Mindstate Design Labs AI-Designed Trial Gets FDA Approval

Mindstate Design Labs has announced major news, receiving both FDA and European Medicines Agency (EMA) approval to commence human trials of its compound, MSD-001. This approval is a clinical validation for Mindstate’s advanced neurotech AI platform, Osmanthus, which specializes in the precision design of altered states of consciousness.

According to Mindstate, MSD-001 is distinct from traditional psychedelics such as MDMA, psilocybin, and LSD. It is designed to target specific serotonin receptors with high specificity, minimizing broader psychotropic effects. This specificity makes MSD-001 an optimal candidate for creating customized states of consciousness.

The upcoming human trials will be conducted at the Centre for Human Drug Research in Leiden, Netherlands. These Phase 1 trials will involve 52 healthy participants in a double-blind, placebo-controlled study, focusing on the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MSD-001. Advanced techniques such as qEEG and fMRI will be utilized to further understand the neural impacts of the drug.

Central to Mindstate’s innovative approach is its Osmanthus platform, which leverages AI to synthesize insights from over 70,000 human drug reports and a comprehensive database of biochemical data on psychedelics. This integration allows for the design of precise psychoactive effects. The platform not only draws from controlled settings and scientific literature but also incorporates real-world experiences shared anonymously online.

From Mindstate CEO Dillan DiNardo: “It seemed obvious that the experiential differences between psychedelics hold the keys to the biological basis of consciousness. If we could figure out which differences in psychedelic pharmacology drive which differences in consciousness, we’d understand the mechanisms of consciousness in an entirely new way. And we could begin using those mechanisms to design an innumerable variety of psychoactive effects – intentionally and with precision.”

 

See below for full comments from Mindstate and stay tuned to Microdose for more on this news.

1/ We're thrilled to announce we've received both FDA & EMA approval to begin human trials in the development of our neurotech platform for designing altered states. It’s time to move beyond “psychedelics” and begin the precision design of mood, cognition, and perception. (1/9)

— Dillan DiNardo (@DillanDiNardo) September 5, 2024

 

5/ Our Osmanthus platform is driven by direct human experience. It represents the scaling, quantification, and systematization of the Shulgin tradition of direct experimentation.

We’ve scaled with 70,000 human reports made possible by Shulgin’s chemistry and the psychonauts who…

— Dillan DiNardo (@DillanDiNardo) September 5, 2024