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2025-04-01

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-

NCT06417177

/ Recruiting早期临床1期IIT

Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.

开始日期2024-06-03

申办/合作机构

University of Missouri

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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111

项与维贝格龙相关的文献（医药）

2025-01-01·LUTS-Lower Urinary Tract Symptoms

Comparison of the 3‐Year Continuation Rate and Discontinuation Factors Between Vibegron and Mirabegron in Patients With Overactive Bladder: A Retrospective Follow‐Up Study in a Rehabilitation Hospital in Japan

Article

作者: Nomi, Masashi ; Mukai, Shigeto ; Yanagiuchi, Akihiro ; Sengoku, Atsushi

ABSTRACT:

Objectives:

The objective of this study is to compare the 3‐year continuation rate and discontinuation factors between vibegron and mirabegron in patients with overactive bladder in a rehabilitation hospital in Japan.

Methods:

The 3‐year continuation rate of the target drugs and reasons for discontinuation as well as patients' backgrounds and adverse effects were evaluated retrospectively from the medical records between September 2018 and December 2020. After selecting patients according to our inclusion and exclusion criteria, 136 cases taking mirabegron and 82 taking vibegron were adjusted for intergroup variability by propensity score matching. We performed Cox proportional hazards regression for the 3‐year continuation rate and Fine‐Gray proportional hazards regression for the 3‐year cumulative incidence of discontinuation events. Subgroup analysis was also performed.

Results:

Approximately 70% of the patients analyzed had neurogenic overactive bladder. The 3‐year continuation rate was 65.2% in vibegron and 30.3% in mirabegron, and the hazard ratio was 0.41 (95% confidence interval: 0.25–0.68, p < 0.001) as for an incidence of discontinuation events of vibegron against mirabegron. The incidence of discontinuation due to inadequate efficacy was 22.7% in vibegron and 47.0% in mirabegron, and similarly the hazard ratio was 0.43 (95% confidence interval: 0.23–0.80, p < 0.01). In the subgroup analysis, vibegron continued significantly more than mirabegron for the 3‐year continuation rate in non‐neurogenic overactive bladder (p < 0.001), in spontaneous voiding (p < 0.001), in anticholinergic combination (p = 0.0017), in female (p < 0.001), and in 70 years or older (p = 0.0028). Additionally, a significant interaction was observed regarding the methods of emptying urine (p = 0.0066).

Conclusions:

Vibegron was superior to mirabegron in the 3‐year continuation rate of administration with a fewer discontinuation due to inadequate efficacy in a patient population with relatively high rates of neurogenic overactive bladder.

2024-12-01·JOURNAL OF UROLOGY

Letter: Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial

Letter

作者: Yu, Ting ; Li, Jun ; Yang, Yu ; Shan, Dan ; Chen, Dong

2024-11-01·LUTS-Lower Urinary Tract Symptoms

Safety and Effectiveness of Vibegron in Japanese Patients With Overactive Bladder: A Japanese Postmarketing Survey

Article

作者: Yoshimura, Shoko ; Yagi, Hiromitsu ; Abe, Kazunori ; Yamasaki, Masakazu

ABSTRACT:

Objectives:

To evaluate the safety and effectiveness of vibegron, a highly selective β3‐adrenoceptor agonist, in Japanese patients with overactive bladder (OAB) in a real‐world clinical setting.

Methods:

This prospective survey was conducted from August 2019 to July 2023 using a central registration method. Patients newly treated with vibegron for OAB were followed for 12 weeks, and those who continued treatment were observed for up to 52 weeks. Adverse drug reactions (ADRs) and the overall improvement level were assessed, and overactive bladder symptom score (OABSS) and International Prostate Symptom Score‐Quality of Life (IPSS QOL) score were collected.

Results:

Of the 1848 patients in the safety analysis set, 154 ADRs were reported in 141 patients (7.63%). Common ADRs were increased residual urine volume (1.30%), constipation (1.14%), dysuria and urinary retention (0.97% each), cystitis (0.65%), and dry mouth (0.32%). The incidence of urinary retention‐related adverse events (AEs) was higher in male patients, patients ≥ 65 years old, and patients with benign prostatic hyperplasia. The effectiveness rate was 88.8% among the 1561 patients in the effectiveness analysis set. Significant improvement in both OABSS and IPSS QOL scores was observed at all observation periods. The rate of achieving the minimal clinically important change in OABSS total score at the final evaluation was 75.35%. OABSS scores were also significantly reduced in all subgroup analyses.

Conclusions:

This survey found no major concerns regarding the safety and effectiveness of vibegron in Japanese OAB patients, except for urinary retention‐related AEs. Vibegron is considered to represent a useful drug for treating OAB symptoms in a real‐world clinical setting.

项与维贝格龙相关的新闻（医药）

2024-12-23

·PRNewswire

Sumitomo Pharma America Announces U.S. FDA Approval of GEMTESA® (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

– GEMTESA® is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH – MARLBOROUGH, Mass., Dec. 23, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) announced today that the U.S. Food and Drug Administration (FDA) has approved GEMTESA® (vibegron), a beta-3 (β3) adrenergic receptor agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH). This approval marks GEMTESA as the first and only β3 agonist approved to treat patients living with OAB and being treated for BPH. It is currently available for prescription in the U.S. BPH is increasingly prevalent in men as they get older, and OAB symptoms, which could be associated with BPH, can often be mistaken as a natural part of aging. There are about 14 million men in the U.S. living with BPH, and up to 75% of them have clinical symptoms of OAB.1,2 OAB symptoms may go unnoticed in men, especially if they have BPH.3 In fact, ~80% of OAB cases in men may go undiagnosed.4 "Millions of patients suffer from OAB along with existing BPH. OAB is a urological condition that has limited treatment options to address their symptoms and impact on their social life." said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. "The FDA's expanded approval of GEMTESA is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH, which underscores our urgency to deliver for those affected by conditions with unmet need." The FDA's approval of GEMTESA is based on results from URO-901-3005, a Phase 3 study of vibegron versus placebo over 24 weeks in approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH. The study met all co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline in the average number of micturition (urination) episodes per day and in the average number of daily urgency episodes (sudden urge to urinate that is difficult to control) compared to placebo.5 An additional endpoint showed a reduction in instances of urge urinary incontinence episodes (unintentional loss of urine immediately after an urgent need to urinate) per day at 12 weeks.5 Adverse reactions, exceeding placebo rate, reported in ≥2% of patients treated with GEMTESA were hypertension and urinary tract infection.5 Please see Important Safety Information below. "The clinical data on once-daily vibegron demonstrated clear improvements in key OAB symptoms in patients also receiving pharmacological therapy for BPH, showcasing the potential of GEMTESA to offer patients a way to gain better control of their symptoms," said Yumi Sato, Chief Development Officer, SMPA. "With this FDA approval and launch of the first β3 agonist for men with OAB symptoms being pharmacologically treated for BPH, we have the potential to give men living with this disease a life with fewer interruptions due to their OAB symptoms." GEMTESA (vibegron) is currently approved for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, and is now available for prescription in the U.S. for the treatment of men with OAB being pharmacologically treated for BPH. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. Angioedema Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. INDICATIONS AND USAGE GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of: 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).6 Approximately 33 million U.S. adults experience the bothersome symptoms of OAB.7 About Benign Prostatic Hyperplasia Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.3,4 Even when the obstruction is alleviated by BPH treatment, unresolved symptoms of OAB may persist. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).3,4 LUTS can be divided into storage, voiding, and postmicturition symptoms.8 More than half of men with LUTS report storage symptoms, and about a quarter report voiding symptoms.4 This suggests that many men with a diagnosis of BPH may have overactive bladder.4 About Sumitomo Pharma Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.] The Sumitomo corporate symbol mark is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. ©2024 Sumitomo Pharma America, Inc. All rights reserved. References 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. 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 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3期临床结果上市批准

2024-12-23

·EndPoints

Sumitomo’s overactive bladder drug adds another indication

Sumitomo Pharma’s oral treatment for overactive bladder symptoms won an expanded label from the FDA, and is now approved to treat men who are simultaneously receiving therapy for prostate enlargement. Monday’s additional indication for the medicine , Gemtesa, opens the door to treat roughly 10.5 million men in the US who are being treated for noncancerous prostate enlargement, known as benign prostatic hyperplasia, who also have overactive bladder symptoms. The expanded approval was based on Phase 3 data showing Gemtesa had a statistically significant reduction in the average number of urinations and urgent urination episodes per day, compared with placebo. More common side effects were hypertension and urinary tract infection. The drug came to Sumitomo from Urovant Sciences, a Roivant spinout that was later acquired by the Japanese pharma. Gemtesa first snagged approval four years ago to treat adults with overactive bladder symptoms. The drug brought in $165 million in the first half of Sumitomos’s fiscal year , a 53% increase from the same period in 2023. Those figures are tracking slightly behind Gemtesa’s $380 million in projected revenue for the full 2024 fiscal year. The company has been trying to course-correct its North American business amid sliding revenue and patent expirations, laying off 400 employees in the region earlier this year and bidding farewell to president and CEO of the American business, Myrtle Potter. It cited lackluster sales of Gemtesa as part of its rationale for the cuts, which followed 500 employee layoffs in 2023. Sumitomo Pharma CEO Toru Kimura teased in a June interview with Japanese publication Nikkei Biotech that even more cuts could be on the way, including the company’s R&D unit.

上市批准临床3期

2024-12-21

·漫游药化

FDA批准上市的38个小分子药物结构

FDA今年很忙，但是再忙也未敢忘批药，截至2021年1月1日，FDA批准了53款新药，其中有38个小分子药物，作为化学人一定会很好奇这些化合物有啥特点，结构是啥，小编今天就带大家先睹为快。 1，Avapritinib (BLU-285) 阿伐普利尼 Avapritinib (BLU-285)是一种小分子激酶抑制剂，可有效抑制PDGFRα D842V突变体的活性、在细胞背景下抑制PDGFRα D842V自我磷酸化（IC50=30 nM）；同时也是KIT突变（KIT D816V）的抑制剂（IC50=0.5 nM）。 2，Tazemetostat (EPZ-6438) Tazverik(tazemetostat) (EPZ-6438) 是组蛋白赖氨酸甲基转移酶（Histone-Lysine N-methyltransferase）EZH2的抑制剂。 3，Pizensy(乳糖醇) Pizensy是一种口服的乳果糖类似物。它是一种渗透性泻药（osmotic laxitaive），可促进水分流入肠道，进而在结肠内达到通便作用。 4，Nexletol (bempedoic acid) bempedoic acid由美国Esperion Therapeutic 公司研发，是一种治疗血脂异常及降低其他心血管疾病风险的新型小分子化合物。合成路线如下： 5，Barhemsys(氨磺必利) 氨磺必利是一个多巴胺D2和D3受体阻断剂，上世纪80年代开始应用于精神分裂症治疗。 6，Nurtec ODT（rimegepant） Biohaven公司的口服CGRP抑制剂rimegepant，用于成人偏头痛的急性治疗。 7， Isturisa(osilodrostat) 3月6日，FDA批准库欣综合征（Cushing syndrome，CS）一线用药Osilodrostat上市，商品名：Isturisa，患者无论是否接受受过垂体切除手术治疗，都可应用Osilodrostat作为治疗药物。Osilodrostat是FDA批准的首个11-β羟化酶抑制，可直接阻断肾上腺皮质醇合成。 8，Zeposia(ozanimod) ozanimod（商品名ZEPOSIA），用于成人复发性MS（RRMS）患者的治疗。 9，Selumetinib（司美替尼） Selumetinib （司美替尼）（ARRY-142886 ; AZD6244）是一种MEK 1/2抑制剂和潜在的新药，由AlstraZeneca于2003年获得Array BioPharma Inc.的许可。阿斯利康和MSD于2017年签订了selumetinib的共同开发和联合商业化协议。 10，Tukysa(Tucatinib) Tukysa（Tucatinib）妥卡替尼 /图卡替尼 (ONT-380)是一种口服TKI(酪氨酸激酶)抑制剂，对HER2具有高度特异性，但对同属人表皮生长因子受体家族的EGFR没有明显抑制作用。 11，Pemigatinib （帕米加替尼） Pemigatinib（INCB054828）是一种口服有效的，选择性FGFR抑制剂，它对FGFR1，FGFR2，FGFR3，FGFR4的IC50值分别为0.4 nM，0.5 nM，1.2 nM和30 nM。 12，Ongentys(opicapone) 13，INCB28060 (Capmatinib) 卡马替尼；苯扎米特 INCB28060是一种新型， ATP竞争性的c-MET抑制剂，IC50为0.13 nM，抑制RONβ， EGFR和HER-3活性。 14，Selpercatinib (LOXO-292) 塞尔帕替尼 Selpercatinib（LOXO-292）是一种有效的，特异性RET抑制剂。 15，Ripretinib 瑞普替尼 Ripretinib（DCC-2618）是一种具有口服活性的，选择性的KIT和PDGFR-alpha抑制剂。 16， Cerianna (fluoroestradiol F18) 17，Artesunate（青蒿琥酯）青蒿琥酯是一类控制疟疾症状的抗疟药。 18，Tauvid（flortaucipir F18） Tauvid（flortaucipir F18）是第一种获得FDA批准，帮助对大脑中的tau病理进行成像的药物。Tauvid是一种放射性诊断试剂，用于需要接受阿尔茨海默病评估的认知障碍成人患者。 19，Lurbinectedin（卢比克替定） lurbinectedin是PharmaMar研发的海鞘素衍生物，为肿瘤创新药。目前，绿叶制药与PharmaMar在华合作共同开发该药物。 20，Dojolvi（triheptanoin）三庚酸甘油酯 Dojolvi（triheptanoin）三庚酸甘油酯，是一种高纯度、人工合成的7碳脂肪酸甘油三酯，在甘油骨架上通过多个化学合成步骤添加了三个7碳脂肪酸形成。专门为LC-FAOD患者提供中链、奇数碳脂肪酸作为能源和代谢产物替代品。 21，Fostemsavir(BMS-663068) Fostemsavir (BMS-663068) 是 BMS-626529 的原药，能结合gp120，抑制 HIV-1 与细胞 CD4 受体的结合。 22，Byfavo（Remimazolam）瑞米唑仑/雷米马唑仑 Byfavo（Remimazolam）瑞米唑仑/雷米马唑仑是一种起效和失效迅速的静脉注射苯二氮卓（benzodiazepine）镇静剂。可用于在时长不超过30分钟的有创医疗程序中，例如结肠镜检查和支气管镜检查。 23，Inqovi(cedazuridine+地西他滨) Inqovi（cedazuridine/decitabine[地西他滨]，口服C-DEC，ASTX727），该药用于骨髓增生异常综合症（MDS）和慢性骨髓单核细胞白血病（CMML）成人患者的治疗。 24，Xeglyze(Abametapir) Xeglyze（Abametapir）0.74％洗护剂是一种金属蛋白酶抑制剂，金属蛋白酶是对虫卵发育和若虫和成虫虱子存活，至关重要的生理过程所必需的酶。 25，Nifurtimox (Synonyms: 硝呋替莫) Nifurtimox 是一种用于锥虫病 (Trypanosoma cruzi) 的抗虫剂。Nifurtimox 有潜力用于神经母细胞瘤细胞的研究。Nifurtimox 影响乳酸脱氢酶 (LDH) 活性。 26，Olinvyk（oliceridine） Olinvyk的活性药物成分为oliceridine，这是一种首创的（first-in-class）静脉镇痛药。oliceridine是首个G蛋白选择性激动剂，与静脉注射吗啡相比，镇痛效果更好。oliceridine以μ阿片受体为靶点，通过一种优化作用机制（MOA），优先参与负责疗效的信号通路，减少引起不良反应的信号通路的激活。 27， Evrysdi(risdiplam) risdiplam是治疗所有3种类型SMA的首个口服药物。 28，Winlevi(clascoterone) Clascoterone（又称CB-03-01）是一种局部雄激素受体（AR）抑制剂，该新的化学实体正在开发治疗痤疮（暂定品牌名为Winlevi）和男女性脱发（暂定品牌名Breezula）。根据美国FDA审查其1%浓度治疗痤疮以及后期开发其高浓度溶液治疗男性雄激素雄性脱发的结果，其被认为是一种“first-in-class”药物。值得一提的是，这是近40年来针对痤疮治疗的首个新机制药物。 29，Detectnet（Cu 64 DOTATATE）放射性诊断试剂铜64盐酸盐 Detectnet是首款将Cu 64放射性同位素与生长抑素类似物DOTATATE偶联的诊断试剂。 30，Pralsetinib 普雷西替尼 Pralsetinib (Blu-667) 是新一代的，高效的，选择性RET抑制剂，对于WT RET，RET突变体V804L，V804M，M918T和CCDC6-RET的IC50为0.3-0.4 nM。 31，瑞德西韦（Remdesivir） 2020年10月22日，美国食品药品管理局（FDA）批准了吉利德科学的抗病毒药物瑞德西韦用于治疗新冠住院患者，成为美国首个正式获批的新冠治疗药物。 32，Lonafarnib (Synonyms: Sch66336) Lonafarnib 是一种口服有效的法尼基蛋白转移酶 (FPTase) 抑制剂，作用于 H-ras，K-ras 和 N-ras，IC50 分别为 1.9 nM，5.2 nM 和 2.8 nM。Lonafarnib 具有抗肝炎三角洲病毒 (HDV) 的活性。 33， Imcivree(Setmelanotide) setmelanotide是一款首创、寡肽类MC4R激动剂，开发用于治疗罕见肥胖遗传性疾病。 34，Gallium 68 PSMA-11 35，Orladeyo（Berotralstat）贝罗司他 rladeyo（Berotralstat）贝罗司他是一种新型、口服、每日1次、强效、选择性人血浆激肽释放酶抑制剂，通过抑制激肽释放酶来阻止缓激肽的生成从而预防水肿发作。Orladeyo （berotralstat）用于预防12岁及以上儿童和成人遗传性血管性水肿（HAE）发作，Orladeyo是首个预防HAE发作的口服非甾体药物。 36，Tirbanibulin (Synonyms: KX2-391; KX-01) 37，Relugolix 瑞卢戈利 Relugolix，也称为TAK-385，是一种口服活性的黄体激素释放激素（LH-RH）受体拮抗剂，IC50为0.12 nM。 38,Gemtesa（vibegron） vibegron可治疗膀胱过度活动症导致的急迫性尿失禁，尿急和尿频等症状。

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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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	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	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
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


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)	憲壓網製廠鹽願餘膚膚(鏇齋膚簾廠構壓範衊積) = 選網繭壓夢選觸蓋蓋齋鏇鬱構鹹廠獵獵願獵願 (艱觸鹽繭繭鏇顧蓋壓繭, 蓋襯餘鹹觸襯簾鹹衊構 ~ 夢醖範顧製鏇廠構鏇遞) 更多	-	2024-08-21
				Vibegron (28-Week Vibegron Group)	憲壓網製廠鹽願餘膚膚(鏇齋膚簾廠構壓範衊積) = 願齋觸鏇顧壓願觸餘衊鏇鬱構鹹廠獵獵願獵願 (艱觸鹽繭繭鏇顧蓋壓繭, 壓憲襯醖鏇觸選襯齋糧 ~ 製憲壓遞構壓淵憲繭製) 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	齋簾夢衊夢鬱觸衊鑰範(選餘觸鬱淵膚觸齋鏇窪) = 襯願鏇鬱夢餘願構顧鏇繭鏇鹹憲廠構網簾蓋鬱 (餘淵簾襯醖鑰築鏇糧夢, 繭網選鏇網齋鏇顧鬱願 ~ 範範廠窪獵鏇夢鹹鏇觸) 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)	鬱膚繭襯遞夢鹹憲齋壓(築選願艱襯齋網鹽繭襯) = 襯遞衊糧糧遞蓋夢鹽襯衊鏇襯積淵獵壓觸齋製 (遞淵簾膚鹽觸鬱遞鏇衊, 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	繭餘艱鹽艱簾遞觸繭廠(鹽鹽範憲鑰醖餘齋艱膚) = 壓鹹窪積鑰齋膚範構製構簾醖鏇繭簾築廠鹽衊 (網積艱艱鏇願齋壓網鹽 ) 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	壓鏇齋艱齋糧遞廠艱鑰(範糧簾積窪襯遞願鑰夢): Difference = -0.5 (95% CI, -0.8 ~ -0.2) 更多	积极	2022-11-21
				Placebo
AUA2022	N/A	膀胱功能障碍 \| 脊柱裂辅助	19	Vibegron	鏇構壓簾衊膚糧觸簾鏇(糧夢獵鬱窪襯願鏇壓範) = 遞築鑰範網齋憲製積壓夢糧網廠憲窪築醖鑰糧 (願製壓膚構範餘齋膚觸 )	-	2022-05-01
				Antimuscarinic therapy	鏇構壓簾衊膚糧觸簾鏇(糧夢獵鬱窪襯願鏇壓範) = 醖艱鑰壓襯鏇醖壓積顧夢糧網廠憲窪築醖鑰糧 (願製壓膚構範餘齋膚觸 )
NCT03492281 (EMPOWUR, Pubmed \| Adv Ther) 人工标引	临床3期	膀胱过度活动症	-	vibegron	積積繭憲糧遞淵製衊膚(構鹽觸廠積獵壓淵壓鏇) = 廠顧蓋遞糧願窪廠蓋鹽鹽膚鬱夢糧鑰鏇艱築鹽 (鏇鏇憲廠範艱繭蓋衊築 ) 更多	积极	2021-12-18
				Placebo	積積繭憲糧遞淵製衊膚(構鹽觸廠積獵壓淵壓鏇) = 範齋選襯積鹹積構鹹鏇鹽膚鬱夢糧鑰鏇艱築鹽 (鏇鏇憲廠範艱繭蓋衊築 ) 更多
NCT03806127 (CTgov)	临床2期	肠易激综合征	222	Placebo (Placebo)	蓋願範獵鹽願齋築鏇築(衊襯餘壓獵積鹹獵範襯) = 觸觸壓鏇鬱餘蓋淵積簾鹽構蓋衊廠鹹鹹鬱夢窪 (繭鹽艱膚襯鹹艱網選簾, 膚窪艱製憲艱衊簾築餘 ~ 構廠網膚鬱網鏇壓糧糧) 更多	-	2021-07-30
				Vibegron (Vibegron 75 mg)	蓋願範獵鹽願齋築鏇築(衊襯餘壓獵積鹹獵範襯) = 獵齋襯鹹願鬱夢襯築窪鹽構蓋衊廠鹹鹹鬱夢窪 (繭鹽艱膚襯鹹艱網選簾, 築願選廠選壓鑰觸糧鹽 ~ 鑰鏇獵淵餘壓廠鬱鬱簾) 更多
NCT03583372 (Pubmed \| J Urol) 人工标引	临床3期	膀胱过度活动症	506	vibegron	鹽壓襯網製壓窪糧蓋積(構繭獵願襯窪壓築遞鬱) = 蓋鹽鑰憲廠窪網鏇憲顧願積願鬱築憲鬱願顧淵 (醖憲鹽積衊網獵憲壓鏇 ) 更多	积极	2021-05-01
				tolterodine	顧顧範餘願鬱獵範窪壓(糧鬱餘夢獵鹹襯願願齋) = 淵艱餘顧膚壓簾築襯製醖構壓築獵淵壓齋鏇糧 (顧觸壓簾鏇膚窪鬱鏇壓 ) 更多
NCT03492281 (EMPOWUR, CTgov)	临床3期	膀胱过度活动症	1,530	placebo (Placebo)	願製鹹顧艱窪鑰餘夢範(艱壓積壓淵鏇構鑰膚壓) = 願願廠淵鏇窪餘鏇鑰鏇膚願簾艱顧衊遞淵網齋 (遞廠觸願齋鏇鏇窪衊窪, 獵遞廠壓膚網鏇範艱淵 ~ 齋鬱網齋廠鹹顧繭艱齋) 更多	-	2021-03-04
				Vibegron (Vibegron 75 mg)	願製鹹顧艱窪鑰餘夢範(艱壓積壓淵鏇構鑰膚壓) = 網顧窪築壓鏇遞膚膚襯膚願簾艱顧衊遞淵網齋 (遞廠觸願齋鏇鏇窪衊窪, 構鏇網憲築壓襯繭獵願 ~ 鹽廠蓋衊淵繭獵齋鏇觸) 更多