The book is a photograph. This page is the part that keeps moving.
Before you read any of this, legalization,
decriminalization and deprioritization are three different things, and almost every story you
read confuses them. Five minutes here and you can read this subject correctly forever.
ARPA-H, the health department's fast-track research agency, held a Proposers' Day in Washington for ASCENT-IBO, a new funding call meant to produce the first ibogaine trials in the country with the federal authorization to actually run. No such trial exists today, despite decades of anecdotal reports from clinics abroad. Applicants have until mid-October to submit study plans, aimed first at basic safety before any larger trial. This is a call for proposals, not a trial underway, and ibogaine stays Schedule I regardless of the outcome.
Xylo Bio dosed its first volunteers in Australia in a Phase 1 trial of XYL-1001, a lab-made molecule designed to activate the same brain receptor psilocybin does without producing hallucinations. The idea, if it survives testing, is a drug that skips the eight-hour supervised session entirely. This is a safety study in healthy volunteers, the first of many required steps, and nobody with depression has taken it yet. Several other companies are chasing the same bet quietly right now.
Definium Therapeutics reported that a second late-stage trial of DT120, its tablet form of LSD, again beat placebo for generalized anxiety disorder, with scores improving within days of a single dose. It is the third positive Phase 3 readout this year for the drug, following results in depression and an earlier anxiety trial, and the company says it will meet with the FDA before filing for approval sometime in 2027. None of that makes LSD legal, available, or even approved. It is one drug, in one company's pipeline, still years from a pharmacy shelf if it gets there at all.
Psyence BioMed formed Texas Ibogaine Research Corporation, a new US subsidiary meant to hold the rights to a pharmaceutical-grade version of ibogaine and eventually carry it through federal drug trials. The licensing deal for that ibogaine supply is not finalized, so there is no drug, no trial and no timeline yet, just a corporate structure built to chase one. It follows the same federal research push behind April's executive order, ARPA-H's new funding call and the University of Miami's donated research file. Ibogaine remains Schedule I regardless of any of it.
The agency set 14 September for a four-hour public hearing at its White Oak campus in Maryland on the future therapeutic use of psychedelic drugs in supervised and supportive settings, with roughly eighty speakers signed up for two minutes apiece. The Federal Register notice is unusually specific about what the agency will not hear: nothing on scheduling, nothing on legalization or decriminalization, nothing on ceremonial or personal use. The four topics on the table are provider training, patient safety, access and data collection. Worth knowing what a hearing is and is not. The agency is listening, not deciding, and not one of the medicines under discussion is approved.
Four agency staffers wrote a commentary in the New England Journal of Medicine describing what they call the FDA's new framework for psychedelic drugs. It walks through the breakthrough therapy designations already granted, the rolling and priority reviews those designations unlock, and the final clinical trial guidance the agency issued in July. It also says, in plain words, that psychedelic therapies remain investigational and that the approach is still evolving. A commentary approves nothing and binds nobody. What it does is tell every drug developer in the country exactly how the agency is thinking, days before it opened the floor to public comment.
31 of these landed after the book went to press.
That is not a flaw in the book, it is the nature of the subject. Chapter Eleven says it out loud:
treat it as a photograph rather than a map. This page is where the photograph gets updated.
One thing worth knowing about how this is written.
Nothing here is a scraped headline. Each entry is read against a primary source and then written
from scratch, which is why the summaries tell you what category a thing is. A law that takes
effect only if the FDA acts first is not legalization, however the headline reads.