Mirabegron

Generic Name: Mirabegron

Brand Names: Myrbetriq, Betmiga

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₄N_₄O_₂S

CAS Number: 223673-61-8

Unique Ingredient Identifier: MVR3JL3B2V

Background: Mirabegron is a sympathomimetic beta-3 adrenergic receptor agonist used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence. It is unique amongst overactive bladder treatment options in that, unlike other treatments such as solifenacin and darifenacin, it lacks significant antimuscarinic activity, which is responsible both for the therapeutic effects of these medications and their broad range of adverse effects. Mirabegron has a comparatively favorable adverse effect profile as compared to other available treatment options, and its complementary mechanism to the antimuscarinics that came before it allows for its use alongside solifenacin in refractory cases.

Mirabegron first received FDA approval in 2012, under the brand name Myrbetriq, for the treatment of adults with overactive bladder. An extended-release granule formulation was subsequently granted approval in March 2021 for the treatment of pediatric patients with neurogenic detrusor overactivity. Mirabegron is also used in other jurisdictions across the globe, including Canada, the EU, and Japan.

Indication: Mirabegron is indicated for the treatment of overactive bladder (OAB) - with symptoms of urge urinary incontinence, urgency, and urinary frequency - either alone or in combination with solifenacin. It is also indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older and weighing 35kg or more.

Associated Conditions: Neurogenic Detrusor Overactivity, Overactive Bladder Syndrome (OABS)

Associated Therapies: -

Clinical Trials

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy Subjects
Drug-Drug Interaction (DDI)
Pharmacokinetics

Interventions: Drug: Mirabegron
Drug: Solifenacin succinate
Drug: Tamsulosin HCl
Drug: Placebo

First Posted Date: 2014-06-23

Last Posted Date: 2014-08-29

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 20

Registration Number: NCT02169713

Locations: 🇩🇪
Parexel International GmbH, Berlin, Germany

A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)

Phase 4

Completed

Conditions: Overactive Bladder (OAB)

Interventions: Drug: Mirabegron
Drug: Tolterodine ER

First Posted Date: 2014-05-15

Last Posted Date: 2020-02-26

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 376

Registration Number: NCT02138747

Locations: 🇺🇸
Site US10010 Skyline Urology, Sherman Oaks, California, United States
🇨🇦
Site CA15003 The Male/Female Health & Research Centre, Barrie, Ontario, Canada
🇺🇸
Site US10035 Millennium Clinical Research Center, Arlington, Virginia, United States

and more 27 locations

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects

Phase 1

Completed

Conditions: Drug-Drug Interaction (DDI)
Pharmacokinetics
Healthy Subjects

Interventions: Drug: Mirabegron
Drug: Solifenacin
Drug: Digoxin

First Posted Date: 2014-04-30

Last Posted Date: 2014-07-11

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 26

Registration Number: NCT02127034

Locations: 🇩🇪
Parexel International GmbH, Berlin, Germany

Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

Phase 4

Completed

Conditions: Nephrolithiasis

Interventions: Drug: Tamsulosin
Drug: Tylenol #3
Drug: Mirabegron

First Posted Date: 2014-03-26

Last Posted Date: 2022-11-08

Lead Sponsor: Nova Scotia Health Authority

Target Recruit Count: 22

Registration Number: NCT02095665

Locations: 🇨🇦
Nova Scotia Health Authority, Central, Halifax, Nova Scotia, Canada

A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)

Phase 4

Completed

Conditions: Parkinsons Disease

Interventions: Drug: Placebo
Drug: Mirabegron

First Posted Date: 2014-03-20

Last Posted Date: 2021-08-16

Lead Sponsor: Daniel Burdick, MD

Target Recruit Count: 30

Registration Number: NCT02092181

Locations: 🇺🇸
Evergreenhealth Booth Gardner Parkinsons Care Center, Kirkland, Washington, United States

Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis

Phase 4

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Placebo
Drug: Mirabegron

First Posted Date: 2014-03-13

Last Posted Date: 2023-10-18

Lead Sponsor: Theodore R. Brown, MD MPH

Target Recruit Count: 28

Registration Number: NCT02086188

Locations: 🇺🇸
EvergreenHealth MS Center, Kirkland, Washington, United States

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

Phase 3

Completed

Conditions: Overactive Bladder
Urinary Bladder Overactive
Urgency Incontinence
Urinary Bladder Diseases\Urologic Diseases

Interventions: Drug: Mirabegron
Drug: Solifenacin succinate
Drug: Placebo to match mirabegron
Drug: Placebo to match solifenacin

First Posted Date: 2014-01-27

Last Posted Date: 2024-10-31

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 1829

Registration Number: NCT02045862

Locations: 🇺🇸
Site US10133, Los Angeles, California, United States
🇺🇸
Site US10553, Lincoln, Nebraska, United States
🇺🇸
Site US10148, Hialeah, Florida, United States

and more 248 locations

Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients

Phase 2

Terminated

Conditions: Urinary Bladder, Neurogenic

Interventions: Drug: Placebo
Drug: Mirabegron

First Posted Date: 2014-01-24

Last Posted Date: 2019-02-05

Lead Sponsor: Lawson Health Research Institute

Target Recruit Count: 32

Registration Number: NCT02044510

Locations: 🇨🇦
Rehabiliation Center, Health Sciences Center, Winnipeg, Manitoba, Canada
🇨🇦
Toronto Western Hospital, Toronto, Ontario, Canada
🇨🇦
Kingston General Hospital and Hotel Dieu Hospital (Queens University), Kingston, Ontario, Canada

and more 2 locations

A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels

Phase 1

Completed

Conditions: Phase 1
Bioavailability
Healthy Subjects

Interventions: Drug: solifenacin succinate
Drug: mirabegron
Drug: mirabegron/solifenacin succinate

First Posted Date: 2013-12-13

Last Posted Date: 2013-12-13

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 72

Registration Number: NCT02010944

Locations: 🇩🇪
Parexel, Berlin, Germany

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

Phase 3

Completed

Conditions: Urinary Bladder Overactive
Urinary Bladder Diseases\Urologic Diseases
Overactive Bladder
Urgency Incontinence

Interventions: Drug: Placebo to match solifenacin succinate
Drug: Mirabegron
Drug: Solifenacin succinate
Drug: Placebo to match mirabegron

First Posted Date: 2013-10-31

Last Posted Date: 2024-10-31

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 3527

Registration Number: NCT01972841

Locations: 🇩🇪
Site DE49034 LMU Muenchen, Munich, Germany
🇩🇪
Site DE49001 Private Practice, Neustadt I. Sachsen, Germany
🇺🇸
Site US10064 The Group for Women, Virginia Beach, Virginia, United States

and more 432 locations

Drug Development Updates

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