Report reveals countries leading the way in cannabis-related clinical trials

After the US, the UK saw the second highest number of clinical trials carried out on cannabinoids in the last decade, according to a new report. 

The upcoming report, due to be published this month by Prohibition Partners and Cannabiscientia, explores the progression of cannabis research over the last 13 years, with an in-depth account of all activity in the context of the global pharmaceutical landscape.

Analysts looked at over 400 clinical trials registered on clinicaltrials.gov between 2010-2023.

The overwhelming majority of these trials took place in the US (54%), however, the UK saw the second highest amount of activity, responsible for 13% of all clinical trials during this time period.

This topped Canada (7.7%) and Israel (6.8%), two countries which are widely thought to be progressing quickly in the field of cannabis research. [It is worth noting the total number of clinical trials reported on clinicaltrials.gov may not encompass all trials conducted globally within the timeframe.]

Despite both having long-standing medical cannabis legislation in place, Germany and Italy saw far fewer clinical trials than the above with each accounting for just 1.4% of the total number.

According to the authors institutional support for the rollout of research and innovation in the medical cannabis field differs from region to region and appears to be ‘somewhat slower’ in EU countries compared to elsewhere in the world. 

Recent years have also seen an increase in clinical trials looking specifically at CBD in its isolated form. 

Of the 107 trials beginning in 2022 onwards, approximately 50% of them included only CBD. The authors say, this is likely to be a result of the fact that ethical committee approvals are easier to obtain for CBD trials in comparison to those which include controlled substances, such as THC. 

GW Pharmaceuticals dominates in clinical research 

There is one company which continues to dominate when it comes to clinical trials investigating the medicinal use of cannabinoids. 

The prevalence of GW Pharmaceuticals, producer of Epidiolex and Sativex, two of the few cannabis-based medicines to secure market authorisation in North America and Europe, may in part explain the high number of trials registered in the UK. [GW was bought by Ireland-based Jazz Pharmaceuticals in 2020 for $7.2 billion]. 

Epidiolex is licensed to treat seizures in two rare forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, while Sativex was first approved for the treatment of spasticity related to multiple sclerosis (MS), but has been prescribed off-label for conditions such as neuropathic pain, chronic pain, cachexia and nausea. Combined these two products are thought to bring in USD$800 million in sales, the majority of which come from Epidiolex.

According to the report, the company has sponsored more clinical trials in the past 10 years than the next five leading sponsors combined. 

Analysis found that the majority of UK clinical trials were linked to GW Pharmaceuticals or its research subsidiary, GW Research Ltd, and involved either Epidiolex or Sativex. 

Clinical trials featuring the two products also make up the majority of completed phase 3 trials globally. 

A monopoly on cannabis-related patents 

The same domination can also be seen in the IP landscape explored in the report, where GW’s patent portfolio dwarfs that of any other company, particularly those with a primarily medical focus.

GW has had the monopoly on cannabis-related patents since the early 2000s, with a portfolio that consists of at least 396 patent families, containing 1,824 individual patents. 

Over 50% of these patents are registered in the US and Europe, including 126 counts in the UK.

And the company has shown no signs of slowing down. As interest in cannabinoid medicine grows, it continues to expand its portfolio at a rapid rate, with over 320 new patents published in 2022 alone.

The treatment of epilepsy is the largest patent family owned by GW and the most common indication explored in related clinical trials, followed by cancer and other syndromes which cause seizures such as tuberous sclerosis and Rett syndrome.  

However, GW also holds patents for novel interventions in a range of other conditions, including psychosis, autism spectrum disorders, inflammatory bowel disease, arthritis and Parkinson’s. 

CBD is the most common cannabinoid in GW’s patent portfolio, featuring in just under half (45%) of all 396 novel interventions, but other cannabinoids including THCV, THC, CBDV, CBDA, CBG and CBC also frequently feature. [The report delves deeper into the portfolio, breaking down data on which cannabinoids are patented for the treatment of which conditions]. 

READ MORE: Clinical trials consistently show cannabis holds ‘promising potential’ for pain, says report

A growing number of players 

But the playing field could open up in the coming years, with a number of companies looking to follow in the footsteps GW.

The report reveals that, while the exact date is unclear, GW’s US market exclusivity on Epidiolex and Sativex is likely to expire at some point in the next decade, with sources predicting that generic versions could be on the market as early as 2026.

Hanyi Biotech, Zynerba Pharmaceuticals, Canopy Growth, Tilray, and Echo Pharmaceuticals in the Netherlands, are all noted in the report as significant players in the field of cannabinoid science. 

Lawrence Purkiss, analyst at Prohibition Partners and co-author of the report, commented: “GW continues to be the dominant player in the pharmaceutical cannabis space by a significant margin, and clearly aims to maintain this dominance through heavy investment in R&D, clinical research and IP.

“That said, there is a significant and growing number of players, and a diverse range of activity going on in clinical research in particular. GW has shown the size of the potential prize with Epidiolex, and there are many others looking to follow suit.”

The full report will be published on 30 August 2023. Click here to pre-order your copy to get 15% off (offer expires on 23 August).