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Myrbetriq (MIRABEGRON)
Myrbetriq works by activating the beta-3 adrenergic receptor in the bladder muscle, leading to relaxation and improved bladder control.
At a glance
| Generic name | MIRABEGRON |
|---|---|
| Sponsor | Apgdi |
| Drug class | beta3-Adrenergic Agonist [EPC] |
| Target | Beta-3 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | FDA-approved |
| First approval | 2012 |
| Annual revenue | 1800 |
Mechanism of action
Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity. Although mirabegron showed very low intrinsic activity for cloned human beta-1 AR and beta-2 AR, results in humans indicate that beta-1 AR stimulation occurred at mirabegron dose of 200 mg.
Approved indications
- Bladder muscle dysfunction - overactive
Common side effects
- Hypertension
- Nasopharyngitis
- Urinary Tract Infection
- Headache
- Constipation
- Upper Respiratory Tract Infection
- Arthralgia
- Diarrhea
- Tachycardia
- Abdominal Pain
- Fatigue
- Back Pain
Drug interactions
- flecainide
- propafenone
- thioridazine
Key clinical trials
- Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity (PHASE2)
- The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists (PHASE1)
- TReating Incontinence for Underlying Mental and Physical Health (PHASE4)
- 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 (PHASE3)
- Double j Stent Related Symptoms (EARLY_PHASE1)
- Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children (PHASE3)
- Mirabegron in Patients With Age-Related Macular Degeneration
- Mechanisms for Activation of Beige Adipose Tissue in Humans (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Myrbetriq CI brief — competitive landscape report
- Myrbetriq updates RSS · CI watch RSS
- Apgdi portfolio CI