This page shows what was measured, who it was measured in, and what that does not settle.
What Ursodeoxycholic acid does in the body
Gallstone formation in obese patients experiencing rapid weight loss
From the FDA-approved label: Ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool. Oral administration of ursodiol increases this fraction in a dose related manner, to become the major biliary acid, replacing/displacing toxic concentrations of endogenous hydrophobic bile acids that tend to accumulate in cholestatic liver disease.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
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 · 724L30Y2QR · read 2026-08-29
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.
No statement of the main limit is recorded.
The four opening statements run to 84 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.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Blood sugar
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved2 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Energy
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Healthy ageing
…Waiting for a reviewer1 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
area above basal for glucose; glucose level
Energy
energy expenditure
Healthy ageing
mortality
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
2 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
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.
Changes of HbA1c
✗ The study did not show it
Who was studied
NCT05500937
How many people
1000
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Symptom assessment
✗ The study did not show it
Who was studied
NCT04786795
How many people
990
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Alanine Aminotransferase at Baseline
✗ The study did not show it
Who was studied
NCT00200343
How many people
596
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Primary Endpoint: mean change in HbA1c
✗ The study did not show it
Who was studied
NCT06353347
How many people
551
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
MACCE
✗ The study did not show it
Who was studied
NCT05690646
How many people
491
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Response to dissolution therapy
✗ The study did not show it
Who was studied
NCT07005752
How many people
484
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.3 registered measures of this kind. No reviewed result.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.5 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
area above basal for glucose
atp concentration
glucose level
maximum plasma concentration
area under the plasma concentration versus time curve
Meaningful
Things that change how a life goes, not only a number.
survival
overall survival
mortality
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (32)
treatment failure
safety measures
tolerability measures
pharmacokinetic measures
energy expenditure
bile acid
number and size of duodenal adenomas
length of parenteral nutrition associated cholestasis
toxicities as assessed by nci ctcae 3 0
time to failure
preterm delivery
pruritus
laboratory values
incidence of gallstones formation after bariatric surgery
peritoneal membrane function
glp 1 secretion
auclast
cmax
return toward a normal fecal bile acid pattern
pruritus grading
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
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.
Ursodiol capsules are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery.
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 ursodiol tablets, 250 mg and 500 mg in pediatric patients have not been established.”
US prescribing information · fb79b62a-b450-4d7a-be28-5ee4d174fd58 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available published data on the use of ursodiol in pregnant women derived from randomized controlled trials, observational studies, and case series collected over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
US prescribing information · fb79b62a-b450-4d7a-be28-5ee4d174fd58 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Ursodiol is naturally present in human milk.”
US prescribing information · fb79b62a-b450-4d7a-be28-5ee4d174fd58 · read 2026-08-30
Where the result stopped carrying
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 for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
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.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
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 (9)
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
✎ 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
Sold as tablet, capsule, tablet, film coated, given by the oral route.
✎ 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∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
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.
Ursodeoxycholic acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 399 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · 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
✎ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
71 products list this as an active ingredient in the United States drug directory. 71 of them contain it and nothing else.
FDA National Drug Code directory · 49345-2612 · read 2026-08-29
They are sold as capsule, powder, powder, for suspension, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 49345-2612 · read 2026-08-29
The regulator's established pharmacologic class for it is bile acid [epc] and bile acids and salts [cs].
FDA National Drug Code directory · 49345-2612 · read 2026-08-29
41 published labels name it as an active ingredient. 41 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 55c1556b-8b47-479a-979b-fd61bdd27c7f · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 55c1556b-8b47-479a-979b-fd61bdd27c7f · read 2026-08-29
Ursodiol is oral at 3 DOSAGE FORMS AND STRENGTHS • Ursodiol Tablets, USP 250 mg: 250 mg tablet • Ursodiol Tablets, USP 500 mg: 500 mg scored tablet • Ursodiol Tablets, USP 250 mg: 250 mg tablet ( 3 ) • Ursodiol Tablets, USP 500 mg: 500 mg…, recorded as fda label in effect 2026-01-27 in the United States.
US prescribing information · fb79b62a-b450-4d7a-be28-5ee4d174fd58 · read 2026-08-30
Recorded price in US: 0.41605–0.63559 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 31 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.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 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.
The path through the body — 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.
Claims that go past the evidence — 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.
Recorded evidence blocks (13)
Q1
What did Ursodeoxycholic acid's largest trial (2000 people) and its longest (16 years) measure?
2000 people in Ursodeoxycholic acid's largest registered study, 16 years in its longest registered window, measuring Mortality. ClinicalTrials.gov · 2026-09-01
34 phase2, 23 na, 21 phase3, 19 phase1, 17 phase4, 4 na or unstated, 1 early phase1; NCT00873275; 2025-02-26; no ageing endpoint recorded. Last human test completed 2025, NCT00873275.
Interpretation These counts include studies where Ursodeoxycholic acid was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
34
na
23
phase3
21
phase1
19
phase4
17
na or unstated
4
2 more recorded rows
early phase1
1
Last recorded human testNCT00873275
2025-02-26
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Ursodeoxycholic acid shown lifespan?
292 mice; cohorts C2011; cohort rows are the workbook's own printed values; no median, percent change or survival statistic is derived from the per-animal data
Show the evidence
ITP cohortC2011
ursodeoxycholic acid; 5000; 5 months; f, m; ITP_C2011_Lifespan.xlsx
safety (1), accrual/recruitment (5), sponsor decision unspecified (2) and other (3): Ursodeoxycholic acid's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"DSMB reviewed interim analysis and terminated the study due to futility."; 11 of 108 registered studies
Show the evidence
Trial
NCT00059202
terminated; "DSMB reviewed interim analysis and terminated the study due to futility."
NCT00062023
terminated; "Study closed by the NCI."
NCT00550862
terminated; "Study stopped by sponsor due to administrative reasons"
NCT01226823
withdrawn; "Modified insurance requests by a new law released after its approval."
NCT02472509
terminated; "Study not feasible - very low recruitment rate"
NCT03201952
terminated; "Difficulty in participant recruitment"
5 further recorded trials
NCT03602976
terminated; "Inability to adequately recruit subjects in COVID-19 pandemic"
NCT03678480
withdrawn; "Corporate decision"
NCT03724175
terminated; "Lack of recruitment and funding."
NCT05526807
terminated; "Slow recruitment"
NCT07102979
terminated; "Slow recruitment and exhaustion of available study funding."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Mouse studies of Ursodeoxycholic acid used 5000 ppm — over how long?
Mouse studies of Ursodeoxycholic acid used "5000 ppm". clinicaltrials.gov+jax-mpd-itp · 2026-09-04
11 recorded entries; mouse, human; tablet, capsule; also "Ursodeoxycholic Acid 300mg tablet", "Ursodeoxycholic Acid 300mg capsule", "Ursodiol 500 MG"
Show the evidence
mouseursodeoxycholic acid C2011
5000 ppm
human
NCT03489889
tablet; Ursodeoxycholic Acid 300mg tablet
NCT03489889
capsule; Ursodeoxycholic Acid 300mg capsule
NCT03512808
Ursodiol 500 MG
NCT03512808
Urso Forte 500Mg Tablet
NCT03724175
NDC 0591-3159-01 Ursodiol Capsules, USP 300 mg
NCT04617561
UDCA;Ursofalk(250mg*25,Losan Pharma GmbH)
4 more recorded rows
humanNCT04834557
Ursodeoxycholic acid (UDCA) 500 mg
humanNCT05043194
Ursodeoxycholic Acid 250 Mg Oral Capsule
humanNCT05832697
Ursodeoxycholic Acid 250 Mg Oral Tablet
humanNCT05832697
Ursodeoxycholic Acid 100 Mg Oral Tablet
recorded 2026-09-04 · last checked 2026-09-04
Q6
Could one person measure Ursodeoxycholic acid's effect on treatment failure?
Treatment failure: measured in Ursodeoxycholic acid's trials.
Interpretation treatment failure is the recorded endpoint.
Show the evidence
biomarkers
treatment failure; 2026-09-01
safety measures; 2026-09-01
tolerability measures; 2026-09-01
pharmacokinetic measures; 2026-09-01
energy expenditure; 2026-09-01
bile acid; 2026-09-01
14 more recorded rows
biomarkers
number and size of duodenal adenomas; 2026-09-01
biomarkers
length of parenteral nutrition associated cholestasis; 2026-09-01
biomarkers
toxicities as assessed by nci ctcae 3 0; 2026-09-01
biomarkers
survival; 2026-09-01
biomarkers
time to failure; 2026-09-01
biomarkers
preterm delivery; 2026-09-01
biomarkers
overall survival; 2026-09-01
biomarkers
pruritus; 2026-09-01
biomarkers
laboratory values; 2026-09-01
biomarkers
area above basal for glucose; 2026-09-01
biomarkers
incidence of gallstones formation after bariatric surgery; 2026-09-01
biomarkers
peritoneal membrane function; 2026-09-01
biomarkers
glp 1 secretion; 2026-09-01
biomarkers
auclast; 2026-09-01
human trials at or under30
33
Not recorded for this substance
a recorded half-life
smallest human trial
0; NCT01226823; PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of area above basal for glucose, area under the plasma concentration versus time curve and atp concentration did Ursodeoxycholic acid's trials measure?
area above basal for glucose, area under the plasma concentration versus time curve and atp concentration lead 40 outcome terms across Ursodeoxycholic acid's trials. ClinicalTrials.gov · 2026-09-01
pharmacokinetic measures, energy expenditure, bile acid, number and size of duodenal adenomas, length of parenteral nutrition associated cholestasis and toxicities as assessed by nci ctcae 3 0 follow.
Show the evidence
treatment failure
1
safety measures
1
tolerability measures
1
pharmacokinetic measures
1
energy expenditure
1
bile acid
1
14 more recorded rows
number and size of duodenal adenomas
1
length of parenteral nutrition associated cholestasis
1
toxicities as assessed by nci ctcae 3 0
1
survival
1
time to failure
1
preterm delivery
1
overall survival
1
pruritus
1
laboratory values
1
area above basal for glucose
1
incidence of gallstones formation after bariatric surgery
1
peritoneal membrane function
1
glp 1 secretion
1
auclast
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Ursodeoxycholic acid's 16 ongoing trials reports first?
Glycaemic control; Recurrence rate of primary biliary cholangitis; latest 2029-12
Show the evidence
Trial
NCT04407650
"Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus"; n 64; "Glycaemic control"; 2025-05-31
NCT04650243
"Clinical Research of Tapering UDCA in PBC Patients With a Complete Response"; n 90; "Recurrence rate of primary biliary cholangitis"; 2025-05
NCT04924868
"Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis"; n 332; "Complication due to gallstones"; 2027-07-01
NCT06517862
"Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia"; n 80; "serum bilirubin level."; 2026-06-30
NCT06610760
"Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia"; n 196; "The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups."; 2026-10-31
NCT06629909
"Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration: a Single Center, Randomized, Phase I Clinical Trial"; n 54; "Changes in Fibroscan and M2BPGi six month after secretome injections"; 2026-10-31
"PD-L1 Inhibitor + RT ± Ursodeoxycholic Acid in Recurrent/Metastatic HER2-Neg Breast Cancer"; n 70; "Objective Response Rate (ORR) of lesions outside the radiotherapy field, assessed by RECIST 1.1 criteria."; 2029-12
NCT06884748
"Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy"; n 30; "Lack of recurrent C. difficile recurrence"; 2028-05-01
NCT06918080
"Hepatoprotective Measures for Children at High Risk of NAFLD"; n 200; "Study of the prevalence of liver steatosis, steatohepatitis and fibrosis among the study population by using LIVERFASt."; 2025-07
NCT06922669
"Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia"; n 232; "Improvement of DILI on the second week"; 2027-09-30
NCT07110987
"The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia"; n 70; "Reduction of total serum bilirubin to below phototherapy threshold"; 2027-03-01
NCT07273734
"UDCA to Prevent Post-TIPS Hepatic Encephalopathy"; n 270; "Incidence of Overt Hepatic Encephalopathy (OHE) within 3 Months After TIPS"; 2027-12-31
NCT07525401
"Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis"; n 88; "Change in serum total bilirubin levels"; 2026-10
NCT07664020
"Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients."; n 130; "Regenerated liver volume"; 2027-11-01
NCT07717242
"Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer"; n 80; "Clinical Complete Response Rate"; 2029-01-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 33 trials of Ursodeoxycholic acid posted no result?
Posted no result
33 of 33 completed trials
Registrations
NCT01576458, NCT00004441, NCT00161083, NCT01073202, NCT01548079 and NCT00808743, and 27 more
Completion dates
oldest 1998-12; newest 2024-08-01
Show the evidence
Trial
NCT01576458
1998-12
NCT00004441
2001-09
NCT00161083
2004-11
NCT01073202
2009-01
NCT01548079
2010-05
NCT00808743
2013-01
14 further recorded trials
NCT01857284
2013-01
NCT00846963
2013-03
NCT01829698
2014-02
NCT02016365
2014-12
NCT02385032
2015-05
NCT02021110
2015-10
NCT01899703
2015-10-07
NCT02622685
2016-02
NCT01974336
2016-09
NCT01088607
2017-06
NCT03512808
2017-07-31
NCT02841306
2017-09
NCT03512821
2017-11-30
NCT03489889
2018-06
Q10
At the median, Ursodeoxycholic acid's trials enrolled 55 people — anything larger?
Median enrolment
55
Largest enrolment
2000
Registered trials counted
107
Q11
What do 399 spontaneous reports say about Ursodeoxycholic acid — 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.
Ursodeoxycholic acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 399 reaction mentions were counted: premature baby 67; pruritus 64; cholestasis 43; alanine aminotransferase increased 39. open-targets-adr · CHEMBL1551 · 2026-06-24
Show the evidence
premature baby
67
pruritus
64
cholestasis
43
alanine aminotransferase increased
39
blood alkaline phosphatase increased
34
jaundice
33
4 more recorded rows
aspartate aminotransferase increased
30
drug-induced liver injury
30
premature delivery
30
interstitial lung disease
29
recorded 2026-06-24 · last checked 2026-09-04
Q12
Was Ursodeoxycholic acid studied with fasting?
fasting is named in Ursodeoxycholic acid's label sentences: "This trial demonstrated no difference in fasting glycemia between women with gestational diabetes mellitus treated with ursodeoxycholic acid and those treated with placebo." openfda-label+europepmc · 2025-07-09
1 recorded statement; fasting
Show the evidence
fasting
This trial demonstrated no difference in fasting glycemia between women with gestational diabetes mellitus treated with ursodeoxycholic acid and those treated with placebo.
recorded 2025-07-09 · last checked 2026-09-04
Q13
What is recorded about Ursodeoxycholic acid and NAD+?
"Hydroxysteroid dehydrogenases (HSDHs) are crucial NAD(P)H-dependent enzymes that catalyze the redox reactions of steroid substrates, playing an essential role in bile acid metabolism and the biosynthesis of ursodeoxycholic acid (UDCA)." — where Ursodeoxycholic acid and NAD+ appear together. Europe PMC · pathway abstract search · 2026-03-26
"Hydroxysteroid dehydrogenases (HSDHs) are crucial NAD(P)H-dependent enzymes that catalyze the redox reactions of steroid substrates, playing an essential role in bile acid metabolism and the biosynthesis of ursodeoxycholic acid (UDCA)."
autophagy
PMID 41903671
"Mechanistic assays revealed that ursodeoxycholic acid (UDCA) upregulated BSEP and reversed resistance via an FXR-independent mechanism: UDCA directly binds cortactin (CTTN), reduces its PRMT1-dependent mono-methylation, and promotes CTTN degradation via chaperone-mediated autophagy (CMA), thereby enabling YY1 nuclear translocation and transcriptional activation of BSEP."
PMID 40121741
"In this study, metformin was found to mitigate methionine-choline deficient (MCD) -diet induced NAFLD through reshaping the gut microbiota to increase ursodeoxycholic acid (UDCA) level, thereby inhibiting farnesoid X receptor (FXR) accompanied with activated autophagy."
NAD+PMID 39378924
"NAD<sup>+</sup>-dependent 7α-hydroxysteroid dehydrogenase (7α-HSDH) and NADPH-dependent 7β-hydroxysteroid dehydrogenase (7β-HSDH) are involved in the biosynthesis of chenodeoxycholic acid (CDCA) to ursodeoxycholic acid (UDCA)."
autophagyPMID 41011192
"Bile acids, including ursodeoxycholic acid and derivatives, modulate HSC activity and autophagy."
NAD+PMID 38016669
"Enzymatic synthesis of ursodeoxycholic acid (UDCA) catalyzed by an NADH-dependent 7β-hydroxysteroid dehydrogenase (7β-HSDH) is more economic compared with an NADPH-dependent 7β-HSDH when considering the much higher cost of NADP<sup>+</sup>/NADPH than that of NAD<sup>+</sup>/NADH."
recorded 2026-03-26 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · NIA ITP via the JAX Mouse Phenome Database · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · openFDA / DailyMed — US Government work
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