Skip to content

TELOTRISTAT ETIPRATE

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What TELOTRISTAT ETIPRATE does in the body

Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

Telotristat, the active metabolite of telotristat ethyl, is an inhibitor of tryptophan hydroxylase, which mediates the rate limiting step in serotonin biosynthesis. The in vitro inhibitory potency of telotristat towards tryptophan hydroxylase is 29 times higher than that of telotristat ethyl. Serotonin plays a role in mediating secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-produced in patients with carcinoid syndrome. Through inhibition of tryptophan hydroxylase, telotristat and telotristat ethyl reduce the production of peripheral serotonin, and the frequency of carcinoid syndrome diarrhea.

Why people take it. Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

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 · 3T25U84H4U · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

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.

What happened in peopleRead 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 13 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.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
MuscleNothing 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 moved1 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.
Which registered measures put each goal on this table
Muscle
lean body mass from baseline and after 13 weeks of treatment

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
1 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 peopleRead 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 in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks

The study did not show it

Who was studied
NCT01677910
How many people
135
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

The study did not show it

Who was studied
NCT02026063
How many people
124
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Percent Change in NTproBNP at 6 Months Visit From Baseline

The study did not show it

Who was studied
NCT04810091
How many people
79
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period

The study did not show it

Who was studied
NCT02063659
How many people
76
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Number of Participants Experiencing a Treatment Emergent Adverse Event

The study did not show it

Who was studied
NCT01456052
How many people
59
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment

The study did not show it

Who was studied
NCT03790111
How many people
53
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · 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 peopleRead 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.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No 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 takeRead 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.

  • who are satisfied their overall symptom control

Measured

Things only a test, a scale or a device shows.

  • plasma concentrations of telotristat ethyl
  • plasma concentrations of metabolite lp 778902
  • lean body mass from baseline and after 13 weeks of treatment

Meaningful

Things that change how a life goes, not only a number.

  • progression free survival

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 (8)
  • any teae in the open label extension phase
  • bowel movements per day averaged over 12 weeks
  • teaes in the open label extension period
  • treatment emergent adverse events
  • apparent volume of distribution of total telotristat ethyl
  • weight stability
  • bowel movements
  • observed carcinoid crises during surgery

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead 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

No description of who was studied is recorded.

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 Xermelo in pediatric patients have not been established.”

    US prescribing information · f9108ac3-ca6e-4faf-9d04-953abb64d072 · read 2026-08-30

  • On older people, the label states: “Of 45 patients in a clinical trial of Xermelo, 19 (42%) patients were 65 years of age and over.”

    US prescribing information · f9108ac3-ca6e-4faf-9d04-953abb64d072 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no human data with Xermelo use in pregnant women to inform a drug-associated risk.”

    US prescribing information · f9108ac3-ca6e-4faf-9d04-953abb64d072 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of telotristat ethyl in human or animal milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · f9108ac3-ca6e-4faf-9d04-953abb64d072 · 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 takeRead 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 2 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 takeRead 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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

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 takeNothing 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.

TELOTRISTAT ETIPRATE appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 592 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • diarrhoea — 116 reaction mentions
  • abdominal pain — 82 reaction mentions
  • nausea — 73 reaction mentions
  • constipation — 72 reaction mentions
  • fatigue — 63 reaction mentions
  • flushing — 54 reaction mentions
  • headache — 41 reaction mentions
  • disease progression — 32 reaction mentions
  • hospitalisation — 30 reaction mentions
  • blood glucose increased — 29 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 unclearRead 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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

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

  • 1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.

    FDA National Drug Code directory · 24538-606 · read 2026-08-29

  • They are sold as powder.

    FDA National Drug Code directory · 24538-606 · read 2026-08-29

  • Xermelo is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 250 mg telotristat ethyl; white to off-white, coated and oval with “T-E” debossed on one side and “250” debossed on the other side., recorded as fda label in effect 2025-10-01 in the United States.

    US prescribing information · f9108ac3-ca6e-4faf-9d04-953abb64d072 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

Names and forms linked to this record

  • Contains

    Telotristat Ethyl

    Evidence on this page does not automatically apply to this one.

  • Contains

    HIPPURIC ACID

    Evidence on this page does not automatically apply to this one.

What it would be like to takeRead 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 TELOTRISTAT ETIPRATE 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 unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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 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 TELOTRISTAT ETIPRATE 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 peopleRead 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.

Where else this substance is registered

FDA substance identifier (UNII)
3T25U84H4U
CAS registry number
1137608-69-5
PubChem compound
25253377
RxNorm concept
1872448
EMA substance identifier
100000168560
DrugBank
DBSALT002591

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was NDA208794, approved 20170228 to TERSERA.

    Drugs@FDA application register · NDA208794 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA208794 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20170511.

    FDA National Drug Code directory · 24538-606 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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 (9)

What did TELOTRISTAT ETIPRATE's largest trial (223 people) and its longest (7.5 years) measure?


223 people in TELOTRISTAT ETIPRATE's largest registered study, 7.5 years in its longest registered window, measuring Midazolam plasma concentration in combination with steady state telotristat etiprate. ClinicalTrials.gov · 2026-09-01

7 phase1, 7 phase2, 4 phase3, 2 na or unstated; NCT04065165; 2027-10; no ageing endpoint recorded. Last human test completed 2022, NCT03910387.

Interpretation These counts include studies where TELOTRISTAT ETIPRATE 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
  • phase1
    7
  • phase2
    7
  • phase3
    4
  • na or unstated
    2
  • Last recorded human test NCT03910387
    2022-06-29

recorded 2026-09-01 · last checked 2026-09-04

TELOTRISTAT ETIPRATE was tested only in human — what did it show?


human: biomarker (20): the rungs where TELOTRISTAT ETIPRATE has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Midazolam plasma concentration in combination with steady state telotristat etiprate — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT02147808
    biomarker; Midazolam plasma concentration in combination with steady state telotristat etiprate; 20

recorded 2026-09-01 · last checked 2026-09-04

4 of TELOTRISTAT ETIPRATE's trials stopped: funding/business, other?


funding/business (3) and other (1): TELOTRISTAT ETIPRATE's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"lack of funding"; 4 of 20 registered studies

Show the evidence

Trial

  • NCT04034745
    withdrawn; "lack of funding"
  • NCT04065165
    withdrawn; "Company decision"
  • NCT04543955
    terminated; "Sponsor cancelled research"
  • NCT04672876
    withdrawn; "Trial funding no longer available."

recorded 2026-09-01 · last checked 2026-09-04

Could one person measure TELOTRISTAT ETIPRATE's effect on any teae in the open label extension phase?


Any teae in the open label extension phase: measured in TELOTRISTAT ETIPRATE's trials.

Interpretation any teae in the open label extension phase is the recorded endpoint.

Show the evidence

biomarkers

  • any teae in the open label extension phase; 2026-09-01
  • bowel movements per day averaged over 12 weeks; 2026-09-01
  • teaes in the open label extension period; 2026-09-01
  • treatment emergent adverse events; 2026-09-01
  • plasma concentrations of telotristat ethyl; 2026-09-01
  • plasma concentrations of metabolite lp 778902; 2026-09-01
7 more recorded rows
  • biomarkers
    who are satisfied their overall symptom control; 2026-09-01
  • biomarkers
    apparent volume of distribution of total telotristat ethyl; 2026-09-01
  • biomarkers
    weight stability; 2026-09-01
  • biomarkers
    lean body mass from baseline and after 13 weeks of treatment; 2026-09-01
  • biomarkers
    bowel movements; 2026-09-01
  • biomarkers
    progression free survival; 2026-09-01
  • biomarkers
    observed carcinoid crises during surgery; 2026-09-01
  • human trials at or under30
    14
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    0; NCT04034745; NA_OR_UNSTATED; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of any teae in the open label extension phase, apparent volume of distribution of total telotristat ethyl and bowel movements did TELOTRISTAT ETIPRATE's trials measure?


any teae in the open label extension phase, apparent volume of distribution of total telotristat ethyl and bowel movements lead 13 outcome terms across TELOTRISTAT ETIPRATE's trials. ClinicalTrials.gov · 2026-09-01

treatment emergent adverse events, plasma concentrations of telotristat ethyl, plasma concentrations of metabolite lp 778902, who are satisfied their overall symptom control, apparent volume of distribution of total telotristat ethyl and weight stability follow.

Show the evidence
  • any teae in the open label extension phase
    1
  • bowel movements per day averaged over 12 weeks
    1
  • teaes in the open label extension period
    1
  • treatment emergent adverse events
    1
  • plasma concentrations of telotristat ethyl
    1
  • plasma concentrations of metabolite lp 778902
    1
7 more recorded rows
  • who are satisfied their overall symptom control
    1
  • apparent volume of distribution of total telotristat ethyl
    1
  • weight stability
    1
  • lean body mass from baseline and after 13 weeks of treatment
    1
  • bowel movements
    1
  • progression free survival
    1
  • observed carcinoid crises during surgery
    1

recorded 2026-09-01 · last checked 2026-09-04

At the median, TELOTRISTAT ETIPRATE's trials enrolled 23.5 people — anything larger?


Median enrolment
23.5
Largest enrolment
223
Registered trials counted
20

What do 592 spontaneous reports say about TELOTRISTAT ETIPRATE — 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.

TELOTRISTAT ETIPRATE appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 592 reaction mentions were counted: diarrhoea 116; abdominal pain 82; nausea 73; constipation 72. open-targets-adr · CHEMBL3348963 · 2026-06-24

Show the evidence
  • diarrhoea
    116
  • abdominal pain
    82
  • nausea
    73
  • constipation
    72
  • fatigue
    63
  • flushing
    54
4 more recorded rows
  • headache
    41
  • disease progression
    32
  • hospitalisation
    30
  • blood glucose increased
    29

recorded 2026-06-24 · last checked 2026-09-04

TELOTRISTAT ETIPRATE and P-GP, BCRP and P-GLYCOPROTEIN: shared by which compounds?


P-GP, BCRP and P-GLYCOPROTEIN appear in TELOTRISTAT ETIPRATE's recorded interaction sentences, 1 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP3A4 pharmacokinetics
    Midazolam (sensitive CYP3A4 substrate) Following administration of multiple doses of telotristat ethyl, the systemic exposure to concomitant midazolam was significantly decreased.

recorded 2026-08-30 · last checked 2026-09-04

What is recorded about TELOTRISTAT ETIPRATE and mTOR?


"We report the latest innovations in their management, in particular the results of three trials concerning the use of the mammalian target of rapamycin (mTOR) inhibitor, everolimus, in non-functional NETs of lung/ gastrointestinal (GI) origin, the first randomised trial of radiolabelled <sup>177</sup>Lu-DOTATATE in patients with mid-gut…" — where TELOTRISTAT ETIPRATE and mTOR appear together. Europe PMC · pathway abstract search · 2016-03-15

mTOR; PMID 29632589

Show the evidence
  • mTOR PMID 29632589
    "We report the latest innovations in their management, in particular the results of three trials concerning the use of the mammalian target of rapamycin (mTOR) inhibitor, everolimus, in non-functional NETs of lung/ gastrointestinal (GI) origin, the first randomised trial of radiolabelled <sup>177</sup>Lu-DOTATATE in patients with mid-gut NETs, and the use of the 5-HT synthesis inhibitor,…"

recorded 2016-03-15 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3348963
PubChem CID
25253377
CAS number
1137608-69-5
RxCUI
1872448
InChIKey
MDSQOJYHHZBZKA-GBXCKJPGSA-N

Relations

Development code
LX 1032 HIPPURATE, LX1032 HIPPURATE, LX-1606 HIPPURATE, LX1606 HIPPURATE
Also called
Telotristat ethyl hippurate, te
Trade name
Xermelo
Sources (7)

Sources

1 more source

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.