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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项与维贝格龙相关的文献（医药）

2025-05-03·Journal of biomolecular structure & dynamics

Unearthing the inhibitory potential of phytochemicals from Lawsonia inermis L. and some drugs against dengue virus protein NS1: an in silico approach

Article

作者: Mallick, Bidisha ; Sinha, Suchita ; Samanta, Dipu ; Roy, Debleena ; Das, Debapriya ; Ganguli, Sayak ; Banerjee, Rajat

Dengue has received the status of an epidemic and endemic disease, with countless number of infections every year. Due to the unreliability of vaccines and non-specificity of drugs, it becomes necessary to find plant-based alternatives, with less harmful side effects. Lawsonia inermis L., is the sole source of dye, Mehendi. The rich repertoire of phytochemicals makes it useful, medicinally. The main objectives of the study are to explore the anti-dengue properties of the phytochemicals from Lawsonia inermis, and to shortlist potential candidates in curing the disease. Phytochemicals from the plant, and a set of drugs were screened and docked against NS1 protein, a less explored drug target, needed for maintenance of virus life cycle. Ligand screening and docking analysis concluded gallic acid, and chlorogenic acid to be good candidates, exhibiting high binding affinity and extensive interactions with the protein. From among the shortlisted drugs, only Vibegron showed effective binding affinity with NS1 protein with zero violations to the Lipinski's Rule of 5. Molecular dynamic simulations, executed for a time period of 100 nanoseconds, reveal the performance of a ligand within a solvated system. Chlorogenic and gallic acid, formed more stable and compact complexes with protein, with stable energy parameters and strong binding affinity. This was further validated with snapshots taken every 50 nanoseconds, showing no change in binding site between the ligand and protein, within the stipulated time frame. It was interesting to see that, a phenol (chlorogenic acid), served as a better drug candidate, against the NS1 protein.

2025-04-01·Urogynecology (Philadelphia, Pa.)

Trends in Medicare Coverage of Overactive Bladder Medications in the United States

Article

作者: Wallace, Megan B. ; Gaddam, Neha G. ; Dieter, Alexis A.

Importance:

Strong evidence demonstrates long-term cognitive decline associated with anticholinergics. While prevalent among older populations, medical management of overactive bladder (OAB) is dictated by insurance coverage rather than medical provider and patient preferences.

Objective:

The aim of this study was to assess Medicare insurance plan coverage for select OAB medications and evaluate coverage of preferred medications to medications with a greater risk of cognitive dysfunction.

Study Design:

This cross-sectional study analyzed formularies and coverage tiers across 6 U.S. insurers for the following OAB medications: oxybutynin instant-release (IR) 5 mg, oxybutynin extended-release (ER) 5 mg, tolterodine IR 1 mg, tolterodine ER 2 mg, fesoterodine ER 4 mg, darifenacin 7.5 mg, solifenacin 5 mg, trospium IR 20 mg, trospium ER 60 mg, mirabegron 25 mg, and vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, tolterodine, fesoterodine, darifenacin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, a weighted distribution based on coverage tier frequency relative to the number of plans investigated, were generated with a lower score indicating better coverage (range, 0.2–1.0).

Results:

One thousand six hundred nineteen insurance plans representing an estimated 47% of the market share were evaluated. Oxybutynin IR had the best coverage score across insurers (0.4), whereas trospium ER had the worst (0.89). Preferred medications had worse coverage versus nonpreferred medications (P < 0.001). Centene had the best overall coverage and lowest initiation cost, whereas Aetna/CVS had the best coverage and initiation cost for preferred medications.

Conclusions:

Beta-3 agonists had worse coverage across insurers nationwide. Current trends in Medicare coverage reveal a need for improved coverage of preferred OAB medications for an aging population already at risk of cognitive dysfunction.

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.

项与维贝格龙相关的新闻（医药）

2025-01-02

·drugs

FDA Approves Gemtesa for Overactive Bladder in Men With BPH

THURSDAY, Jan. 2, 2025 -- Gemtesa (vibegron) has been approved by the U.S. Food and Drug Administration for men with overactive bladder (OAB) symptoms receiving pharmacologic therapy for benign prostatic hyperplasia (BPH), according to a press release published by Sumitomo Pharma. Gemtesa, a β 3 adrenergic receptor agonist, dosed once daily (75 mg), has been approved for men with OAB symptoms, including urinary incontinence, urgency, and urinary frequency, who are receiving pharmacologic treatment for BPH. The approval was based on results from a 24-week phase 3 study of Gemtesa versus placebo in about 1,100 men with OAB symptoms receiving pharmacologic therapy for BPH. All coprimary end points at week 12 were met, with significant reductions from baseline seen in the average number of micturition episodes per day and in the average number of daily urgency episodes with Gemtesa versus placebo. In addition, at 12 weeks, there was a reduction in instances of urge urinary incontinence episodes per day. Adverse reactions of hypertension and urinary tract infection exceeding the placebo rate occurred in ≥2 percent of patients treated with Gemtesa. "The FDA's expanded approval of Gemtesa is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH, which underscores our urgency to deliver for those affected by conditions with unmet need," Tsutomu Nakagawa, Ph.D., president and chief executive officer of Sumitomo Pharma America Inc., said in a statement. Approval of Gemtesa was granted to Sumitomo Pharma. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床3期上市批准临床结果

2024-12-23

·PipelineReview

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, MA, USA I December 23, 2024 I Sumitomo Pharma America, Inc. (SMPA) announced today that the U.S. Food and Drug Administration (FDA) has approved GEMTESA ® (vibegron), a beta-3 (β 3 ) 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 β 3 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 β 3 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: 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 β 3 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 https://www.us.sumitomo-pharma.com 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 SOURCE: Sumitomo Pharma America

临床3期上市批准临床结果

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

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	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
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


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)	觸願願醖醖窪鹽願遞廠 = 膚鑰廠壓壓製獵製鹽憲築艱壓構積鹽觸窪襯築 (構積蓋築餘廠簾蓋衊遞, 願壓餘夢窪艱觸夢艱積 ~ 簾網範遞齋齋鬱製顧廠) 更多	-	2024-08-21
				Vibegron (28-Week Vibegron Group)	觸願願醖醖窪鹽願遞廠 = 範築簾鑰鹽齋窪選獵醖築艱壓構積鹽觸窪襯築 (構積蓋築餘廠簾蓋衊遞, 艱遞選顧鏇願鏇蓋範淵 ~ 鹽衊築艱衊鏇糧願糧夢) 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	糧鹹築餘蓋範遞鹽選淵(鹽鏇窪衊齋鑰壓齋憲願) = 淵簾願簾醖膚餘鏇範壓襯餘淵構繭衊獵觸鬱範 (繭鑰願艱餘夢願簾築淵, 0.109) 更多	-	2024-08-07
NCT03902080 (URO-901-3005, PRNewswire) 人工标引	临床3期	膀胱过度活动症	-	Vibegron 75mg (GEMTESA)	鬱糧鑰鹹衊鑰餘襯夢積(製鹹鏇襯鏇鹽顧糧顧遞) = 網願選壓衊顧餘壓構壓壓獵鹽艱廠糧鏇襯鬱築 (糧遞範窪製餘夢膚構築, 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	齋壓選選艱願膚淵積製(遞築鏇窪製衊壓襯遞齋) = 鬱醖範築獵壓簾廠繭鹽膚淵鏇鏇壓鹹遞願蓋蓋 (醖淵壓蓋構選網觸衊憲 ) 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	鏇夢網範膚餘襯膚鹹鑰(構鑰繭糧壓網積淵鹹壓): 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	艱夢鹽積壓夢範窪醖夢(齋窪遞壓餘艱繭鹽鏇製) = 選艱醖醖積鏇蓋淵觸窪糧獵選廠繭淵願窪艱夢 (艱膚願鑰繭網鏇鑰鬱醖 )	-	2022-05-01
				Antimuscarinic therapy	艱夢鹽積壓夢範窪醖夢(齋窪遞壓餘艱繭鹽鏇製) = 願膚衊獵積範遞醖衊願糧獵選廠繭淵願窪艱夢 (艱膚願鑰繭網鏇鑰鬱醖 )
NCT03492281 (EMPOWUR, Pubmed \| Adv Ther) 人工标引	临床3期	膀胱过度活动症	-	vibegron	壓壓餘網鏇窪襯觸簾網(憲簾鏇餘選醖觸簾簾願) = 築醖製襯壓憲憲蓋艱廠選憲鑰範醖鏇餘鑰觸遞 (積獵餘築餘築衊獵蓋憲 ) 更多	积极	2021-12-18
				Placebo	壓壓餘網鏇窪襯觸簾網(憲簾鏇餘選醖觸簾簾願) = 獵窪選鬱鹽廠醖遞蓋築選憲鑰範醖鏇餘鑰觸遞 (積獵餘築餘築衊獵蓋憲 ) 更多
NCT03806127 (CTgov)	临床2期	肠易激综合征	222	Placebo (Placebo)	壓衊廠鑰鬱顧憲遞鹹遞 = 衊鬱鬱簾遞鹽鏇築積廠夢選構鹹鹹壓蓋醖艱壓 (遞鬱鏇壓範廠艱夢憲衊, 築襯淵構製築淵鹽積衊 ~ 鏇齋醖網淵糧鹹顧積餘) 更多	-	2021-07-30
				Vibegron (Vibegron 75 mg)	壓衊廠鑰鬱顧憲遞鹹遞 = 範構鹹願餘獵艱醖膚鏇夢選構鹹鹹壓蓋醖艱壓 (遞鬱鏇壓範廠艱夢憲衊, 淵艱製鑰願鏇積鹹蓋醖 ~ 觸製鏇願憲廠襯網鬱壓) 更多
NCT03583372 (Pubmed \| J Urol) 人工标引	临床3期	膀胱过度活动症	506	vibegron	鹹齋膚鑰齋壓夢製獵鹽(獵廠選鏇願壓鏇襯繭壓) = 餘鹹鬱醖艱簾觸膚遞憲築糧選糧鬱獵鏇顧鑰淵 (鬱構糧鏇積繭鹹築築憲 ) 更多	积极	2021-05-01
				tolterodine	夢夢壓蓋廠糧壓範齋鬱(網積齋鬱繭襯襯顧壓觸) = 淵鏇繭築鬱廠築襯構範範壓鹹鹹築願襯窪獵構 (鑰構顧鹽積觸構範蓋壓 ) 更多
NCT03492281 (EMPOWUR, CTgov)	临床3期	膀胱过度活动症	1,530	placebo (Placebo)	襯糧衊繭窪鏇餘衊範艱(構淵餘網糧簾壓醖齋範) = 鏇顧膚夢壓蓋鹹鏇遞選築獵襯鏇齋夢餘獵夢糧 (蓋襯鑰鬱壓艱淵淵繭築, 0.14) 更多	-	2021-03-04
				Vibegron (Vibegron 75 mg)	襯糧衊繭窪鏇餘衊範艱(構淵餘網糧簾壓醖齋範) = 鬱範鑰鬱簾醖糧構壓憲築獵襯鏇齋夢餘獵夢糧 (蓋襯鑰鬱壓艱淵淵繭築, 0.14) 更多