GEMTESA (vibegron) is an oral medication indicated for the treatment of overactive bladder (OAB) with signs of urge urinary incontinence (UUI), urgency and urinary frequency in adults.
It is available as an oral once-daily, oval, light green, film-coated tablet in 75mg strength.
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The drug was originally developed by Merck, a pharmaceutical company based in the US. Japanese company KYORIN Pharmaceutical licensed the drug from Merck in July 2014 for development in Japan and other Asian territories.
KYORIN signed an agreement with Kissei Pharmaceutical for the co-development and co-marketing of the drug in March 2016.
Urovant Sciences, a subsidiary of Sumitovant Biopharma, licensed the drug from Merck in February 2017 for global development, excluding Japan, China and other Asian countries.
Regulatory approvals for GEMTESA
KYORIN received approval for vibegron for the treatment of adults with OAB from Japan’s Ministry of Health, Labour and Welfare in September 2018. Vibegron was launched under the brand name Beova in November 2018.
A new drug application for vibegron was submitted to the US Food and Drug Administration (FDA) in December 2019, and accepted for review in March 2020.
The FDA approved vibegron for the treatment of adults with OAB in December 2020. Vibegron was commercially launched under the brand name GEMTESA in the US in April 2021.
In December 2024, vibegron received expanded FDA approval for the treatment of men living with OAB and being treated with pharmacological therapy for benign prostatic hyperplasia (BPH). This approval was based on the URO-901-3005 Phase III clinical trial.
Regional licensing agreements
In March 2021, KYORIN and Eisai, a pharmaceutical company based in Japan, entered into a license agreement for the development and distribution of vibegron in Thailand, the Philippines, Malaysia and Brunei. Eisai is responsible for the development and marketing of vibegron in these countries.
Urovant and France-based pharmaceutical company Pierre Fabre signed an agreement in July 2022 to commercialise vibegron in the European Economic Area, the UK, Switzerland, Turkey, and certain eastern European countries.
In March 2023, KYORIN and Sumitomo Pharma signed a licensing agreement for the development, production and commercialisation of vibegron in Taiwan, Hong Kong, Singapore, Indonesia and Vietnam.
In June 2025, Sumitomo Pharma and Knight Therapeutics, a speciality pharmaceutical company, signed exclusive licensing and supply agreements covering the commercialisation of various drugs including MYFEMBREE®, ORGOVYX® and vibegron in Canada. The companies also agreed to an asset purchase, under which Knight will buy a portfolio of established products from Sumitomo.
OAB causes and symptoms
OAB is a clinical condition that happens when the muscles of the bladder contract involuntarily. When the bladder muscle contracts too frequently or at the wrong time, the affected person might have signs of an OAB.
The condition is marked by a sudden need to urinate that is difficult to manage with or without accidental urinary discharge and typically with elevated urinary frequency. Unintentional urinary leakage due to urgency is referred to as UUI. Excessive urination (usually eight or more times in 24 hours) and nocturnal symptoms are some of the other symptoms of OAB.
More than 30 million people in the US suffer from the troubling symptoms of OAB, which can significantly hamper the day-to-day activities of patients.
Vibegron’s mechanism of action
Vibegron is a small molecule, selective human beta-3 adrenergic agonist that binds to and activates the beta-3 adrenergic receptor on the bladder.
Activation of the beta-3 adrenergic receptor increases the capacity of the bladder by calming the detrusor smooth muscle during bladder filling.
The drug’s safety and efficacy in children remain unestablished.
Clinical trials on GEMTESA
The FDA’s approval of GEMTESA was based on a 12-week, double-blind, randomised, placebo-controlled and active-controlled clinical trial named EMPOWUR.
A total of 1,515 patients with OAB were randomised in a 5:5:4 ratio to receive either GEMTESA 75mg (n=545), placebo (n=540) or active control (tolterodine; n=430) orally once daily for 12 weeks.
The patients with signs of OAB for at least three months, with an average of eight or more micturitions a day and at least one UUI a day, or an average of eight or more micturitions a day and at least three urgency episodes a day, were eligible to enter the trial.
The study’s population included OAB opioid-naive patients, as well as patients who had undergone previous OAB drug therapy.
The co-primary endpoints of the trial were changes in micturition frequency and UUI episodes at week 12.
At 12 weeks, micturition reduced by an adjusted mean of 1.8 episodes a day in patients receiving GEMTESA compared to 1.3 episodes a day for placebo and 1.6 episodes a day for tolterodine.
In incontinent patients, urge incontinence episodes decreased by an adjusted mean of two episodes a day for GEMTESA versus 1.4 for placebo and 1.8 for tolterodine.
GEMTESA was also substantially superior to placebo for secondary endpoints including the number of urgency episodes, volume per urination, and proportion of incontinent patients with a 75% or higher reduction in the urge incontinence episode.
The most common adverse reactions of GEMTESA in patients during the trial were diarrhoea, nausea, headache, upper respiratory tract infection and nasopharyngitis.
EMPOWUR extension study
GEMTESA’s long-term safety, tolerability and efficacy in adults with OAB were evaluated in a 40-week Phase III EMPOWUR extension study.
The study enrolled 500 patients who completed the EMPOWUR study and were administered either vibegron or tolterodine. Urovant announced the results of the study in May 2022.
After 52 weeks of treatment, 61% of patients with wet OAB receiving vibegron experienced a 75% reduction in UUI episodes compared to 54.4% of patients treated with tolterodine, and 40.8% of patients treated with vibegron experienced a 100% reduction compared to 34.2% of patients treated with tolterodine.
Additional studies
The URO-901-3005 trial was a Phase III, double-blind, randomised, placebo-controlled, multicentre study that evaluated the safety and efficacy of vibegron in men with OAB who were receiving pharmacological therapy for BPH.
A total of 1,105 men were enrolled and randomly assigned in a 1:1 ratio to receive either vibegron 75mg once daily or placebo.
The co-primary endpoints of the study were the change in baseline (CFB) in the number of micturition episodes per day and the CFB in the number of urgency episodes at week 12.
At week 12, the trial met its co-primary endpoints, showing statistically significant reductions from baseline with vibegron versus placebo. The number of micturitions per day was -2.04 in the vibegron group compared to -1.30 in the placebo group, and the urgency episodes were -2.88 in the vibegron group compared to -1.93 in the placebo group.
Furthermore, participants treated with vibegron achieved all secondary outcomes, including a significant improvement in the principal secondary measure, with a greater fall in mean nocturia episodes per night of -0.88 in the vibegron group compared to -0.66 in the placebo group.
Vibegron also delivered statistically significant reductions from baseline in mean daily urge UUI episodes of -2.19 versus -1.39 in the placebo group, and the International Prostate Symptom Storage score was -3 compared to -2.1 in the placebo group.
In addition, the average voided volume per micturition increased significantly with vibegron relative to placebo (25.63ml versus 10.56ml).
The long-term safety, tolerability and efficacy of vibegron in patients who had completed the URO-901-3005 primary trial were further assessed in the COURAGE trial (URO-901-3006), a Phase III, randomised controlled study.
The COURAGE trial included 276 patients who were randomised 1:1 to once-daily vibegron 75mg or placebo for 24 weeks.
Vibegron was reported to be well tolerated for up to 52 weeks in men with OAB symptoms on pharmacological therapy for BPH.
Treatment efficacy with vibegron 75mg once daily was maintained over 52 weeks in participants who continued on vibegron, and efficacy improved after 28 weeks of vibegron therapy in those who had initially received a placebo during the first 12 weeks of the URO-901-3005 study.
The adverse events reported most frequently during the trials were hypertension (6.3%), Covid-19 (5.6%) and elevated hepatic enzymes (2.1%).
