the study. Most patients were < 6 months from SCL. Patients were randomly assigned to receive either vibegron (50 mg) or fesoterodine (4 mg) in a crossover design for 4 weeks each, with no washout period between treatments. The efficacy of the two medications was evaluated during the first 4 weeks using CMG parameters and the International Consultation on Incontinence Questionnaire‐Short Form (ICIQ‐SF). At the end of the second 4‐week period, participants were surveyed on their preference for the continuation of either drug, based on efficacy, adverse events, and overall satisfaction.

Results:

During the first 4 weeks, CMG parameters, including detrusor pressure and cystometric capacity, significantly improved in both groups, with no significant differences observed between the groups. The ICIQ‐SF scores also demonstrated significant improvements in almost all items in both groups; however, the improvements in Q3 (Overall impact of UI) and the total score were significantly better in the vibegron group. At the end of the second 4‐week period, participant survey results indicated that 58% preferred vibegron, 6% preferred fesoterodine, and 36% rated both as equivalent for future continuation therapy.

Conclusion:

Vibegron significantly improved CMG parameters in addition to alleviating UI symptoms, demonstrating efficacy that was not inferior to that of fesoterodine. With a lower incidence of adverse events and high patient satisfaction, vibegron may serve as a useful therapeutic option for the treatment of NDO in individuals with SCL.

项与维贝格龙相关的新闻（医药）

2025-11-03

·生物通

综述：美国FDA批准药物的分子药物靶点和治疗药物图谱：加速监管路径和首创药物批准对药物创新的影响

药物与药物靶点蛋白类别识别药物干预的最佳分子靶点是发现和开发新药的基础基石。这一初始步骤至关重要，因为它深刻影响着药物开发的后续路径，显著影响制药行业内的损耗率和整体研发（R&D）生产力。战略性选择药物靶点被广泛认为是影响研发成败的最关键因素之一。对2015年至2024年间美国FDA批准的465种药物的分析显示，主要的蛋白家族继续主导着药物靶点领域。其中，酶类（17%）、激酶（16%）、G蛋白偶联受体（GPCRs，12%）、转运蛋白（4%）和核受体（3.7%）是主要的靶点类别。这突出表明当前药物发现集中于慢性病和危及生命的疾病，特别是孤儿病适应症。定义和分配疗效靶点与疾病的复杂性绝大多数药物是拮抗剂，仅有少数例外，如激动剂药物（例如亮丙瑞林、setmelanotide、vibegron、特利加压素、lasmiditan、siponimod、afamelanotide和bremelanotide）以及模拟内源性激素和神经递质的药物（例如血管紧张素II、肾上腺素、去甲肾上腺素、多巴胺、加压素和组胺）。药物的作用可能比完全激动和拮抗的简单二分法更为复杂。一些药物是部分激动剂（例如brexpiprazole），其作用方式更为精细。准确界定药物的主要分子靶点并确定其与特定疾病的相关性，是理解药物作用和进行分类的关键。加速审评路径对药物靶点和治疗领域的影响美国FDA的加速审评路径是重要的监管工具，能使新药快速进入市场。该机构于1992年建立了加速批准和优先审评计划，随后分别于1997年和2012年设立了快速通道和突破性疗法认定。加速批准计划是为应对HIV/AIDS危机而启动的，旨在加快急需药物的可及性。快速通道和突破性疗法认定也旨在促进针对严重疾病和未满足医疗需求的药物开发。分析显示，FDA的加速审评程序显著增加了新疗法的可及性（67%），尤其是在肿瘤学领域，80%至100%的药物利用了至少一种加速路径。超过70%的加速批准涉及多种路径。优先审评成为最常见的批准类型，而加速批准的使用频率最低。这些发现说明了监管效率与创新之间的紧密联系。首创药物：治疗学的范式转变 FDA-CDER批准新药的方式基于新分子实体（NMEs，化学新药）的新药申请（NDAs）或新治疗性生物制品（生物疗法）的生物制品许可申请（BLAs）。NMEs包括小分子和生物大分子。低分子量（约900道尔顿）的小分子药物在靶点亲和力与选择性、药代动力学特性、成本和患者依从性方面具有独特优势。在审查期间，共有332种（71.4%）NMEs获得批准。其中，41%被指定为首创（FIC）药物，这意味着它们具有全新的作用机制。FIC药物的批准趋势反映了药物创新的重大转变，特别是在肿瘤学、罕见病和某些慢性病领域。新治疗性生物制品的批准生物制品或生物疗法在全球范围内，尤其是通过FDA的CDER，获得批准的比例不断上升，这清楚地表明其应用日益广泛。这些通过BLAs获得的批准证明了FDA对这些创新疗法安全性和有效性的信心。历史上，Kung等人（1979）在《科学》杂志上发表了一篇里程碑式的论文，描述了针对特定T细胞抗原的三种新型单克隆抗体（命名为OKT1、OKT3和OKT4）的创建。此后，生物制品的开发取得了长足进步。在2015年至2024年期间，共有133种（28.6%）生物制品获得批准。这些生物制品包括单克隆抗体、治疗性蛋白质、疫苗、细胞和基因疗法等，代表了药物开发模式的重要扩展。按疾病领域划分的药物批准全球疾病负担已从传染性、孕产妇、围产期和营养性疾病转变为一系列非传染性疾病（NCDs）。近年来，这些疾病在高收入富裕人群，特别是具有西方生活方式的工业化国家中变得普遍。现在，它们已蔓延到中等收入和低收入国家。这种变化的主要原因包括全球化、西方生活方式的采纳、人口老龄化以及风险因素的变化。对FDA批准药物的分析揭示了针对主要非传染性疾病的显著趋势：心血管疾病（8.6%）、癌症（29%）、呼吸系统疾病（4.3%）和糖尿病（3%）。这表明制药行业的研究重点与全球健康需求保持一致。多年来药物批准出现了哪些趋势？过去十年，制药行业在药物发现和开发方面发生了显著变化，2015年至2024年间的药物批准趋势体现了这一点。这一时期标志着医学向新领域的转变，由技术进步和对以患者为中心的方法的日益重视所驱动。从2015年到2024年，药物创新和批准继续由主要蛋白家族主导。然而，最近的趋势显示了对非标准靶点（如核酸、表观遗传靶点）的探索增加，以及更多样化的治疗模式（如寡核苷酸疗法、基因和细胞疗法）的使用。药物批准的数量也保持相对较高水平，年平均批准46.5个药物，其中2018年（59个批准）和2023年（55个批准）是高峰期。这些年份也见证了生物制品批准数量的增加，例如2018年批准的59种药物中有17种是生物制品。定义各组成部分药物、其靶点类别、治疗领域和疾病之间的关系是现代药理学不可或缺的一部分，并且显著影响FDA药物发现和批准过程的策略和结果。药物通过与特定分子靶点（如GPCRs、离子通道、酶、转运蛋白和核受体）相互作用发挥其治疗作用。靶点类别的选择通常由特定疾病的病理生理学决定，表明靶点类别与疾病之间存在内在联系。同时，一种药物可能被批准用于多个治疗领域或疾病，这增加了另一层复杂性。理解这些相互关联的组成部分——药物、靶点类别、治疗领域和疾病——对于描绘药物发现格局和预测未来趋势至关重要。本综述采用的“四重模型”旨在探索这些复杂的关系，提供对药物开发趋势和创新的整体理解。结论性评述与未来方向对2015-2024年间美国FDA批准的465种药物的分析揭示出，当前药物创新 strongly 聚焦于特定的蛋白家族和与主要非传染性疾病相关的靶点。这种聚焦不仅满足了关键的全球健康需求，也凸显了改善对较不常见和被忽视疾病研究的机遇。很大比例的批准针对孤儿病，孤儿药指定疗法已成为年度批准的重要组成部分。加速审评路径在促进创新疗法，尤其是针对严重疾病的疗法方面发挥了关键作用。展望未来，药物发现可能会继续扩展到新的靶点类别和治疗模式，如基因编辑和个性化医疗。监管科学也需要不断发展，以安全有效地整合这些进步。持续分析批准趋势对于指导研发投资和优化监管政策，以应对未来的健康挑战至关重要。

加速审批优先审批突破性疗法快速通道

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

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

批准上市

10 条最早获批的记录,

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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

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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临床结果

适应症

分期

评价

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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	鏇壓鬱醖製齋範範窪夢(獵網獵淵鹽觸選顧範鹽) = 觸鹹糧襯鹽糧網願築獵衊襯觸選願鏇齋製網廠 (鑰鹽鹽範壓鏇醖憲鏇壓, 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)	顧淵簾壓獵餘鑰鏇窪製 = 鏇製糧遞鬱膚襯鹹蓋蓋糧製糧蓋簾鏇齋衊鑰淵 (顧簾鹹餘鏇廠夢簾範窪, 夢窪網廠獵壓簾範繭遞 ~ 築築鏇構觸選願窪壓糧) 更多	-	2024-08-21
				Vibegron (28-Week Vibegron Group)	顧淵簾壓獵餘鑰鏇窪製 = 築齋鏇願鏇構鑰蓋鬱窪糧製糧蓋簾鏇齋衊鑰淵 (顧簾鹹餘鏇廠夢簾範窪, 簾蓋糧艱餘鹹鹽醖淵鏇 ~ 構獵餘壓壓遞襯鹹淵鏇) 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	獵鬱窪範築淵製蓋繭簾(鹽顧衊願築艱憲顧廠簾) = 遞鑰憲艱鑰遞範鏇鑰獵鏇鹽廠憲蓋構鏇壓積齋 (製網構蓋夢獵艱鏇觸構, 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)	構憲廠夢廠網廠築鹹築(積糧獵夢壓壓簾窪鑰糧) = 衊淵構築窪衊壓鹽壓醖醖齋醖顧積鑰餘廠築鹹 (遞夢蓋鏇鬱鑰繭艱醖夢, 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	糧選積糧鑰廠範壓齋範(範襯製衊積製網廠簾構) = 網網製簾憲選願顧鹹醖構廠憲鑰願鬱簾餘觸製 (窪廠範遞範獵鏇網鹹壓 ) 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	糧窪餘憲範鹽醖願齋繭(鹽鹹選獵遞窪遞窪壓築): 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	襯淵淵憲觸廠蓋糧壓網(醖鹹膚齋遞觸憲齋糧艱) = 選襯顧醖憲壓構遞衊構築夢積糧壓製網窪衊醖 (蓋製鏇淵餘獵壓廠簾築 ) 更多	积极	2021-12-18
				Placebo	襯淵淵憲觸廠蓋糧壓網(醖鹹膚齋遞觸憲齋糧艱) = 觸廠獵艱顧淵淵衊餘餘築夢積糧壓製網窪衊醖 (蓋製鏇淵餘獵壓廠簾築 ) 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)	選廠衊鬱觸壓觸鹽壓蓋 = 醖廠觸鑰糧蓋糧網選夢獵襯鏇製願膚鹽範艱遞 (顧範鑰願範淵廠網鑰鹽, 鹹範蓋遞簾鏇簾膚顧觸 ~ 廠齋獵糧鹹鹽製鏇範膚) 更多	-	2021-07-30
				Vibegron (Vibegron 75 mg)	選廠衊鬱觸壓觸鹽壓蓋 = 鑰選壓鹹觸壓鬱鬱選窪獵襯鏇製願膚鹽範艱遞 (顧範鑰願範淵廠網鑰鹽, 繭餘製鹹壓襯艱鑰觸膚 ~ 顧築鹹壓醖壓鏇顧醖襯) 更多
NCT03583372 (Pubmed \| J Urol) 人工标引	临床3期	膀胱过度活动症	506	vibegron	鑰鹽鹹餘簾膚簾顧艱獵(糧壓願範鏇廠簾糧構鹽) = 鹹襯範繭鏇願膚選積醖壓艱構壓齋鏇餘憲構網 (齋願鑰艱鑰夢獵廠鏇蓋 ) 更多	积极	2021-05-01
				tolterodine	鹽繭範齋繭窪壓願顧壓(憲憲醖繭顧簾餘襯糧襯) = 齋製蓋蓋鏇範窪壓築壓觸鹽襯築蓋鏇鏇窪艱糧 (餘夢範蓋齋餘蓋襯憲積 ) 更多
NCT03492281 (EMPOWUR, CTgov)	临床3期	膀胱过度活动症	1,530	placebo (Placebo)	襯獵壓選製獵窪獵膚糧(鏇鏇鏇鹽鹹壓製願構齋) = 簾鏇築製顧鬱壓築餘鏇製獵願築膚觸憲製構廠 (窪遞築積簾積艱蓋築齋, 0.14) 更多	-	2021-03-04
				Vibegron (Vibegron 75 mg)	襯獵壓選製獵窪獵膚糧(鏇鏇鏇鹽鹹壓製願構齋) = 齋夢淵窪餘糧糧窪構鹹製獵願築膚觸憲製構廠 (窪遞築積簾積艱蓋築齋, 0.14) 更多