NDAORALFOR SUSPENSION, EXTENDED RELEASEPriority Review
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
MYRBETRIQ GRANULES (mirabegron) by Ascentage Pharma is adrenergic beta3-agonists [moa]. Approved for overactive bladder, urgency incontinence. First approved in 2021.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYRBETRIQ GRANULES is an oral, extended-release suspension formulation of mirabegron, a beta-3 adrenergic agonist approved in March 2021. It treats overactive bladder and urgency incontinence by relaxing bladder smooth muscle through a novel mechanism distinct from anticholinergic agents. The granule formulation offers improved dosing flexibility for patients who cannot swallow tablets.
Peak10.4 years to LOE
Peak-stage lifecycle indicates a mature, stable commercial footprint with established sales infrastructure, though lacking published spending data limits visibility into market penetration and team size projections.
Mechanism of Action
Adrenergic beta3-Agonists
Pharmacologic Class:
beta3-Adrenergic Agonist
Indications (2)
Clinical Trials (20)
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
Started Feb 2024
7 enrolled
Neurogenic Detrusor Overactivity
Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults
Started Aug 2023
37 enrolled
Healthy
Does Mirabegron Increase the Body Heat Generated by the Nervous System
Started Apr 2023
19 enrolled
Thermoregulation
Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study
Started Jul 2022
600 enrolled
Overactive Bladder
Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)
Started May 2022
30 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.