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Gemtesa FDA Approval History

FDA Approved: Yes (First approved December 23, 2020)
Brand name: Gemtesa
Generic name: vibegron
Dosage form: Tablets
Company: Urovant Sciences

Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

Development Timeline for Gemtesa

DateArticle
Dec 23, 2020ApprovalFDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB)
Mar  5, 2020Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder
Dec 30, 2019Urovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive Bladder
Sep 24, 2019Urovant Sciences Reports Positive Long-Term Data from the Double-Blind Extension of the Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder
Mar 19, 2019Urovant Sciences Announces Positive Topline Results from Pivotal Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder

Further information

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