Back to discover
Drug

Vibegron

Approved · EMA
Emerging researchLate-stage development

Also known as Gemtesa, Vibegronum.

RxNorm2472254ChEMBLCHEMBL2107826UNIIM5TSE03W5U
1
Research papers
4
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Beta3-adrenergic Receptors and Cardiovascular Function in Aging Women

Clinical trial2026-06-29Results expected Q2 2028 · ClinicalTrials.gov

A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

Clinical trial2026-06-15Results expected Q1 2030 · ClinicalTrials.gov

Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity

Clinical trial2026-02-23Results expected Q3 2028 · ClinicalTrials.gov

Exploring the Additive Effect of Vibegron to Intradetrusor OnabotulinumtoxinA in Women With Refractory Overactive Bladder

Clinical trial2025-12-31Withdrawn · ClinicalTrials.gov

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Clinical trial2024-08-21Results posted · ClinicalTrials.gov

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center 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)

Clinical trial2024-08-07Results posted · ClinicalTrials.gov

Approval: Obgemsa (EMA)

Regulatory2024-06-27EMA

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

Clinical trial2021-08-02Results posted · ClinicalTrials.gov

An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

Clinical trial2021-03-18Results posted · ClinicalTrials.gov

An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

Clinical trial2021-03-04Results posted · ClinicalTrials.gov

Vibegron (RVT-901/MK-4618/KRP-114V) Administered Once Daily as Monotherapy or Concomitantly with Tolterodine in Patients with an Overactive Bladder: A Multicenter, Phase IIb, Randomized, Double-blind, Controlled Trial.

Research2018-10-25European urology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Vibegron
Aliases & brands
GemtesaVibegronum
RxNorm CUI
2472254
ChEMBL ID
CHEMBL2107826
UNII
M5TSE03W5U
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-06-27
Latest approval
2024-06-27
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-06-27Approval
Approval: Obgemsa (EMA)

Indication: Obgemsa is indicated in symptomatic treatment of adult patients with overactive bladder (OAB) syndrome.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2023
4
Active studies
4
Recruiting
7
Late-stage (III+)
8
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 14
Early Phase 12Phase 13Phase 22Phase 2 / 31Phase 35Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

RecruitingPH II/IIIUrovant Sciences GmbHn=712030

Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity

Not yet recruitingPH IIIWake Forest University Health Sciencesn=402028

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center 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)

CompletedPH IIIKey trialUrovant Sciences GmbHn=1,1052023

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

CompletedPH IIIUrovant Sciences GmbHn=2762022

An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

CompletedPH IIIUrovant Sciences GmbHn=5062019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center 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)

CompletedPH IIIKey trialUrovant Sciences GmbHn=1,1052023

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

CompletedPH IIIUrovant Sciences GmbHn=2762022

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

CompletedPH IIUrovant Sciences GmbHn=2222020

An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

CompletedPH IIIUrovant Sciences GmbHn=5062019

An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

CompletedPH IIIKey trialUrovant Sciences GmbHn=1,5302019

A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder A 52-week Extension to: A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder

CompletedPH IIMerck Sharp & Dohme LLCn=1,3952013

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • European urology1
Leading researchers
  • Bennett N1
  • Frenkl TL1
  • Green S1
  • Mitcheson HD1
  • Mudd PN Jr1
  • Muldowney K1
  • Pinto CA1
  • Rocha BA1
Leading institutions
free-text, unnormalised
  • Bay State Clinical Trials Inc1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.