Small Pharma is working in collaboration with Imperial College London’s Centre for Psychedelic Research.
Small Pharma (London, UK), a neuropharmaceutical company committed to accelerating the development of effective therapeutic treatments for mental health disorders, has received regulatory approval for the world’s first patient clinical trial using N,N-dimethyltryptamine (DMT).
Small Pharma is investigating the potential of psychedelics as a ”potentially revolutionary treatment” for depression and other mental health conditions and is exploring compounds — specifically DMT — to deliver solutions. This clinical trial is the world’s first formal trial to evaluate the combination of DMT and psychotherapy to treat patients with major depressive disorder, to get to the root causes of the problem.
DMT (the abbreviation for dimethyltryptamine), also known as the ”spirit molecule,” is a chemical substance that occurs in many plants and animals (including humans), one which is a derivative and structural analogue of tryptamine. Originating in traditional ceremony, DMT is a naturally occurring molecule with unique psychedelic properties underpinned by a similar pharmacology to psilocybin and LSD. DMT is a serotonergic psychedelic that exerts its effects through serotonergic receptors in the brain including 5-HT2A, 5-HT1A, 5-HT2C and 5-HT7 receptors amongst others.
Peter Rands, CEO of Small Pharma said: “DMT delivers a psychedelic experience in 20 mins and has unique properties that lend itself to clinical use. By adopting responsible evidence-based research and development into psychedelic medicine, we hope to help rebrand these once stigmatised compounds as highly effective medical therapies, which can be integrated into current healthcare systems and made accessible to the millions of people suffering from depression.”
Small Pharma is working in collaboration with Imperial College London’s Centre for Psychedelic Research, headed up by Robin Carhart-Harris. Dr. David Erritzoe is lead investigator in Small Pharma’s first clinical trial of DMT. Small Pharma has now received approval for its Phase I/IIa clinical trial evaluating the effects of DMT-assisted therapy in psychedelic naïve healthy volunteers and its efficacy in patients suffering with major depressive disorder. The first phase of the study will start January 2021 with the proof of concept (IIa) phase following shortly thereafter.
Read Pharm Exec's interview with Small Pharma's Carol Routledge here.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
ABM’s Digital Solution for Good Manufacturing Practices
April 30th 2025Learn how our digital GMP solution ensures compliance with high regulatory standards, and offers faster, more accurate data access. By utilizing a mobile app for data collection and a management dashboard for task visibility and validation, it goes beyond traditional paper methods to meet growing industry needs.