CLINICAL TRIALS PROFILE FOR NABILONE

All Clinical Trials for Nabilone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00272207 ↗	A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia	Completed	Valeant Canada Limited	Phase 2	2006-04-01	The purpose of the study is to determine whether or not the drug Nabilone significantly reduces pain and improves quality of life in patients with fibromyalgia.
NCT00272207 ↗	A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia	Completed	Winnipeg Regional Health Authority	Phase 2	2006-04-01	The purpose of the study is to determine whether or not the drug Nabilone significantly reduces pain and improves quality of life in patients with fibromyalgia.
NCT00381199 ↗	Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia	Completed	McGill University Health Center	N/A	2006-04-01	Most chronic pain patients with insomnia are currently not well-managed using existing medications. If found to safely improve sleep with chronic pain patients, nabilone could be added to the treatment options available in the management of fibromyalgia and associated symptoms. The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients with fibromyalgia.
NCT00381199 ↗	Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	N/A	2006-04-01	Most chronic pain patients with insomnia are currently not well-managed using existing medications. If found to safely improve sleep with chronic pain patients, nabilone could be added to the treatment options available in the management of fibromyalgia and associated symptoms. The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients with fibromyalgia.
NCT00384410 ↗	Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients	Unknown status	Bausch Health Americas, Inc.	Phase 2	2005-12-01	Sleep disturbance is perhaps one of the most prevalent complaints of patients with long-standing painful conditions. Nabilone is a medication that is approved by Health Canada as an anti-emetic (prevent vomiting) for patients undergoing chemotherapy. Nabilone, due to its sleep promoting properties, is sometimes prescribed by physicians to pain patients to help improve their sleep. However, there is no direct research evidence to either support or refute this practice. This study will investigate if nabilone is effective in improving sleep in insomnia and pain patients.
NCT00384410 ↗	Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients	Unknown status	Valeant Pharmaceuticals International, Inc.	Phase 2	2005-12-01	Sleep disturbance is perhaps one of the most prevalent complaints of patients with long-standing painful conditions. Nabilone is a medication that is approved by Health Canada as an anti-emetic (prevent vomiting) for patients undergoing chemotherapy. Nabilone, due to its sleep promoting properties, is sometimes prescribed by physicians to pain patients to help improve their sleep. However, there is no direct research evidence to either support or refute this practice. This study will investigate if nabilone is effective in improving sleep in insomnia and pain patients.
NCT00384410 ↗	Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients	Unknown status	University Health Network, Toronto	Phase 2	2005-12-01	Sleep disturbance is perhaps one of the most prevalent complaints of patients with long-standing painful conditions. Nabilone is a medication that is approved by Health Canada as an anti-emetic (prevent vomiting) for patients undergoing chemotherapy. Nabilone, due to its sleep promoting properties, is sometimes prescribed by physicians to pain patients to help improve their sleep. However, there is no direct research evidence to either support or refute this practice. This study will investigate if nabilone is effective in improving sleep in insomnia and pain patients.

Clinical Trial Conditions for Nabilone

Condition Name

Condition Name for Nabilone
Intervention	Trials
Fibromyalgia	3
Neuropathic Pain	3
Healthy	3
Parkinson Disease	3

Condition MeSH

Condition MeSH for Nabilone
Intervention	Trials
Marijuana Abuse	5
Neuralgia	5
Myofascial Pain Syndromes	3
Fibromyalgia	3

Clinical Trial Locations for Nabilone

Trials by Country

Trials by Country for Nabilone
Location	Trials
Canada	17
United States	8
Austria	2
Denmark	1
Israel	1

Trials by US State

Trials by US State for Nabilone
Location	Trials
New York	4
Texas	2
Maryland	1
Massachusetts	1

Clinical Trial Progress for Nabilone

Clinical Trial Phase

Clinical Trial Phase for Nabilone
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	3
Phase 3	7

Clinical Trial Status

Clinical Trial Status for Nabilone
Clinical Trial Phase	Trials
Completed	15
Not yet recruiting	10
Unknown status	5

Clinical Trial Sponsors for Nabilone

Sponsor Name

Sponsor Name for Nabilone
Sponsor	Trials
University of Manitoba	5
New York State Psychiatric Institute	5
Valeant Canada Limited	3

Sponsor Type

Sponsor Type for Nabilone
Sponsor	Trials
Other	46
Industry	10
NIH	4

Last updated: May 3, 2026

Nabilone: Clinical Trial Status, Market Read-Through, and Revenue Projection

What is nabilone and how is it positioned commercially?

Nabilone is a synthetic cannabinoid indicated in multiple jurisdictions for chemotherapy-induced nausea and vomiting (CINV) in patients who do not respond adequately to conventional antiemetics, and for other cannabis-related symptom indications depending on country labeling. Commercial positioning is limited by (1) narrow, indication-specific claims versus broader cannabinoid platforms, (2) generic availability in several markets, and (3) regulatory and reimbursement variability for “medical cannabis” alternatives.

Key commercial facts that drive market outcomes:

• Originator: nabilone (brand: Cesamet in multiple markets historically).
• Form factor: oral capsules/tablets (formulation and strength vary by market).
• Competitive set: generic nabilone where available; therapeutics for CINV (NK1 antagonists, 5-HT3 antagonists, olanzapine) and anti-spasticity/neuropathic pain products in off-label use.
• Market constraint: nabilone is not a high-volume modern cannabinoid product category in most geographies, so forecast upside depends on survivability of branded differentiation (supply reliability, payer coverage, guideline placement) rather than major new mechanism adoption.

---

What does the clinical trials landscape look like for nabilone?

A precise, up-to-date clinical trials status requires a live registry pull (ClinicalTrials.gov / EU CTR / WHO ICTRP). Under the operational constraints, no clinical trial update can be issued without verifiable, current trial-level data (trial phase, status, start and completion dates, indication, sponsor).

No such trial-level inputs are present in the provided materials. As a result, a complete and accurate “clinical trials update” cannot be produced in this format.

---

Where does nabilone trade in the market: demand drivers and headwinds?

Demand drivers:

• CINV niche retention: in jurisdictions where labeling supports CINV after inadequate response to standard therapy, demand is anchored to oncology practice patterns and guideline adherence.
• Treatment-refractory subsets: for patients with persistent symptoms despite standard regimens, cannabinoids can act as an add-on option.
• Payer coverage pockets: reimbursement can concentrate in specific countries, health systems, and formularies.

Headwinds:

• Therapeutic substitution: modern CINV regimens (multi-agent standard of care) and newer supportive drugs reduce incremental patient volumes eligible for cannabinoid use.
• Generic pressure: where generics exist, price erosion typically limits branded revenue sustainability unless availability and supply contracts protect the originator.
• Safety monitoring and access: adverse event profiles (sedation, dizziness, psychiatric effects) can tighten prescribing thresholds in some health systems.
• Off-label fragmentation: off-label use depends on national practice norms and can vary widely; it is not a stable forecast base.

---

What is the forecast approach and what can be projected reliably?

Under strict accuracy rules, a numeric projection requires:

• historical market size for nabilone (by geography),
• pricing and reimbursement baselines,
• generic share and expected erosion,
• current and planned supply/launch events,
• and demand indicators linked to oncology cycles and payer criteria.

None of those numeric inputs are available in the provided context. A “market analysis and projection” with hard numbers would risk being fabricated.

Accordingly, no numeric revenue projection can be issued.

---

Market sizing framework (non-numeric): how investors should underwrite nabilone returns

Even without current numeric inputs, the underwriting logic for nabilone revenue is specific:

1) Patient funnel

• Eligible population within CINV after inadequate response to standard therapy.
• Share of oncology prescribers using cannabinoids versus escalating standard-of-care options.
• Time-on-therapy equals the number of chemotherapy cycles and symptom control duration.

2) Access and reimbursement

• Formulary status (preferred vs non-preferred).
• Prior authorization requirements.
• Coverage for specific regimens and line-of-therapy rules.

3) Pricing and net revenue

• Wholesale price less discounts, rebates, and channel fees.
• Generic share and substitution dynamics.
• Contracted hospital purchasing vs retail reimbursement.

4) Competitive displacement

• CINV standard regimen intensity changes.
• Availability of alternative cannabinoid products.
• Clinical guideline updates affecting “after failure” eligibility.

---

What is needed to make the projection investable (and what is missing)?

A complete projection must tie to:

• geography-by-geography revenue starting points,
• unit forecasts (scripts or treatment courses),
• net pricing and mix,
• and competitive share over time.

Without those inputs, any numeric forecast would not meet a high-stakes standard.

---

Key Takeaways

• Nabilone is a niche cannabinoid product with revenue largely tied to CINV labeling/reimbursement and treatment-refractory practice patterns.
• A current clinical trials update cannot be delivered without verified trial registry data.
• A numeric market projection cannot be issued without historical market size, pricing/net revenue, generic share, and geographic access baselines.

---

FAQs

1) Is nabilone primarily used for CINV or does it have broader approved indications?
It is primarily used for CINV in key markets, with other labeled uses varying by country and additional utilization occurring via local off-label practice.

2) What typically drives nabilone revenue in major markets?
Formulary access for CINV after standard therapy failure, payer coverage rules, and substitution by modern CINV regimens.

3) How does generic competition affect nabilone forecasts?
It usually compresses net pricing through substitution and reduced branded share, turning growth into volume-only scenarios unless branded contracts preserve pricing.

4) Can off-label use materially change nabilone market outcomes?
It can in certain health systems, but off-label adoption is fragmented and not stable enough for a clean base-case forecast without country-specific prescribing data.

5) What clinical trial signals would matter for nabilone’s future?
New, phase-advanced studies that change labeled indications, expand payer-relevant endpoints, or demonstrate differentiation versus standard CINV pathways.

---

References

[1] ClinicalTrials.gov. (n.d.). Nabilone studies search results. https://clinicaltrials.gov/
[2] European Union Clinical Trials Register. (n.d.). Nabilone search results. https://www.clinicaltrialsregister.eu/
[3] WHO International Clinical Trials Registry Platform (ICTRP). (n.d.). Nabilone search results. https://trialsearch.who.int/