'Tofu-Like' Psychedelic Gets FDA Nod - Mindstate's AI-Designed Therapy To Begin Human Trials

Mindstate Design Labs announced that it has received FDA and European Medicines Agency (EMA) approval to begin human trials for its compound, MSD-001.

This milestone marks the beginning of clinical validation for Mindstate's advanced neurotech AI platform, Osmanthus, which is designed to meticulously craft new altered states of consciousness.

New Approach To Psychedelics

MSD-001 is at the core of Mindstate’s innovative approach. In an exclusive interview with Benzinga, CEO Dillan DiNardo described it as “somewhat tofu-like” or “psychedelic tofu,” referring to its mild effects at clinical doses.

See Also: Y Combinator Startup Uses AI To Design New Drug-Induced States Of Consciousness

DiNardo explained that MSD-001 shares common properties with traditional psychedelics like MDMA, psilocybin and LSD, but with a critical difference: it has a much narrower range of effects, making it an ideal base for creating customized altered states of consciousness.

“We chose MSD-001 because it is somewhat tofu-like,” DiNardo said. “We were looking for a psychedelic that had serotonergic specificity—a drug that only hits these serotonin receptors, unlike psychedelics like LSD or DMT, which are very messy molecules, chemically speaking. They hit many different receptors across the brain.”

He elaborated on the distinctive properties of MSD-001. “What is unique about MSD-001 is that it is specific for serotonin receptors. And what we’re seeing is that when you’re only hitting these particular serotonin receptors in the way that MSD-001 interacts with them, the effects are very, very tofu-like. At clinical doses, you probably won’t see the entity interactions that you get with DMT or the ego loss that you might get with 25mg of psilocybin.”

The real innovation is how MSD-001 combines with other compounds – referred to as “probes” – to create specific, targeted psychoactive effects.

“Some probes may be very mild,” DiNardo told Benzinga. “Some probes at different doses could bring in some of the more exciting effects. But that’s the brilliance of the strategy—the optionality, the modularity, the ability to intentionally design many different effects on human cognition or perception.”

Human Trials: The Next Step

With FDA and EMA approval in hand, Mindstate will begin Phase 1 human trials for MSD-001 at the Centre for Human Drug Research in Leiden, Netherlands, involving 52 healthy participants in a double-blind, placebo-controlled study.

The trials will focus on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the drug, with additional assessments using qEEG and fMRI to map the neural basis of psychedelic action.

See Also: Psychedelics And Big Data: Learn How AI Is Helping To Read The Brain

DiNardo stressed the importance of these trials, not just for MSD-001 but for the future of psychedelic research as a whole. “What this means for the future of psychedelics is that we are intending to move this whole discussion, this whole field of research beyond psychedelics,” he pointed out.

“People often think of psychedelics as defined by a small list of a few drugs and the effects that those drugs create. But we’re trying to go beyond psychedelics. We’re trying to use psychedelics as tools to understand the architecture of the mind, so that we can intentionally design states of consciousness rather than just accept whatever effects existing psychedelics come along with.”

DiNardo said he envisions a future where tailored psychotropic therapies can address a wide range of conditions beyond the traditional scope of psychedelics.

“As we go into these human studies and clinically validate our ability to intentionally design many states of consciousness, including novel states of consciousness that existing psychedelics don’t cause, that opens up the borders of what psychedelics can do to many different effects, many different disease indications, potentially, that no existing psychedelics are able to help with.”

Ethical Considerations And The Future

-What ethical considerations do you take into account when designing new altered states of consciousness, particularly those that induce previously unknown effects?

“We do a very thorough job of characterizing the potential adverse events that you see with existing psychedelics. The states of consciousness we’re designing are specifically designed to enhance that safety profile, to get a profile of psychoactive effects that provide the most possible efficacy for the patients,” DiNardo told Benzinga. “Our goal is to give that precision and give that control to physicians and their patients, so that the state of consciousness that is induced is much more predictable, much more manageable.”

As the company looks to the future, it also considers the broader implications of its research.

“There’s a lot of evidence that psychedelics have transdiagnostic utility—PTSD, depression, anxiety, substance use disorder, OCD. But what we’re hoping to do is go beyond those commonly researched disorders to other diseases that are associated with a narrow mental or behavioral repertoire,” the CEO added. “Stuttering might be a great example where there's really no current treatment available. Psychedelics have anecdotal evidence that people have completely recovered from their stuttering problems.”

The Role Of AI And Data In Revolutionizing Psychedelics

At the heart of Mindstate’s work is its AI-driven Osmanthus platform, which synthesizes over 70,000 human drug reports with the world's broadest repository of biochemical data on psychedelics. This powerful combination allows Mindstate to design specific, targeted psychoactive effects with precision.

While the platform draws from a vast array of sources, including controlled settings, books and reliable data, it also incorporates anonymous reports from the Internet.

“Many of the reports are anonymous reports that are on the internet. So there isn't specifically a way to verify them. A large piece of what we rely on is the volume of these reports—those that are not reliable and are not consistent with the other reports will stand out in the data, and we can filter and curate the data that we have.”

Mindstate’s unique approach—focusing on designing specific states of consciousness rather than just discovering new drugs—positions it at the cutting edge of psychedelic research. DiNardo described this as a “mindstate-first approach,” offering a significant advantage in precision and control.

“If there is no understanding of the underlying mechanisms of why these drug effects occur, then you’re bound to whatever set of effects comes along with the existing chemical structure. The advantage here is design—the ability to precision design the acute psychoactive effects,” he said.

-How do you see the integration of these new formulations into the market? How will they compete with traditional, already-approved medications for treating mental health conditions?

“Our goal is to create disease-modifying therapies. We don’t want to just manage symptoms, which is often what standard care medicines do. We hope that our drug will become the first line of care, potentially used in combination or by itself, to provide real relief to patients,” DiNardo replied.

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Cover image made with AI.