The number of clinical trials using cannabis-based medicines to treat patients with symptoms from a variety of conditions, including cancer, epilepsy, and autism spectrum disorder, has increased dramatically since 2010, a new report found.

Analysis and findings have been published this week by Prohibition Partners in The Pharmaceutical Cannabis Report: 3rd Edition, in collaboration with Cannabiscientia, just hours before the US Department of Health and Human Services (HHS) sent a recommendation to the Drug Enforcement Administration (DEA), stating that cannabis should be reclassified from Schedule I to Schedule III – potentially paving the way for many more patients to benefit from cannabis-based medicines.

Key Findings:

• Pain, from various conditions, is by far the most prevalent symptom treated in clinical trials involving cannabinoids – with pain being the target condition in 46% of trials since 2010.
• The most commonly featured conditions in the patent landscape include epilepsy, cancer and associated conditions, seizures, and autism spectrum disorder.
• Clinical trials featuring patented compounds (Sativex and Epidiolex) dominate completed phase 3 trials
• It is estimated that global sales within the pharmaceutical cannabis industry will amount to approximately US$1.11 billion in 2023, with projections indicating a growth to US$1.37 billion by 2027.

In 2010, only eight clinical trials globally used cannabis-based medicines as a treatment for conditions such as Diabetes and Anxiety. In 2022 alone, 60 clinical trials began – a 650% increase in comparison to 2010.

So far this year, 49 clinical trials involving cannabis-based medicines have already started, with more due to kick-off before the end of the year.

Almost every year since 2015, the number of clinical trials has increased year-on-year.

Almost half of all clinical trials globally involving pharmaceutical cannabis medicines since 2010 have targeted ‘pain’ from various conditions.

Of the 440 clinical trials analysed, in 46% – or 202 trials in total – ‘pain’ was found to be the target condition for treatment. Chronic or neuropathic pain, in particular, has been the target symptom in the majority of trials, encompassing conditions such as fibromyalgia/myofascial pain, cancer-related pain and pain associated with neurodegenerative diseases such as MS and Parkinson’s.

In recent years, there has, instead, been a notable increase in clinical trials examining the potential benefits of cannabis and cannabinoids for various mental-related disorders, such as anxiety and depression.

The types of medicines being used in these clinical trials consist of a variety of different cannabinoids. Of all trials analysed, 34.5% used a combination of the two most commonly-known cannabinoids – THC and CBD.

Lawrence Purkiss, senior analyst at Prohibition Partners and co-author of the report, said: “Looking at the development of clinical trials in cannabis over the last decade gives great insight into the potential breakthroughs in the space in the coming years. From analysing the patent landscape in conjunction with the clinical trials record, it’s clear that the possibilities for further cannabinoid-based treatments are incredibly broad, with significant interest already in specific areas.”

On the HHS’s recommendation, Stephen Murphy, CEO of Prohibition Partners, said: “The HHS recommendation further splits the path of cannabis between adult-use and medical purposes. This helps advance access, but also opens the door for the existing healthcare and pharmaceutical industry to embrace patient demand.”

“The just-published The Pharmaceutical Cannabis Report: 3rd Edition highlights the path forward for cannabis and the explosion of clinical research and development that will be further enhanced once this recommendation comes to fruition.”