SAN FRANCISCO, CA – September 24, 2025 – Mindstate Design Labs Inc., a clinical-stage AI neuroengineering platform company, today announced results from its first-in-human Phase I study of MSD-001, a proprietary oral formulation of 5MeOMiPT, a 5-HT2A agonist and neuroplastogen under clinical evaluation for the treatment of multiple psychiatric conditions with high unmet need. The trial confirmed that MSD-001 was safe and well-tolerated across dose ranges and delivered the first clinical validation of the Osmanthus platform’s capacity to design psychoactive effects.
The Phase I trial of MSD-001 was the first stage in the company’s development of Osmanthus as a more programmable substrate to reliably elicit specific psychoactive effect profiles. While MSD-001 as a single agent has the potential to be a rapid-acting, durable, intermittent treatment for psychiatric conditions, its primary role will be as a neutral psychoactive base in multiple fixed-dose combinations with other compounds. Each combination is designed to elicit a specific acute psychoactive effect that has the potential to improve efficacy, decrease adverse events, broaden patient access, and open new treatment possibilities beyond either the current standard of care or psychedelics.
Consistent with Mindstate Design Labs’ goal of developing a neutral psychoactive base compound, MSD-001 produced strong but narrowly defined psychoactive effects - no hallucinations, and markedly lower scores on all seven non-visual Altered States of Consciousness (ASC) scale dimensions compared to psychedelics - even with real-time intensity scores reaching 10/10 in the dose range evaluated.
In addition to a favorable safety and tolerability profile, MSD-001 exhibited dose-proportional and linear pharmacokinetic properties. No serious adverse events were reported. All adverse events were mild or moderate in severity and resolved before discharge. Observed events served to confirm action at 5-HT2A with expected affective, cognitive, and sensory effects.
“We are excited to see the results from this robust and comprehensive single ascending dose study showing that MSD-001 demonstrated a favorable safety profile, a clear, dose-proportional pharmacokinetic profile, and a pharmacodynamic profile characterized by mild tryptamine-like subjective effects with no hallucinations,” said Mindstate Design Labs CSO Dr. Robert Silva. “These results provide strong clinical validation of our Osmanthus platform and establish a solid foundation for advancing into trials in which we will further explore the potential of MSD-001 in fixed-dose combinations to be novel, safe, and effective treatments for serious psychiatric conditions.”
Mindstate Design Labs’ Osmanthus platform incorporates an ensemble of machine learning and statistical models of relationships between biochemical targets and psychoactive effects, quantifying the biochemical interactions that correlate with specific mental states. A central thesis and pharmacological framework of Osmanthus is that much of the broad range of psychoactive effects associated with psychedelic compounds may emerge as a result of interactions between canonical 5-HT2A signaling and other biochemical targets.
The company progressed MSD-001 into clinical development in part to isolate the psychoactive effects of canonical 5-HT2A signaling, expecting a uniquely narrower range of psychoactive effects than psychedelic compounds, corresponding to this agent’s serotonergic selectivity among other key pharmacological characteristics. The narrower range of psychoactive effects demonstrated in the trial corroborates not only the Osmanthus platform’s capacity to predict specific psychoactive effects of one drug, but also the central Osmanthus framework by which specific psychoactive effects might be consistently induced through fixed-dose combinations.
“Like CRISPR, CAR-T, or mRNA harnessed biological mechanisms for more programmable therapeutic delivery, Osmanthus has the potential to repurpose the mechanisms of psychedelics into a substrate for programmable mental states,” said Mindstate Design Labs CEO Dillan DiNardo.
The company will now progress fixed-dose combinations based on MSD-001 into the next phase of clinical trials. The lead program will engage a combination of serotonergic and adrenergic targets designed to elicit anxiolytic-like effects on mood, increase insight-related cognitive function, and upregulate aesthetic perception. This “tranquil insightful beauty” subset of psychoactive effects is occasionally reported as an effect of certain psychedelic drugs, most of which are not currently in preclinical or clinical development. By engaging the biochemical targets characterized by Osmanthus as being associated with these psychoactive effects, Mindstate Design Labs plans to assess the efficacy outcomes from consistently eliciting these effects for psychiatric patient populations.
“Science hasn’t bottled a new acute psychoactive state in over half a century, and psychiatry remains the largest unmet need in medicine,” said DiNardo. “Many mental health disorders require interventions that act directly on the brain’s distributed information processing. Just as stimulants reliably deliver focus and benzodiazepines deliver calm, there are likely dozens of untapped mental states that could be transformative for patients if similarly made available in pharmaceutical form.”
About Mindstate Design Labs
Mindstate Design Labs is a clinical-stage AI neuroengineering platform company developing novel classes of psychoactive therapeutics for psychiatric indications with high unmet need. The company’s Osmanthus platform maps the molecular biology underlying emotion, perception, and cognition to identify how specific neurotransmitter system interactions produce distinct emotional and cognitive states.
Mindstate Design Labs is backed by Y Combinator, Initialized Capital, Metaplanet, Day One Ventures, and angels including the founders of OpenAI, Neuralink, Instacart, Coinbase & Twitch.
To learn more, visit www.mindstate.design and follow us on X and LinkedIn.
Contact Information
Inquiries can be directed to info@mindstate.design.