For decades, psychedelic compounds occupied an uncomfortable place in medicine. Scientists were intrigued, patients were searching for new options, and regulators remained cautious.
That is changing.
On April 18, President Donald Trump signed an executive order that explicitly includes ibogaine compounds and directs federal agencies to accelerate research and explore a lawful Right to Try pathway for eligible patients. On August 18, Trump announced that the University of Miami had provided the federal government with its historical ibogaine Investigational New Drug (IND) application.
This is significant, but it is important to understand what it does not mean.
An IND is not a drug approval, nor does an old application automatically authorize other companies or patients to access ibogaine. Any new sponsor would still need its own FDA authorization, supported by appropriate manufacturing, nonclinical, and clinical evidence. The potential value of the Miami material is that historical scientific and safety data could, if legally accessible and relevant, potentially reduce duplication of research. But what the file contains, who can provide access, and how much of it could be used for future development remain important open questions.
Meanwhile, the FDA has taken other steps toward psychedelic medicine. In April, it allowed a Phase I study of noribogaine, ibogaine's principal active metabolite, to proceed for alcohol use disorder. In July, the FDA finalized guidance for clinical investigations of psychedelic drugs, covering issues including manufacturing, clinical pharmacology, abuse potential, trial design, and safety monitoring.
These developments signal a clear change in direction- but not a lowering of the scientific bar.
Hope is not evidence
The mental-health crisis demands new solutions. Millions of people live with depression, PTSD, addiction, and other psychiatric conditions, while existing treatments do not work adequately for everyone. This is why psychedelic compounds deserve serious scientific investigation.
But enthusiasm cannot replace evidence.
We need rigorous clinical trials, pharmaceutical-grade manufacturing, precise dosing, and long-term safety data. If psychedelic compounds are to become medicines, they must meet the same standards as every other pharmaceutical treatment. The key question is therefore not simply whether patients should "take psychedelics." It is whether we can understand the biological mechanisms behind these compounds and translate them into safe, standardized and scalable medicines.
From psychedelic experience to pharmaceutical treatment
This is particularly relevant to ibogaine. Ibogaine has attracted scientific interest for its potential role in addiction and psychiatric disorders, but high-dose use also raises serious safety concerns, including QT-interval prolongation and potentially dangerous cardiac arrhythmias. The next stage of research should therefore focus on the fundamentals: Which mechanisms matter? What dose and formulation are appropriate? Which patients may benefit? And can therapeutic effects be achieved without an intense or prolonged psychedelic experience? These are scientific questions that should be answered through controlled clinical research.
Israel should not miss this moment
The United States is bringing psychedelic drug development into a far more visible regulatory conversation. The executive order, FDA actions, the upcoming September public hearing, and the University of Miami announcement all point in the same direction: greater institutional willingness to investigate these compounds. For Israel, this represents an opportunity, but also a responsibility. We should not compete to make the loudest claims about psychedelics. We should compete to produce the strongest evidence. The first chapter of the psychedelic story was about the experience.
Trump's announcement does not prove that ibogaine will become a major psychiatric treatment, and the Miami file is not a regulatory shortcut. It is, however, another sign that the scientific establishment is prepared to investigate a question that was once largely left at the margins of medicine. Now science must determine where that path leads.
Prof. Itamar Grotto is Executive Chairman of PsyRx and a former senior official at Israel's Ministry of Health.
