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Nabilone

  • 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 Nabilone does in the body

The nausea and vomiting associated with cancer chemotherapy

From the FDA-approved label: Pharmacodynamics Cesamet (nabilone) is an orally active synthetic cannabinoid which, like other cannabinoids, has complex effects on the central nervous system (CNS). , the CB (1) receptor, which has been discovered in neural tissues. Nontherapeutic Effects: Cesamet, a synthetic cannabinoid, has the potential to be abused and to produce psychological dependence. Cesamet has complex effects on the central nervous system. , “inner mental life”) are similar to those of cannabis.

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 · 2N4O9L084N · read 2026-08-29

  • Its recorded molecular formula is C24H36O3, weighing 372.55.

    US prescribing information · 83c7ac15-ece9-47de-b83c-d575544fa449 · 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 93 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

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

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

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

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

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

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 16 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
PainNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer4 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Body weightNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved2 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Pain
visual analogue scale pain scores; visual analogue scale for pain; brief pain inventory; pain relief
Body weight
weight loss; body mass index
Blood sugar
changes in insulin sensitivity

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Waiting for a reviewer
4 registered symptom measure.
Not recorded
Harms were not a registered measure for this goal.
Only a number moved
2 registered test measure.

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.

AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo

The study did not show it

Who was studied
NCT07644052
How many people
420
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

Incidence of postoperative nausea and/or vomiting

The study did not show it

Who was studied
NCT02115529
How many people
331
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days

The study did not show it

Who was studied
NCT05494437
How many people
234
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Agitation - Cohen-Mansfield Agitation Inventory (CMAI)

The study did not show it

Who was studied
NCT04516057
How many people
112
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

Change From Baseline in Cannabis Use at 10 Weeks

The study did not show it

Who was studied
NCT01347762
How many people
84
Study design
Phase 2/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

Total amount of opioid consumption postoperatively

The study did not show it

Who was studied
NCT03422861
How many people
80
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 happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.6 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

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

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • visual analogue scale pain scores
  • visual analogue scale for pain
  • agitation cohen mansfield agitation inventory
  • brief pain inventory
  • pain relief
  • cohen mansfield agitation inventory

Measured

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

  • changes in insulin sensitivity
  • weight loss
  • body mass index

Meaningful

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

No registered study measured anything of this kind.

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (7)
  • cannabis use at 10 weeks
  • anorexia
  • yale brown obsessive compulsive scale
  • douleur neuropathique 4
  • cue reactivity
  • skin conductance response
  • expectancy ratings

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

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.

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 have not been established in patients younger than 18 years of age.”

    US prescribing information · 83c7ac15-ece9-47de-b83c-d575544fa449 · read 2026-08-30

  • On older people, the label states: “Clinical studies of Cesamet did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · 83c7ac15-ece9-47de-b83c-d575544fa449 · read 2026-08-30

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

    US prescribing information · 83c7ac15-ece9-47de-b83c-d575544fa449 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

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

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

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

What it would be like to 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: S2.

No source is stored against this line.

What is in the pack

Sold as capsule, given by the oral route.

Source-linked record

Where this came from

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

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to 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

  • 3 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.

    FDA National Drug Code directory · 73548-2162 · read 2026-08-29

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

    FDA National Drug Code directory · 73548-2162 · read 2026-08-29

  • The regulator's established pharmacologic class for it is cannabinoid [epc] and cannabinoids [cs].

    FDA National Drug Code directory · 73548-2162 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 83c7ac15-ece9-47de-b83c-d575544fa449 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 83c7ac15-ece9-47de-b83c-d575544fa449 · read 2026-08-29

  • Cesamet is oral at HOW SUPPLIED Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0187-1231-50., recorded as fda label in effect 2021-01-19 in the United States.

    US prescribing information · 83c7ac15-ece9-47de-b83c-d575544fa449 · 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.

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 Nabilone 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 Nabilone are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
2N4O9L084N
RxNorm concept
104885

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: S2.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was NDA018677, approved 19851226 to BAUSCH.

    Drugs@FDA application register · NDA018677 · read 2026-08-29

  • Marketing status on the register: discontinued.

    Drugs@FDA application register · NDA018677 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20120101.

    FDA National Drug Code directory · 73548-2162 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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

This order is fixed in code and does not count clicks or time on the page.

What is not here

6 questions this page could not answer

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

  • The path through the body — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

What did Nabilone's largest trial (420 people) and its longest (7 years) measure?


420 people in Nabilone's largest registered study, 7 years in its longest registered window, measuring Visual Analogue Scale Pain Scores. ClinicalTrials.gov · 2026-09-01

17 phase2, 10 phase3, 6 phase4, 5 phase1, 2 na, 1 na or unstated; NCT01347762; 2017-06-09; no ageing endpoint recorded. Last human test completed 2025, NCT05885685.

Interpretation These counts include studies where Nabilone was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase2
    17
  • phase3
    10
  • phase4
    6
  • phase1
    5
  • na
    2
  • na or unstated
    1
1 more recorded row
  • Last recorded human test NCT05885685
    2025-12-05

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

Nabilone was tested only in human — what did it show?


human: mechanism-only (34): the rungs where Nabilone has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Visual Analogue Scale Pain Scores — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human mechanism-only
Show the evidence
  • human NCT00272207
    mechanism-only; Visual Analogue Scale Pain Scores; 34

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

6 of Nabilone's trials stopped: safety, accrual/recruitment, other?


safety (2), accrual/recruitment (2) and other (2): Nabilone's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Enrollment was too slow"; 6 of 34 registered studies

Show the evidence

Trial

  • NCT00418678
    terminated; "Enrollment was too slow"
  • NCT03251326
    terminated; "Recruitment difficulties"
  • NCT04801641
    terminated; "Poor tolerability of medication and no preliminary efficacy"
  • NCT04807829
    withdrawn; "The study was stopped due to drug unavailability. The drug is unavailable because production was discontinued in the US."
  • NCT04880278
    withdrawn; "The Principal Investigator is no longer at the Institution and a request for early termination of the grant supporting the study was submitted to NIH."
  • NCT05742698
    terminated; "Terminated due to slow recruitment: only 3 randomized in 2 years. Eligible population overestimated and funding exhausted; PI deemed further recruitment unfeasible. No participants on treatment, no safety concerns. All sites are now closed."

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

Human studies of Nabilone used nabilone 0.5 mg — over how long?


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

4 recorded entries; human; also "nabilone 0.5 mg", "Nabilone 0.25 mg", "Nabilone 0.5 MG Oral Capsule"

Show the evidence

human

  • NCT01222468
    nabilone 0.5 mg
  • NCT03769896
    Nabilone 0.25 mg
  • NCT05180968
    Nabilone 0.5 MG Oral Capsule
  • NCT05273320
    02392925 Teva-Nabilone 0.25 mg Capsule; 02384892 Teva-Nabilone 1 mg Capsule

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

Which of agitation cohen mansfield agitation inventory, anorexia and body mass index did Nabilone's trials measure?


agitation cohen mansfield agitation inventory, anorexia and body mass index lead 16 outcome terms across Nabilone's trials. ClinicalTrials.gov · 2026-09-01

Interpretation changes in insulin sensitivity, agitation cohen mansfield agitation inventory, anorexia, weight loss, body mass index and yale brown obsessive compulsive scale follow.

Show the evidence
  • visual analogue scale pain scores
    1
  • visual analogue scale for pain
    1
  • cannabis use at 10 weeks
    1
  • changes in insulin sensitivity
    1
  • agitation cohen mansfield agitation inventory
    1
  • anorexia
    1
10 more recorded rows
  • weight loss
    1
  • body mass index
    1
  • yale brown obsessive compulsive scale
    1
  • brief pain inventory
    1
  • douleur neuropathique 4
    1
  • cue reactivity
    1
  • pain relief
    1
  • skin conductance response
    1
  • expectancy ratings
    1
  • cohen mansfield agitation inventory
    1

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

Which of Nabilone's 2 ongoing trials reports first?


2 registered trials of Nabilone are open; earliest completion 2027-04. ClinicalTrials.gov · 2026-09-01

Agitation - Cohen-Mansfield Agitation Inventory (CMAI); AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo; latest 2027-09

Show the evidence

Trial

  • NCT04516057
    "Nabilone for Agitation Blinded Intervention Trial"; n 112; "Agitation - Cohen-Mansfield Agitation Inventory (CMAI)"; 2027-04
  • NCT07644052
    "Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder"; n 420; "AUCs of the CSCW over Days 2 to 7, inclusive, comparing PP-01 vs Placebo"; 2027-09

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

Which 15 trials of Nabilone posted no result?


Posted no result
15 of 15 completed trials
Registrations
NCT00272207, NCT00381199, NCT00380913, NCT00380965, NCT00381264 and NCT01025700, and 9 more
Completion dates
oldest 2007-03; newest 2023-08-21
Show the evidence

Trial

  • NCT00272207
    2007-03
  • NCT00381199
    2007-03
  • NCT00380913
    2007-10
  • NCT00380965
    2007-10
  • NCT00381264
    2007-10
  • NCT01025700
    2010-10
9 further recorded trials
  • NCT00699634
    2011-04
  • NCT00480181
    2012-07
  • NCT01517100
    2014-10-06
  • NCT01222468
    2015-02
  • NCT02115529
    2015-11
  • NCT03210766
    2016-01-31
  • NCT02351882
    2019-03
  • NCT05180968
    2023-08-11
  • NCT05494437
    2023-08-21

At the median, Nabilone's trials enrolled 23 people — anything larger?


Median enrolment
23
Largest enrolment
420
Registered trials counted
34

Nabilone and CYP1A2, CYP2C8 and CYP2E1: shared by which compounds?


CYP1A2, CYP2C8 and CYP2E1 appear in Nabilone's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP1A2 pharmacokinetics
    In vitro P450 inhibition studies using human liver microsomes showed that nabilone did not significantly inhibit CYP1A2, 2A6, 2C19, 2D6, and 3A4 (using midazolam and nifedipine as substrates).
  • CYP2C8 pharmacokinetics
    IC 50 > 50 µM) and had a moderate inhibitory effect on CYP2C8 and 2C9 (IC 50 > 10 µM).
  • CYP2E1 pharmacokinetics
    Nabilone had a weak inhibitory effect on CYP 2E1 and 3A4 (testosterone;

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

Was Nabilone studied with fasting?


fasting is named in Nabilone's label sentences: "In the nabilone vs. placebo study, when compared with placebo, nabilone resulted in significantly elevated post-dose fasting GIP levels and post-OGTT GIP levels, but no change in post-dose fasting GLP-1 levels together with significantly lower post-OGTT GLP-1 levels." openfda-label+europepmc · 2026-08-30

1 recorded statement; fasting

Show the evidence
  • fasting
    In the nabilone vs. placebo study, when compared with placebo, nabilone resulted in significantly elevated post-dose fasting GIP levels and post-OGTT GIP levels, but no change in post-dose fasting GLP-1 levels together with significantly lower post-OGTT GLP-1 levels.

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

Where it is registered
Identifiers, relations and other names

The exact record

PubChem CID
5284592
CAS number
51022-71-0
RxCUI
104885
InChIKey
GECBBEABIDMGGL-RTBURBONSA-N
Trade name
Cesamet
Also called
(±)-3-(1,1-DIMETHYLHEPTYL-6,6A.BETA.,7,8,10,10A.ALPHA.-HEXAHYDRO-1-HYDROXY-6,6-DIMETHYL-9H-DIBENZO(B,D)PYRAN-9-ONE, 9H-DIBENZO(B,D)PYRAN-9-ONE, 3-(1,1-DIMETHYLHEPTYL)-6,6A,7,8,10,10A-HEXAHYDRO-1-HYDROXY-6,6-DIMETHYL-, TRANS-, (±)-, NABILONE [MART.], NABILONE [MI], NABILONE [ORANGE BOOK], NABILONE [USAN], NABILONE [VANDF], Nabilone [WHO-DD]
Development code
CPD 109514
Sources (7)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC and ClinicalTrials.gov organism ladder ·
  • openfda-label 83c7ac15-ece9-47de-b83c-d575544fa449 ·
  • openfda-label+europepmc K1:2N4O9L084N ·
1 more source

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
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  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 source rows
  • no critical contamination: no quarantine open
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