[{"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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Clinical Studies Evaluating Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Urology","graph2":"Phase III"},{"orgOrder":0,"company":"Pierre Fabre","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pierre Fabre Laboratories Receive Positive CHMP Opinion for OBGEMSA\u2122(vibegron) in Overactive Bladder Syndrome","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Urology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Vibegron
Obgemsa (vibegron) is a beta-3 adrenergic agonist, small molecule drug candidate, which is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Gemtesa (vibegron) is a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia.
KYORIN will grant Sumitomo Pharma the exclusive rights to develop, manufacture, and commercialize the therapeutic agent for OAB called Vibegron in in Taiwan and Other Asian Countries, and Sumitomo Pharma will develop, manufacture, and commercialize the Compound.
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.
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).
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.
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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