CLINICAL TRIALS PROFILE FOR DRONABINOL

All Clinical Trials for Dronabinol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000737 ↗	A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome	Completed	Bristol-Myers Squibb	Phase 1	1969-12-31	To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
NCT00000737 ↗	A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome	Completed	Roxane Laboratories	Phase 1	1969-12-31	To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
NCT00000737 ↗	A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
NCT00000854 ↗	A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.
NCT00079560 ↗	Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS	Completed	National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2	2001-12-01	Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are used to increase appetite, food intake, and weight in patients with HIV who experience unintended weight loss. This study will compare the effects of MJ and Marinol use in marijuana smokers who are HIV infected.
NCT00123201 ↗	Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache	Completed	Nektar Therapeutics	Phase 2	2005-09-01	The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache.
NCT00123201 ↗	Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache	Completed	Solvay Pharmaceuticals	Phase 2	2005-09-01	The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache.

Clinical Trial Conditions for Dronabinol

Condition Name

Condition Name for Dronabinol
Intervention	Trials
Cannabis	9
Pain	6
Marijuana Dependence	6
Chronic Pain	5

Condition MeSH

Condition MeSH for Dronabinol
Intervention	Trials
Marijuana Abuse	25
Vomiting	8
Disease	6
Nausea	6

Clinical Trial Locations for Dronabinol

Trials by Country

Trials by Country for Dronabinol
Location	Trials
United States	167
Germany	7
Austria	4
Netherlands	3
Canada	3

Trials by US State

Trials by US State for Dronabinol
Location	Trials
New York	17
Illinois	11
California	10
Maryland	10
Texas	9

Clinical Trial Progress for Dronabinol

Clinical Trial Phase

Clinical Trial Phase for Dronabinol
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	9
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for Dronabinol
Clinical Trial Phase	Trials
Completed	53
Recruiting	21
Not yet recruiting	13

Clinical Trial Sponsors for Dronabinol

Sponsor Name

Sponsor Name for Dronabinol
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	22
Yale University	8
New York State Psychiatric Institute	7

Sponsor Type

Sponsor Type for Dronabinol
Sponsor	Trials
Other	120
NIH	36
Industry	27

Dronabinol: Clinical Trials, Market Analysis, and Projections

Introduction to Dronabinol

Dronabinol, a synthetic form of tetrahydrocannabinol (THC), the primary psychoactive component of cannabis, has been a significant player in the medical field for several decades. Initially approved by the U.S. Food and Drug Administration (FDA) in 1985, dronabinol is used to treat nausea and vomiting associated with cancer chemotherapy and loss of appetite in patients with HIV/AIDS[4][5].

Clinical Trials Update

Reducing Agitation in Alzheimer’s Disease

A recent clinical trial led by the Johns Hopkins University School of Medicine and Tufts University School of Medicine has shown promising results in using dronabinol to reduce agitation in patients with Alzheimer’s disease. The trial involved 75 patients across five clinical sites, who were randomly assigned to receive either 5 milligrams of dronabinol or a placebo twice daily for three weeks.

The results indicated a significant reduction in agitation, with the dronabinol group showing an average decrease of 30% in agitation scores measured by the Pittsburgh Agitation Scale (PAS) and the Neuropsychiatric Inventory Agitation/Aggression subscale (NPI-C). This reduction was notable compared to the placebo group, which showed no change. Additionally, dronabinol was well tolerated by patients, offering a safer alternative to current treatments for agitation, such as antipsychotics, which can have adverse effects like delirium or seizures[1][4].

Future Research Directions

The success of this trial has encouraged researchers to plan longer-term studies and expand the sample size to further explore the efficacy and safety of dronabinol in treating Alzheimer’s agitation. There is also a growing interest in investigating other potential benefits of medical cannabis for both patients and caregivers[1][4].

Market Analysis

Current Market Size and Growth

The global dronabinol market has been experiencing steady growth. As of 2023, the market was valued at approximately $240.9 million and is projected to reach $373.8 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period of 2024-2030[2].

Another report estimates that the dronabinol market will reach $351.3 million by 2027, with a CAGR of 6.7% during the period 2022-2027. This growth is driven by the increasing application of dronabinol in treating nausea, vomiting, and appetite loss, particularly in patients undergoing cancer chemotherapy and those with HIV/AIDS[3].

Market Segmentation

The dronabinol market can be segmented based on type, application, and geography.

• Type: The market is segmented into oral liquid, capsules, and others. The oral liquid segment held the largest market share in 2021, primarily due to its ease of administration and FDA approval for treating nausea and vomiting associated with cancer chemotherapy and appetite loss in AIDS patients. The capsule segment is expected to grow with the fastest CAGR during the forecast period[3].
• Application: The anti-nausea segment dominates the market, driven by the increasing use of dronabinol to treat severe nausea and vomiting caused by cancer chemotherapy. The stimulate appetite segment is also growing rapidly, particularly in treating AIDS patients with weight loss due to appetite loss[3].
• Geography: North America accounted for the highest revenue share in 2021 and is expected to continue dominating the market due to the high prevalence of nausea associated with cancer chemotherapy in this region[3].

Competitive Landscape

The global dronabinol market is competitive, with top players such as LGC Group, Merck, and Alfa Chemistry. The market landscape is characterized by a detailed analysis of these companies based on sales, main products, gross profit margin, revenue, and growth production. Emerging players and startups are also being closely monitored for their innovative strategies and market impact[5].

Market Projections

Regional Analysis

The dronabinol market is analyzed across various regions, including North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. North America is expected to maintain its dominance due to the high incidence of cancer and HIV/AIDS, which are key drivers for the use of dronabinol. Other regions, such as the Asia-Pacific and Rest of the World, are also expected to contribute significantly to the market growth due to increasing awareness and adoption of dronabinol for various medical conditions[5].

Drivers and Challenges

The growth of the dronabinol market is driven by several factors, including the increasing prevalence of AIDS and cancer, which necessitate treatments for nausea, vomiting, and appetite loss. The therapeutic potential of dronabinol in managing these symptoms effectively is a significant driver. However, the market also faces challenges such as side effects like anxiety, panic attacks, and other psychoactive impacts, which can vary based on dosage and individual patient responses[3].

Key Takeaways

• Clinical Efficacy: Dronabinol has shown significant efficacy in reducing agitation in Alzheimer’s patients and is well tolerated compared to current treatments.
• Market Growth: The global dronabinol market is projected to grow at a CAGR of 6.4% to 6.7% during the forecast period, reaching a value of $373.8 million to $351.3 million by 2030 and 2027, respectively.
• Market Segmentation: The market is segmented by type, application, and geography, with the oral liquid segment and anti-nausea application dominating.
• Regional Dominance: North America is expected to continue its dominance in the market due to high prevalence of relevant medical conditions.
• Competitive Landscape: The market is competitive with key players like LGC Group, Merck, and Alfa Chemistry, and emerging players contributing to market dynamics.

FAQs

What is dronabinol used for?

Dronabinol is used to treat nausea and vomiting associated with cancer chemotherapy and loss of appetite in patients with HIV/AIDS. It is also being researched for its potential in reducing agitation in Alzheimer’s disease patients[1][4].

How effective is dronabinol in treating Alzheimer’s agitation?

A recent clinical trial showed that dronabinol reduced agitation in Alzheimer’s patients by an average of 30% over three weeks, with no significant adverse effects compared to the placebo group[1][4].

What is the current market size of the dronabinol market?

As of 2023, the global dronabinol market was valued at approximately $240.9 million[2].

What is the projected growth rate of the dronabinol market?

The market is expected to grow at a CAGR of 6.4% to 6.7% during the forecast period of 2024-2030[2][3].

Which region dominates the dronabinol market?

North America dominates the dronabinol market due to the high prevalence of cancer and HIV/AIDS in this region[3].

Sources

1. ScienceDaily: "Clinical trial shows synthetic cannabis reduces agitation in Alzheimer's disease" - Retrieved December 25, 2024.
2. Valuates Reports: "Global Dronabinol Market Research Report 2024" - Retrieved December 31, 2024.
3. IndustryARC: "Dronabinol Market Report, 2022-2027" - Retrieved December 31, 2024.
4. Johns Hopkins Medicine: "Clinical Trial Shows Synthetic Cannabis Reduces Agitation in Alzheimer’s Disease" - Retrieved December 31, 2024.
5. OpenPR: "Dronabinol Market Outlook 2024-2031: Top Key Players, Emerging Trends, and Growth Opportunities" - Retrieved December 31, 2024.