[{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Announces Publication of Phase 3 EMPOWUR Trial Results","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Urology","graph2":"Phase III"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Presents Clinical Efficacy & Safety Data on Lead Drug Candidate Vibegron at American Urological Association Annual Meeting","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 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Find Clinical Drug Pipeline Developments & Deals by Urovant Sciences
GEMTESA (vibegron) 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.
Urovant Sciences and Pierre Fabre will share responsibility for Gemtesa (vibegron), clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.
In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA (Vibegron) was safe and well-tolerated. Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition.
Interim 12-week analysis from an ongoing Phase 2a trial of an investigational novel gene therapy product URO-902 (hMaxi-K), showed clinically relevant improvement in the common symptoms of overactive bladder (OAB) compared to placebo.
Post-hoc analysis indicates significant reductions in urgency episodes and micturitions in patients treated with GEMTESA vs. placebo in both types of overactive bladder (OAB).
Interim 12-week analysis from a Phase 2a trial of the potential gene therapy, URO-902, in women with overactive bladder and urge urinary incontinence will be featured in a late-breaker presentation during plenary session.
The Therapeutics and Clinical Risk Management paper points out that in international phase 3 EMPOWUR trial, treatment with GEMTESA was associated with significant improvements compared with placebo.
URO-902 showed a clinically meaningful and statistically significant effect on a number of relevant outcome measures in OAB including number of micturitions, urgency episodes, and quality of life indicators compared to placebo, 12 weeks post-administration.
New data from dedicated ambulatory blood pressure study of patients with overactive bladder (OAB) showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate.
The commercial launch of GEMTESA, a beta-3 (β3) adrenergic receptor agonist, was announced in April 2021. EMTESA reduces the bothersome symptoms of OAB by relaxing the detrusor bladder muscle so that the bladder can hold more urine.
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