TheraRadar
Data updated: May 26, 2026

MYRBETRIQ (mirabegron)

Adrenergic beta3-Agonists
Urology Approved 2012-06-28

Myrbetriq helps adults manage overactive bladder symptoms such as sudden urges to urinate, frequent bathroom visits, and urge-related leakage. It is used either as a standalone therapy or in combination with solifenacin succinate to improve bladder control. Additionally, the medication treats neurogenic detrusor overactivity in pediatric patients three years of age and older.

Source: FDA Label • APGDI • beta3-Adrenergic Agonist
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How MYRBETRIQ Works

This medication works by activating beta-3 adrenergic receptors found in the bladder's detrusor muscle. This stimulation causes the muscle to relax during the storage phase of the fill-void cycle, which increases the bladder's overall capacity.

Source: FDA Label
3
Indications
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

Details

Status
Prescription
First Approved
2012-06-28
Patent Cliff
2030

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

APGDI
Active Ingredient: MIRABEGRON

MYRBETRIQ Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2012 to 2021 · 2 indication expansions
Mar 2021 SUPPL Priority
Efficacy
FDA Letter Label
Apr 2018 SUPPL
Efficacy
FDA Letter Label
Jul 2017 SUPPL
Label · Labeling
FDA Letter Label

What MYRBETRIQ Treats

2 indications

MYRBETRIQ is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Overactive Bladder
  • Neurogenic Detrusor Overactivity
Source: FDA Label

MYRBETRIQ Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

9

Same indication, different mechanism — what else might this patient receive?

GEMTESA
SUMITOMO PHARMA
2020 2 indic.
DARIFENACIN
MACLEODS PHARMS
2017 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to MYRBETRIQ

3 of 12

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BOTOX
OnabotulinumtoxinA
2 shared
AbbVie
Shared indications:
Overactive BladderNeurogenic Detrusor Overactivity
TOVIAZ
FESOTERODINE FUMARATE
2 shared
Pfizer
Shared indications:
Overactive BladderNeurogenic Detrusor Overactivity
DARIFENACIN
DARIFENACIN HYDROBROMIDE
1 shared
MACLEODS PHARMS LTD
Shared indications:
Overactive Bladder
View all 12 similar drugs Pro
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Clinical Trial Registry

70 trials
Trial Sponsor ID Phase Status Title
NCT07585513 BEAT-POTS STUDY00004929 26BIPA1622610 Ph 2 not yet recruiting Beta-3 Enhanced Autonomic Therapy for POTS
NCT05713799 10000220 000220-DK Ph 2 not yet recruiting Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
NCT03049462 170054 17-DK-0054 Ph 1 recruiting The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists
NCT07566208 MACH-1 STUDY00004239 Ph 2 not yet recruiting Using Mirabegron to Control Arrhythmia-1
NCT07187466 SQUARE PD RRD6-001-24W Ph 4 not yet recruiting Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
NCT05621616 178-CL-207 2021-005455-37, 2023-507903-74 Ph 3 active not recruiting A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
NCT05362292 TRIUMPH 21-35858 1R01AG075471-01 Ph 4 recruiting TReating Incontinence for Underlying Mental and Physical Health
NCT04666636 60821 R01DK124626 Ph 2 recruiting Mechanisms for Activation of Beige Adipose Tissue in Humans
NCT07310797 14-IRB074 TCRD-TPE-115-35 Ph 4 not yet recruiting Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
NCT06551246 BeDry Ph 3 recruiting Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
NCT06465576 StayDry Ph 4 recruiting Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
NCT05990387 results posted 2011690870; Aim 2 Ph 1, Ph 2 completed MIrabegron and Physiological Function in Cold Environments
NCT02599480 Beta3_LVH Beta3_LVH V1.0 Ph 2 completed Assessment of Efficacy of Mirabegron, a New beta3-adrenergic Receptor in the Prevention of Heart Failure
NCT02216214 PILLAR results posted 178-MA-1005 Ph 4 completed Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
NCT00912964 CAPRICORN results posted 178-CL-074 2008-007087-42 Ph 3 completed A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT01638000 BEYOND results posted 178-EC-001 2011-005713-37 Ph 3 completed A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
NCT00688688 TAURUS results posted 178-CL-049 2007-001452-39 Ph 3 completed Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT00662909 ARIES results posted 178-CL-047 Ph 3 completed A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT00689104 SCORPIO results posted 178-CL-046 2007-001451-19 Ph 3 completed Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT04562090 results posted 178-MA-2295 CTR20202160 Ph 4 completed A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder
NCT04641975 Dolphin results posted 178-CL-204 2016-001767-37 Ph 3 terminated A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
NCT02757768 PLUS results posted 178-MA-1008 2015-004036-36 Ph 4 completed A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
NCT02751931 Crocodile results posted 178-CL-206A 2015-002876-25 Ph 3 completed Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity
NCT04501640 results posted 178-MA-2294 CTR20201670 Ph 4 completed A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants
NCT02656173 results posted 178-MA-3016 Ph 4 completed A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)
NCT01972841 SYNERGY results posted 178-CL-101 2012-005735-91, U1111-1153-9095 Ph 3 completed This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
NCT02526979 178-CL-203 2015-000700-26 Ph 1 completed A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
NCT02045862 SYNERGY II results posted 178-CL-102 2012-005736-29 Ph 3 completed A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder
NCT01340027 Symphony results posted 178-CL-100 2010-020601-32 Ph 2 completed A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
NCT02211846 178-CL-202 2014-000340-15 Ph 1 completed A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
NCT00940121 178-CL-076 Ph 1 completed Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron
NCT05634174 UC-MEDVH-01 Ph 1 active not recruiting ADRB3 Signaling Pathway in Human Adipose Tissue
NCT02893553 results posted WEC-16-015 Ph 2 completed The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury
NCT06534762 Miraberon Ph 2 recruiting Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study
NCT04766021 results posted 2011690870; Aim 1 Ph 1, Ph 2 completed Mirabegron and Physiological Function in Cold Environments
NCT02086188 MIRROR results posted TRB2013 Ph 4 completed Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis
NCT02462837 results posted MYRB-14B02 Ph 2 terminated Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement
NCT02540707 201506092MIND Ph 4 completed Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes
NCT02095665 SPAM SPAM Ph 4 completed Ureteral Stent-related Pain and Mirabegron (SPAM) Trial
NCT03926754 BEAT-HF II 2016-002367-34 H-16030780 Ph 2, Ph 3 completed Beta 3 Agonist Treatment in Heart Failure-2
NCT02744430 results posted H-38959 Ph 2 completed Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain
NCT02092181 Maestro results posted DBPA-2013-01 Ph 4 completed A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)
NCT02916693 results posted IRB00097439 Ph 1, Ph 2 completed Mirabegron For Erectile Dysfunction
NCT02495389 results posted 207102 Ph 4 completed Mirabegron and Urinary Urgency Incontinence
NCT02981459 030-586061 Ph 4 withdrawn Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
NCT01876433 Beat-HF 2012-004805-29 Ph 2 completed Beta 3 Agonist Treatment in Heart Failure
NCT02138747 PREFER results posted 178-MA-1001 Ph 4 completed A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
NCT02787083 MirabegronIC results posted MYRB-15G02 Ph 3 terminated A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis
NCT02311569 SAKK 33/14 Ph 2 completed Sympathicomimetic Agonist in Patients With Myeloproliferative Neoplasms With JAK2-mutation
NCT02536976 MICT-PD results posted 04412-15-A Ph 4 completed Mirabegron in Parkinson Disease and Impaired Cognition

Showing 50 of 70 trials

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MYRBETRIQ FDA Label Details

Indications & Usage

FDA Label (PDF)

MYRBETRIQ is indicated for the treatment of Overactive Bladder; Neurogenic Detrusor Overactivity.

View full patent landscape →
10 OB patents · 4 families · 79 international docs across 25 countries

MYRBETRIQ Patents & Exclusivity

Latest Patent: Mar 2030

Patents (10 active)

US11707451*PED Expires Mar 28, 2030
US12097189*PED Expires Mar 28, 2030
US10842780*PED Expires Mar 28, 2030
US12059409*PED Expires Mar 28, 2030
US10842780 Expires Sep 28, 2029
US12097189 Expires Sep 28, 2029
US11707451 Expires Sep 28, 2029
US12059409 Expires Sep 28, 2029
US8772315*PED Expires Apr 30, 2029
US8772315 Expires Oct 30, 2028
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2030
  • • 52 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 12 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA202611 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.