Mirabegron

Overactive Bladder Syndrome, Neurogenic Detrusor Overactivity, Obesity

Treatment

2 FDA approvals

20 Active Studies for Mirabegron

What is Mirabegron

Mirabegron

The Generic name of this drug

Treatment Summary

Mirabegron is a medication that relaxes the bladder muscles to help with urinary frequency and incontinence. It is different from other treatments because it doesn’t have the same range of side effects as other medications. It was approved by the FDA in 2012 and can be used to treat adults with overactive bladder. In 2021, an extended-release granule formulation was approved for pediatric patients with neurogenic detrusor overactivity. Mirabegron is also used in other countries like Canada, the European Union, and Japan.

Myrbetriq

is the brand name

image of different drug pills on a surface

Mirabegron Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Myrbetriq

Mirabegron

2012

8

Approved as Treatment by the FDA

Mirabegron, also known as Myrbetriq, is approved by the FDA for 2 uses which include Overactive Bladder Syndrome (OABS) and Overactive Bladder Syndrome .

Overactive Bladder Syndrome (OABS)

Used to treat Overactive Bladder Syndrome (OABS) in combination with Solifenacin

Overactive Bladder Syndrome

Used to treat Overactive Bladder Syndrome (OABS) in combination with Solifenacin

Effectiveness

How Mirabegron Affects Patients

Mirabegron relaxes the bladder muscles, allowing the bladder to hold more urine and decreasing urgency. It has been reported to cause urinary retention in people with bladder outlet obstruction, so should be used with caution in these patients. Mirabegron also increases both blood pressure and heart rate, which can be dangerous for those with uncontrolled hypertension, so should also be used with caution in these cases.

How Mirabegron works in the body

Mirabegron is a drug that relaxes the muscles of the bladder, allowing it to hold more urine. This can help relieve feelings of urgency and the need to go to the bathroom frequently.

When to interrupt dosage

The proposed measurement of Mirabegron is contingent upon the diagnosed state, for example Neurogenic Detrusor Overactivity, Overactive Bladder Syndrome and weight no less than 35 kg. The amount likewise fluctuates relying upon the approach of delivery (e.g. Granule, for suspension, extended release - Oral or Tablet, extended release - Oral) indicated in the table beneath.

Condition

Dosage

Administration

Overactive Bladder Syndrome

, 25.0 mg, 50.0 mg, 8.0 mg/mL

Oral, Tablet, extended release - Oral, , Tablet, extended release, Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Granule, for suspension, extended release, Granule, for suspension, extended release - Oral

Neurogenic Detrusor Overactivity

, 25.0 mg, 50.0 mg, 8.0 mg/mL

Oral, Tablet, extended release - Oral, , Tablet, extended release, Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Granule, for suspension, extended release, Granule, for suspension, extended release - Oral

Obesity

, 25.0 mg, 50.0 mg, 8.0 mg/mL

Oral, Tablet, extended release - Oral, , Tablet, extended release, Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Granule, for suspension, extended release, Granule, for suspension, extended release - Oral

Warnings

Mirabegron Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Mirabegron may interact with Pulse Frequency

There are 20 known major drug interactions with Mirabegron.

Common Mirabegron Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Mirabegron.

Axitinib

Major

The serum concentration of Axitinib can be increased when it is combined with Mirabegron.

Bendamustine

Major

The serum concentration of Bendamustine can be increased when it is combined with Mirabegron.

Binimetinib

Major

The serum concentration of Binimetinib can be increased when it is combined with Mirabegron.

Cabazitaxel

Major

The serum concentration of Cabazitaxel can be increased when it is combined with Mirabegron.

Mirabegron Toxicity & Overdose Risk

Taking too much of this drug can cause racing heartbeats and an increased heart rate. Long-term overdoses may also cause a rise in blood pressure. If someone overdoses on this drug, they should be monitored by an ECG and receive supportive treatments to help reduce any symptoms.

image of a doctor in a lab doing drug, clinical research

Mirabegron Novel Uses: Which Conditions Have a Clinical Trial Featuring Mirabegron?

33 active clinical trials are currently being conducted to explore the possible benefits of Mirabegron in treating Neurogenic Detrusor Overactivity, weight at least 35 kg and Overactive Bladder Syndrome.

Condition

Clinical Trials

Trial Phases

Obesity

0 Actively Recruiting

Overactive Bladder Syndrome

31 Actively Recruiting

Phase 3, Not Applicable, Phase 4, Phase 1, Phase 2, Early Phase 1

Neurogenic Detrusor Overactivity

2 Actively Recruiting

Phase 2, Phase 3, Phase 1

Mirabegron Reviews: What are patients saying about Mirabegron?

5

Patient Review

1/25/2013

Mirabegron for Overactive Bladder

5

Patient Review

5/25/2013

Mirabegron for Overactive Bladder

This medication is much cheaper than having a surgical implant, and it works just as well for me. The only downside is that it's still pretty pricey.

5

Patient Review

7/10/2015

Mirabegron for Urine Leakage When there is a Strong Desire to Void

Worked great with no real side effects to speak of. The only problem is that it's quite expensive--$116 a month.

4.7

Patient Review

6/26/2014

Mirabegron for Overactive Bladder

I had leakage and urgent incontinence/flooding. Detrol was effective but dry mouth was horrible. Mirabegron has worked almost as well and with no side effects.

4.3

Patient Review

7/27/2016

Mirabegron for Overactive Bladder

I was pleasantly surprised at how quickly this medication worked. However, I developed an upset stomach as a result of taking it. This seems to be a common side effect, but it's still worth mentioning.

4

Patient Review

6/29/2013

Mirabegron for Overactive Bladder

I've tried so many different medications for incontinence, and this one was by far the most effective. I only had to get out of bed once during the night, which is a huge improvement from before.

3.7

Patient Review

1/18/2020

Mirabegron for Overactive Bladder

I've been taking Mirabegron for a while now and it's helped me a lot. It's definitely my preferred choice of medication, but I had to stop taking it for a couple months because I started developing a skin rash about six months ago. Not sure if it was the Mirabegron or not, but that is one of the potential side effects so I figured it was best to be safe.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about mirabegron

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the best time to take mirabegron?

"You can take mirabegron at any time of day, but try to take your doses at the same time of day each day to avoid missing doses. Swallow the tablet with a drink of water."

Answered by AI

What type of drug is mirabegron?

"Paraphrase:

Mirabegron belongs to a class of medications called beta-3 adrenergic agonists. These drugs work by relaxing the muscles in the bladder, which prevents frequent or uncontrolled urination."

Answered by AI

What is the drug mirabegron used for?

"a strong need to pee often (urinary frequency)

leaking urine (urinary incontinence)

waking up at night to urinate (nocturia)

Mirabegron eases the symptoms of overactive bladder but does not cure the condition. Symptoms it alleviates include:

sudden and urgent need to urinate

frequent need to urinate

urinary incontinence

waking up at night to urinate"

Answered by AI

What are the side effects of taking mirabegron?

"The following are symptoms of a bladder infection: bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, frequent urge to urinate, pounding in the ears, slow, fast, or irregular heartbeat."

Answered by AI

Clinical Trials for Mirabegron

Image of Virtua Primary Care in Camden, United States.

Saphenous Nerve Stimulation for Overactive Bladder

18+
All Sexes
Camden, NJ

The goal of this clinical trial is to study the NiNA System and how it works to treat overactive bladder. Up to 290 participants will be enrolled in the study in the USA and Australia. The investigational NiNA System includes a wearable neurostimulator device ("NiNA" or "Device"), a flexible wrap to secure the Device to the calf during treatment of the saphenous nerve (SAFN), with smartphone-based control application with patient support features that allow users to control the stimulation therapy and receive reminder on days they are supposed to provide therapy ("NiNA App") or an enhanced smartphone-based control application which also has patient support features and educational multi-media content ("NiNA Care App"). The main questions the study aims to answer are: 1) How does the NiNA system compare to a common overactive bladder (OAB) medication; 2) How well does the NiNA system improve overactive bladder symptoms; and, 3) Does the NiNA system produce any unwanted side-effects. In the study half the participants randomly receive the NiNA system and the other half first receive the OAB medication and later are treated with the NiNA System. The Participants in the investigative Device arm (NiNA) will: Provide NiNA system treatments very day for 30 minutes during a 28 day induction/restore period. This is followed by maintenance treatments (30 minutes, 3-times a week) until 12 weeks, when the primary endpoint data are measured. Participants continue maintenance (30 minutes, 3-times a week) for the remaining 52 weeks of the study. Participants in the OAB medication arm will: Take a capsule every day (tolterodine tartrate extended release (ER) 4 mg) for twelve weeks. At 12 weeks, OAB medication arm Participants will stop taking the OAB medication and cross-over to treatment with the NiNA system. One-third of the cross-over Participants will be use a phone-based software application that allows them to control the neurostimulator and receive reminders on days the are scheduled to provide their therapy (NiNA App) and the other two-thirds of the cross-over Participants will use a phone based software application that also contains educational videos that reinforce the therapy (NiNA Care App). Assignment to each arm is random. The study will measure primary and secondary endpoints completely remotely using digital questionnaires that are presented to Participants on a specialized software application installed on their phones ("Study App"): Changes in OAB symptoms at a defined set of time points using the following instruments: 1. Bladder diary (3-day, consecutive); 2. Self-administered and validated Quality-of-Life questionnaires (see Effectiveness Assessments); 3. Additional assessments of participant satisfaction and preferences will be obtained using participant study surveys and questionnaires at defined study time points.

Phase 3
Waitlist Available

Virtua Primary Care

NinaMED Pty Ltd

Image of Mayo Clinic in Rochester in Rochester, United States.

Flyte Device for Urinary Incontinence in Cancer Survivors

18+
Female
Rochester, MN

This clinical trial studies how well and how easy it is to use a device called Flyte in improving problems with bladder control (urinary incontinence) among endometrial and cervical cancer survivors who have undergone radiation therapy. Urinary incontinence is common after pelvic radiation therapy and can affect daily life and well-being. Access to in-person pelvic floor physical therapy can be limited. The Flyte device is designed for in-home use to deliver a series of mechanical vibrations at a specific frequency while the pelvic floor muscles are contracting and relaxing (i.e., normal, guided Kegel exercises). This treatment is called mechanotherapy. The Flyte device may improve urinary incontinence symptoms, as well as overall quality of life among endometrial and cervical cancer survivors who have undergone radiation therapy.

Recruiting
Has No Placebo

Mayo Clinic in Rochester

Shariska Harrington, MD

Image of Cleveland Clinic in Cleveland, United States.

Self-Start Triage Model for Overactive Bladder

18+
Female
Cleveland, OH

The primary objective of this study is to investigate whether providing a standing, take-home prescription for empiric Macrobid (self-start model) is superior to standard call-in/urgent care triage (triage model) among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Thus, the research team will compare Unplanned Healthcare Utilization, i.e. the frequency of triage calls, MyChart messages, Urgent Care visits, and Emergency Department visits related to urinary symptoms, between participants in the self-start intervention group and those in the triage control group. The team hypothesizes that patients in the "self-start" intervention group will demonstrate a lower frequency of healthcare utilization events when compared to those in the standard of care control.

Phase < 1
Recruiting

Cleveland Clinic

Shannon Wallace, MD

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Nitrous Oxide for Pain During Bladder Botox Injections

18+
Female
Cincinnati, OH

The goal of this clinical trial is to assess if a mix of nitrous oxide and oxygen can improve pain control during bladder Botox injections. The primary question it aims to answer is: Does using nitrous oxide lower the overall level of pain during the procedure? Researchers will compare a 50:50 nitrous oxide/oxygen mixture (administered with the Pro-Nox system) plus standard care (with lidocaine in the bladder) to sham mask plus standard care to see if nitrous oxide works better for lowering pain. Participants will: * Receive their bladder Botox injection in the office setting * Either use nitrous oxide/oxygen plus standard care during the procedure, or sham mask plus standard care * Answer brief questions about pain, anxiety, satisfaction, and willingness to repeat the procedure

Phase 4
Waitlist Available

Cincinnati Urogynecology Associates (+1 Sites)

Have you considered Mirabegron clinical trials?

We made a collection of clinical trials featuring Mirabegron, we think they might fit your search criteria.
Go to Trials

Have you considered Mirabegron clinical trials?

We made a collection of clinical trials featuring Mirabegron, we think they might fit your search criteria.
Go to Trials