This page shows what was measured, who it was measured in, and what that does not settle.
What Mirabegron does in the body
An overactive bladder — sudden urgency, going too often, and leaking — for people who cannot tolerate or do not want an anticholinergic drug
Your bladder does not just squeeze — while it is filling, a separate set of nerve signals actively tells the muscle to stay relaxed so it can hold more. Mirabegron amplifies that relaxing signal by switching on a receptor called beta-3, which in the human bladder is almost the only beta-receptor there is. Because it is not touching the acetylcholine system at all, it does not dry the mouth, blur vision or add to the anticholinergic load older bladder drugs carry. What it does carry instead is a blood-pressure warning, because beta receptors elsewhere in the body are not entirely indifferent to it.
What happened in people
Incontinence episodes per 24 hours fell 1.38 to 1.57 on mirabegron 50 mg against 0.96 to 1.17 on placebo, across three phase 3 trials totalling over 6,500 patients
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
The limit that matters most
That mirabegron is a metabolic or weight-loss drug — the brown fat result used four times the licensed dose in twelve healthy young men
Where it acts
Detrusor smooth muscle of the bladder wall during the storage phase
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · MVR3JL3B2V · read 2026-08-29
Its recorded molecular formula is C21H24N4O2S, weighing 396.51.
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 159 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Change from baseline to week 12 in mean incontinence episodes and mean micturitions per 24 hours
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. No active comparator arm, so this trial says nothing about how mirabegron compares with the drugs it was intended to replace.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily; granules for oral suspension in paediatric use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
TAURUS — 12-month randomised active-controlled long-term safety study of mirabegron versus tolterodine ER (NCT00688688) · a recorded source, not a stored snapshot
Change from baseline to week 12 in mean incontinence episodes and mean micturitions per 24 hours
✓ The study showed what it set out to show
Who was studied
SCORPIO (NCT00689104)
How many people
2336
Study design
Phase 3 randomised double-blind placebo- and active-controlled, 12 weeks
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Mirabegron 50 mg: incontinence -1.57 versus placebo -1.17 (p=0.003), micturitions -1.93 versus -1.34 (p<0.001). Tolterodine SR 4 mg: incontinence -1.27 (p=0.11), micturitions -1.59 (p=0.11)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The tolterodine arm missed on both co-primary endpoints against placebo. That result belongs to tolterodine and is rarely reported as a finding about tolterodine.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily; granules for oral suspension in paediatric use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
TAURUS — 12-month randomised active-controlled long-term safety study of mirabegron versus tolterodine ER (NCT00688688) · a recorded source, not a stored snapshot
Change from baseline to week 12 in mean incontinence episodes and mean micturitions per 24 hours
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The 25 mg and 50 mg arms are indistinguishable from each other on both endpoints, which is the trial that establishes 25 mg as a licensed dose and also undercuts any dose-response argument for going higher.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily; granules for oral suspension in paediatric use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
TAURUS — 12-month randomised active-controlled long-term safety study of mirabegron versus tolterodine ER (NCT00688688) · a recorded source, not a stored snapshot
Number and severity of treatment-emergent adverse events over 12 months, against tolterodine ER 4 mg
A safety endpoint with no hypothesis test of efficacy and no placebo arm; no efficacy p-value exists for the 12-month comparison
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The longest randomised exposure to this drug carries no placebo arm and no efficacy primary. Every efficacy number quoted for mirabegron comes from a 12-week study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily; granules for oral suspension in paediatric use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
TAURUS — 12-month randomised active-controlled long-term safety study of mirabegron versus tolterodine ER (NCT00688688) · a recorded source, not a stored snapshot
Change from baseline to end of treatment in mean incontinence episodes and micturitions per 24 hours, combination versus each monotherapy
✓ The study showed what it set out to show
Who was studied
SYNERGY (NCT01972841)
How many people
3527
Study design
Phase 3 randomised double-blind placebo- and active-controlled, 12 weeks
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Combination versus mirabegron monotherapy p=0.001 (25 mg) and p<0.001 (50 mg) for incontinence; placebo -1.34, mirabegron 50 mg -1.76, solifenacin 5 mg -1.79, combination -1.98
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The 715-patient ambulatory blood-pressure substudy of this trial found no consistent 24-hour blood-pressure or heart-rate signal in any active arm, which sits uneasily with the label warning it was designed to interrogate.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral extended-release tablet, once daily; granules for oral suspension in paediatric use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
TAURUS — 12-month randomised active-controlled long-term safety study of mirabegron versus tolterodine ER (NCT00688688) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Mirabegron
What a person takes: Oral extended-release tablet, once daily; granules for oral suspension in paediatric use.
The measurement behind this step
A controlled-absorption tablet swallowed whole and not crushed or chewed, because the release mechanism is the formulation rather than the molecule. Food reduces exposure, so the label specifies administration conditions. The paediatric neurogenic detrusor overactivity indication uses a granule formulation dosed by weight.
Getting in
An extended-release tablet, once a day, sensitive to food
One tablet daily, swallowed whole. The tablet is engineered to release slowly, and how much gets absorbed depends on whether it is taken with food.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Oral controlled-absorption system tablet, once daily. Bioavailability is dose-dependent and is reduced by food, which is why the label specifies conditions of administration. Metabolised by multiple routes including CYP3A4 and CYP2D6; mirabegron itself is a moderate CYP2D6 inhibitor, which is the source of its main interaction profile.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
Reaching the cell
It meets the receptor on the outside of the bladder muscle cell
The beta-3 receptor sits on the surface of the muscle cell facing the bloodstream. The drug arrives and sits on it. Nothing needs to be carried inside.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Beta-3 adrenoceptors are G-protein-coupled receptors in the plasma membrane with an extracellular-facing orthosteric pocket. Beta-3 is the predominant beta-adrenoceptor subtype expressed in human detrusor, which is the anatomical fact the whole drug class rests on and the reason a beta-3-selective agonist can relax bladder without the beta-1 and beta-2 effects that would follow a non-selective one.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
What it acts on
It switches the receptor on rather than blocking it
This is the opposite of how every older bladder drug works. Instead of blocking a squeeze signal, mirabegron turns up a relaxation signal the body already uses while the bladder fills.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Agonism, not antagonism. Beta-3 activation couples to Gs, which is why the pharmacology is additive with muscarinic blockade rather than redundant to it — the two drugs act on opposite arms of the autonomic supply to the same muscle. That is the mechanistic basis for the combination licence, and BESIDE is the trial that had to test whether the mechanism translated.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
The change it makes
Cyclic AMP rises and the muscle lets go during filling
Switching the receptor on raises an internal messenger that tells the muscle to relax. The bladder holds more before it starts demanding to be emptied.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Gs coupling activates adenylyl cyclase, cyclic AMP rises, protein kinase A phosphorylates targets that lower intracellular calcium and reduce myosin light-chain kinase sensitivity. Detrusor tone during the storage phase falls and functional bladder capacity increases without impairing the voiding contraction itself, which is why post-void residual volume is not the problem here that it is with antimuscarinics.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
What that does for a person
A third to a half an episode a day, and a dry mouth that does not arrive
The diary improves by roughly a third to a half an accident a day more than placebo. The difference people notice most is what does not happen: no dry mouth, no constipation from the drug.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Incontinence episodes per 24 hours fell 1.38 to 1.57 on 50 mg against 0.96 to 1.17 on placebo across ARIES, SCORPIO and CAPRICORN. Because no muscarinic receptor is touched, dry mouth rates approach placebo, and one-year persistence runs 32% to 38% against 12% to 25% for antimuscarinics. The trade appearing in its place is a blood-pressure warning, a mean QTcI increase of 3.7 msec at 50 mg, and moderate CYP2D6 inhibition.
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults with overactive bladder, disproportionately those who stopped an antimuscarinic because of dry mouth or who are already carrying a heavy anticholinergic load from other prescriptions. A paediatric granule formulation is licensed separately for neurogenic detrusor overactivity.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness have been established only for the following pediatric indications: Mirabegron: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older and weighing 35 kg or more.”
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-30
On older people, the label states: “Of 5,648 patients who received mirabegron monotherapy in the phase 2 and 3 studies for OAB, 2,029 (35.9%) were 65 years of age or older, and 557 (9.9%) were 75 years of age or older.”
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no studies with the use of mirabegron in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes.”
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-30
On people with reduced liver function, the label states: “Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, is not recommended for use in this patient population.”
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-30
On people with reduced kidney function, the label states: “Mirabegron has not been studied in patients with End-Stage Renal Disease (eGFR < 15 mL/min/1.73 m 2 ) or patients requiring hemodialysis and, therefore, is not recommended for use in these patient populations.”
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-30
Where the result stopped carrying
The active-control arm in its own registration trial: tolterodine could not beat placebo in SCORPIO, and the same happened to tolterodine again in EMPOWUR seven years later
Generic competition: seventeen listed products and a median acquisition cost still near ten dollars a tablet
The dose-response case: 25 mg and 50 mg were indistinguishable on both co-primary endpoints in CAPRICORN
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral extended-release tablet, once daily; granules for oral suspension in paediatric use
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
A controlled-absorption tablet swallowed whole and not crushed or chewed, because the release mechanism is the formulation rather than the molecule. Food reduces exposure, so the label specifies administration conditions. The paediatric neurogenic detrusor overactivity indication uses a granule formulation dosed by weight.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
No anticholinergic effects, which is the point of the drug: dry mouth rates approach placebo. The label warns that mirabegron can increase blood pressure, is not recommended in severe uncontrolled hypertension, and requires periodic blood-pressure measurement; it also warns of urinary retention in patients with bladder outlet obstruction, particularly if an antimuscarinic is taken as well, and of angioedema. Mirabegron is a moderate CYP2D6 inhibitor, so exposure to substrates of that enzyme rises. The measured QT effect is 3.7 msec at the licensed dose.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Where this came from
ARIES — phase 3 placebo-controlled trial of mirabegron in overactive bladder (NCT00662909) · a recorded source, not a stored snapshot
SCORPIO — phase 3 placebo- and tolterodine-controlled trial of mirabegron in overactive bladder (NCT00689104) · a recorded source, not a stored snapshot
CAPRICORN — phase 3 placebo-controlled trial of mirabegron 25 mg and 50 mg (NCT00912964) · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral extended-release tablet, once daily; granules for oral suspension in paediatric use
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Food reduces exposure, so the label specifies administration conditions. The paediatric neurogenic detrusor overactivity indication uses a granule formulation dosed by weight.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
47 products list this as an active ingredient in the United States drug directory. 47 of them contain it and nothing else.
FDA National Drug Code directory · 71335-2808 · read 2026-08-29
They are sold as for suspension, extended release, granule, for suspension, extended release, powder, tablet, extended release and tablet, film coated, extended release, taken oral.
FDA National Drug Code directory · 71335-2808 · read 2026-08-29
The regulator's established pharmacologic class for it is adrenergic beta3-agonists [moa], cytochrome p450 2d6 inhibitors [moa] and cytochrome p450 3a inhibitors [moa].
FDA National Drug Code directory · 71335-2808 · read 2026-08-29
14 published labels name it as an active ingredient. 14 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-29
Mirabegron is oral at 3 DOSAGE FORMS AND STRENGTHS Mirabegron extended-release tablets are supplied in two different strengths as described below: 25 mg brown, oval, biconvex, bevel edged, film-coated tablets, debossed with "25" on one side…, recorded as fda label in effect 2026-03-26 in the United States.
US prescribing information · e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Mirabegron studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That mirabegron is a metabolic or weight-loss drug — the brown fat result used four times the licensed dose in twelve healthy young men
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the label blood-pressure warning reflects a measurable hypertensive effect at the approved dose — a 715-patient ambulatory monitoring substudy found no consistent signal
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That combination with solifenacin is the demonstrated next step after partial response — BESIDE compared it with solifenacin 5 mg, not with solifenacin 10 mg
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the 12-month TAURUS trial demonstrates 12-month efficacy — its primary endpoint was adverse events and it had no placebo arm
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Mirabegron are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
Three placebo-controlled trials, all positive, all under half an episode a day
In plain words
Mirabegron beat placebo in all three of its registration trials, on both endpoints, with small p-values. The size of the win was consistently between a quarter and half an accident a day.
What was measured
Change from baseline to week 12 in mean incontinence episodes and micturitions per 24 hours, against placebo, in three registration trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ARIES (NCT00662909, n=2,149) reported incontinence episodes per 24 hours falling 1.13 on placebo, 1.47 on 50 mg (p=0.026) and 1.63 on 100 mg (p<0.001); micturitions fell 1.05, 1.66 (p=0.001) and 1.75 (p<0.001). SCORPIO (NCT00689104, n=2,336) reported incontinence 1.17 on placebo against 1.57 on 50 mg (p=0.003), micturitions 1.34 against 1.93 (p<0.001). CAPRICORN (NCT00912964, n=2,030) reported incontinence 0.96 on placebo, 1.36 on 25 mg (p=0.005) and 1.38 on 50 mg (p=0.001). Three independent trials, over 6,500 patients, and a treatment effect that lands between 0.34 and 0.59 incontinence episodes a day every time. The consistency is the strongest thing about this dataset and the magnitude is the most easily overstated.
Source
ClinicalTrials.gov results records for ARIES (NCT00662909), SCORPIO (NCT00689104) and CAPRICORN (NCT00912964)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
In SCORPIO the active control — the standard drug — could not beat placebo
In plain words
SCORPIO included an arm on tolterodine, the established treatment, purely as a yardstick. On both main endpoints, the yardstick failed to separate from placebo. Mirabegron did. The comparison people rarely draw from that trial is the one about tolterodine.
What was measured
Tolterodine arm versus placebo on both co-primary endpoints, in two separate phase 3 trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In SCORPIO (n=2,336; placebo 480, mirabegron 50 mg 473, mirabegron 100 mg 478, tolterodine SR 4 mg 475), incontinence episodes per 24 hours fell 1.17 on placebo and 1.27 on tolterodine, p=0.11 (95% CI -0.42 to 0.21); micturitions fell 1.34 and 1.59, p=0.11 (95% CI -0.55 to 0.06). Mirabegron 50 mg reached p=0.003 and p<0.001 on the same endpoints in the same trial. The pattern repeated seven years later in EMPOWUR (NCT03492281, n=1,530), where tolterodine ER 4 mg missed on micturitions against placebo (p=0.0988) while vibegron reached p<0.001. Two large, well-conducted, independently sponsored trials in which a drug prescribed to millions of people could not be distinguished from placebo is not a fluke of assay sensitivity; it is a statement about the size of the effect.
Written into the record, not signed off as a reviewed claim
The blood-pressure warning stayed, and the measurement that tested it found nothing
In plain words
Mirabegron carries a blood-pressure warning on its label. When 715 patients wore 24-hour blood-pressure monitors in a later trial, no consistent increase showed up.
What was measured
24-hour ambulatory systolic and diastolic blood pressure and heart rate against placebo, in 715 patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The US label states the drug can increase blood pressure, is not recommended in severe uncontrolled hypertension, and asks for periodic measurement; it quotes mean increases of approximately 0.5 to 1 mmHg over placebo at the 50 mg dose. The adverse-event table sits awkwardly beside that: hypertension was reported in 11.3% at 25 mg, 7.5% at 50 mg and 7.6% on placebo, with no dose gradient in the direction the warning implies. Weber and colleagues then reported an ambulatory blood-pressure monitoring substudy of SYNERGY in 715 patients, and found no consistent increase from baseline in mean 24-hour systolic or diastolic pressure for any active arm against placebo, no signal in the one-hour averages spanning both drugs' Tmax, no difference on shift or outlier analysis, and no 24-hour heart-rate signal. The warning has not been removed. That is a defensible regulatory position for a chronic drug in an elderly population, and it is also a case where the most careful measurement disagrees with the label text.
Written into the record, not signed off as a reviewed claim
The brown fat result everyone cites used four times the approved dose in twelve men
In plain words
Mirabegron became famous outside urology for switching on brown fat and raising resting metabolic rate by 13%. That experiment gave twelve healthy men 200 mg — four times the licensed dose.
What was measured
Brown adipose tissue 18F-FDG uptake and resting metabolic rate after a single 200 mg dose, against placebo, in 12 healthy men
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Cypess and colleagues gave 200 mg of oral mirabegron to twelve healthy male subjects and measured brown adipose tissue activity by 18F-fluorodeoxyglucose PET-CT. All twelve showed higher brown fat metabolic activity than on placebo (p=0.001) and resting metabolic rate rose by 203 ± 40 kcal/day, a 13% increase (p=0.001). Brown fat activity significantly predicted the change in resting metabolic rate (p=0.006). The maximum licensed dose for overactive bladder is 50 mg, and the label's own QT data show the cardiovascular effect scaling with dose: mean QTcI difference from placebo of 3.7 msec at 50 mg against 8.1 msec at 200 mg. Twelve healthy young men receiving a single supratherapeutic dose is a physiology experiment, and it is a legitimate and important one. It is not evidence that the licensed dose does anything to body weight in anybody.
Written into the record, not signed off as a reviewed claim
It genuinely does not dry the mouth, and people stay on it longer as a result
In plain words
The one thing mirabegron clearly does better than the older drugs is not cause dry mouth. That shows up in how long people keep taking it: roughly a third are still on it after a year, against one in five on an antimuscarinic.
What was measured
One-year persistence, median time to discontinuation and dry-mouth incidence against antimuscarinics
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In a systematic review of thirty observational studies using electronic prescription claims, one-year persistence was 32% to 38% for mirabegron against 12% to 25% for antimuscarinics in the three studies reporting both, with median time to discontinuation of 5.6 to 7.4 months against under five months. Mean medication possession ratio was 0.59 for mirabegron against 0.41 to 0.53 for antimuscarinics. In patients aged 65 and over, dry mouth occurred with a six-fold higher incidence on tolterodine ER 4 mg than on mirabegron over 12 weeks, and a three-fold higher incidence over one year. The review was conducted by authors including employees and consultants of the manufacturer, which is a reason to weigh the size of the difference carefully rather than to discount its direction — the tolerability mechanism is not in dispute, because mirabegron has no muscarinic activity to produce the effect in the first place.
Written into the record, not signed off as a reviewed claim
BESIDE tested adding mirabegron against the low dose of the drug already prescribed
In plain words
The trial behind the combination licence compared solifenacin plus mirabegron with solifenacin 5 mg. Against solifenacin 10 mg — simply raising the dose already prescribed — the difference nearly vanishes.
What was measured
Change from baseline in mean incontinence episodes per 24 hours, combination versus each solifenacin dose
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
BESIDE (NCT01908829) randomised 2,174 patients still incontinent after four weeks on solifenacin 5 mg to combination with mirabegron, to solifenacin 5 mg, or to solifenacin 10 mg. Incontinence episodes per 24 hours fell 1.80 on combination, 1.53 on solifenacin 5 mg and 1.67 on solifenacin 10 mg. The registered primary comparison against solifenacin 5 mg gave a difference of -0.26 episodes (95% CI -0.47 to -0.05), p=0.001. Against solifenacin 10 mg the gap is 0.13 episodes a day and was not the primary hypothesis. Adding a second mechanism and doubling the first drug are the two options a prescriber has, and the trial was designed to answer only one of them.
Written into the record, not signed off as a reviewed claim
The longest trial measured adverse events, not whether anyone got better
In plain words
TAURUS ran for a year in 2,792 patients — the longest study of this drug. Its primary endpoint was how many people had side effects, not how well it worked.
What was measured
Registered primary outcome and arm structure of the only 12-month randomised trial of this drug
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
TAURUS (NCT00688688) randomised 2,792 patients to mirabegron 50 mg, mirabegron 100 mg or tolterodine ER 4 mg for twelve months, with the number and severity of treatment-emergent adverse events as the registered primary outcome. There is no placebo arm. This is a normal and appropriate design for a long-term safety commitment, and it is worth stating plainly what follows from it: the longest randomised exposure anyone has to this drug can describe its tolerability over a year, and cannot describe the size of its benefit over a year. Every efficacy figure quoted for mirabegron comes from a 12-week trial.
Written into the record, not signed off as a reviewed claim
Generic status did not bring the price down
In plain words
Mirabegron is off patent and there are seventeen listed products, yet pharmacies still pay about nine dollars sixty a tablet. Generic solifenacin costs eighteen cents.
What was measured
Median pharmacy acquisition cost per tablet and number of listed products, against the antimuscarinic comparators on the same file
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The CMS National Average Drug Acquisition Cost file effective 19 August 2026 lists mirabegron as generic with a median across seventeen products of US$9.60 per tablet. The comparable figures on the same file are US$0.1754 for solifenacin across forty products, US$0.2533 for tolterodine across fifty-four, and US$0.0817 for oxybutynin across ninety-two. Number of suppliers, not molecular complexity, is what these medicines' prices track: the extended-release formulation is a real technical barrier, and seventeen listings that leave the median near ten dollars indicate a market that has not behaved the way a mature generic market does.
Source
CMS National Average Drug Acquisition Cost file, effective 19 August 2026, as stored on this record
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
14 documents were read for this substance.
RNAWiki source record
13 of them state the same bioavailability, and they agree.
RNAWiki source record
3 of them state the same tMax, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
MVR3JL3B2V
RxNorm concept
1300791
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
14 approved applications cover products containing this substance. The earliest was NDA202611, approved 20120628 to APGDI.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
The first beta-3 adrenergic agonist licensed for any condition, which relaxes the bladder wall during filling instead of blocking the signal that empties it: across its three placebo-controlled registration trials the 50 mg dose removed 1.38 to 1.57 incontinence episodes a day against placebo 0.96 to 1.17, and in two of those trials the antimuscarinic used as active control could not separate from placebo at all.
Recorded evidence blocks (11)
Q1
On the Mirabegron label: indicated for what?
"1 INDICATIONS & USAGE Mirabegron for extended-release oral suspension is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older. ( 1.2 ) 1.2 Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron for Extended-Release Oral Suspension Mirabegron for…": indications and usage on Mirabegron's label. DailyMed label · 1c9022af-4841-4f3f-9737-1c5eef58e86b · 2026-05-22
Q2
159 registered trials of Mirabegron — at which phases?
Registered studies posting no result
121 of 159
159 registered studies of Mirabegron: 40 phase4, 38 phase1, 29 phase2, 28 phase3, 17 na or unstated, 7 na, 5 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
151 with a PubMed record
Show the evidence
phase4
40
phase1
38
phase2
29
phase3
28
na or unstated
17
na
7
8 more recorded rows
early phase1
5
completed
107
unknown
23
recruiting
9
not yet recruiting
8
active not recruiting
5
terminated
5
withdrawn
2
recorded 2026-09-01 · last checked 2026-09-04
Q3
7 of Mirabegron's trials stopped: futility/efficacy, accrual/recruitment, other?
"Slow recruitment and small observed effect size"; 7 of 159 registered studies
Show the evidence
Trial
NCT02044510
terminated; "Slow recruitment and small observed effect size"
NCT02462837
terminated; "insufficient rate of accrual"
NCT02787083
terminated; "Low enrollment"
NCT02981459
withdrawn; "Withdrawn by Sponsor"
NCT03411252
terminated; "inability to enroll"
NCT03695822
withdrawn; "I did not pass the 2018 Ministry of Science and Technology research project subsidy, so I applied for the project to close the case."
1 further recorded trialNCT04641975
terminated; "Termination due to operational futility"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Mirabegron used mirabegron 25 mg — over how long?
Human studies of Mirabegron used "mirabegron 25 mg". ClinicalTrials.gov · 2026-09-01
16 recorded entries; human; also "mirabegron 50 mg", "mirabegron 25 mg matching placebo", "mirabegron 50 mg matching placebo"
Show the evidence
human
NCT01908829
mirabegron 25 mg
NCT01908829
mirabegron 50 mg
NCT01908829
mirabegron 25 mg matching placebo
NCT01908829
mirabegron 50 mg matching placebo
NCT01950520
Mirabegron 50mg
NCT01950520
Mirabegron 200mg
10 more recorded rows
humanNCT02468375
mirabegron 50mg
humanNCT03059134
Mirabegron 25mg
humanNCT03411252
Mirabegron 50 MG
humanNCT03412513
Betmiga PR 50mg
humanNCT04420533
Mirabegron 50 MG Extended Release Oral Tablet
humanNCT04666636
Mirabegron 100 mg
humanNCT05221021
Mirabegron 50 MG [Myrbetriq]
humanNCT06133075
Mirabegron 25 MG
humanNCT06181019
50 mg of mirabegron
humanNCT06803030
Mirabegron 25 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Mirabegron's half-life is 26 to 31 hours — which schedules were studied?
26 to 31 hours, the half-life Mirabegron's label states: "Elimination Mirabegron for Pediatric Neurogenic Detrusor Overactivity (NDO) The mean terminal elimination half-life (t 1/2 ) of mirabegron is approximately 26 to 31 hours in pediatric patients." DailyMed label · 1c9022af-4841-4f3f-9737-1c5eef58e86b · 2026-05-22
tmax 4-5 hours.
Show the evidence
half lifepharmacokinetics
26 to 31 hours; Elimination Mirabegron for Pediatric Neurogenic Detrusor Overactivity (NDO) The mean terminal elimination half-life (t 1/2 ) of mirabegron is approximately 26 to 31 hours in pediatric patients.
tmaxpharmacokinetics
4-5 hours; Absorption Mirabegron for Pediatric Neurogenic Detrusor Overactivity (NDO) The median T max of mirabegron following oral administration of a single dose of mirabegron for extended-release oral suspension in pediatric patients under fed state was 4-5 hours.
metabolismpharmacokinetics
Metabolism Mirabegron is metabolized via multiple pathways involving dealkylation, oxidation, (direct) glucuronidation, and amide hydrolysis.
recorded 2026-05-22 · last checked 2026-09-04
Q6
Which running trial of Mirabegron could settle insulin sensitivity?
NCT05051436 measures Oral glucose tolerance test, reading out 2027-01.
2 open trials; n 96; "The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics"
Show the evidence
Trial
NCT05051436
"The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics"; n 96; "Oral glucose tolerance test"; 2027-01
NCT05713799
"Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity"; n 60; "Changes in the Insulin sensitivity index (SI) obtained from FSIGT, in (mU/L)^-1 * min^-1"; 2030-03-01
Q7
Which 68 trials of Mirabegron posted no result?
Posted no result
68 of 68 completed trials
Registrations
NCT01478490, NCT01651312, NCT01604928, NCT01646294, NCT01478529 and NCT01476800, and 62 more
Completion dates
oldest 2002-11; newest 2023-12-05
Show the evidence
Trial
NCT01478490
2002-11
NCT01651312
2003-02
NCT01604928
2005-01-25
NCT01646294
2005-05
NCT01478529
2006-03
NCT01476800
2006-11
14 further recorded trials
NCT00337090
2007-03
NCT00527033
2008-04-03
NCT00776516
2008-12
NCT00856570
2008-12
NCT01663961
2008-12
NCT01478568
2009-01
NCT01297179
2009-03
NCT01579461
2009-04
NCT00939757
2009-07
NCT01297192
2009-07
NCT00940121
2009-07-13
NCT00750620
2009-09
NCT00965926
2009-09
NCT01284868
2009-11
Q8
At the median, Mirabegron's trials enrolled 76 people — anything larger?
Median enrolment
76
Largest enrolment
10711
Registered trials counted
159
Q9
What do 1040 spontaneous reports say about Mirabegron — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Mirabegron appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1040 reaction mentions were counted: blood pressure increased 219; urinary retention 180; hypertension 169; atrial fibrillation 95. FAERS via Open Targets · CHEMBL2095212 · 2026-06-24
Show the evidence
blood pressure increased
219
urinary retention
180
hypertension
169
atrial fibrillation
95
dry mouth
85
palpitations
83
4 more recorded rows
arrhythmia
81
urinary incontinence
47
hypertensive crisis
42
dysuria
39
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Mirabegron's label not list?
The following are drug interactions for which monitoring is recommended: Drugs Metabolized by CYP2D6 : Mirabegron is a CYP2D6 inhibitor and, when used concomitantly with drugs metabolized by CYP2D6, especially narrow therapeutic index drugs, appropriate monitoring and possible dose adjustment of those drugs may be necessary.
drug_interactions
( 7.2 , 12.3 ) 7.1 Drugs Metabolized by CYP2D6 Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure of drugs metabolized by CYP2D6 enzyme is increased when coadministered with mirabegron.
drug_interactions
Therefore, appropriate monitoring and dose adjustment may be necessary when mirabegron is coadministered with these drugs, especially with narrow therapeutic index CYP2D6 substrates [see Warnings and Precautions ( 5.4 ) and Clinical Pharmacology ( 12.3 )] .
pharmacokinetics
Although, in vitro studies suggest a role for CYP2D6 and CYP3A4 in the oxidative metabolism of mirabegron, in vivo results indicate that these isozymes play a limited role in the overall elimination.
pharmacokinetics
In healthy subjects who were genotypically poor metabolizers of CYP2D6, mean C max and AUC tau were approximately 16% and 17% higher than in extensive metabolizers of CYP2D6, respectively.
pharmacokinetics
In vitro and ex vivo studies have shown the involvement of butylcholinesterase, uridine diphospho-glucuronosyltransferases (UGT), and possibly alcohol dehydrogenase in the metabolism of mirabegron, in addition to CYP3A4 and CYP2D6.
2 more recorded rows
Interaction statementpharmacokinetics
Mirabegron is a substrate for CYP3A4, CYP2D6, butyrylcholinesterase, UGT, the efflux transporter P-glycoprotein (P-gp), and the influx organic cation transporters (OCT) OCT1, OCT2, and OCT3.
Interaction statementpharmacokinetics
Sulfonylurea hypoglycemic agents glibenclamide (a CYP3A4 substrate), gliclazide (a CYP2C9 and CYP3A4 substrate), and tolbutamide (a CYP2C9 substrate) did not affect the in vitro metabolism of mirabegron.
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
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✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
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