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Priya Life Science Compound trial record
Compound · clinical trials

Nabilone clinical trials

Also listed in trial records as Cesamet
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our USA and Canada registers that name Nabilone as an intervention. Synced 10 Nov 2026
2Current trials
2Recruiting now
2Lead sponsors
2Country registers
At a glance

Nabilone is named as an intervention in 2 current clinical trials in our USA and Canada registers. 2 are recruiting patients now. All registered phases are Phase 3. The sponsor with the most trials is PleoPharma, Inc (1). The most-studied condition is Cannabis Withdrawal.

Where Nabilone is approved

All regulators →

Of the three regulators tracked here, the first to approve Nabilone was the US, on 26 Dec 1985.

USUnited States (FDA)
26 Dec 1985
Cesamet
NDA018677 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Nabilone

All medicines →
ENNHS England
£282k
345 items dispensed, Sep 2025 to Aug 2026
-23% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
No single-ingredient product reimbursed by Medicaid in 2025
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Nabilone works

All drug targets →
  • Cannabinoid CB1 receptor agonist Agonist
    Target: CNR1 cannabinoid receptor 1
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on CNR1
Diseases it has been tested for in clinical trials, by furthest phase
  • AgitationPhase 3
  • Alzheimer diseasePhase 3
  • Parkinson diseasePhase 3
  • PruritusPhase 3
  • Neuropathic painPhase 3
  • AnorexiaPhase 2/3
  • Cannabis dependencePhase 2/3
  • Non-small cell lung carcinomaPhase 2/3
  • IrritabilityPhase 2
  • SpasticityPhase 2
17 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2218896, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9071, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Nabilone

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Nabilone

ChEMBL
CHEMBL2218896
PubChem CID
39860
CAS number
56496-90-3
Wikidata
Q27087822

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting2100%

Trials by phase

  • Phase 32100%
01

Clinical trials of Nabilone

2 trials
StudyPhaseStatusLead sponsorRegisters
Nabilone for Agitation Blinded Intervention Trial
NCT04516057 · ClinicalTrials.gov ↗ · Alzheimer Disease, Agitation
Phase 3 Recruiting Sunnybrook Health Sciences Centre Canada
Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder
NCT07644052 · Cannabis Withdrawal
Phase 3 Recruiting PleoPharma, Inc USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Nabilone

3 conditions
Cannabis Withdrawal1Alzheimer Disease1Agitation1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
PleoPharma, Inc1
Sunnybrook Health Sciences Centre1
04

By country register

RegisterTrialsRecruiting
Clinical trials in USA11
Clinical trials in Canada11

A trial with sites in more than one country appears in each of those registers.

05

Questions about Nabilone trials

How many clinical trials are testing Nabilone?

2 current trials in our USA and Canada registers name Nabilone as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Nabilone trials recruiting patients?

Yes. 2 of the 2 trials are recruiting: 1 with sites in USA and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Nabilone clinical trials?

PleoPharma, Inc (1) and Sunnybrook Health Sciences Centre (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Nabilone works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Nabilone works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Nabilone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.