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.
In its third-quarter results on November 3, Compass Pathways said the final submission of its new drug application for COMP360 in treatment-resistant depression is nearing completion and will be filed in the next two weeks. The company reported $444.0 million in cash and said it is working toward a launch in the first half of 2027, if approved. It points to the national priority voucher it received in April, which it says could shorten review to one to two months. Those are company projections: the application has not been filed, the FDA has not accepted or approved anything, and psilocybin remains Schedule I.
Psychedelic Alpha reported on November 2 that Usona Institute, a nonprofit, has completed a new drug application to the FDA for psilocybin in major depressive disorder. The report relies on sources: Usona declined to comment, and neither the company nor the FDA has confirmed a submission. Usona holds a national priority voucher, which is meant to bring a decision in about two months, and the sources say it is working with the agency on a risk evaluation and mitigation strategy. No application has been accepted, nothing is approved, and psilocybin is still Schedule I.
The FDA approved an abbreviated application from NRx Pharmaceuticals for a preservative-free ketamine, which the company has called KETAFREE. As a generic it carries the same label as Ketalar, approved in 1970, which covers anesthesia only, so this is not an approval for depression. NRx's chief executive said the only difference is that it contains no benzethonium chloride, a preservative used in some multidose vials. Still pending at the agency are NRx's citizen petition to remove preservative-containing ketamine products and its separate application for a preservative-free IV ketamine for depression and suicidality.
The public comment period on the FDA's psychedelics docket, opened in July alongside a Part 15 public hearing, closed on October 5. Psychedelic Alpha counted 610 submissions, just under 500 of them distinct, with nearly 100 template-style entries and 14 duplicates. Its author, who says Claude was used to sort the comments, describes the overall tone as mostly supportive with some division, including a coordinated opposition. This is one outlet's own tally, not an FDA finding. The agency has not published a summary of the comments or announced any policy change from the docket.
Researchers at the University of California, Santa Cruz, reported in Nature Neuroscience (published October 15, announced October 22) that psilocybin increased the formation of new dendritic spines, the tiny contact points between neurons, within 24 hours in mice. In healthy mice the extra connections returned toward baseline over about three weeks. In mice put under chronic stress the increase was larger and the loss of existing connections was reduced. The team found that the serotonin 2A receptor on a specific class of cortical neurons was needed for the growth but not for a behavior used as a proxy for hallucinations. This was done in mice, with a head twitch standing in for a trip, and it does not show that people grow lasting new connections or that this is how psilocybin helps depression.
Andrew Gradison of the Department of Veterans Affairs told the Psychedelic Healthcare Forum in New York that the VA has selected ten sites so far, chosen partly for their experience with psychedelic clinical trials, and has started a community of practice for them. He said about 2.1 million of the veterans who use VA care have PTSD, major depression or treatment-resistant depression, that the VA would begin treating patients immediately if a drug became available in early 2027, and that treating more than 1,000 veterans in the first year will be a challenge because demand will exceed supply. He described the pace as slower than veterans would like. No psychedelic drug is approved, the sites were not named, and nobody is being treated under this plan yet.
54 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.