Next Gen Empathogens

Mental health conditions affect millions globally, creating a significant public health challenge. Current treatments, such as MDMA-assisted therapy, often have delayed effects, limited efficacy, and undesirable side effects including neurotoxicity, cardiovascular issues, and the potential for abuse. These limitations highlight the need for safer, more effective empathogenic therapies that align with regulatory frameworks and ensure clinical accessibility.

This project will develop a suite of Next Gen Empathogens, a novel class of molecules designed to exert similar therapeutic benefits to MDMA while minimizing risks and side effects. These effects are predicted with high confidence based on known structure-activity relationships of empathogenic molecular scaffolds.

The research team is led by Greg Dwulet, Ph.D. and Tyler Quigley, Ph.D., who have combined expertise across medicinal chemistry, neuroscience, animal behavioral studies, and the psychedelic IP landscape. They will direct preclinical studies within a distributed network of CROs and labs with input from the IPT community. The project’s success may lead to promising new treatments for a variety of mental health conditions, positioned to address a critical need in a rapidly expanding market.

Mental health conditions such as PTSD, depression, anxiety, and social functioning disorders affect millions worldwide, significantly impairing quality of life and posing a major public health challenge. Existing pharmacological treatments (e.g., SSRIs, benzodiazepines, antipsychotics) often have delayed effects, suboptimal efficacy, and burdensome side effects. MDMA-assisted therapy has shown promise in addressing these issues, but clinical adoption is limited by several drawbacks.

MDMA’s therapeutic empathogenic effects are primarily mediated by its action on the serotonin system, specifically through inhibition of the serotonin transporter. However, MDMA’s activity at dopamine and norepinephrine transporters, along with its pharmacokinetic properties (e.g., rapid onset), lead to stimulant effects, potential for abuse, and other safety concerns. These concerns include cardiovascular risks, neurotoxicity, challenging "come-downs," and the potential to provoke worsening symptoms.

The time is now to develop safer, more effective empathogenic therapies as breakthrough therapeutics that address the risks and limitations of current options. This need extends to developing compounds that align with regulatory frameworks and are less prone to abuse, ensuring accessibility and safety in clinical settings.

This project will develop a novel class of empathogens (“Next Gen Empathogens”) designed by Greg Dwulet, Ph.D. Through extensive reviews of the scientific and patent literature, he identified a series of underdeveloped molecular scaffolds which, based on known structure-activity relationships, have a high likelihood of targeting the serotonin transporter and key receptors responsible for MDMA’s effects. Further, these compounds are designed to minimize the risks associated with MDMA, thereby providing enhanced safety and efficacy for clinical use.

Objectives:

We will synthesize and test these novel compounds, generate IND-enabling data, and position lead candidates for licensing or progression towards clinical trials.

1. IP: File provisional patent applications to protect novel compounds.
2. Synthesis: Synthesize compounds for biological testing and to support patent applications.
3. In Vitro Testing: Evaluate compounds in receptor binding and transporter activity assays and off-target assays for potency, selectivity, and safety.
4. In Vivo Testing: Advance promising compounds to behavioral models to confirm safety and efficacy.

Leadership:

• Greg Dwulet, Ph.D. (Chemistry) – Principal Research Scientist, Inventor, Registered Patent Agent

  • Expertise in medicinal chemistry and psychedelic patents.

• Tyler Quigley, Ph.D. (Animal Behavior) – Research Scientist, PsyDAO Science Lead

  • Expertise in neuroscience, behavioral models, psychedelic patents, and project management.

Note: Lead researchers are not university-affiliated—the proposed work will begin immediately upon funding.

Funds will go 100% towards IP, research, salary, and liquidity pool generation—not university coffers.

Finally, this will be the first Catalyst project to advance a set of NCE’s through pre-clinical research completely within-DAO, leveraging a distributed network of CROs and research labs. We also intend to engage in decentralized science platforms if/when they become available to test psychedelic compounds: "e.g., pump.science."

Market Size:

The global psychedelic drugs market is rapidly expanding. In 2023, the market was valued at approximately $2.71 billion and is projected to reach $7.35 billion by 2031. This surge is driven by the rising prevalence of mental health disorders, significant investments in psychedelic research, and shifting public and regulatory attitudes.

Therapeutic areas that drive market growth include:

1. Post-Traumatic Stress Disorder (PTSD) affects approx. 5-10% of the global population. MDMA-assisted therapy has shown groundbreaking efficacy in clinical trials, paving the way for Next Gen Empathogens to capture a share of this growing market.

2. Depression and Anxiety impact over 300 million people worldwide, creating a pressing need for innovative treatments with faster onset and fewer side effects.

3. Social Functioning Disorders such as autism spectrum disorder and social anxiety disorder are additional markets where empathogenic therapies could have a transformative impact.

Opportunity:

• Clinical Superiority: There is a significant likelihood that these compounds have better safety and tolerability, improved pharmacokinetics, and greater therapeutic potential.
• Intellectual Property: Filing provisional patent applications immediately upon funding will establish strong, broad, and valuable IP.
• Regulatory Advantages: In jurisdictions where MDMA remains a controlled substance, these novel compounds may face fewer regulatory hurdles, accelerating market entry.