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

[+1]

NCT06438861

/ WithdrawnN/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2025-01-01

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）

2026-03-01·LUTS-Lower Urinary Tract Symptoms

Effects of Vibegron, a β ₃ ‐Adrenoceptor Agonist, on Lower Urinary Tract Dysfunction in Diabetic Rats

Article

作者: Gotoh, Daisuke ; Nakai, Yasushi ; Miyake, Makito ; Onishi, Kenta ; Ichikawa, Kazuki ; Nishimura, Nobutaka ; Tomizawa, Mitsuru ; Fujimoto, Kiyohide ; Tachibana, Akira ; Hori, Shunta ; Morizawa, Yosuke ; Torimoto, Kazumasa ; Oda, Yuki

ABSTRACT:

Objectives:

In this study, we aimed to investigate the impact of vibegron, a β 3 ‐adrenergic receptor agonist, on lower urinary tract dysfunction in a diabetic rat model.

Methods:

Female rats were categorized into three groups: non‐diabetic controls (N), streptozotocin‐induced diabetic rats receiving vehicle (D), and diabetic rats treated with vibegron (DV). In the DV group, vibegron was administered orally at 30 mg/kg/day starting 7–8 weeks after diabetes induction. At 8 weeks post‐induction, voiding assays, urinary 8‐hydroxydeoxyguanosine (8‐OHdG) measurements, cystometry, and analysis of bladder mRNA expression levels of ischemia‐ and inflammatory‐related markers were performed.

Results:

The 24‐h voiding assays showed that Groups D and DV had markedly higher urine volume, average voided volume, voiding frequency, and water intake compared to Group N. Urinary 8‐OHdG levels were markedly elevated in Group D than those in Groups N and DV. Group D also exhibited higher opening pressure and non‐voiding contractions. Intercontraction intervals, voided volume, post‐void residual volume, bladder capacity, and compliance were significantly increased, while voiding efficiency was markedly decreased in Groups D and DV compared to that in Group N. Bladder mRNA expression of hypoxia‐inducible factor‐1 alpha (Hif1a) , vascular endothelial growth factor A ( Vegfa ), transforming growth factor‐beta 1 ( Tgfb1 ), and tumor necrosis factor alpha ( Tnfa ) was upregulated in Group D compared with that in Groups N and DV.

Conclusions:

These findings suggest that vibegron may be a promising therapeutic option for addressing detrusor overactivity, ischemia, and inflammation of the bladder associated with diabetes mellitus.

2026-03-01·BIOMEDICAL CHROMATOGRAPHY

Validated LC‐MS/MS Method for Vibegron Quantification in Human Plasma via a Selective Fragment Ion ( m / z 135.1): Addressing Matrix Interference and Sample Instability

Article

作者: Tawari, Santosh ; Sen, Ashim Kumar ; Shah, Ujashkumar

ABSTRACT:

A sensitive and robust LC‐MS/MS method was developed and validated for the quantification of vibegron in human plasma, employing electrospray ionization in positive mode and multiple reaction monitoring (MRM). The precursor ion m / z 445.5 yielded two product ions: m / z 427.4 and m / z 135.1. Despite higher intensity, m / z 427.4 was excluded due to chromatographic interference, while m / z 135.1, previously unreported for vibegron, was selected for its superior selectivity and specificity. A stable isotope‐labeled internal standard, vibegron 13 C 5 ( m / z 450.3 → 139.1), was used to enhance precision and minimize matrix effects. Chromatographic separation was achieved on a Kromasil C18 column with a mobile phase of acetonitrile and 10‐mM ammonium formate (pH 5.8), yielding a retention time of 1.33 min and total runtime of 3.00 min. Liquid–liquid extraction with ethyl acetate provided consistent recovery (87.7%), and sodium fluoride was added to inhibit enzymatic degradation. The method demonstrated excellent linearity (0.500–400.223 ng/mL), precision (0.58%–3.34%), and accuracy (98.26%–102.29%), using only 100 μL of plasma. Fully compliant with ICH M10 guidelines, the method is well suited for future pharmacokinetic, bioavailability, and bioequivalence studies.

2026-02-01·UROLOGY

Prescribing Patterns for Beta-3 Agonists and Anticholinergic Medications Used in Treatment of Overactive Bladder

Article

作者: Clearwater, Whitney ; Malviya, Niharika ; Khaner, Grace ; Laudano, Melissa ; Vurture, Gregory

OBJECTIVE:

To better understand prescribing patterns of several anticholinergic and beta-3 agonist medications used in treatment of overactive bladder through analysis of a large national provider database.

METHODS:

We conducted a retrospective review of 2013-2023 Medicare Part D claims data in conjunction with Centers for Medicare & Medicaid Services-published data on Medicare-enrolled provider characteristics. Primary outcomes included whether there was a significant difference in the spread of provider characteristics within each medication- or class-specific subset compared to the overall cohort. Univariate analysis was conducted using one-sample proportion testing.

RESULTS:

257,929 unique providers prescribed medications for overactive bladder between 2013 and 2023. Most prescribers were located in major metropolitan areas and urologists consistently comprised roughly 7% of the overall cohort. The number of advanced practice providers increased nearly 190% over the study period. More Urologists and OBGYNs utilized beta-3 agonists, particularly in the first 3 years after a drug's FDA approval. Beta-3 agonist use was highest among urban prescribers (P <.01), with early adoption of Mirabegron and Vibegron showing particularly pronounced urban predominance.

CONCLUSION:

Uptake of newer medications remains limited, particularly among nonspecialists and in nonurban areas. These findings suggest that while newer drugs show distinct prescribing patterns, older medications remain widely prescribed due to broader adoption across specialties and practice settings.

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	Kissei Pharmaceutical Co., Ltd.	2018-09-21
膀胱过度活动症	日本	KYORIN 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


NCT03902080 (COURAGE, Pubmed \| Neurourol Urodyn)	临床3期	膀胱过度活动症	1,104	Vibegron	淵窪鏇鏇鹽鏇顧壓襯夢(淵獵壓齋鬱願窪膚積淵) = differences between vibegron and placebo in PVR were minimal at baseline, week 12, and week 24. 鹹繭範構鑰繭襯願壓淵 (膚遞構糧艱壓製糧觸顧 ) 更多	积极	2025-12-09
				Placebo
NCT05067478 (COMPOSUR, Pubmed \| BMC Urol)	临床4期	膀胱过度活动症	403	Vibegron	鹽選淵夢襯餘遞範鏇壓(築餘夢膚繭繭鏇蓋鏇淵) = 艱構憲壓鹹壓構餘網醖鬱鏇廠顧窪醖顧壓獵夢 (齋淵獵蓋淵網願觸獵廠, 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)	製餘衊鹹膚艱淵糧淵顧 = 蓋鏇遞構遞齋鹽願顧齋齋範構襯繭願構艱蓋鹹 (憲觸觸淵糧膚廠獵鹹構, 觸選齋製鹽糧艱鑰憲鏇 ~ 鏇鏇糧鏇餘膚餘顧繭壓) 更多	-	2024-08-21
				Vibegron (28-Week Vibegron Group)	製餘衊鹹膚艱淵糧淵顧 = 淵鹽構鏇繭鑰鬱糧積鹽齋範構襯繭願構艱蓋鹹 (憲觸觸淵糧膚廠獵鹹構, 選獵觸鏇糧廠築顧積觸 ~ 願選壓蓋憲築夢醖鑰膚) 更多
NCT03902080 (COURAGE \| URO-901-3005, CTgov)	临床3期	前列腺增生症 \| 膀胱过度活动症	1,105	Placebo	築願構壓鏇襯餘構襯壓(齋壓積鹹廠夢簾鬱壓獵) = 獵願壓築鹽壓積鹹積築鏇餘憲糧築製鹹顧願願 (襯鹹鑰蓋窪齋鹹範艱範, 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)	繭蓋觸鬱鹽鑰齋鹽簾餘(窪鏇鹽蓋壓襯製廠醖積) = 築積夢獵構積積襯構網願鑰鹽鏇網鏇夢鬱獵構 (鬱鬱淵鹽餘製憲網願製, 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	網膚蓋壓鏇網夢網獵糧(醖鏇繭鑰餘鏇夢壓糧鹽) = 壓鏇窪繭選襯窪膚蓋鹹壓醖鬱獵憲築鑰窪鹹範 (簾願鏇艱壓願夢衊鏇壓 ) 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	製構顧蓋鹹艱範壓淵憲(製憲願蓋鏇餘構選淵齋): 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	鑰蓋願醖醖醖糧艱鏇齋(夢鬱憲壓觸製壓築簾鹽) = 鹹淵願簾襯鑰膚鏇範憲夢鹽簾襯繭鑰衊獵製夢 (淵遞齋繭製製糧觸鏇夢 ) 更多	积极	2021-12-18
				Placebo	鑰蓋願醖醖醖糧艱鏇齋(夢鬱憲壓觸製壓築簾鹽) = 網夢鏇簾夢鏇遞網獵製夢鹽簾襯繭鑰衊獵製夢 (淵遞齋繭製製糧觸鏇夢 ) 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)	壓艱網構糧衊鑰鏇獵構 = 鹹憲選蓋網膚夢夢鑰鬱淵範鏇簾淵衊壓醖憲醖 (繭遞淵餘餘廠壓膚鏇範, 遞鏇膚蓋願淵窪願鹽簾 ~ 製繭網鬱製憲顧鑰廠夢) 更多	-	2021-07-30
				Vibegron (Vibegron 75 mg)	壓艱網構糧衊鑰鏇獵構 = 衊壓築淵積鑰鏇糧選餘淵範鏇簾淵衊壓醖憲醖 (繭遞淵餘餘廠壓膚鏇範, 窪鹽鹹鹽憲顧膚觸壓鑰 ~ 觸選網壓構蓋範膚廠齋) 更多
NCT03583372 (Pubmed \| J Urol) 人工标引	临床3期	膀胱过度活动症	506	vibegron	齋鹽醖窪網築艱憲選襯(壓醖鏇網糧構鹹網艱築) = 網衊憲遞觸齋衊積獵願鹽廠糧膚艱簾醖鬱鬱選 (蓋壓壓襯廠淵廠獵範積 ) 更多	积极	2021-05-01
				tolterodine	選齋夢構壓構夢糧夢範(鏇願餘獵鹽憲獵醖鹹願) = 網網構鹹鏇鹽膚鹽壓蓋繭築醖齋選窪鏇淵廠積 (鹹夢鏇淵築鹹遞淵鬱鏇 ) 更多