Data updated: May 26, 2026
MYRBETRIQ GRANULES (mirabegron)
Adrenergic beta3-Agonists
Trial Activity: Declining 11 active trials
Urology
Approved 2021-03-25
Myrbetriq is a medication used for adults who experience overactive bladder. It helps patients with symptoms like urge urinary incontinence, sudden urgency, and frequent urination. This drug provides a therapeutic option for managing these common urinary storage issues.
How MYRBETRIQ GRANULES Works
Mirabegron works by activating beta-3 adrenergic receptors, which relaxes the detrusor smooth muscle during the storage phase of the bladder's fill-void cycle. This relaxation increases the overall capacity of the bladder.
Development Insights
Astellas Pharma Inc conducting 20 trials (29%)
84 indications explored (Broad Platform)
→ overactive bladder (14 trials)
→ pharmacokinetics of mirabegron (10 trials)
→ urinary bladder, overactive (7 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
5
Years on Market
Details
- Status
- Prescription
- First Approved
- 2021-03-25
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE
MYRBETRIQ GRANULES Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
What MYRBETRIQ GRANULES Treats
2 indicationsMYRBETRIQ GRANULES is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Urge Urinary Incontinence
Source: FDA Label
MYRBETRIQ GRANULES Competitive Set
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Indication competitors
9
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Drugs Similar to MYRBETRIQ GRANULES
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
DARIFENACIN
DARIFENACIN HYDROBROMIDE
MACLEODS PHARMS LTD
Shared indications:
Overactive BladderUrge Urinary Incontinence
DARIFENACIN HYDROBROMIDE
DARIFENACIN HYDROBROMIDE
TORRENT
Shared indications:
Overactive BladderUrge Urinary Incontinence
DETROL LA
TOLTERODINE TARTRATE
UPJOHN
Shared indications:
Overactive BladderUrge Urinary Incontinence
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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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Completed studies with published results, ranked by significance
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Trial Timeline
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 GRANULES FDA Label Details
Indications & Usage
FDA Label (PDF)MYRBETRIQ GRANULES is indicated for the treatment of Overactive Bladder; Urge Urinary Incontinence.
View full patent landscape →
2 OB patents · 1 families ·
17 international docs across 14 countries
MYRBETRIQ GRANULES Patents & Exclusivity
Latest Patent: Sep 2036
Patents (2 active)
US10058536*PED
Expires Sep 30, 2036
US10058536
Expires Mar 31, 2036
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for MYRBETRIQ GRANULES
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 2 active patents
Trial Analysis
- • 69 total trials
- • Stage: Declining
Competitive Landscape
- • 12 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment