Official HCP Site—GEMTESA® (vibegron) 75 mg tablets

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THE MECHANISM OF ACTION FOR GEMTESA

GEMTESA is NOT an anticholinergic treatment — it works differently by selectively targeting β₃-adrenergic receptors¹

Bladder relaxation is predominantly mediated by β₃-adrenergic receptors^1,2

M₃ (muscarinic) receptor

Activating the muscarinic receptors contracts the bladder detrusor muscle to mediate bladder emptying.²

β₃ receptor

Activating the β₃-adrenergic receptors relaxes the bladder detrusor muscle to increase capacity^1-3

GEMTESA IS A SELECTIVE β₃-ADRENERGIC AGONIST^1-4

* Clinical relevance of the in vitro receptor binding assay data is unknown.^1,4,5

^† At 10 μM (exceeds mean human C_max values of GEMTESA by ~30x).^1,4,5

C_max=maximum serum concentration.

See how GEMTESA could help your patients

GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of:

overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

INDICATIONS AND USAGE

GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of:

overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

Please see full Prescribing Information.

References:

GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
Yamaguchi O, Chapple CR. β₃-Adrenoceptors in urinary bladder. Neurourol Urodyn. 2007;26(6):752-756. doi:10.1002/nau.20420
Edmondson SD, Zhu C, Kar NF, et al. Discovery of vibegron: a potent and selective β₃ adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem. 2016;59(2):609-623. doi:10.1021/acs.jmedchem.5b01372
Brucker BM, King J, Mudd PN Jr, McHale K. Selectivity and maximum response of vibegron and mirabegron for β₃-adrenergic receptors. Curr Ther Res Clin Exp. 2022;96:100674. doi:10.1016/j.curtheres.2022.100674
Data on file. Sumitomo Pharma America, Inc.

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

12-week double-blind treatment period²

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

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.

THE MECHANISM OF ACTION FOR GEMTESA

GEMTESA is NOT an anticholinergic treatment — it works differently by selectively targeting β₃-adrenergic receptors¹

Bladder relaxation is predominantly mediated by β₃-adrenergic receptors^1,2

M₃ (muscarinic) receptor

β₃ receptor

12-week double-blind treatment period²

12-week patient demographics^1-3

GEMTESA met efficacy endpoints^1,2

12-week study efficacy endpoints

Baseline patient demographics^1,2

GEMTESA met efficacy endpoints at Week 12²

THE MECHANISM OF ACTION FOR GEMTESA

GEMTESA is NOT an anticholinergic treatment — it works differently by selectively targeting β3-adrenergic receptors1

Bladder relaxation is predominantly mediated by β3-adrenergic receptors1,2

M3 (muscarinic) receptor

β3 receptor

12-week double-blind treatment period2

12-week patient demographics1-3

GEMTESA met efficacy endpoints1,2

12-week study efficacy endpoints

Baseline patient demographics1,2

GEMTESA met efficacy endpoints at Week 122

GEMTESA is NOT an anticholinergic treatment — it works differently by selectively targeting β₃-adrenergic receptors¹

Bladder relaxation is predominantly mediated by β₃-adrenergic receptors^1,2

M₃ (muscarinic) receptor

β₃ receptor

12-week double-blind treatment period²

12-week patient demographics^1-3

GEMTESA met efficacy endpoints^1,2

Baseline patient demographics^1,2

GEMTESA met efficacy endpoints at Week 12²