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Varenicline

  • 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 Varenicline does in the body

The signs and symptoms of dry eye disease

From the FDA-approved label: Varenicline binds with high affinity and selectivity at α 4 β 2 neuronal nicotinic acetylcholine receptors. The efficacy of varenicline in smoking cessation is believed to be the result of varenicline’s activity at α 4 β 2 sub-type of the nicotinic receptor where its binding produces agonist activity, while simultaneously preventing nicotine binding to these receptors. Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to α 4 β 2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine.

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 · 82269ASB48 · read 2026-08-29

  • Its recorded molecular formula is C13H13N3∙C4H6O6, weighing 361.35 Daltons.

    US prescribing information · 0fefd790-b526-4f2f-8c83-5f39f7306556 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 116 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.

Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint

The study did not show it

Who was studied
NCT01456936
How many people
8144
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

Short-term smoking cessation

The study did not show it

Who was studied
NCT06926153
How many people
6500
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

verified abstinence 6 months

The study did not show it

Who was studied
NCT02328794
How many people
6006
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

Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.

The study did not show it

Who was studied
NCT01574703
How many people
4595
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

Biochemically Confirmed Smoking Abstinence Sustained for 6 Months

The study did not show it

Who was studied
NCT04798664
How many people
3228
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

The proportion of adult participants who engage in any evidence-based tobacco use treatments

The study did not show it

Who was studied
NCT06582693
How many people
3200
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
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.

  • TYRVAYA (varenicline solution) nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease. TYRVAYA (varenicline solution) nasal spray is a cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of CHANTIX in pediatric patients have not been established.”

    US prescribing information · 0fefd790-b526-4f2f-8c83-5f39f7306556 · read 2026-08-30

  • On older people, the label states: “A combined single- and multiple-dose pharmacokinetic study demonstrated that the pharmacokinetics of 1 mg varenicline given once daily or twice daily to 16 healthy elderly male and female smokers (aged 65–75 yrs) for 7 consecutive days was similar to that of younger subjects.”

    US prescribing information · 0fefd790-b526-4f2f-8c83-5f39f7306556 · read 2026-08-30

  • On people who are pregnant, the label states: “There are no adequate and well-controlled studies of CHANTIX use in pregnant women.”

    US prescribing information · 0fefd790-b526-4f2f-8c83-5f39f7306556 · read 2026-08-30

  • On people who are breastfeeding, the label states: “It is not known whether CHANTIX is excreted in human milk.”

    US prescribing information · 0fefd790-b526-4f2f-8c83-5f39f7306556 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Varenicline is substantially eliminated by renal glomerular filtration along with active tubular secretion.”

    US prescribing information · 0fefd790-b526-4f2f-8c83-5f39f7306556 · 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

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

Sold as tablet, spray, tablet, film coated, given by the oral, nasal 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

  • 83 products list this as an active ingredient in the United States drug directory. 83 of them contain it and nothing else.

    FDA National Drug Code directory · 71921-308 · read 2026-08-29

  • They are sold as powder, spray, tablet and tablet, film coated, taken nasal and oral.

    FDA National Drug Code directory · 71921-308 · read 2026-08-29

  • The regulator's established pharmacologic class for it is cholinergic agonists [moa], cholinergic receptor agonist [epc] and partial cholinergic nicotinic agonist [epc].

    FDA National Drug Code directory · 71921-308 · read 2026-08-29

  • 41 published labels name it as an active ingredient. 41 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 59e125e3-5204-122b-e063-6394a90a0092 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 59e125e3-5204-122b-e063-6394a90a0092 · read 2026-08-29

  • Recorded price in US: 0.33637–0.35025 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 33 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 Varenicline 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 Varenicline 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

  • 40 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
82269ASB48

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

  • 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

  • 26 approved applications cover products containing this substance. The earliest was NDA021928, approved 20060510 to PF PRISM CV.

    Drugs@FDA application register · NDA021928 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA021928 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20060510.

    FDA National Drug Code directory · 71921-308 · 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 (9)

On the Varenicline label: indicated for what?


"Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment.": indications and usage on Varenicline's label. DailyMed label · 59e125e3-5204-122b-e063-6394a90a0092 · 2026-08-25

295 registered trials of Varenicline — at which phases?


Registered studies posting no result
135 of 295

295 registered studies of Varenicline: 89 phase2, 79 phase4, 57 phase3, 47 na, 28 phase1, 11 na or unstated, 8 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

431 with a PubMed record

Show the evidence
  • phase2
    89
  • phase4
    79
  • phase3
    57
  • na
    47
  • phase1
    28
  • na or unstated
    11
9 more recorded rows
  • early phase1
    8
  • completed
    223
  • recruiting
    18
  • terminated
    18
  • withdrawn
    15
  • unknown
    13
  • active not recruiting
    5
  • not yet recruiting
    2
  • enrolling by invitation
    1

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

27 of Varenicline's trials stopped: safety, accrual/recruitment, funding/business, other?


safety (1), accrual/recruitment (16), funding/business (1) and other (9): Varenicline's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"insufficient recuirment"; 27 of 295 registered studies

Show the evidence

Trial

  • NCT00525928
    withdrawn; "insufficient recuirment"
  • NCT00673595
    terminated; "Difficulty with recruiting sujects and subjects complying with the protocol"
  • NCT00702793
    withdrawn; "No participants enrolled"
  • NCT00733967
    withdrawn; "No longer active"
  • NCT00781755
    withdrawn; "Study design was altered such that a treatment component was removed through the VA IRB. We did not and will not begin this clinical trial."
  • NCT00803868
    terminated; "The DSMB recommended that the study be stopped as a result of concerns regarding safety and intolerability and insufficient evidence of efficacy."
14 further recorded trials
  • NCT00895557
    withdrawn; "This study never started, no funding."
  • NCT00907218
    terminated; "extremely slow enrollment"
  • NCT01532232
    terminated; "Lack of accrual"
  • NCT01560507
    terminated; "Low Recruitment"
  • NCT02147132
    terminated; "Difficulty recruiting eligible participants; study medication was expiring."
  • NCT02412631
    terminated; "Lorcaserin removed from market"
  • NCT02473562
    terminated; "insufficient patient enrollment, insufficient funds for completion"
  • NCT02488889
    withdrawn; "Investigator left institution prior to enrollment of study participants"
  • NCT02582008
    terminated; "Slow accrual"
  • NCT02683161
    terminated; "Inability to adequately recruit participants during pre-post operative period."
  • NCT02856581
    terminated; "Slow accrual"
  • NCT02888444
    terminated; "Poor recruitment"
  • NCT03059563
    terminated; "Global pandemic"
  • NCT03069768
    withdrawn; "Unable to obtain varenicline to provide to participants"

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

Human studies of Varenicline used Varenicline 0.5 MG — over how long?


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

6 recorded entries; human; nasal, oral; also "Varenicline 0.5 MG", "OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)", "Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg"

Show the evidence

human

  • NCT03742154
    Varenicline 0.5 MG
  • NCT03873246
    nasal; OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)
  • NCT04072146
    oral; Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg
  • NCT04072146
    nasal; OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg
  • NCT04167306
    Varenicline Tartrate 1 mg b.i.d
  • NCT06798324
    Varenicline 1mg BID

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

Varenicline's half-life is 24 hours — which schedules were studied?


24 hours, the half-life Varenicline's label states: "Elimination The elimination half-life of varenicline is approximately 24 hours." DailyMed label · 59e125e3-5204-122b-e063-6394a90a0092 · 2026-08-25

Show the evidence
  • half life pharmacokinetics
    24 hours; Elimination The elimination half-life of varenicline is approximately 24 hours.
  • metabolism pharmacokinetics
    Metabolism Varenicline undergoes minimal metabolism, with 92% excreted unchanged in the urine.

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

Which 70 trials of Varenicline posted no result?


Posted no result
70 of 70 completed trials
Registrations
NCT00150241, NCT00150228, NCT00150254, NCT00635401, NCT00143286 and NCT00143299, and 64 more
Completion dates
oldest 2002-01; newest 2024-08-16
Show the evidence

Trial

  • NCT00150241
    2002-01
  • NCT00150228
    2002-09
  • NCT00150254
    2002-10
  • NCT00635401
    2004-08
  • NCT00143286
    2005-03
  • NCT00143299
    2005-03
14 further recorded trials
  • NCT00143364
    2005-03
  • NCT00141206
    2005-04
  • NCT00141167
    2006-01
  • NCT00139750
    2006-02
  • NCT00143325
    2006-06
  • NCT00452894
    2007-03
  • NCT00371813
    2007-06
  • NCT00948649
    2007-09
  • NCT00463918
    2007-12
  • NCT00527150
    2008-02
  • NCT00661765
    2008-06
  • NCT00694044
    2008-06
  • NCT00301145
    2008-11
  • NCT00523445
    2009-07

At the median, Varenicline's trials enrolled 102 people — anything larger?


Median enrolment
102
Largest enrolment
885185
Registered trials counted
295

What do 2169 spontaneous reports say about Varenicline — 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.

Varenicline appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2169 reaction mentions were counted: depression 373; nausea 371; vomiting 302; suicidal ideation 233. FAERS via Open Targets · CHEMBL1076903 · 2026-06-24

Show the evidence
  • depression
    373
  • nausea
    371
  • vomiting
    302
  • suicidal ideation
    233
  • nightmare
    216
  • agitation
    178
4 more recorded rows
  • abnormal dreams
    146
  • insomnia
    135
  • anxiety
    116
  • irritability
    99

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

Which 10 reactions does Varenicline's label not list?


abnormal dreams, agitation and anxiety and 7 more reported for Varenicline, absent from its label. FAERS via Open Targets · CHEMBL1076903 · 2026-06-24

2 label terms; 10 reported and unlisted; 59e125e3-5204-122b-e063-6394a90a0092

Show the evidence
  • abnormal dreams
    count not stated
  • agitation
    count not stated
  • anxiety
    count not stated
  • depression
    count not stated
  • insomnia
    count not stated
  • irritability
    count not stated
4 more recorded rows
  • nausea
    count not stated
  • nightmare
    count not stated
  • suicidal ideation
    count not stated
  • vomiting
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1076903
PubChem CID
5310966
CAS number
249296-44-4
RxCUI
591622
InChIKey
JQSHBVHOMNKWFT-DTORHVGOSA-N
Also called
oc-01, Vareniclina, var, vcn, vrn, VARENICLINE TARTRATE, Tyrvaya, Varenicline tartrate [JAN], Varenicline tartrate [MART.], Varenicline tartrate [MI], Varenicline tartrate [ORANGE BOOK], Varenicline tartrate [USAN]
Development code
CP-526,555, CP-526555, CP-526,555-18, CP-526555-18
Trade name
Champix, Chantix, Chantix / Tyrvaya
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

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.