We're here to help you navigate your GEMTESA journey — from taking your first dose to preparing for your follow-up appointments with your doctor.
Start here to learn how to make the most of your overactive bladder (OAB) treatment journey with GEMTESA.
Whether you're considering treatment or have already been prescribed GEMTESA, GPS offers a wide range of resources and tools to get you on the road to OAB symptom relief.
*Restrictions and maximum saving limits apply. Coverage and out-of-pocket costs may vary. Offer not valid for patients participating in Medicare, Medicaid, or other government healthcare programs. See full Program Terms, Conditions, and Eligibility Criteria.
Looking for inspiration? Meet our GEMTESA Go-Getters — real-world patients who have found success with GEMTESA in their OAB treatment journeys.
†Based on prescription data for unique patients through May 2026.
GEMTESA® is a prescription medicine used to treat the following symptoms due to a condition called overactive bladder (OAB) in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH): leakage episodes, urgency, and frequency.
IMPORTANT SAFETY INFORMATION & USE
Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.
Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of GEMTESA? GEMTESA may cause serious side effects including:
inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing and may be life-threatening. Stop using GEMTESA and get emergency medical help right away if you have symptoms of angioedema or trouble breathing.
The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
GEMTESA® is a prescription medicine used to treat the following symptoms due to a condition called overactive bladder in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH):
urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
urgency: the need to urinate right away
frequency: urinating often
It is not known if GEMTESA is safe and effective in children.
IMPORTANT SAFETY INFORMATION & USE
Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.
Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of GEMTESA? GEMTESA may cause serious side effects including:
inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing and may be life-threatening. Stop using GEMTESA and get emergency medical help right away if you have symptoms of angioedema or trouble breathing.
The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
50.6% OF PATIENTS ENROLLED HAD HYPERTENSION AT BASELINE3
A 12-week, Phase 3, randomized, double-blind, placebo- and active-controlled multicenter study to evaluate the safety and efficacy of GEMTESA in 1500+ patients with symptoms of OAB.1,2
12-week patient demographics1-3
60
Years Old Mean Age
FEMALE
85%
FEMALE
MALE
15%
MALE
Treatment naïve or had prior ACh or β3-agonist use in 12 months before study
77% OAB WET*
23% OAB DRY*
Symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day2†
* OAB wet=average of ≥1 urge urinary incontinence episode per day; OAB dry=average of ≥3 urgency episodes and average of <1 urge urinary incontinence episode per day.2
† UUI was defined as leakage of urine of any amount because the patient felt an urge or need to urinate immediately.1
GEMTESA met efficacy endpoints1,2
12-week study efficacy endpoints
Co-primary endpoints
CFB in average daily number of micturitions and urge urinary incontinence episodes at Week 12
Key secondary endpoints
CFB in average daily number of urgency episodes at Week 12
Percent of OAB-wet patients at Week 12 with ≥75% reduction in total number of urge urinary incontinence episodes in 24 hours*
Percent of all OAB patients at Week 12 with 50% reduction in total number of urgency episodes per 24 hours*
Efficacy analyses were performed using the FAS, except for incontinence episode endpoints, which used the FAS-I.2
* Data were based on unadjusted values for a supportive outcome measure that was a prescribed secondary endpoint in the pivotal EMPOWUR trial.2 ACh=anticholinergic; CFB=change from baseline; FAS=full analysis set; FAS-I=full analysis set for incontinence; OAB=overactive bladder; UUI=urge urinary incontinence.
Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807
Data on file. Sumitomo Pharma America, Inc.
Adverse events up to 52 weeks1-3
Reported in >2% of patients treated with GEMTESA 75 mg for up to 52 weeks.1-3
Adverse reactions reported in >2% of patients treated with GEMTESA 75 mg for up to 52 weeks in the long-term extension study, not already listed in the 12-week table, were urinary tract infection, constipation, and bronchitis.1-3
Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. Once-daily vibegron 75 mg for overactive bladder: long-term safety and efficacy from a double-blind extension study of the international phase 3 trial (EMPOWUR). J Urol. 2021;205(5):1421-1429. doi:10.1097/JU.0000000000001574
24-week study design1,2
64.9% and 66.6% OF PATIENTS had preexisting hypertension in the GEMTESA and placebo ARMS, RESPECTIVELY2
The safety and efficacy of GEMTESA were evaluated in a 24-week, double-blind, randomized, placebo-controlled trial in 553 male patients with OAB on pharmacological treatment for BPH.
Baseline patient demographics1,2
67 years mean age
Were taking pharmacological therapy for ≥3 months to treat BPH (ie, treatment with an alpha blocker, with or without a 5-α reductase inhibitor)
Symptoms of OAB with average ≥3 urgency episodes per day, with or without incontinence, average ≥2 nocturia episodes per night, and average of ≥8 micturitions per day
GEMTESA met efficacy endpoints at Week 122
Co-primary endpoints:
Change from baseline in the average daily number of micturitions
Change from baseline in the average daily number of “need to urinate immediately” (urgency) episodes
Key secondary endpoints:
Change from baseline in the average daily number of UUI episodes
Change from baseline in the average volume voided per micturition
Staskin D, Owens-Grillo J, Thomas E, Rovner E, Cline K, Mujais S. Efficacy and safety of vibegron for persistent symptoms of overactive bladder in men being pharmacologically treated for benign prostatic hyperplasia: results from the phase 3 randomized controlled COURAGE trial. J Urol. 2024;212(2):256-266. doi:10.1097/JU.0000000000003999
