This page shows what was measured, who it was measured in, and what that does not settle.
What SOLIFENACIN, (1R,3'R)- does in the body
A bladder that squeezes without asking — sudden urgency, going far too often, and leaking before you get there
The bladder wall is a muscle that contracts when a nerve chemical, acetylcholine, lands on receptors embedded in it. In an overactive bladder that contraction arrives early and unbidden while the bladder is still filling, and that is what urgency feels like. Solifenacin occupies those receptors so the chemical cannot land, and the wall stays quieter for longer. The same receptor runs the salivary glands, the gut and the focusing muscle of the eye, which is why dry mouth, constipation and blurred vision are not incidental side effects — they are the identical drug action in the wrong organ.
What happened in people
Micturitions per 24 hours fell 2.37 on solifenacin 5 mg and 2.81 on 10 mg, against 1.59 on placebo, in the 12-week pivotal trial
✎ 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.
That a 51% reduction in urgency episodes is a 51% drug effect — the placebo arm supplies most of the movement, and only the difference belongs to the drug
Where it acts
Detrusor smooth muscle of the bladder wall, and the urothelium and suburothelial afferent nerves beneath it
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
Its recorded molecular formula is C27H32N2O6, weighing 480.55.
US prescribing information · 6479d24f-373e-4c9e-abaf-349f90a2bbb1 · 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 145 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.
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.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
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 end of treatment in mean incontinence episodes and mean micturitions per 24 hours
✓ 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 episodes; placebo -1.34, solifenacin 5 mg -1.79, mirabegron 50 mg -1.76
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 comparison a reader most wants — solifenacin monotherapy against placebo — is present in the arm means but is not the registered hypothesis, so it carries no p-value in the results record. The margin from those means is 0.45 incontinence episodes a day.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, once daily; a separate oral suspension exists for paediatric use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
SYNERGY — solifenacin and mirabegron combination versus each monotherapy and placebo in overactive bladder (NCT01972841) · a recorded source, not a stored snapshot
Change from baseline to end of treatment in mean incontinence episodes per 24 hours, combination versus solifenacin 5 mg
Difference -0.26 episodes per 24 hours (95% CI -0.47 to -0.05), p=0.001 for combination versus solifenacin 5 mg
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. Solifenacin 10 mg monotherapy fell 1.67 episodes against the combination arm 1.80. That 0.13 gap is the clinically relevant comparison and was not the primary hypothesis.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, once daily; a separate oral suspension exists for paediatric use
Interval reported. 95% CI -0
Written into the record, not signed off as a reviewed claim.
SYNERGY — solifenacin and mirabegron combination versus each monotherapy and placebo in overactive bladder (NCT01972841) · a recorded source, not a stored snapshot
Change from baseline to final visit in mean micturitions per 24 hours, mirabegron 50 mg versus solifenacin 5 mg in patients dissatisfied with prior antimuscarinics
Solifenacin -3.13 versus mirabegron -2.95; adjusted difference -0.18 (95% CI -0.42 to 0.06), p=0.15. Non-inferiority met; no superiority in either direction.
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. Every patient enrolled had already failed an antimuscarinic, and the trial then gave half of them another antimuscarinic. That both arms improved by about three voids a day with no placebo arm to subtract makes the size of the drug effect unrecoverable from this trial.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, once daily; a separate oral suspension exists for paediatric use
Interval reported. 95% CI -0
Written into the record, not signed off as a reviewed claim.
SYNERGY — solifenacin and mirabegron combination versus each monotherapy and placebo in overactive bladder (NCT01972841) · a recorded source, not a stored snapshot
Efficacy of solifenacin 5 and 10 mg on overactive bladder symptoms at weeks 4, 8 and 12
✗ The study did not show it
Who was studied
VOLT (NCT00463541)
How many people
2225
Study design
Open-label single-arm, 12 weeks
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
No controlled comparison exists. `endpoint met: false` here records the absence of a control arm, not a missed endpoint.
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. A single-arm design in a condition with a placebo response of 1.34 incontinence episodes a day cannot separate drug effect from regression to the mean or from the act of keeping a diary.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, once daily; a separate oral suspension exists for paediatric use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
SYNERGY — solifenacin and mirabegron combination versus each monotherapy and placebo in overactive bladder (NCT01972841) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 4 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
SOLIFENACIN, (1R,3'R)-
What a person takes: Oral tablet, once daily; a separate oral suspension exists for paediatric use.
The measurement behind this step
A conventional immediate-release tablet swallowed whole once a day. There is no modified-release engineering here of the kind tamsulosin uses, because the molecule already has a long enough half-life to hold a once-daily schedule on its own. Dose is capped in the presence of strong CYP3A4 inhibitors and in significant renal or hepatic impairment.
Getting in
Swallowed once a day, and slow to leave
One tablet daily. The drug hangs around in the body far longer than most, which is why the dose is once a day and why side effects do not clear quickly if they arrive.
╌╌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 tablet, once daily, with a long terminal half-life supporting once-daily dosing. Cleared substantially by CYP3A4, so strong inhibitors of that enzyme raise exposure and the label caps the dose accordingly. Dispensed as the succinate salt.
It reaches the bladder wall without entering a cell
The target sits on the outer surface of the muscle cell, facing outward. The drug arrives from the bloodstream and sits down on it; nothing has 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
Muscarinic receptors are G-protein-coupled receptors in the plasma membrane with an outward-facing orthosteric pocket. No transporter and no intracellular accumulation is required. The same access applies in the salivary gland and the gut, which is why the unwanted effects appear on the same timescale as the wanted one.
Parasympathetic nerves release acetylcholine into the bladder wall to tell it to squeeze. Solifenacin sits in the receptor that message binds to, so the message does not get through.
╌╌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
Competitive antagonism at muscarinic receptors with relative preference for M3 over M2. Competitive means surmountable: a strong enough acetylcholine surge still produces a contraction, which is the pharmacological reason a person on this drug can still be caught by urgency.
The calcium spike that drives the squeeze does not fire
A contraction needs a burst of calcium inside the muscle cell. With the receptor occupied, the burst is smaller, and the involuntary squeeze during filling is blunted.
╌╌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
Loss of M3-Gq/11 coupling reduces phospholipase C activation, so inositol trisphosphate falls, sarcoplasmic reticulum calcium release drops and myosin light-chain phosphorylation declines. M2 blockade additionally removes the inhibition of adenylyl cyclase that normally opposes relaxation. Detrusor tone during filling falls and functional bladder capacity rises.
The diary improves by less than one leak and under one extra trip a day compared with placebo. Roughly one person in nine at the low dose, and one in four at the high dose, gets a dry mouth in exchange.
╌╌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
Micturitions per 24 hours fell 2.37 on 5 mg against 1.59 on placebo in the pivotal trial; incontinence episodes fell 1.79 against 1.34 on placebo in SYNERGY. Dry mouth 10.9% and 27.6% at 5 and 10 mg against 4.2% on placebo. The identical M3 blockade produces both columns of that table, and no dosing strategy separates them.
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.
Mostly women, mostly over 50, and disproportionately people already taking several other medicines with anticholinergic activity. It is the best-selling drug of its class worldwide.
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 of solifenacin succinate tablets have not been established in pediatric patients.”
US prescribing information · 6479d24f-373e-4c9e-abaf-349f90a2bbb1 · read 2026-08-30
On older people, the label states: “In placebo-controlled clinical studies, similar safety and effectiveness were observed between geriatric patients (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger adult patients (1188 patients < 65 years) treated with solifenacin succinate [see Clinical Pharmacology ( 12.3 )].”
US prescribing information · 6479d24f-373e-4c9e-abaf-349f90a2bbb1 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes.”
US prescribing information · 6479d24f-373e-4c9e-abaf-349f90a2bbb1 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 6479d24f-373e-4c9e-abaf-349f90a2bbb1 · read 2026-08-30
On people with reduced liver function, the label states: “Solifenacin plasma concentrations are greater in patients with moderate hepatic impairment compared to subjects with normal hepatic function [see Clinical Pharmacology ( 12.3 )].”
US prescribing information · 6479d24f-373e-4c9e-abaf-349f90a2bbb1 · read 2026-08-30
On people with reduced kidney function, the label states: “Solifenacin plasma concentrations are greater in patients with severe renal impairment compared to subjects with normal renal function [see Clinical Pharmacology ( 12.3 )].”
US prescribing information · 6479d24f-373e-4c9e-abaf-349f90a2bbb1 · read 2026-08-30
Where the result stopped carrying
Persistence: median time to discontinuation is under five months for oral antimuscarinics across almost every real-world study reviewed
The head-to-head against a different mechanism: BEYOND could not separate solifenacin from mirabegron on its primary endpoint, p=0.15
The comparison with structured behavioural training, which reduced incontinence episodes 80.7% against 68.5% for the antimuscarinic arm and has never been repeated against a modern agent
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 tablet, once daily; a separate oral suspension exists for 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 conventional immediate-release tablet swallowed whole once a day. There is no modified-release engineering here of the kind tamsulosin uses, because the molecule already has a long enough half-life to hold a once-daily schedule on its own. Dose is capped in the presence of strong CYP3A4 inhibitors and in significant renal or hepatic impairment.
✎ 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
The commonest effects are dry mouth, constipation and blurred vision, all dose-dependent and all on-target. The label warns of angioedema and anaphylactic reactions with potential airway obstruction, of urinary retention in patients with bladder outflow obstruction, of decreased gastrointestinal motility, of somnolence affecting driving, of caution in narrow-angle glaucoma, and of QT prolongation in patients already at risk. The class-level concern that does not appear in a 12-week trial is cumulative anticholinergic burden in older adults.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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 tablet, once daily; a separate oral suspension exists for 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
There is no modified-release engineering here of the kind tamsulosin uses, because the molecule already has a long enough half-life to hold a once-daily schedule on its own. Dose is capped in the presence of strong CYP3A4 inhibitors and in significant renal or hepatic impairment.
✎ 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
67 products list this as an active ingredient in the United States drug directory. 67 of them contain it and nothing else.
FDA National Drug Code directory · 55111-895 · read 2026-08-29
They are sold as powder, tablet, tablet, coated, tablet, film coated and tablet, film coated, extended release, taken oral.
FDA National Drug Code directory · 55111-895 · read 2026-08-29
The regulator's established pharmacologic class for it is cholinergic muscarinic antagonist [epc] and cholinergic muscarinic antagonists [moa].
FDA National Drug Code directory · 55111-895 · read 2026-08-29
34 published labels name it as an active ingredient. 34 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 9558ed7a-e942-4261-8aea-6033352f79b8 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 9558ed7a-e942-4261-8aea-6033352f79b8 · read 2026-08-29
solifenacin succinate is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: • 5 mg: white to off-white color, round, biconvex tablets debossed “V” on one side and “18” on other side. • 10 mg: white to off-white color, round, biconvex tablets debossed “V” on…, recorded as fda label in effect 2022-08-01 in the United States.
US prescribing information · 6479d24f-373e-4c9e-abaf-349f90a2bbb1 · read 2026-08-30
Recorded price in US: 0.155–0.17539 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 38 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
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 SOLIFENACIN, (1R,3'R)- 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 a 51% reduction in urgency episodes is a 51% drug effect — the placebo arm supplies most of the movement, and only the difference belongs to the drug
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 therapy is the established next step after solifenacin 5 mg — BESIDE tested it against the 5 mg dose, not against the 10 mg dose of the same drug
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 bladder antimuscarinics cause dementia — a class odds ratio of 1.65 in a nested case-control study, with no randomised evidence at all
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 trial populations describe the treated population — real-world one-year persistence for this class runs from 12% to 25%
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 SOLIFENACIN, (1R,3'R)- 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.
The pivotal trial margin is about three-quarters of a void a day over placebo
In plain words
In the trial that got the drug licensed, people on placebo cut 1.59 trips to the toilet a day. People on the 5 mg dose cut 2.37. The difference between them is the drug effect, and it is under one trip a day.
What was measured
Change from baseline in mean micturitions per 24 hours at 12 weeks, against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Cardozo and colleagues ran a multicentre, multinational, randomised, double-blind, placebo-controlled phase 3 trial with 12 weeks of once-daily treatment. The primary variable was change from baseline in mean micturitions per 24 hours. Placebo fell 1.59, solifenacin 5 mg fell 2.37 (p=0.0018) and solifenacin 10 mg fell 2.81 (p=0.0001). Urgency episodes fell 2.84 on 5 mg (a 51% reduction, p=0.003) and 2.90 on 10 mg (52%, p=0.002), and half of patients incontinent at baseline achieved continence. Nocturia reached significance only at 10 mg, falling 0.71 episodes against 0.52 on placebo, p=0.036. The p-values are solid and the absolute differences are small; both statements are true at once and the second is the one a reader is rarely shown.
Written into the record, not signed off as a reviewed claim
The dry mouth is the same receptor, in the salivary gland, and it doubles with dose
In plain words
Dry mouth is not an unlucky side reaction. It is the drug doing exactly what it was designed to do, in the gland that makes saliva. At the higher dose more than one patient in four reports it.
What was measured
Incidence of dry mouth, constipation and blurred vision by dose in the pooled registration trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The US label reports dry mouth in 4.2% on placebo, 10.9% on 5 mg and 27.6% on 10 mg; constipation in 2.9%, 5.4% and 13.4%; blurred vision in 1.8%, 3.8% and 4.8%. The pivotal publication reports the same gradient at 2.3%, 7.7% and 23%. The M3 receptor blocked in the detrusor is the M3 receptor in the salivary acinar cell and in the ciliary muscle, so the therapeutic effect and the adverse effects rise together and cannot be separated by dosing. This is the clearest on-target-wrong-organ example in the class, and it is why the efficacy gain from doubling the dose has to be weighed against a roughly two-and-a-half-fold rise in dry mouth.
Source
US prescribing information for solifenacin succinate tablets, Adverse Reactions section; Cardozo L et al., J Urol 2004;172:1919-1924
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
Against placebo in a modern trial, under half an incontinence episode a day
In plain words
SYNERGY is one of the few recent trials of this drug with a real placebo arm. Placebo took away 1.34 leaks a day on its own. Solifenacin took away 1.79. The drug is responsible for the difference: 0.45 leaks a day.
What was measured
Change from baseline in mean incontinence episodes and micturitions per 24 hours, all arms including placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SYNERGY (NCT01972841) randomised 3,527 patients to placebo, mirabegron 25 mg or 50 mg, solifenacin 5 mg, or solifenacin plus mirabegron at either dose. Change from baseline to end of treatment in mean incontinence episodes per 24 hours was -1.34 on placebo, -1.70 and -1.76 on mirabegron 25 and 50 mg, and -1.79 on solifenacin 5 mg. Micturitions per 24 hours fell 1.64 on placebo and 2.20 on solifenacin. The combination arms reached -2.04 and -1.98 for incontinence, significantly better than the corresponding mirabegron monotherapy (p=0.001 and p<0.001). Read from the placebo arm rather than from baseline, every active arm in this trial sits within half an episode a day of every other.
Written into the record, not signed off as a reviewed claim
BESIDE beat solifenacin 5 mg and did not separate from solifenacin 10 mg
In plain words
The trial used to argue for adding a second drug on top of solifenacin compared the combination with the low dose. Against the high dose of solifenacin alone, the gap nearly disappears.
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 incontinent patients already on solifenacin 5 mg for four weeks 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 was combination against solifenacin 5 mg: difference -0.26 episodes (95% CI -0.47 to -0.05), p=0.001. The comparison a prescriber actually faces — add a second drug, or raise the dose of the one already prescribed — is 1.80 against 1.67, a gap of 0.13 episodes a day that the trial was not designed to test as its primary endpoint.
Written into the record, not signed off as a reviewed claim
Most people have stopped within a year, and a quarter never reach six months
In plain words
Whatever the trials show at 12 weeks, in ordinary use this class of drug is abandoned. Across thirty real-world studies, between 12% and 25% of patients were still taking an antimuscarinic a year later.
What was measured
One-year persistence and adherence with oral antimuscarinics in electronic prescription claims, across 30 studies
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Yeowell and colleagues systematically reviewed thirty observational studies drawing on electronic prescription claims. Overall persistence ranged from 5% to 47%. In the three studies reporting both drug groups, one-year persistence was 12% to 25% for antimuscarinics and 32% to 38% for mirabegron. Median time to discontinuation was under five months for antimuscarinics in all but one study, against 5.6 to 7.4 months for mirabegron. The proportion adherent at one year ranged from 15% to 44%. A 12-week efficacy result describes a population that, in practice, has largely dispersed before the first anniversary of the prescription; the review was funded by the manufacturer of the comparator drug, which is a reason to check the underlying studies rather than a reason to dismiss the direction.
Written into the record, not signed off as a reviewed claim
The class-wide dementia association is large, consistent, and not from a trial
In plain words
Two very large British database studies found more dementia in people who had taken bladder antimuscarinics. Neither randomised anyone, and a bladder that is misbehaving can itself be an early sign of the disease being counted as the outcome.
What was measured
That bladder antimuscarinics cause dementia — a large and dose-graded association in two national primary-care databases, with no randomised trial in this class ever powered for a cognitive endpoint
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Coupland and colleagues studied 58,769 dementia cases and 225,574 matched controls aged 55 and over, using prescriptions for 56 anticholinergic drugs issued 1 to 11 years before diagnosis. The adjusted odds ratio rose from 1.06 (95% CI 1.03 to 1.09) at the lowest exposure to 1.49 (1.44 to 1.54) at the highest, and bladder antimuscarinics as a class carried an adjusted odds ratio of 1.65 (1.56 to 1.75). The population-attributable fraction for total anticholinergic exposure was 10.3%. Richardson and colleagues, in 40,770 cases and 283,933 controls, found an adjusted odds ratio of 1.11 (1.08 to 1.14) for any drug with a definite anticholinergic score, with the association for urological drugs still present 15 to 20 years before diagnosis. Persistence that far back argues against simple reverse causation and is the strongest part of the case; the absence of any randomised evidence is the weakest.
Written into the record, not signed off as a reviewed claim
A measured QT effect at three times the maximum dose, and a boxed-adjacent warning
In plain words
At three times the highest dose anyone is meant to take, solifenacin lengthened an electrical interval in the heart by about 8 milliseconds. That is small. The label still names it, alongside angioedema, as a reason for caution.
What was measured
Mean change in Fridericia-corrected QT interval at 30 mg against placebo, with 90% confidence interval
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The US label reports a dedicated QT study in which the 30 mg dose — three times the maximum recommended 10 mg — produced a mean increase in the Fridericia-corrected QT interval of 8 msec (90% CI 4 to 13), an effect smaller than that of moxifloxacin as positive control at its therapeutic dose. The Warnings and Precautions section carries angioedema and anaphylactic reactions with potential airway obstruction, urinary retention, reduced gastrointestinal motility, somnolence affecting the ability to drive, and caution in narrow-angle glaucoma. The QT finding is measured, quantified and modest; it is included here because "no clinically significant effect at the approved dose" and "no effect" are different statements and the label makes only the first.
Source
US prescribing information for solifenacin succinate tablets, Clinical Pharmacology and Warnings and Precautions sections (openFDA drug label endpoint)
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
A 2,225-patient study of this drug had no control arm at all
In plain words
One of the largest studies on the registry for solifenacin, VOLT, enrolled 2,225 patients and gave every one of them the drug. With nobody on placebo, it cannot say what the drug did.
What was measured
Enrolment and design of the largest open-label solifenacin study on the public registry
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
VOLT (NCT00463541) was an open-label study of solifenacin 5 and 10 mg in patients with overactive bladder symptoms, enrolling 2,225 participants and assessing symptoms at weeks 4, 8 and 12. It is completed. An open-label single-arm design in a condition whose placebo arms lose 1.34 incontinence episodes and 1.64 voids a day cannot distinguish drug effect from regression to the mean, from diary-keeping itself, or from expectation. It remains a legitimate safety and tolerability dataset and an illegitimate efficacy one, and the distinction is not always made when its patient numbers are quoted.
Source
ClinicalTrials.gov record, VOLT, NCT00463541
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
34 documents were read for this substance.
RNAWiki source record
34 of them state the same bioavailability, and they agree.
RNAWiki source record
34 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
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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
28 approved applications cover products containing this substance. The earliest was NDA021518, approved 20041119 to ASTELLAS.
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7 questions this page could not answer
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A competitive M3 muscarinic antagonist that blocks the acetylcholine signal telling the bladder wall to contract: in its 12-week pivotal trial it removed 2.37 voids a day at 5 mg against 1.59 on placebo, and in the placebo-controlled SYNERGY trial 1.79 incontinence episodes a day against placebo 1.34 — margins of roughly three-quarters of a void and less than half an episode a day, bought at a dry-mouth rate of 10.9% at 5 mg and 27.6% at 10 mg against 4.2% on placebo.
Recorded evidence blocks (8)
Q1
On the SOLIFENACIN, (1R,3'R)- label: indicated for what?
"Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate is a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence,…": indications and usage on SOLIFENACIN, (1R,3'R)-'s label. DailyMed label · 56026679-4002-a6c6-e063-6294a90a7b55 · 2026-07-06
Q2
131 registered trials of SOLIFENACIN, (1R,3'R)- — at which phases?
Registered studies posting no result
92 of 131
131 registered studies of SOLIFENACIN, (1R,3'R)-: 48 phase4, 27 phase3, 17 na, 15 na or unstated, 15 phase1, 12 phase2. CLINICALTRIALS_SNAPSHOT · 2026-09-01
214 with a PubMed record
Show the evidence
phase4
48
phase3
27
na
17
na or unstated
15
phase1
15
phase2
12
7 more recorded rows
completed
92
unknown
17
terminated
9
recruiting
8
not yet recruiting
2
withdrawn
2
active not recruiting
1
recorded 2026-09-01 · last checked 2026-09-04
Q3
11 of SOLIFENACIN, (1R,3'R)-'s trials stopped: safety, accrual/recruitment, other?
45-68 hours; Elimination The elimination half-life (t 1/2 ) of solifenacin following chronic dosing is approximately 45-68 hours.
tmaxpharmacokinetics
3 to 8 hours; Absorption After oral administration of solifenacin succinate in healthy volunteers, peak plasma concentrations (C max ) of solifenacin were reached within 3 to 8 hours after administration and, at steady-state, ranged from 32.3 to 62.9 ng/mL for the 5 and 10 mg solifenacin succinate tablets, respectively.
bioavailabilitypharmacokinetics
90 %; The absolute bioavailability of solifenacin is approximately 90%, with plasma concentrations of solifenacin proportional to the dose administered.
metabolismpharmacokinetics
Metabolism Solifenacin is extensively metabolized in the liver.
recorded 2026-07-06 · last checked 2026-09-04
Q6
Which 54 trials of SOLIFENACIN, (1R,3'R)- posted no result?
Posted no result
54 of 54 completed trials
Registrations
NCT00802373, NCT00463541, NCT00454740, NCT00454896, NCT00801944 and NCT00333112, and 48 more
Completion dates
oldest 2004-10; newest 2024-05-29
Show the evidence
Trial
NCT00802373
2004-10
NCT00463541
2005-04
NCT00454740
2005-08
NCT00454896
2005-09
NCT00801944
2005-10
NCT00333112
2007-01
14 further recorded trials
NCT00337558
2007-05
NCT00510406
2007-09
NCT00368706
2008-03
NCT01297192
2009-07
NCT02634489
2009-07
NCT01015040
2009-11
NCT00771394
2010-01
NCT00699049
2010-03
NCT00979472
2010-06
NCT01953887
2010-07
NCT00884104
2010-12
NCT01122563
2011-01
NCT00629642
2011-01-28
NCT01489709
2011-04
Q7
At the median, SOLIFENACIN, (1R,3'R)-'s trials enrolled 130 people — anything larger?
Median enrolment
130
Largest enrolment
5589
Registered trials counted
129
Q8
SOLIFENACIN, (1R,3'R)- and CYP3A4, CYP1A1 and CYTOCHROME P450: shared by which compounds?
CYP3A4 Inhibitors : Do not exceed the 5 mg dose of Solifenacin succinate tablets with concomitant use of strong CYP3A4 inhibitors.
drug_interactions
( 7.1 ) 7.1 Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4.
drug_interactions
Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology ( 12.3 )] .
drug_interactions
The dosage of Solifenacin succinate tablets greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 )] .
pharmacokinetics
The primary pathway for elimination is by way of CYP3A4; however, alternate metabolic pathways exist.
pharmacokinetics
Drug Interaction Studies Strong CYP3A4 Inhibitors In a crossover study, following blockade of CYP3A4 by coadministration of the strong CYP3A4 inhibitor, ketoconazole 400 mg once daily for 21 days, the mean C max and AUC of solifenacin increased by 1.5 and 2.7-fold, respectively [see Dosage and Administration ( 2.4 ) and Drug Interactions ( 7.1 )] .
2 more recorded rows
Interaction statementpharmacokinetics
CYP3A4 Inducers Because solifenacin is a substrate of CYP3A4, inducers of CYP3A4 may decrease the concentration of solifenacin.
Interaction statementpharmacokinetics
Drugs Metabolized by Cytochrome P450 Enzymes In vitro studies demonstrated that, at therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes.
ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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