Drugs in Dev. Urology
Phase III
Japan 
Sumitomo Pharma’s Vibegron Supplemental NDA Accepted By FDA
Details : Gemtesa (vibegron) is a beta-3 adrenergic receptor agonist for treating male overactive bladder (OAB) with benign prostatic hyperplasia.
Product Name : Gemtesa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 13, 2024
Details : 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.
Product Name : Gemtesa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 09, 2023
Lead Product(s) : Mirabegron
Therapeutic Area : Urology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : 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.
Product Name : Myrbetriq
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 01, 2021
Lead Product(s) : Mirabegron
Therapeutic Area : Urology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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