MYRBETRIQ GRANULES

Peak

mirabegron

NDAORALFOR SUSPENSION, EXTENDED RELEASEPriority Review
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Adrenergic beta3-Agonists

Pharmacologic Class:

beta3-Adrenergic Agonist

Clinical Trials (5)

NCT05621616Phase 3Active 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

Started Feb 2024
7 enrolled
Neurogenic Detrusor Overactivity
NCT05767632Phase 1Completed

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
NCT04641975Phase 3Terminated

A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)

Started Mar 2021
26 enrolled
Overactive Bladder (OAB)Pharmacokinetics of Mirabegron
NCT04562090Phase 4Completed

A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder

Started Jan 2021
249 enrolled
Urge IncontinenceOveractive Bladder (OAB)
NCT04501640Phase 4Completed

A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants

Started Sep 2020
24 enrolled
Pharmacokinetics of MirabegronFood EffectHealthy Chinese Subjects

Loss of Exclusivity

LOE Date
Sep 30, 2036
128 months away
Patent Expiry
Sep 30, 2036

Patent Records (2)

Patent #ExpiryTypeUse Code
10058536
Mar 31, 2036
Product
U-3108
10058536*PED
Sep 30, 2036