Vibegron

Vibegron is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling.

• 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. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).ICD-10: N32.81, N40.0

• GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] .contraindicated

The recommended dose is one 75 mg tablet orally once daily. ( 2.1 ) Swallow tablet whole with water. ( 2.1 ) Tablet may be crushed and mixed with applesauce. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of GEMTESA is one 75 mg tablet orally, once daily with or without food. Swallow GEMTESA tablets whole with a glass of water. In adults, GEMTESA tablets also may be crushed, mixed with a tablespoon (approximately 15 mL) of applesauce and taken immediately with a glass of water [see Clinical Pharmacology ( 12.3 )] .

Urinary Retention : Monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, in whom the risk of urinary retention may be greater. If urinary retention develops, discontinue GEMTESA. ( 5.1 ) Angioedema : Angioedema of the face and/or larynx has been reported with GEMTESA. ( 5.2 ) 5.1 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 [see Adverse Reactions ( 6.1 )] . 5.2 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. GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any component of GEMTESA [see Contraindications ( 4 ) and Adverse Reactions ( 6.2 )] .

The following clinically significant adverse reaction is described elsewhere in the labeling: Urinary retention [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America, Inc. at 1-833-876-8268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overactive Bladder in Adults The safety of GEMTESA was evaluated in a 12-week, double-blind, placebo- and active-controlled study (Study 3003) in patients with OAB [see Clinical Studies ( 14.1 )] . A total of 545 patients received GEMTESA. The majority of the patients were White (78%) and female (85%) with a mean age of 60 years (range 18 to 93 years). Adverse reactions that were reported in Study 3003 at an incidence greater than placebo and in ≥2% of patients treated with GEMTESA are listed in Table 1 .

Pediatric use : Safety and effectiveness in pediatric patients have not been established. ( 8.4 ) End-stage Renal Disease with or without Hemodialysis : Not recommended. ( 8.6 ) Severe Hepatic Impairment : Not recommended. ( 8.7 ) 8.1 Pregnancy Risk Summary There are no available data on GEMTESA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, no effects on embryo-fetal development were observed following administration of vibegron during the period of organogenesis at exposures approximately 275-fold and 285-fold greater than clinical exposure at the recommended daily dose of GEMTESA, in rats and rabbits, respectively. Delayed fetal skeletal ossification was observed in rabbits at approximately 898-fold clinical exposure, in the presence of maternal toxicity. In rats treated with vibegron during pregnancy and lactation, no effects on offspring were observed at 89-fold clinical exposure. Developmental toxicity was observed in offspring at approximately 458-fold clinical exposure, in the presence of maternal toxicity. No effects on offspring were observed at 89-fold clinical exposure (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

Mean vibegron C max and AUC increased in a greater than dose-proportional manner up to 600 mg (8 times the approved recommended dosage). Steady state concentrations are achieved within 7 days of once daily dosing.

There is no experience with inadvertent GEMTESA overdosage. In case of suspected overdose, treatment should be symptomatic and supportive.

• Dec 23, 2020NDANDA213006Sumitomo Pharma Am

1. 1Drug Ineffective96514%
2. 2Diarrhoea3605.0%
3. 3Headache3424.8%
4. 4Urinary Tract Infection3144.4%
5. 5Urinary Retention2773.9%
6. 6Fatigue2653.7%
7. 7Inability To Afford Medication2653.7%
8. 8Death2403.4%
9. 9Nausea2343.3%
10. 10Constipation2243.1%
11. 11Urinary Incontinence2032.8%
12. 12Pollakiuria1972.8%
13. 13Dizziness1962.7%
14. 14Therapeutic Product Effect Incomplete1962.7%
15. 15Fall1942.7%

The 10 most recently updated of 16 ClinicalTrials.gov registrations naming Vibegron as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Vibegron for ENergy Thinking and Resilience in Aging
  Not yet recruiting · Phase 3 · Interventional · 40 enrolled · Wake Forest University Health Sciences
  NCT06987383updated 2026-02-23
• Role of Combination Therapy in Women With Refractory Overactive Bladder
  Withdrawn · Interventional · 0 enrolled · University of Alabama at Birmingham
  NCT06438861updated 2026-02-12
• Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children
  Active not recruiting · Phase 3 · Interventional · 151 enrolled · Menoufia University
  NCT07398261updated 2026-02-09
• Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
  Recruiting · Phase 4 · Interventional · 432 enrolled · Women and Infants Hospital of Rhode Island
  NCT05806164updated 2025-09-25
• Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)
  Completed · Observational · 403 enrolled · Urovant Sciences GmbH
  NCT05067478updated 2024-12-27
• Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
  Completed · Phase 3 · Interventional · 276 enrolled · Urovant Sciences GmbH
  NCT04103450updated 2024-08-21
• Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
  Completed · Phase 3 · Interventional · 1,105 enrolled · Urovant Sciences GmbH
  NCT03902080updated 2024-08-07
• A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC
  Recruiting · Phase 2 · Phase 3 · Interventional · 85 enrolled · Urovant Sciences GmbH
  NCT05491525updated 2024-07-03
• To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder
  Completed · Phase 3 · Interventional · 210 enrolled · Jeil Pharmaceutical Co., Ltd.
  NCT04917315updated 2022-01-28
• Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
  Completed · Phase 2 · Interventional · 222 enrolled · Urovant Sciences GmbH
  NCT03806127updated 2021-08-02

Frequently asked questions

How does Vibegron work?

Vibegron is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling.

What is Vibegron used for?

According to FDA labeling, Vibegron carries indications including: 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. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Vibegron?

Vibegron is classified as Drugs for urinary frequency and incontinence, beta3-Adrenergic Agonist, Adrenergic beta3-Agonists, Decreased Bladder Contractility, Decreased Bladder Sphincter Tone.

What are the brand names for Vibegron?

Vibegron is marketed under brand names including Gemtesa.

What are the contraindications for Vibegron?

Vibegron labeling lists contraindications including: GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] .. Always consult the full prescribing information and a clinician.