There is only one GEMTESA — no generic substitute

Curious if you may have
overactive bladder (OAB)?

Get on the road to relief from all 3 key OAB symptoms — leakage episodes, urgency (that “gotta-go” feeling), and frequency.

Assess your OAB symptoms

A group of people driving past a restroom on the road

There is only one GEMTESA — no generic substitute

Curious if you may have overactive bladder (OAB)?

Get on the road to relief from all 3 key OAB symptoms — leakage episodes, urgency (that “gotta-go” feeling), and frequency.

Assess your OAB symptoms

More than 1 million people with OAB have chosen GEMTESA*

Watch GEMTESA patient stories

*Based on prescription data for unique patients through May 2026.

How GEMTESA can help

GEMTESA is the ONLY OAB treatment of its kind^† with:

Proven efficacy and safety data in men also being treated for benign prostatic hyperplasia (BPH)

Learn why BPH treatment may not be enough

Proven relief from all 3 key symptoms of OAB — leakage episodes, urgency (that “gotta-go” feeling), and frequency

Discover how GEMTESA can help

GEMTESA is the only OAB treatment of its kind^† that does not have significant impact on blood pressure.
At 12 weeks, in a clinical study of men and women, people taking GEMTESA and those taking placebo had similar rates of hypertension (1.7% [9 out of 545 people] vs 1.7% [9 out of 540 people], respectively) and increased blood pressure (0.7% [4 out of 545 people] vs 0.9% [5 out of 540 people], respectively). In a 24-week study of OAB in men being treated for BPH, rates of hypertension were 9.0% with GEMTESA (50 of 553 people) vs 8.3% with placebo (46 of 551 people). In a 4-week blood pressure study of 200 adults with OAB, GEMTESA did not cause meaningful changes in blood pressure, including in people who already had high blood pressure or were taking medicine to treat it.

Explore the GEMTESA safety information

^†In the beta₃-agonist category.

Savings program and support

Help is here at every step of your OAB journey with the GEMTESA Patient Support (GPS) program

GEMTESA is proud to offer a savings program for eligible patients with commercial insurance^‡ and more predictable costs for Medicare Part D enrollees.

Discover savings program and support

GPS offers access support and tools to help you make the most out of your GEMTESA journey.

Learn about GEMTESA Patient Support (GPS)

^‡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.

Holly Robinson Peete and Rodney Peete talk about their OAB treatment journey

We’re in this journey together!

We’re in this journey together!

Meet celebrity couple Holly and Rodney — real patients and GEMTESA Go-Getters who are making the most of their OAB treatment journey.

Watch Holly and Rodney’s stories

Holly and Rodney are real patients taking GEMTESA who have been compensated for their time.

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.

Please see full Prescribing Information and Patient Product Information for GEMTESA.

What is GEMTESA?

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.

Please see full Prescribing Information and Patient Product Information for GEMTESA.

STUDIED IN MORE THAN 1500 PATIENTS WITH OAB^1,2

12-week double-blind treatment period²

12 week double blind treatment period, Diagram

12 week double blind treatment period, Diagram

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 demographics^1-3

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/day^2†

* 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 endpoints^1,2

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.

References:

GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
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.