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Gemtesa FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 30, 2024.

FDA Approved: Yes (First approved December 23, 2020)
Brand name: Gemtesa
Generic name: vibegron
Dosage form: Tablets
Company: Sumitomo Pharma Co., Ltd.
Treatment for: Overactive Bladder

Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist for use in the treatment of overactive bladder.

Development timeline for Gemtesa

DateArticle
Dec 23, 2024Approval Sumitomo Pharma America Announces U.S. FDA Approval of Gemtesa (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia
Dec 23, 2020Approval FDA 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

See also

Gemtesa (vibegron) Consumer information

Further information

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