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Drug

Mirabegron

Approved · EMA
ClassBeta-3 adrenergic receptor agonistEmerging researchLate-stage development

Also known as Myrbetriq.

RxNorm1300786ChEMBLCHEMBL2095212ATCG04BD12UNIIMVR3JL3B2V
2
Research papers
19
Active clinical trials
Beta-3 adrenergic receptor
Primary target
2
Regulatory events
Latest activity
beta

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

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity

Clinical trial2026-07-10Results expected Q1 2030 · ClinicalTrials.gov

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

Clinical trial2026-07-10Results expected Q3 2026 · ClinicalTrials.gov

Mechanisms for Activation of Beige Adipose Tissue in Humans

Clinical trial2026-07-07Results expected Q2 2027 · ClinicalTrials.gov

Efficacy and Safety of Milaberon in Combination With Standard Therapy in Advanced Solid Tumors: an Open, Multicenter, Clinical Study

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

Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Randomized Controlled Trial Comparing Mirabegron and Tamsulosin for Ureteral Stone Expulsion and Clinical Symptom Improvement

Clinical trial2026-06-08Results expected Q4 2029 · ClinicalTrials.gov

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Overactive Bladder and Daytime Urinary Incontinence (BeDry)

Clinical trial2026-06-08Results expected Q4 2027 · ClinicalTrials.gov

Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity.

Research2020-05-01The Journal of clinical investigation

Prospective Pilot Study of Mirabegron in Pediatric Patients with Overactive Bladder.

Research2016-02-11European urology

Drug Safety Update: Mirabegron (Betmiga▼): risk of severe hypertension and associated cerebrovascular and cardiac events

Regulatory2015-10-14MHRA

Approval: Betmiga (EMA)

Regulatory2012-12-20EMA

Profile

Identifiers & mechanism

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

Canonical name
Mirabegron
Aliases & brands
Myrbetriq
RxNorm CUI
1300786
ChEMBL ID
CHEMBL2095212
ATC codes
G04BD12
UNII
MVR3JL3B2V
Primary mechanism
Beta-3 adrenergic receptor agonist
Regulatory jurisdictions
emamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Beta-3 adrenergic receptor
ADRB3 · P13945
AGONISTBeta-3 adrenergic receptor agonist

Regulatory timeline

2 events

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
2012-12-20
Latest approval
2012-12-20
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2012-12-20Approval
Approval: Betmiga (EMA)
Indication: Overactive bladder in adults  Betmiga prolonged-release tablets are indicated for symptomatic treatment of urgency, increased micturition frequency and/or urgency… Show full indication

Overactive bladder in adults  Betmiga prolonged-release tablets are indicated for symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.  Neurogenic detrusor overactivity in the paediatric population  Betmiga prolonged release tablets are indicated for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2015-10-14Safety communicationSafety
Drug Safety Update: Mirabegron (Betmiga▼): risk of severe hypertension and associated cerebrovascular and cardiac events
Evidence ↗

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

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

121 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
121
registered trials across all phases
LATEST COMPLETION 2025
19
Active studies
14
Recruiting
69
Late-stage (III+)
75
Completed
27
Discontinued
PHASE DISTRIBUTIONn = 121
Early Phase 15Phase 123Phase 1 / 23Phase 221Phase 2 / 32Phase 323Phase 438Phase N / A6

Late-stage studies

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

A Randomized Controlled Trial Comparing Mirabegron and Tamsulosin for Ureteral Stone Expulsion and Clinical Symptom Improvement

RecruitingPH IVTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundationn=5002030

Sequential Multiple Assignment Randomized Trial to Treat Urinary Symptoms in Parkinson Disease

Not yet recruitingPH IVVA Office of Research and Developmentn=1462030

Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)

Active, not recruitingPH IVUniversity of Aarhusn=2162027

Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence

RecruitingPH IVUniversity of California, San Franciscon=2702027

Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women

Active, not recruitingPH IVShachi Tyagin=1202027

Recent completions

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

Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation: A Comparative Prospective Randomized Study

CompletedN/ASouth Valley Universityn=522025

Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk: a Feasibility Randomized Clinical Study

CompletedPH IThe University of Texas Medical Branch, Galvestonn=482025

A Pilot Interventional Study to Evaluate the Safety and Tolerability of Mirabegron and Montelukast in Patients With Liver Cirrhosis

CompletedPH IVKafrelsheikh Universityn=782025

Using Mirabegron to Increase Blood Pressure in Patients With Postural Orthostatic Tachycardia Syndrome

CompletedPH IICedars-Sinai Medical Centern=202025

The Mechanism of Human Non-Shivering Thermogenesis and Basal Metabolic Rate

CompletedPH IINational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)n=472024

Mirabegron and Physiological Function in Cold Environments - Aim 1

CompletedPH I/IIIndiana Universityn=172024

Research activity

2 papers

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

Publications over time
20162020
Major research themes5
Acetanilides1Adipose Tissue, Brown1Insulin Resistance1Positron Emission Tomography Computed Tomography1Thiazoles1
Journals, researchers & institutions
Top journals
  • European urology1
  • The Journal of clinical investigation1
Leading researchers
  • Ader M1
  • Baskin AS1
  • Bergman RN1
  • Blais AS1
  • Bolduc S1
  • Brychta RJ1
  • Cai H1
  • Cassimatis TM1
Leading institutions
free-text, unnormalised
  • CHU de Québec-Université Laval1
  • Clinical Laboratory Core1
  • Clinical Mass Spectrometry Core1
  • Diabetes and Obesity Research Institute1
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1
  • NYU School of Medicine1
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.