In the realm of social impact ventures, innovation isn't just about new products—it's about fostering meaningful change that can improve lives. At the heart of our work is a commitment to challenging the status quo and exploring uncharted territories to uncover solutions for the greater good. Among the many areas of disruption we focus on, the psychedelics industry stands out for its groundbreaking potential to reshape mental health care. As the global mental health crisis deepens, the role of psychedelics in offering new therapeutic pathways is more relevant than ever.

Psychedelic-assisted therapy (PAT) offers a fresh perspective on healing, with research showing promising results in treating conditions that have long resisted traditional therapies. By pushing the boundaries of what’s possible, we aim to contribute to the global conversation on mental wellness and bring innovative, scalable solutions to those who need them most.

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Beyond the trip

Psychedelics, once associated mainly with counterculture and kaleidoscopic visuals, have evolved in public perception. The colorful tropes of the 70s have been replaced by a growing body of research and advocacy, transforming these substances into tools with vast therapeutic potential. Today, millions of dollars are funneled into the study of psychedelics, including psilocybin, MDMA, and ketamine—each showing promise in treating mental health disorders that conventional treatments have struggled to address.

Influential voices such as Michael Pollan, author of How to Change Your Mind, and Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), are driving awareness of the therapeutic benefits of psychedelics. Their efforts, alongside others in the field, are gradually shifting public perceptions. A 2023 survey from the Berkeley Psychedelics Survey revealed that 60% of registered U.S. voters support legalizing regulated therapeutic access to psychedelics, with 78% advocating for more research into these substances.

Promising clinical applications

Psilocybin for Treatment-Resistant Depression

Psilocybin, the active compound in certain mushrooms, is now being explored as a potential treatment for major depressive disorder, specifically in patients whose symptoms persist despite traditional antidepressants. 

Compass Pathways, a leading biotechnology company, has conducted trials with its synthetic psilocybin compound, Comp360. While early results suggest promise, adverse effects have also been noted, with experts calling for further, larger studies to assess long-term safety and efficacy.

Ketamine for Alcohol Use Disorder

First developed as a battlefield anesthetic, ketamine has more recently gained attention for its potential in treating alcohol use disorder (AUD). Today, Ketamine is still widely used for anesthesia and acute pain in surgical, operative, and emergency trauma settings and is only approved by the FDA for such use. For the treatment of alcohol use disorder, however, trials are currently underway to determine the safety and efficacy of ketamine compared with placebo in increasing abstinence in patients with alcohol use disorder.

With over 360 million people globally impacted by AUD and many not responding to conventional treatments, there is a growing need for alternative approaches. Awakn Life Sciences conducted a Phase 2 clinical trial that demonstrated ketamine, when used in conjunction with psychological therapy, can significantly reduce heavy drinking days and increase abstinence compared to placebo.

MDMA for Post-Traumatic Stress Disorder (PTSD)

MDMA, commonly known as ecstasy, has shown promise in treating PTSD, in combination with talk therapy. Recent trials have demonstrated the compound's ability to reduce fear responses and increase social engagement, openness, and empathy and compassion. It wouldn’t be the first time MDMA was legal. In the 1970s and early 1980s, MDMA was often used in couples therapy before it became classified as a Schedule 1 substance in 1985.  

While PTSD affects 13 million Americans and has an economic impact of more than $232B, there have been no new drug treatments approved by the FDA for PTSD in more than twenty years. 

In 2024, the FDA requested additional clinical trials before approving an MDMA-based therapy developed by Lykos Therapeutics (formerly MAPS Public Benefit Corporation). Although disappointing, this decision highlights the challenges of bringing novel treatments to market while ensuring safety and efficacy.

Thinking outside the box

The rise of psychedelic-assisted therapies presents opportunities and challenges to still overcome. On one hand, these treatments offer new hope for millions suffering from conditions like depression, PTSD, and addiction. On the other, regulatory hurdles and the hesitance of insurers are significant obstacles. 

Challenges to overcome

One of the primary challenges in the psychedelic space is regulatory uncertainty. While public support for these treatments is growing, the healthcare system and regulatory bodies have been slow to catch up. For example, even though states like Oregon and Colorado have taken steps to legalize psychedelics for therapeutic use, federal approval remains a complex and time-consuming process.

Another key challenge is the labor-intensive nature of PAT. Unlike traditional medications, psychedelic therapies often require lengthy sessions with licensed therapists, making it difficult to scale quickly. Educational institutions like Penn Nursing, in collaboration with Columbia School of Social Work, are developing programs to train a new generation of practitioners in this emerging field. 

The business case for psychedelics

Despite these challenges, there are significant opportunities. The global mental health crisis has spurred demand for innovative solutions, and psychedelics may play a critical role in addressing this need. The global psychedelic market reached over $2.7 billion in 2023 and is projected to grow to nearly $7.4 billion by 2031.

For investors, the potential is clear. Pioneering companies such as Atai Life Sciences, Compass Pathways, Cybin, and MindMed are making strides with clinical trials and partnerships aimed at developing effective treatments. Atai, for instance, has partnered with Japanese pharma company Otsuka to develop R-ketamine for depression, while Compass Pathways focuses on its psilocybin compound for treatment-resistant depression.

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A hopeful path forward

At the intersection of social impact and innovation, we are both believers and builders in the potential of psychedelic-assisted therapies. Our personal experiences have shown us the transformative power of these treatments to shift mindsets and enrich lives. 

As we continue to support the growth of the psychedelics industry, our hope is that mental wellness remains a central focus, ensuring that these therapies become accessible, safe, and integrated into mainstream healthcare. Together, we can build a future where psychedelic-assisted therapies are not only a viable option but a powerful catalyst for positive change.