Skip to content

Asenapine

  • 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 Asenapine does in the body

Bipolar I disorder [see Clinical Studies (14.2)]

From the FDA-approved label: The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown. It has been suggested that the efficacy of asenapine in schizophrenia could be mediated through a combination of antagonist activity at D 2 and 5-HT 2A receptors.

Why people take it. Bipolar I disorder [see Clinical Studies (14.2)]

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 · JKZ19V908O · read 2026-08-29

  • Its recorded molecular formula is C17H16ClNO, weighing 401.84.

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-30

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 72 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.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

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 in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline

The study did not show it

Who was studied
NCT00212784
How many people
1225
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. Transdermal

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

Time to Relapse or an Impending Relapse

The study did not show it

Who was studied
NCT00150176
How many people
831
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. Transdermal

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

Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6.

The study did not show it

Who was studied
NCT02876900
How many people
617
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. Transdermal

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 time (in days) to recurrence of any mood event during the double-blind treatment period

The study did not show it

Who was studied
NCT01396291
How many people
561
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. Transdermal

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

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.

The study did not show it

Who was studied
NCT01098110
How many people
532
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. Transdermal

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

Maintenance of the effect (Asenapine comparable to olanzapine in terms of the reduction of symptoms achieved in the short term (ie. 3 week studies [A7501004 or A7501005]) as measured on the Young Mania Rating Scale

The study did not show it

Who was studied
NCT00143182
How many people
504
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. Transdermal

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.

  • Asenapine sublingual tablets are indicated for: Schizophrenia in adults [see Clinical Studies (14.1) ] Bipolar I disorder [see Clinical Studies (14.2) ] Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults Asenapine sublingual tablets are an atypical antipsychotic…

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 efficacy of asenapine as adjunctive therapy in the treatment of bipolar I disorder have not been established in the pediatric population.”

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-30

  • On older people, the label states: “Clinical studies of asenapine in the treatment of bipolar mania and another indication did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients.”

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-30

  • On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine during pregnancy.”

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Lactation studies have not been conducted to assess the presence of asenapine in human milk, the effects of asenapine on the breastfed infant, or the effects of asenapine on milk production.”

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-30

  • On people with reduced liver function, the label states: “Asenapine is contraindicated in patients with severe hepatic impairment (Child-Pugh C) because asenapine exposure is 7-fold higher in subjects with severe hepatic impairment than the exposure observed in subjects with normal hepatic function.”

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dosage adjustment for asenapine is required on the basis of a patient’s renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 mL/minute).”

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · 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.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to 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

Transdermal

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: S6.

No source is stored against this line.

What is in the pack

Sold as system, tablet, film, extended release, given by the transdermal, sublingual 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

Transdermal

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

  • 40 products list this as an active ingredient in the United States drug directory. 40 of them contain it and nothing else.

    FDA National Drug Code directory · 62938-0039 · read 2026-08-29

  • They are sold as film, extended release, powder and tablet, taken sublingual and transdermal.

    FDA National Drug Code directory · 62938-0039 · read 2026-08-29

  • The regulator's established pharmacologic class for it is atypical antipsychotic [epc].

    FDA National Drug Code directory · 62938-0039 · read 2026-08-29

  • 7 published labels name it as an active ingredient. 7 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-29

  • Asenapine is sublingual at 3 DOSAGE FORMS AND STRENGTHS 2.5 mg: White to off white, round tablets debossed with ‘L’ on one side and ‘70’ on the other side. 5 mg: White to off white, round tablets debossed with “464” on one side and plain on other…, recorded as fda label in effect 2023-01-20 in the United States.

    US prescribing information · cf587c48-9cd2-4dc5-b0e9-21783c5633a6 · read 2026-08-30

  • Recorded price in US: 2.14754–3.11692 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 13 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

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

What it would be like to 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.

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 Asenapine 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 Asenapine 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

  • 7 documents were read for this substance.

    RNAWiki source record

  • 6 of them state the same bioavailability, and they agree.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
JKZ19V908O
RxNorm concept
859975

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

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • 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

  • 5 approved applications cover products containing this substance. The earliest was NDA022117, approved 20090813 to ABBVIE.

    Drugs@FDA application register · NDA022117 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA022117 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20100805.

    FDA National Drug Code directory · 62938-0039 · 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 (8)

On the Asenapine label: indicated for what?


"Asenapine is indicated for: • Bipolar I disorder [see Clinical Studies (14.2)] • Acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults Asenapine is an atypical antipsychotic indicated for ( 1 ): Bipolar I disorder o Acute…": indications and usage on Asenapine's label. DailyMed label · 16e1cc9f-7699-49ea-b179-acb65e162304 · 2025-02-25

45 registered trials of Asenapine — at which phases?


Registered studies posting no result
22 of 45

45 registered studies of Asenapine: 32 phase3, 6 phase4, 3 na or unstated, 2 phase1, 2 phase2. CLINICALTRIALS_SNAPSHOT · 2026-09-01

52 with a PubMed record

Show the evidence
  • phase3
    32
  • phase4
    6
  • na or unstated
    3
  • phase1
    2
  • phase2
    2
  • completed
    40
3 more recorded rows
  • terminated
    2
  • unknown
    2
  • suspended
    1

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

3 of Asenapine's trials stopped: accrual/recruitment, other?


accrual/recruitment (1) and other (2): Asenapine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Study transferring to another facility"; 3 of 45 registered studies

Show the evidence

Trial

  • NCT01684657
    suspended; "Study transferring to another facility"
  • NCT01807741
    terminated; "funding ended due to recruitment delays"
  • NCT02893371
    terminated; "Per PI, this study is not a clinical trial and was inadvertently entered in the system"

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

Human studies of Asenapine used Asenapine 5 mg — over how long?


studies of Asenapine used the recorded amount. ClinicalTrials.gov · 2026-09-01

8 recorded entries; human; also "Asenapine 5 mg", "Asenapine 10 mg", "asenapine 2.5 mg"

Show the evidence

human

  • NCT01098110
    Asenapine 5 mg
  • NCT01098110
    Asenapine 10 mg
  • NCT01190254
    asenapine 2.5 mg
  • NCT01190254
    asenapine 5.0 mg
  • NCT01206517
    Asenapine 2.5 mg
  • NCT01549041
    Asenapine 10 mg daily in the evening
2 more recorded rows
  • human NCT01549041
    Asenapine 5 mg twice daily
  • human NCT01670019
    Asenapine 5-20 mg daily

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

Asenapine's half-life is 24 hrs — which schedules were studied?


24 hrs, the half-life Asenapine's label states: "Following an initial more rapid distribution phase, the mean terminal half-life is approximately 24 hrs." DailyMed label · 16e1cc9f-7699-49ea-b179-acb65e162304 · 2025-02-25

tmax 1 hour; bioavailability 35 %.

Show the evidence
  • half life pharmacokinetics
    24 hrs; Following an initial more rapid distribution phase, the mean terminal half-life is approximately 24 hrs.
  • tmax pharmacokinetics
    1 hour; Following a single 5 mg dose of asenapine, the mean C max was approximately 4 ng/mL and was observed at a mean t max of 1 hour.
  • bioavailability pharmacokinetics
    35 %; The absolute bioavailability of sublingual asenapine at 5 mg is 35%.
  • metabolism pharmacokinetics
    Elimination of asenapine is primarily through direct glucuronidation by UGT1A4 and oxidative metabolism by cytochrome P450 isoenzymes (predominantly CYP1A2).

recorded 2025-02-25 · last checked 2026-09-04

Which 17 trials of Asenapine posted no result?


Posted no result
17 of 17 completed trials
Registrations
NCT00878462, NCT00151424, NCT00212784, NCT00159796, NCT00159744 and NCT00156117, and 11 more
Completion dates
oldest 2005-10-15; newest 2018-07-05
Show the evidence

Trial

  • NCT00878462
    2005-10-15
  • NCT00151424
    2006-02-06
  • NCT00212784
    2006-03-15
  • NCT00159796
    2006-04-28
  • NCT00159744
    2006-04-29
  • NCT00156117
    2006-05-30
11 further recorded trials
  • NCT00143182
    2006-06-28
  • NCT00156104
    2006-09-16
  • NCT00212771
    2006-10
  • NCT00156091
    2007-06
  • NCT00212836
    2007-08-02
  • NCT01948024
    2013-08
  • NCT01395992
    2015-01
  • NCT01617200
    2015-03
  • NCT01396291
    2015-06
  • NCT01498770
    2017-12-21
  • NCT02600741
    2018-07-05

At the median, Asenapine's trials enrolled 218 people — anything larger?


Median enrolment
218
Largest enrolment
1037352
Registered trials counted
45

Asenapine and CYP1A2, CYP2D6 and UGT1A4: shared by which compounds?


CYP1A2, CYP2D6 and UGT1A4 appear in Asenapine's recorded interaction sentences, 8 in all. DailyMed label · 16e1cc9f-7699-49ea-b179-acb65e162304 · 2025-02-25

CYP1A2, CYP1A2, CYP1A2, CYP2D6, CYP2D6, CYP3A4; 7 shared nodes; drug_interactions, pharmacokinetics

Show the evidence

Interaction statement

  • drug_interactions
    ( 5.7 , 7.1 , 12.3 ) • Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine by half when used in combination with asenapine.
  • drug_interactions
    Strong CYP1A2 Inhibitors (e.g., Fluvoxamine) Asenapine is metabolized by CYP1A2.
  • drug_interactions
    CYP2D6 substrates and inhibitors (e.g., paroxetine) Asenapine may enhance the inhibitory effects of paroxetine on its own metabolism.
  • drug_interactions
    7.2 Drugs Having No Clinically Important Interactions with Asenapine No dosage adjustment of asenapine is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions (7.1) for paroxetine dosage adjustment), imipramine, cimetidine, valporate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin).
  • pharmacokinetics
    Elimination of asenapine is primarily through direct glucuronidation by UGT1A4 and oxidative metabolism by cytochrome P450 isoenzymes (predominantly CYP1A2).
  • pharmacokinetics
    Metabolism and Elimination: Direct glucuronidation by UGT1A4 and oxidative metabolism by cytochrome P450 isoenzymes (predominantly CYP1A2) are the primary metabolic pathways for asenapine.
2 more recorded rows
  • Interaction statement pharmacokinetics
    In vitro studies indicate that asenapine is a substrate for UGT1A4, CYP1A2 and to a lesser extent CYP3A4 and CYP2D6.
  • Interaction statement pharmacokinetics
    Asenapine is a weak inhibitor of CYP2D6.

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

CYP2D6

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

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

recorded 2025-02-25 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

PubChem CID
163091
CAS number
65576-45-6
RxCUI
859975
InChIKey
VSWBSWWIRNCQIJ-HUUCEWRRSA-N
Salt form
Asenapine Maleate
Trade name
Secuado, Saphris, Secuado / Saphris, Sycrest
Also called
(3ARS,12BRS)-5-CHLORO-2-METHYL-2,3,3A,12B-TETRAHYDRO-1H-DIBENZO(2,3:6,7)OXEPINO(4,5-C)PYRROLE, 1H-DIBENZ(2,3:6,7)OXEPINO(4,5-C)PYRROLE, 5-CHLORO-2,3,3A,12B-TETRAHYDRO-2-METHYL-, (3AR,12BR)-REL-, ASENAPINE [MI], ASENAPINE [ORANGE BOOK], ASENAPINE [VANDF], Asenapine [WHO-DD], asenapine [INN]
Sources (5)

Sources

  • CLINICALTRIALS_SNAPSHOT K1:JKZ19V908O ·
  • ClinicalTrials.gov clinicaltrials.gov ·
  • drugsfda+ema drugsfda+ema ·
  • DailyMed label 16e1cc9f-7699-49ea-b179-acb65e162304 ·
  • Drugs@FDA K1:JKZ19V908O ·

ClinicalTrials.gov — US Government work · 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: 5 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.