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The latest

Can a State Fast-Track a Psychedelic Breakthrough? Inside Texas’ Plan to Fund Ibogaine Trials

Texas is on the verge of launching the largest publicly funded psychedelic research initiative in U.S. history: a $50 million public-private partnership to support FDA-approvable ibogaine trials. The initiative has drawn support from high-profile figures like Rick Perry, but also concerns over safety, cost, access, and the lack of recognition for Indigenous knowledge. We take a look at the bold plan, the political manoeuvring that made it possible, and the questions that still remain.

Gilgamesh’s Next-Gen Psychedelic GM-2505 Prints Impressive Results in Phase 2a Major Depressive Disorder Study

As Gilgamesh Pharmaceuticals is set to share positive results from its Phase 2a study of GM-2505 (aka bretisilocin, a serotonergic psychedelic) in major depressive disorder later today at ASCP, we speak with the company’s Chief Strategy and Development Officer Jorge Quiroz and Chief Operating Officer Yoni Falkson to dig a little deeper into the study, its results, and the company’s plans for the candidate.

Matt Zorn, the Government’s Former Adversary, Is Now Its Psychedelics Czar

Matt Zorn made his name suing federal agencies over cannabis and psychedelics policy. Now, he’s inside the system as Deputy General Counsel at HHS, with what appears to be a mandate over psychedelics reform. Here, we recount Zorn’s path from ‘thorn in the side’ of the federal government to insider, what we might expect from him in his new role, and how insiders are reacting to the news.

Pα+ Psychedelic Bulletin #198: New Data Offers Look at Spravato’s Long-Term Use, Highlights Psychedelic Opportunity; MAHA Report Slams Psychiatric Meds; Momentum Builds for Beckley

New Data Offers Look at Spravato’s Long-Term Use, Highlights Opportunity for Psychedelics • MAHA Report Slams Psychiatric Drug Use Among America’s Youth, Trump Era Drug Policy Priorities Raise Questions for Psychedelics • Beckley Psytech’s Small Study Supports Adjunctive Use of 5-MeO-DMT with SSRIs in TRD • and more…

Psychedelics in Japan: Dr. Hiroyuki Uchida on Studies, Stigma, and the Road Ahead

As global interest in psychedelic therapies grows, Japan is beginning to chart its own path, grounded in cultural nuance, regulatory caution, and scientific rigour. In this interview, Dr. Hiroyuki Uchida of Keio University discusses his journey into psychedelic research, the challenges of launching Japan’s first psilocybin trials, and the steps being taken to ensure a safe, culturally appropriate psychedelic future.

FDA’s Makary Hints at Faster Reviews for Psychedelic Therapies

In a brief interview on Friday, FDA Commissioner Marty Makary publicly addressed psychedelic therapies for the first time in his new role, floating the potential for expedited reviews. While he emphasised urgency, he stopped short of outlining any concrete policy changes. Here, we cover the interview and provide our analysis.

The Library

Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.

The Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.

It’s exclusively available to our Pα+ subscribers, with new content added regularly.

Pα+ Library: Bifurcated Scheduling

Pα+ Library: we introduce some of the key concepts in the matter of bifurcated scheduling; a process by which an approved drug product may be placed in a different schedule to the substance itself. As we discuss in this piece, this could have significant repercussions for psychedelic research, legality, and even taxes.

Pα+ Library: Psychedelic REMS

Pα+ Library: we sketch out what a psychedelic REMS might look like, highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.

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