[{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and sNDA for Myrbetriq Tablets","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Sumitomo","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sumitomo Pharma Announces Positive Topline Results from Phase 3 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":"Small molecule","graph2":"Sumitomo"}]
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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.
The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.