UK trial to test psilocin-based drug for major depressive disorder

A first-of-its-kind trial testing a novel psilocin-based drug for major depressive disorder has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

UK trial to test psilocin-based drug for major depressive disorder

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a first-of-its-kind trial to run this year to test psychedelic drugs as a treatment for major depressive disorder (MDD). The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy.

The novel psilocin prodrug

MSP-1014, the drug being used in the clinical trial is anticipated to exert similar efficacy to psilocybin in improving symptoms of depression.

“This is an exciting milestone as we prepare to enter our first-in-human clinical trial with our novel psilocin prodrug… [which based on preclinical data] has the potential to be a better tolerated psychedelic therapeutic compared to psilocybin,” Joseph Araujo, Chief Scientific Officer of Mindset Pharma, the company that developed the psilocin prodrug.

Approval “for a Phase II study should provide us with a strong efficacy signal and expedite our pathway to approval for MSP-1014 as a new effective and more tolerable treatment for patients suffering from MDD,” added Mindset Pharma’s Chief Scientific Officer Araujo.

The MHRA’s regulatory decision comes after Mindset Pharma, along with several other psychedelic drug developers, agreed In December 2022 to trial therapies for mental health conditions in London. One of the reasons for this was to benefit from the UK’s drug regulatory process. For example, ethics applications can be fast-tracked and reviews can be combined. 

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“We’re incredibly excited to be given the green light for this [UK] trial to explore an innovative treatment” for a mental health condition such as major depressive disorder, Tom McDonald, CEO at Clerkenwell Health commented.

Several other trials planned for the next year by psychedelic-assisted therapy clinical trial organisation Clerkenwell Health will “test the potential of psychedelics-related medicines for complex mental health and central nervous system conditions including alcohol use disorder and PTSD,” McDonald added.