Insights

Read our independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and culture.

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The latest

Pα+ Psychedelic Bulletin #215: FDA’s Move to Single-Trial Approvals; Freedom to Heal Act Looks to Unlock Right to Try Psychedelics; Compass Clarifies Q1 Readout Plans

One and Done? FDA to Approve Drugs on a Single Phase 3, What It Means for Psychedelics • Freedom to Heal Act Seeks to Close Federal Right to Try Gap for Psychedelics • Compass Clarifies Q1 Readout Plans • DEA Increases Aggregate Production Quotas for Psychedelics • Sinema’s Ibogaine Experience • and more…

The View from D.C.: Psychedelic Politics, Blockers and Approvals on the Horizon

Psychedelic Alpha’s Josh Hardman reports from Washington, D.C., where conversations with regulators, lawmakers, and insiders suggest a turbulent but potentially transformative period ahead. Amid the noise, there remains quiet confidence that multiple psychedelic approvals could land within the next 18 months.

ARPA-H Launches $100M Effort to “Demystify” Mental Health and Catalyse Rapid-Acting Behavioural Health Therapeutics, Including Psychedelics

The Advanced Research Projects Agency for Health (ARPA-H) has carved out up to $100M for an initiative that aims to develop objective measures of mental and behavioural health, it announced today. Here, we take a closer look about ARPA-H’s first major foray into mental health, and how it could catalyse psychedelic drug development and practice.

Pα+ Psychedelic Bulletin #214: LSD Microdosing Program Collapses; AtaiBeckley’s Phase 2b Debrief; UK Government Responds to MPs’ Psilocybin-Related Questions

Largest LSD Microdosing Trial to Date Fails Across All Endpoints • AtaiBeckley’s Phase 2b Debrief: More Detail on SAE and Phase 3 Considerations • UK Government Holds Line on Psilocybin Despite New Cross-Party Written Questions • MAHA Summit Features Psychedelics • VA Reveals Phase 3 Psilocybin Study • Task Force Calls for Psilocybin Decrim • and more…

Beyond the Brain Reset: Óscar Soto on Mechanisms of Psychedelic Action

In this interview with Psychedelic Alpha’s Josh Hardman, psychiatrist, therapist and researcher Dr. Óscar Soto discusses psychedelic trial design, therapeutic fidelity, and the evolving role of subjective experience in psychedelics and psychiatry. He also shares his views from the field, with a particular focus on clinical trials of 5-MeO-DMT.

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.

The Psychedelic Practitioner

The Psychedelic Practitioner by Psychedelic Alpha is a new publication designed specifically for therapists, clinicians, facilitators, and other professionals working with—or preparing to work with—psychedelic therapies and related treatments.

The Psychedelic Practitioner: Issue 1

The Psychedelic Practitioner by Psychedelic Alpha is a new publication designed specifically for therapists, clinicians, facilitators, and other professionals working with—or preparing to work with—psychedelic therapies and related treatments.

The Psychedelic News Feed Archives

Archived versions of our Psychedelic News Feed.