This page shows what was measured, who it was measured in, and what that does not settle.
What Orlistat does in the body
The risk for weight regain after prior weight loss
From the FDA-approved label: Orlistat is a reversible inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides are not absorbed, the resulting caloric deficit may have a positive effect on weight control.
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
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 95M8R751W8 · read 2026-08-29
Its recorded molecular formula is C29H53NO5, weighing 495.7.
US prescribing information · 6240792b-9224-2d10-e053-2a91aa0a2c3e · 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.
No statement of the main limit is recorded.
The four opening statements run to 104 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.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
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 32 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
Body weight
∅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 moved11 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.
Blood sugar
…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.
△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.
Cholesterol
∅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.
Fertility and sexual health
∅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.
Which registered measures put each goal on this table
Body weight
body weight at 48 weeks; weight loss; weight loss compared to baseline; body weight at week 20; body mass index; fat mass; visceral fat mass improvement; body weight between baseline and 12 months
Blood sugar
type 2 diabetes remission; achieving hba1c of 6 without diabetic medication; fasting blood glucose
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
11 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.
Integrated management rate of multiple risk factor in type 2 diabetes
✗ The study did not show it
Who was studied
NCT03430284
How many people
6300
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
Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
✗ The study did not show it
Who was studied
NCT05809596
How many people
949
Study design
Not applicable
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
Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss.
✗ The study did not show it
Who was studied
NCT01755676
How many people
638
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
Body Weight
✗ The study did not show it
Who was studied
NCT01606813
How many people
611
Study design
Not applicable
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
Absolute weight loss compared to baseline
✗ The study did not show it
Who was studied
NCT00156897
How many people
600
Study design
Phase 2
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
Mean Change From Baseline in Body Weight at Week 20
✗ The study did not show it
Who was studied
NCT00422058
How many people
564
Study design
Phase 2
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.1 registered measure 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.18 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. 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.
body weight at 48 weeks
weight loss
weight loss compared to baseline
body weight at week 20
body mass index
waist circumference
blood pressure
fat mass
visceral fat mass improvement
achieving hba1c of 6 without diabetic medication
and 8 more.
Meaningful
Things that change how a life goes, not only a number.
type 2 diabetes remission
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 (13)
live birth rate
weight
physical activity
anti mullerian hormone levels
blood lipid
bile acid
gastrointestinal flora
primary objective
hip circumference
waist to hip
follicle stimulating hormone
luteinizing hormone
free testosterone
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 1 to 2 hours hours
Read from the label, which states: “Based on limited data, the half-life of the absorbed orlistat is in the range of 1 to 2 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
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.
ORLISTAT is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. ORLISTAT is also indicated to reduce the risk for weight regain after prior weight loss.
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: “Safety and effectiveness in pediatric patients below the age of 12 have not been established.”
US prescribing information · 6240792b-9224-2d10-e053-2a91aa0a2c3e · read 2026-08-30
On older people, the label states: “Clinical studies of XENICAL did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients [see Clinical Studies (14) ] .”
US prescribing information · 6240792b-9224-2d10-e053-2a91aa0a2c3e · read 2026-08-30
On people who are pregnant, the label states: “Category X XENICAL is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.”
US prescribing information · 6240792b-9224-2d10-e053-2a91aa0a2c3e · read 2026-08-30
On people who are breastfeeding, the label states: “It is not known if XENICAL is present in human milk.”
US prescribing information · 6240792b-9224-2d10-e053-2a91aa0a2c3e · 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.
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 (10)
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
✎ 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
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S3.
No source is stored against this line.
What is in the pack
Sold as capsule, 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.
Orlistat appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 490 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
diarrhoea — 94 reaction mentions
abdominal pain — 79 reaction mentions
drug interaction — 57 reaction mentions
abdominal pain upper — 49 reaction mentions
rectal haemorrhage — 45 reaction mentions
haematochezia — 35 reaction mentions
cholelithiasis — 34 reaction mentions
steatorrhoea — 34 reaction mentions
acute hepatic failure — 32 reaction mentions
nephropathy — 31 reaction mentions
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
14 products list this as an active ingredient in the United States drug directory. 14 of them contain it and nothing else.
FDA National Drug Code directory · 62331-045 · read 2026-08-29
They are sold as capsule and powder, taken oral.
FDA National Drug Code directory · 62331-045 · read 2026-08-29
The regulator's established pharmacologic class for it is intestinal lipase inhibitor [epc] and lipase inhibitors [moa].
FDA National Drug Code directory · 62331-045 · read 2026-08-29
4 published labels name it as an active ingredient. 4 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 6240792b-9224-2d10-e053-2a91aa0a2c3e · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 6240792b-9224-2d10-e053-2a91aa0a2c3e · read 2026-08-29
Xenical is oral at 3 DOSAGE FORMS AND STRENGTHS XENICAL 120 mg turquoise capsules imprinted with XENICAL 120 in black ink., recorded as fda label in effect 2026-01-09 in the United States.
US prescribing information · 6240792b-9224-2d10-e053-2a91aa0a2c3e · read 2026-08-30
Recorded price in US: 7.00327 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, for the one priced product, 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.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Orlistat 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
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.
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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 Orlistat 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.
How many documents were read
4 documents were read for this substance.
RNAWiki source record
2 of them state the same halfLife, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
95M8R751W8
RxNorm concept
226917
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Suppression classes recorded: S3.
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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
2 approved applications cover products containing this substance. The earliest was NDA020766, approved 19990423 to CHEPLAPHARM.
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What is not here
5 questions this page could not answer
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Recorded evidence blocks (12)
Q2
What did Orlistat's largest trial (638 people) and its longest (13 years) measure?
638 people in Orlistat's largest registered study, 13 years in its longest registered window, measuring increase in fecal bilirubin concentration during orlistat. ClinicalTrials.gov · 2026-09-01
18 phase4, 15 phase2, 14 na, 3 na or unstated, 2 phase3, 1 phase1; NCT00001723; 2011-10; no ageing endpoint recorded. Last human test completed 2024, NCT05579249.
Interpretation These counts include studies where Orlistat 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
phase4
18
phase2
15
na
14
na or unstated
3
phase3
2
phase1
1
1 more recorded row
Last recorded human testNCT05579249
2024-11-27
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Orlistat shown lifespan?
Interpretation increase in fecal bilirubin concentration during orlistat — the recorded outcome words.
Show the evidence
mouse
lifespan
humanNCT00461799
biomarker; increase in fecal bilirubin concentration during orlistat; 53
recorded 2026-09-01 · last checked 2026-09-04
Q4
4 of Orlistat's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?
futility/efficacy (1), accrual/recruitment (1), funding/business (1) and other (1): Orlistat's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Lack of funding"; 4 of 53 registered studies
Show the evidence
Trial
NCT01351753
terminated; "Lack of funding"
NCT01597531
terminated; "Difficulty recruiting patients"
NCT01675154
terminated; "Due to unavailability of the drug."
NCT04531176
terminated; "After an unplanned yet IRB approved interim analysis, it was found that there was not a significant difference between the 3 arms of the study. The study was closed due to futility. All Patients are off study and this study will not resume."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Orlistat used Orlistat 120 mg — over how long?
11 recorded entries; human; also "Orlistat 120 mg", "120 mg orlistat", "60 mg orlistat"
Show the evidence
human
NCT01126970
Orlistat 120 mg
NCT01550926
120 mg orlistat
NCT01550926
60 mg orlistat
NCT01755676
Orlistat 60 mg
NCT02141230
Alli® 60 mg
NCT02529631
orlistat 60 mg
5 more recorded rows
humanNCT03884127
Orlistat 120 MG
humanNCT05934110
MR orlistat 120 mg
humanNCT05934110
Conventional orlistat 120 mg,
humanNCT06993428
EMP16-02 120 mg orlistat/40 mg acarbose
humanNCT07326839
Orlistat 120 mg tid
recorded 2026-09-01 · last checked 2026-09-04
Q6
Orlistat's half-life is 1 to 2 hours — which schedules were studied?
1 to 2 hours, the half-life Orlistat's label states. openfda-label · 6240792b-9224-2d10-e053-2a91aa0a2c3e · 2026-08-30
Show the evidence
half life
1 to 2 hours hours; Based on limited data, the half-life of the absorbed orlistat is in the range of 1 to 2 hours.
bioavailability
Nifedipine (extended-release tablets) In 17 normal-weight subjects receiving XENICAL 120 mg three times a day for 6 days, XENICAL did not alter the bioavailability of nifedipine (extended-release tablets).
metabolism
Metabolism Based on an oral 14 C-orlistat mass balance study in obese patients, two metabolites, M1 ((the hydrolyzed β-lactone ring product of orlistat) and M3 (sequential metabolite after M1's cleavage of the N-formyl leucine side-chain), accounted for approximately 42% of total radioactivity in plasma.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of achieving hba1c of 6 without diabetic medication, anti mullerian hormone levels and bile acid did Orlistat's trials measure?
achieving hba1c of 6 without diabetic medication, anti mullerian hormone levels and bile acid lead 32 outcome terms across Orlistat's trials. ClinicalTrials.gov · 2026-09-01
body weight at week 20, live birth rate, body mass index, weight, waist circumference and blood pressure follow.
Show the evidence
body weight at 48 weeks
1
weight loss
1
weight loss compared to baseline
1
body weight at week 20
1
live birth rate
1
body mass index
1
14 more recorded rows
weight
1
waist circumference
1
blood pressure
1
fat mass
1
visceral fat mass improvement
1
physical activity
1
anti mullerian hormone levels
1
type 2 diabetes remission
1
achieving hba1c of 6 without diabetic medication
1
fasting serum triglycerides
1
blood lipid
1
bile acid
1
gastrointestinal flora
1
body weight between baseline and 12 months
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Orlistat's 8 ongoing trials reports first?
"Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia"; n 28; "Change in Triglycerides"; 2029-05-30
NCT06818955
"Orlistat Overcoming Third-generation EGFR-TKI Resistance"; n 36; "ORR"; 2025-11-15
NCT06854614
"Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)"; n 150; "Weight change"; 2028-04-28
NCT06993428
"A Trial With EMP16 in Preparation for Late Phase Studies"; n 39; "Primary objective"; 2025-07-29
NCT07326839
"Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT"; n 120; "The rate of patients achieving target serum uric acid levels"; 2027-11-09
NCT07437001
"Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women"; n 60; "Body Mass Index (BMI)"; 2026-06-15
2 further recorded trials
NCT07714070
"Orlistat Plus Progestin for Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia"; n 48; "Relative change in progesterone receptor (PR) expression from baseline at 3 months (delta PR%)"; 2029-12
NCT07747909
"Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial"; n 120; "Polycystic Ovary Syndrome (PCOS) Features"; 2026-09-15
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 20 trials of Orlistat posted no result?
Posted no result
20 of 20 completed trials
Registrations
NCT00461799, NCT00212199, NCT00156897, NCT00160407, NCT00991926 and NCT01550926, and 14 more
Completion dates
oldest 2004-01; newest 2023-12-01
Show the evidence
Trial
NCT00461799
2004-01
NCT00212199
2004-08
NCT00156897
2005-10
NCT00160407
2006-12
NCT00991926
2009-02
NCT01550926
2009-03
14 further recorded trials
NCT02706067
2009-03
NCT00207311
2009-05
NCT01003483
2009-11
NCT01170806
2010-04
NCT01184560
2010-07
NCT01387243
2010-12
NCT01126970
2011-02
NCT01414465
2011-06
NCT01797757
2012-12
NCT00152360
2013-03
NCT02529631
2013-08
NCT01755676
2017-12-21
NCT02041234
2022-06
NCT05496075
2023-12-01
Q10
At the median, Orlistat's trials enrolled 74 people — anything larger?
Median enrolment
74
Largest enrolment
638
Registered trials counted
53
Q11
What do 490 spontaneous reports say about Orlistat — 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.
Orlistat appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 490 reaction mentions were counted: diarrhoea 94; abdominal pain 79; drug interaction 57; abdominal pain upper 49. open-targets-adr · CHEMBL175247 · 2026-06-24
Show the evidence
diarrhoea
94
abdominal pain
79
drug interaction
57
abdominal pain upper
49
rectal haemorrhage
45
haematochezia
35
4 more recorded rows
cholelithiasis
34
steatorrhoea
34
acute hepatic failure
32
nephropathy
31
recorded 2026-06-24 · last checked 2026-09-04
Q12
Was Orlistat studied with exercise?
exercise is named in Orlistat's label sentences: "FIT-PLESE was designed to study the effect of a pre-fertility treatment 16-week randomized lifestyle intervention program (Nutrisystem diet + exercise + orlistat vs. training alone) on improvement in live birth rate among obese women with unexplained infertility." openfda-label+europepmc · 2023-02-22
1 recorded statement; exercise
Show the evidence
exercise
FIT-PLESE was designed to study the effect of a pre-fertility treatment 16-week randomized lifestyle intervention program (Nutrisystem diet + exercise + orlistat vs. training alone) on improvement in live birth rate among obese women with unexplained infertility.
recorded 2023-02-22 · last checked 2026-09-04
Q13
What is recorded about Orlistat and AMPK?
"This study investigates the mechanism by which ECD improves lipid metabolism through the AMPK/SIRT1/PGC-1α signaling pathway.</p><p> Methods: AML-12 hepatocytes were cultured and divided into Control, Model (palmitic acid-induced lipid deposition), and treatment groups (ECD serum: 2%, 4%, 8%; orlistat: 10 μM)." — where Orlistat and AMPK appear together. Europe PMC · pathway abstract search · 2025-10-15
"This study investigates the mechanism by which ECD improves lipid metabolism through the AMPK/SIRT1/PGC-1α signaling pathway.</p><p> Methods: AML-12 hepatocytes were cultured and divided into Control, Model (palmitic acid-induced lipid deposition), and treatment groups (ECD serum: 2%, 4%, 8%; orlistat: 10 μM)."
sirtuinPMID 41116265
"This study investigates the mechanism by which ECD improves lipid metabolism through the AMPK/SIRT1/PGC-1α signaling pathway.</p><p> Methods: AML-12 hepatocytes were cultured and divided into Control, Model (palmitic acid-induced lipid deposition), and treatment groups (ECD serum: 2%, 4%, 8%; orlistat: 10 μM)."
NAD+PMID 40303304
"FASN inhibitor orlistat reversed lipogenesis and endothelial permeability induced by NAMPT."
autophagy
PMID 38463820
"The lipase inhibitor orlistat and the autophagy inhibitor CQ were used to determine the effects of ACOT7 on FA metabolism, autophagy, and cellular drug sensitivity, as well as the therapeutic value of ACOT7 targeting."
PMID 38463820
"After treatment with orlistat or CQ, FA metabolism in VCR-resistant RB cells decreased, cell viability and autophagy were inhibited, EMT was inhibited, and the sensitivity of RB cells to VCR was increased."
PMID 29974191
"3-Methyladenine (3-MA) was used as an autophagy inhibitor in combined treatment with orlistat."
mTOR
PMID 29974191
"These results suggested orlistat-induced autophagy flux, which was further found involved in inhibiting the Akt/mTOR/p70S6K signaling pathway."
PMID 27188391
"Orlistat inhibits cell growth in endometrial cancer cell lines through inhibition of fatty acid metabolism, induction of cell cycle G1 arrest, activation of AMPK and inhibition of the mTOR pathway."
AMPKPMID 27188391
"Orlistat inhibits cell growth in endometrial cancer cell lines through inhibition of fatty acid metabolism, induction of cell cycle G1 arrest, activation of AMPK and inhibition of the mTOR pathway."
mTORPMID 32045588
"Altogether, this study demonstrates the antilipogenic and antiproliferative efficacy of orlistat in hepatocarcinogenesis, suggesting that orlistat may be beneficial for the treatment of HCC, especially in NAFLD-related HCCs featuring activated AKT/mTOR cascade and increased lipogenesis in livers."
AMPKPMID 33440724
"In vitro findings and clinical data reveal that the FASN inhibitor, orlistat, and the AMPK activator, metformin, may inhibit coronavirus replication and reduce systemic inflammation to restore immune homeostasis."
recorded 2025-10-15 · 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 · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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