Recognizing the FDA Priority Review Voucher for methylone and its Shulgin roots

The Shulgin Foundation welcomes the White House Executive Order on accelerating research into treatments for serious mental illness as a meaningful step toward advancing rigorous scientific inquiry into psychedelic compounds. For decades, Alexander “Sasha” Shulgin and his wife Ann advocated for careful, methodical exploration of these substances—guided by curiosity, documentation, and respect for their complexity. This order signals a continued shift toward recognizing that potential, supporting expanded clinical research, and encouraging public–private collaboration. Introducing mechanisms such as FDA priority review vouchers for promising psychedelic therapies may help to move these compounds toward approval and rescheduling more swiftly. It also reflects a broader cultural movement toward reducing stigma and reconsidering long-standing barriers that have limited scientific progress in this field.

At the same time, it is important to be clear about what this policy means in practice. The Executive Order does not legalize or decriminalize psychedelic substances, nor does it establish immediate, widespread access for patients. Pathways such as “Right to Try” remain limited and highly controlled, and the development of safe, effective treatments will continue to depend on careful clinical validation and regulatory review. The order also does not directly address the cultural and ethical dimensions of plant medicines, including the knowledge and stewardship of Indigenous communities, whose relationships to these substances long predate modern science. Lastly, this order does not address the movement for legal personal use for healthy individuals. As research accelerates, these considerations will need continued focus and must remain part of the broader conversation.

We also note with great interest today’s announcement that the FDA has granted a priority review voucher to Otsuka for its methylone program in PTSD—a compound first synthesized by Sasha Shulgin and Peyton Jacob III in the mid-1990s. Methylone is the cathinone analogue of MDMA, and has similar psychological effects and is shorter acting than MDMA. This moment reflects a full-circle evolution: from early-stage exploratory chemistry to the threshold of potential clinical application. It underscores the importance of the Shulgin archive and legacy—not only as history, but as a living foundation for ongoing discovery.

As this new chapter unfolds, the Shulgin Foundation remains committed to supporting research that is both rigorous and humane—grounded in science, informed by history, and attentive to the human contexts in which these compounds are studied and, one day, may be responsibly applied.