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Dexlansoprazole

  • 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 Dexlansoprazole does in the body

Heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks

From the FDA-approved label: Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.

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 · UYE4T5I70X · 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 95 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.

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 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.

The rate of hospitalisation due to peptic ulcer bleeding in patients who enter the randomised study (only the first event per patient will be analysed), adjudicated by a blinded Committee as definite or probable.

The study did not show it

Who was studied
NCT01506986
How many people
30024
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

The incidence of gastric cancer between the intervention and placebo groups

The study did not show it

Who was studied
NCT02112214
How many people
5224
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

Financial impact on the total cost of patient care resulting from implementation of a Pharmacogenetics testing program within a safety-net and Academic healthcare system

The study did not show it

Who was studied
NCT02297126
How many people
4465
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

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

The study did not show it

Who was studied
NCT00251719
How many people
2054
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

Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

The study did not show it

Who was studied
NCT00251693
How many people
2038
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

pH of gastric contents

The study did not show it

Who was studied
NCT02703896
How many people
1920
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 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

People similar to this profile were included.

  • Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: • Healing of all grades of erosive esophagitis (EE). ( 1.1 ) • Maintenance of healed EE and relief of heartburn. ( 1.2 ) • Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD).

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 dexlansoprazole have not been established in pediatric patients less than 12 years of age.”

    US prescribing information · caad4ada-2cf9-4e12-99df-6ca4388cf0f6 · read 2026-08-30

  • On older people, the label states: “Of the total number of patients (n=4,548) in clinical studies of dexlansoprazole, 11% of patients were aged 65 years and over, while 2% were 75 years and over.”

    US prescribing information · caad4ada-2cf9-4e12-99df-6ca4388cf0f6 · read 2026-08-30

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

    US prescribing information · caad4ada-2cf9-4e12-99df-6ca4388cf0f6 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of dexlansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · caad4ada-2cf9-4e12-99df-6ca4388cf0f6 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage adjustment for dexlansoprazole delayed-release capsules is necessary for patients with mild hepatic impairment (Child-Pugh Class A).”

    US prescribing information · caad4ada-2cf9-4e12-99df-6ca4388cf0f6 · 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 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 (10)
It was studied for a different goal
The studies measured something else entirely. 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 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

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 capsule, delayed release, tablet, orally disintegrating, delayed release, 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 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.

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

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

  • 41 products list this as an active ingredient in the United States drug directory. 41 of them contain it and nothing else.

    FDA National Drug Code directory · 64374-101 · read 2026-08-29

  • They are sold as capsule, delayed release, capsule, delayed release pellets and powder, taken oral.

    FDA National Drug Code directory · 64374-101 · read 2026-08-29

  • The regulator's established pharmacologic class for it is proton pump inhibitor [epc] and proton pump inhibitors [moa].

    FDA National Drug Code directory · 64374-101 · read 2026-08-29

  • 15 published labels name it as an active ingredient. 15 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · caad4ada-2cf9-4e12-99df-6ca4388cf0f6 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · caad4ada-2cf9-4e12-99df-6ca4388cf0f6 · read 2026-08-29

  • Dexlansoprazole is oral at 3 DOSAGE FORMS AND STRENGTHS Dexlansoprazole Delayed-Release Capsules 30 mg: strength is an opaque, white capsule with “par” imprinted on the cap and “147” imprinted on the body. 60 mg: strength is an opaque, green caps…, recorded as fda label in effect 2024-01-29 in the United States.

    US prescribing information · caad4ada-2cf9-4e12-99df-6ca4388cf0f6 · 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

  • Racemate of

    Lansoprazole

    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 Dexlansoprazole 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.

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 Dexlansoprazole 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.

How many documents were read

  • 15 documents were read for this substance.

    RNAWiki source record

  • 15 of them state the same tMax, and they agree.

    RNAWiki source record

  • 15 of them state the same proteinBinding, and they agree.

    RNAWiki source record

  • 15 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
UYE4T5I70X
CAS registry number
138530-94-6
PubChem compound
9578005
ChEMBL
CHEMBL1201863
WHO international nonproprietary name list entry
8524
RxNorm concept
816346
EMA substance identifier
100000124233
DrugBank
DB05351

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or 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

  • 6 approved applications cover products containing this substance. The earliest was NDA022287, approved 20090130 to TAKEDA PHARMS USA.

    Drugs@FDA application register · NDA022287 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA022287 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20090130.

    FDA National Drug Code directory · 64374-101 · 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

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • 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 (10)

On the Dexlansoprazole label: indicated for what?


"Dexlansoprazole delayed-release capsules are proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). ( 1.1 ) Maintenance of healed EE and relief of heartburn.": indications and usage on Dexlansoprazole's label. DailyMed label · 59e0c5d7-12e9-b5d7-e063-6394a90a7366 · 2026-08-25

47 registered trials of Dexlansoprazole — at which phases?


Registered studies posting no result
21 of 47

47 registered studies of Dexlansoprazole: 14 phase1, 14 phase3, 9 phase4, 7 phase2, 4 na, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

34 with a PubMed record

Show the evidence
  • phase1
    14
  • phase3
    14
  • phase4
    9
  • phase2
    7
  • na
    4
  • early phase1
    1
4 more recorded rows
  • completed
    35
  • withdrawn
    5
  • terminated
    4
  • unknown
    3

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

8 of Dexlansoprazole's trials stopped: safety, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (1), accrual/recruitment (1), funding/business (1), sponsor decision unspecified (1) and other (4): Dexlansoprazole's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Principal investigator left institution"; 8 of 47 registered studies

Show the evidence

Trial

  • NCT01317472
    terminated; "Principal investigator left institution"
  • NCT01328392
    withdrawn; "The sponsor did not fund the study."
  • NCT01479231
    withdrawn; "Souces of funding have been terminated"
  • NCT01637571
    withdrawn; "Sponsor could not fund"
  • NCT02162758
    terminated; "Business Decisions; No Safety Concerns"
  • NCT02442752
    withdrawn; "Withdrawn: Business decision (no enrollment)"
2 further recorded trials
  • NCT02615184
    terminated; "Study related"
  • NCT02873702
    terminated; "Compound is not expected to change the current treatment practice or fill significant clinical need for patients in China over currently available EE agents."

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

Human studies of Dexlansoprazole used Dexlansoprazole 60 MG — over how long?


Human studies of Dexlansoprazole used "Dexlansoprazole 60 MG". ClinicalTrials.gov · 2026-09-01

5 recorded entries; human; capsule; also "Dexilant 60 MG", "Dexlansoprazole 60 mg once daily", "Dexilant® 60 mg capsule, hard"

Show the evidence

human

  • NCT03043521
    Dexlansoprazole 60 MG
  • NCT03079050
    Dexilant 60 MG
  • NCT03087162
    Dexlansoprazole 60 mg once daily
  • NCT04877834
    capsule; Dexilant® 60 mg capsule, hard
  • NCT06778395
    Dexlansoprazole 60 mg

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

Dexlansoprazole's half-life is 7 Days — which schedules were studied?


7 Days, the half-life Dexlansoprazole's label states: "Mean (%CV) Pharmacokinetic Parameters in Patients 12 to 17 Years of Age with Symptomatic GERD on Day 7 After Administration of Dexlansoprazole Delayed-Release Capsules Once Daily for 7 Days Dose C max (ng/mL) AUC tau (ng∙h/mL) CL/F (L/h) 30 mg (N=17) 691 (53) 2886 (47) 12.8 (48) 60 mg (N=18) 1136 (51) 5120 (58) 15.3…" DailyMed label · 59e0c5d7-12e9-b5d7-e063-6394a90a7366 · 2026-08-25

tmax 0.7 hours.

Show the evidence
  • half life pharmacokinetics
    7 Days; Mean (%CV) Pharmacokinetic Parameters in Patients 12 to 17 Years of Age with Symptomatic GERD on Day 7 After Administration of Dexlansoprazole Delayed-Release Capsules Once Daily for 7 Days Dose C max (ng/mL) AUC tau (ng∙h/mL) CL/F (L/h) 30 mg (N=17) 691 (53) 2886 (47) 12.8 (48) 60 mg (N=18) 1136 (51) 5120 (58) 15.3 (49) Age: Geriatric Population The terminal elimination half-life of…
  • tmax pharmacokinetics
    0.7 hours; Effect on Food In food-effect studies in healthy subjects receiving dexlansoprazole delayed-release capsules under various fed conditions compared to fasting, increases in C max ranged from 12 to 55%, increases in AUC ranged from 9 to 37%, and T max varied (ranging from a decrease of 0.7 hours to an increase of three hours) [see Dosage and Administration (2.3) ] .
  • metabolism pharmacokinetics
    Metabolism Dexlansoprazole is extensively metabolized in the liver by oxidation, reduction, and subsequent formation of sulfate, glucuronide and glutathione conjugates to inactive metabolites.

recorded 2026-08-25 · last checked 2026-09-04

Which 10 trials of Dexlansoprazole posted no result?


Posted no result
10 of 10 completed trials
Registrations
NCT01149395, NCT02529787, NCT03043521, NCT03128736, NCT03011125 and NCT03079050, and 4 more
Completion dates
oldest 2012-04; newest 2022-11-25
Show the evidence

Trial

  • NCT01149395
    2012-04
  • NCT02529787
    2013-03
  • NCT03043521
    2015-08-12
  • NCT03128736
    2016-03-30
  • NCT03011125
    2017-03-09
  • NCT03079050
    2017-07-30
4 further recorded trials
  • NCT03319121
    2017-12
  • NCT03087162
    2017-12-01
  • NCT03202537
    2022-07-31
  • NCT04877834
    2022-11-25

At the median, Dexlansoprazole's trials enrolled 68 people — anything larger?


Median enrolment
68
Largest enrolment
2054
Registered trials counted
47

What do 3562 spontaneous reports say about Dexlansoprazole — 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.

Dexlansoprazole appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3562 reaction mentions were counted: chronic kidney disease 1349; acute kidney injury 632; renal failure 449; renal injury 333. FAERS via Open Targets · CHEMBL1201863 · 2026-06-24

Show the evidence
  • chronic kidney disease
    1349
  • acute kidney injury
    632
  • renal failure
    449
  • renal injury
    333
  • end stage renal disease
    318
  • tubulointerstitial nephritis
    139
4 more recorded rows
  • gastrooesophageal reflux disease
    114
  • renal impairment
    101
  • rebound acid hypersecretion
    75
  • renal haemangioma
    52

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

Which 10 reactions does Dexlansoprazole's label not list?


acute kidney injury, chronic kidney disease and end stage renal disease and 7 more reported for Dexlansoprazole, absent from its label. FAERS via Open Targets · CHEMBL1201863 · 2026-06-24

2 label terms; 10 reported and unlisted; 59e0c5d7-12e9-b5d7-e063-6394a90a7366

Show the evidence
  • acute kidney injury
    count not stated
  • chronic kidney disease
    count not stated
  • end stage renal disease
    count not stated
  • gastrooesophageal reflux disease
    count not stated
  • rebound acid hypersecretion
    count not stated
  • renal failure
    count not stated
4 more recorded rows
  • renal haemangioma
    count not stated
  • renal impairment
    count not stated
  • renal injury
    count not stated
  • tubulointerstitial nephritis
    count not stated

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

Dexlansoprazole and CYP3A4, CYP1A2 and CYTOCHROME P450: shared by which compounds?


CYP3A4, CYP1A2 and CYTOCHROME P450 appear in Dexlansoprazole's recorded interaction sentences, 8 in all. DailyMed label · 59e0c5d7-12e9-b5d7-e063-6394a90a7366 · 2026-08-25

CYP1A2, CYP1A2, CYP2C19, CYP2C19, CYP2C19, CYP2C9; 9 shared nodes; drug_interactions, pharmacokinetics, clinical_pharmacology

Show the evidence

Interaction statement

  • drug_interactions
    Clinically Relevant Interactions Affecting Dexlansoprazole Delayed-Release Capsules When Co-Administered with Other Drugs and Substances CYP2C19 or CYP3A4 Inducers Clinical Impact: Decreased exposure of dexlansoprazole when used concomitantly with strong inducers [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of dexlansoprazole is expected when used concomitantly with strong inhibitors [see Clinical Pharmacology (12.3) ] .
  • pharmacokinetics
    Oxidative metabolites are formed by the cytochrome P450 (CYP) enzyme system including hydroxylation mainly by CYP2C19, and oxidation to the sulfone by CYP3A4.
  • pharmacokinetics
    Elimination Effect of Dexlansoprazole on Other Drugs Cytochrome P 450 Interactions Dexlansoprazole is metabolized, in part, by CYP2C19 and CYP3A4 [see Clinical Pharmacology (12.3) ] .
  • pharmacokinetics
    Furthermore, in vivo studies showed that dexlansoprazole delayed-release capsules did not have an impact on the pharmacokinetics of co-administered phenytoin (CYP2C9 substrate) or theophylline (CYP1A2 substrate).
  • pharmacokinetics
    The subjects' CYP1A2 genotypes in the drug-drug interaction study with theophylline were not determined.
2 more recorded rows
  • Interaction statement pharmacokinetics
    Effect of Other Drugs on Dexlansoprazole Because dexlansoprazole is metabolized by CYP2C19 and CYP3A4, inducers and inhibitors of these enzymes may potentially alter exposure of dexlansoprazole.
  • Interaction statement clinical_pharmacology
    Oxidative metabolites are formed by the cytochrome P450 (CYP) enzyme system including hydroxylation mainly by CYP2C19, and oxidation to the sulfone by CYP3A4.

CYP1A2

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole

CYP2C19

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • CYP2C9
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2026-08-25 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201863
PubChem CID
9578005
CAS number
138530-94-6
RxCUI
816346
InChIKey
MJIHNNLFOKEZEW-RUZDIDTESA-N

Relations

Trade name
Dexilant, Dexilant solutab, Dexlansoprazole Delayed Release, Dexlansoprazole Delayed Release / Dexilant / Dexilant Solutab
Also called
Dexlansoprazol, Kapidex, Lansoprazole, (r)-, Lansoprazole r-form, dexlansoprazole modified release (mr), dexlansoprazole mr, tak-390mr, Dexlansoprazole [INN], Dexlansoprazole [MART.], Dexlansoprazole [ORANGE BOOK], Dexlansoprazole [USAN], Dexlansoprazole [VANDF]
Development code
NSC-758710, T-168390, TAK-390
Salt form
Dexlansoprazole Sesquihydrate
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

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: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 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

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