Biotech & drug discovery · Psychiatry
Mindstate Design Labs
A company that ran machine learning over 70,000 trip reports, picked a 40 year old Shulgin tryptamine, and took it through Phase 1 in Leiden. The safety data is on the record. The bigger claim, that mental states can be engineered to order, is still a claim.
The blandest drug in the room
Most psychedelic startups are building something more. Mindstate set out to build something less.
Its founders wanted a compound that switches on the serotonin machinery classic psychedelics use and then does almost nothing interesting on its own. No entities. No ego dissolution. No four hour confrontation with your own subconscious.
Dillan DiNardo, the co-founder and chief executive, calls the result “psychedelic tofu.” He put it another way to WIRED in September 2025: “We created the least psychedelic psychedelic that’s psychoactive.”
The point of a bland base is what you mix into it. Mindstate calls the base a primer and the additions probes, and pairs them so the combination produces one narrow, chosen effect: anxiolysis, insight, heightened aesthetic perception. Its website states the ambition in a line: “Experience is an engineerable output of biology.”
Why anyone would want a duller psychedelic
The therapeutic case for psychedelics comes bundled with a logistics problem and a safety problem. Sessions run for hours and need supervision, and the experience is unpredictable. In 2024 the FDA declined to approve MDMA-assisted therapy for post-traumatic stress disorder and asked for another late stage trial.
A second generation formed around one question: how much of the trip do you need? Some companies answer by deleting the subjective effects. Mindstate answers the opposite way. DiNardo told Fierce Biotech that “ultimately, the therapeutic impact of psychedelics comes from the subjective experience.”
The specifying is done by a platform called Osmanthus, which the company describes as “A molecular experience interface.” It is an ensemble of machine learning and statistical models trained on biochemical data alongside roughly 70,000 first person trip reports pulled from clinical datasets, books, drug forums, Reddit and, the company says, the dark web. DiNardo told Fierce Biotech those reports amount to basically “every trip report in existence.”
An artificial life pioneer and a venture investor
The scientific co-founder is Thomas Ray, a Harvard trained evolutionary biologist who spent the 1990s doing something very strange. With no computer science training he wrote a virtual machine and let self-replicating programs mutate inside it. The company describes that system as “the first known instance of evolution by natural selection apart from life on earth.” For two decades since, Ray has worked on the natural history of psychoactivity.
DiNardo came from the money side, with more than fifty biopharma, device and health tech investments at a billion dollar venture fund behind him. The rest of the roster is unusual for a seven person biotech. Josie Kins, who founded PsychonautWiki and the effect taxonomy site EffectIndex, is on staff as a phenomenologist. Rob Silva, the chief scientific officer, ran global development at MindMed. Rand Hindi, who sold the AI startup Snips to Sonos, appears on the website as a scientific advisor and on the SEC filing as a director.
Leiden, and what came back
Mindstate filed its first investigational new drug application in early 2024 and told Lucid News that September that it had clearance from the FDA and from the European Medicines Agency. The trial that ran was registered as NCT06702332 at one site, the Centre for Human Drug Research in Leiden. Dosing began November 11, 2024 and the study finished July 11, 2025.
On September 24, 2025 the company published topline results: 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.” No serious adverse events. The same release named the first combination program, aimed at a state it nicknames “tranquil insightful beauty.” In December 2025 Graeme Bell, a former chief financial officer at Intellia, Anacor, Tmunity and Valo Health, joined the board.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| Phase 1 as registered | NCT06702332. Randomized, double blind, placebo controlled single ascending dose study. Start Nov 11, 2024, completion Jul 11, 2025. Enrollment 47, actual. One site, Leiden. Condition listed only as “Mental Health Disorders.” No results posted to the registry. | Public record |
| Phase 1 findings | In the company release of Sep 24, 2025 and a conference abstract at ICPR 2026: doses of 0.5 to 10 mg, no serious adverse events, onset about 30 minutes, effects most consistent at 6 to 10 mg. | Company-stated |
| Enrollment, planned versus actual | Lucid News reported in Sep 2024 that the study would involve 52 participants. The registry and the abstract both give 47. | Differs from registry |
| What the molecule is | 5-MeO-MiPT was first described by Alexander Shulgin, David Repke and colleagues in 1985. MSD-001 is a proprietary oral formulation of it, selected by the platform rather than designed by it. | Public record |
| Pharmacology, as described | The company release calls MSD-001 “a 5-HT2A agonist and neuroplastogen” and AdisInsight lists 5-HT2A agonism. The trial abstract calls it “an orally bioavailable tryptamine targeting 5-HT1A, 5-HT7, and 5-HT1D receptors.” | Descriptions differ |
| Brain imaging | DiNardo told WIRED the imaging showed “many of the same brain-wave patterns associated with psilocybin and other first-generation psychedelics.” The abstract is narrower: “EEG showed reduced delta/theta and increased gamma activity, while fMRI and NeuroCart effects were limited.” | Company-stated |
| US controlled substance status | Unscheduled federally. DEA proposed Schedule I for 5-MeO-MiPT and four other tryptamines on Jan 14, 2022 and withdrew on Jul 22, 2022 after a legal challenge, saying it would seek a fresh HHS evaluation. Florida schedules it, and the Federal Analogue Act can reach it outside medical and scientific use. | Public record |
| Peer reviewed output | One PubMed record carries a Mindstate Design Labs affiliation: a Mar 2024 Neuron paper on large language models, co-authored by Thomas Ray. Nothing for MSD-001. | Not found |
| The combination program | Announced Sep 24, 2025. No second trial appears under the sponsor on ClinicalTrials.gov as of Sep 22, 2026. | Not found |
| Capital | An $11.5 million seed reported in 2022, and one Form D filed Nov 26, 2024: $12,698,587 sold of $15,103,934 offered, 43 investors. | Public record |
Read plainly: a single ascending dose study in 47 healthy volunteers is a safety and pharmacokinetics exercise, and by that standard it went well. It says nothing yet about whether the drug treats anything. Every claim beyond safety, including the imaging, the altered states scores and the assertion that the platform predicted the effect profile in advance, rests on a press release and a conference abstract.
What to watch
- A registered trial for the fixed dose combination. That is where the design claim gets tested.
- A peer reviewed publication of the dose escalation data, or results posted to ClinicalTrials.gov.
- A named indication. The registry lists only “Mental Health Disorders”; the website points at anhedonia in major depressive disorder.
- Any renewed DEA move on 5-MeO-MiPT. The 2022 withdrawal was provisional, and scheduling would change the cost of every trial that follows.
- A new Form D. The only one on file dates to November 2024 and left about 16 percent unsold.
In their words
“We created the least psychedelic psychedelic that’s psychoactive.”
Dillan DiNardo, CEO, to WIRED, 2025 · Independent
“The thesis was, if we essentially stripped out all of those other biochemical interactions, we’d be left with a drug that was quite tofu-like by psychedelic standards.”
Dillan DiNardo, to WIRED, 2025 · Independent
“They’re unpredictable, they’re unreliable, they’re scary.”
Dillan DiNardo on first generation psychedelics, to Lucid News, 2024 · Independent
“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.”
Rob Silva, chief scientific officer, company release, September 2025 · Company release
“Science hasn’t bottled a new acute psychoactive state in over half a century, and psychiatry remains the largest unmet need in medicine.”
Dillan DiNardo, company release, September 2025 · Company release
“These findings suggest that a mild psychedelic experience, one without hallucinations, could make for a safe and potentially therapeutic experience, especially if it is catalyzed through a process of psychological support.”
Alan Davis, Center for Psychedelic Drug Research, Ohio State University, to WIRED, 2025 · Independent
“There are lots of drugs that are mood altering that are not psychedelic drugs.”
Rachel Yehuda, Parsons Research Center for Psychedelic Healing, Mount Sinai, to WIRED, 2025 · Independent
“It remains to be seen how much we can rely on AI to predict outcomes or ensure safety.”
Jonny Martell, Centre for Psychedelic Research, Imperial College London, to the Evening Standard, 2025 · Independent
Related companies
Sources
- Public recordClinicalTrials.gov NCT06702332 and sponsor search
- Public recordForm D and filing index, CIK 0002046478
- Public recordPubMed searches for the Mindstate affiliation and for MSD-001
- Public recordSchedules of Controlled Substances: placement of five tryptamines including 5-MeO-MiPT in Schedule I
- Public recordData science opportunities of large language models for neuroscience and biomedicine
- IndependentA Startup Used AI to Make a Psychedelic Without the Trip
- IndependentMindstate looks to test first AI-derived psychedelic on humans
- IndependentMindstate Uses AI to Design Next-Gen Psychedelics
- IndependentA start-up has created a psychedelic that won’t scare patients
- IndependentInside the Challenge to DEA’s Proposed Tryptamine Scheduling
- IndependentMSD 001 drug record, phase and mechanism
- Independent5-MeO-MiPT, legal status and the ICPR 2026 trial abstract
- CompanyTopline MSD-001 trial results and lead fixed dose combination program
- CompanyAppointment of Graeme Bell to Board of Directors
- CompanyCompany website, platform, program and team pages
- CompanyCompany profile, batch and team size
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
