Cannabinoid-based drug developers face challenging regulatory landscape despite increasing use of cannabinoid receptors, says GlobalData

A surge in the cannabinoid drug pipeline has led to cannabinoid receptors becoming the most popular target in preclinical development this year, says GlobalData. However, the leading data and analytics company notes that the current regulatory landscape poses a challenge for cannabinoid-based drug developers and regulators.

CB1 receptors are the joint first most popular target in preclinical trials for central nervous system diseases, according to GlobalData. This is closely followed by CB2 receptors in second place. Collectively, cannabinoid receptors (CB1 and CB2) are the most popular targets in preclinical development, with 391 drugs tagged in total.

The most popular indication for these drugs is neuropathic and general pain, accounting for 27% of the drug pipeline. This is followed by epilepsy at 8% of the pipeline and multiple sclerosis at 7%.

Kevin Marcaida, Pharma Analyst at GlobalData, comments: “Cannabinoid-based drugs have long been cited to treat a variety of illnesses ranging from pain, inflammatory conditions, and neurological disorders. Despite the current popularity of cannabinoid receptors, the regulatory landscape is challenging and complex. In the US, the world’s largest pharmaceutical market, most states have legalized cannabinoids for medical use. However, at the federal level, cannabinoids remain illegal under the Controlled Substances Act. In most EU and commonwealth countries, including the UK, New Zealand, and Australia, cannabinoids are legal for medical use. However, access is restricted, requiring a special permit given under exceptional circumstances.”

In Asia, Africa, and the Middle East, cannabinoid-based drugs are mostly illegal and continue to present a major regulatory obstacle. These strict policies could lead to restricted progress in late-stage development, which could impact the future market. China and Japan have some of the world’s strictest regulations on cannabinoids, including bans on cannabis for medical use and scientific research, as the drug is considered a dangerous narcotic.

In contrast, Latin American countries such as Brazil, Uruguay, and Mexico are early adopters of medical cannabis. These countries utilize full legal oversight on cannabinoid medical use, cultivation, and trade, which led to the establishment of a robust regulated market to help the region to deal with future developments.

Marcaida adds: “To ensure the future growth of cannabinoid-based drugs, more progress is required in Asia, Africa, and the Middle East to ensure advancements in legalization, oversight, and regulatory alignment.”

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