Federal regulators are taking steps to accelerate the development and review of psychedelic-based therapies, signaling growing interest in their potential medical use.
The U.S. Food and Drug Administration launched a series of initiatives to speed up research, clinical trials and review of medications using perception-altering psychedelics. The agency is providing national priority review vouchers to companies developing psilocybin- and methylone-based therapies, potentially shortening regulatory review timelines once applications are submitted.
The FDA also cleared an early phase clinical trial for noribogaine hydrochloride as a potential therapy for alcohol use disorder. This is the first time regulators have allowed a domestic clinical study of a compound derived from ibogaine, a naturally occurring psychoactive compound.
“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance use disorders,” FDA Commissioner Marty Makary said.
The aggressive regulatory push to cut red tape in psychedelic research comes after a recent executive order. The order directed federal health agencies to accelerate approval of innovative mental health therapies beyond existing prescription medications.
Psychedelics May Break The Schedule I Barrier
At this time, psilocybin and other psychedelics remain classified as Schedule I substances under federal law. This classification has historically restricted clinical advancement due to the label of high-risk for abuse and lacking accepted medical value.
The federal government’s stance on psychedelics has shifted from strict prohibition toward cautious support for scientific research and clinical development.
Following the ‘War On Drugs’ era, private donors largely funded early research on psychedelics. The National Institutes of Health signaled a major turning point when it broke a 50-year streak to offer federal grants for a psychedelic-based study in 2021.
Recent executive actions and National Priority Vouchers represent the boldest federal effort yet to prioritize these therapies.
While federal policy pivots, several states are already serving as real-world laboratories. Oregon and Colorado have established regulated programs allowing supervised psilocybin services, creating early models for legal psychedelic use outside traditional FDA-approved medical settings.
These states provide the first blueprints for integrating psychedelics into clinics and public health systems.
FDA Is Prioritizing Rigorous Investigational Controlled Clinical Development
The FDA is now using National Priority Vouchers to support more studies investigating psychedelic medications for depression and addiction disorders.
The FDA emphasized these actions are aimed at accelerating rigorous clinical development. To bridge this gap, the FDA is utilizing the Commissioner’s National Priority Voucher program.
This is a new pilot program that aimed to cut through regulatory delays for drugs that serve national priorities. These vouchers can reduce the approval timeline from years to mere months.
Companies studying psilocybin for major depression and treatment-resistant depression are eligible for these vouchers. Incentives are also being granted to companies studying methylone for post-traumatic stress disorder.
While the FDA works toward final guidance for sponsors developing psychedelic therapies, the agency has already outlined expectations for well-controlled clinical trials.
Why Priority Vouchers Are No Guarantee Of Success For Psilocybin-Based Studies
The new National Priority Vouchers offer a path to clinical development, but do not address the main challenge of designing clinical trials for psychedelics.
Federal regulators acknowledged designing clinical studies to evaluate these compounds have unique methodological challenges. Specifically, maintaining effective blinding in these randomized controlled trials is often difficult due to the psychoactive effects.
This challenge was a central reason for the FDA’s high-profile rejection of Lykos Therapeutics’ MDMA-assisted therapy in late 2024 despite promising data. The FDA’s response letter cited concerns about trial design, including functional unblinding, insufficient durability data and limitations in adverse-event reporting.
However, newer studies are navigating these methodological hurdles with innovative designs.
In February, researchers published a landmark study on the medical use of synthetic psilocybin across North America and Europe. The Phase 3 clinical trial involved over 1,000 participants and used active placebos to help maintain the blind.
The trial used low-dose active placebos that produced mild physical effects, making it more difficult for participants and researchers to determine who received the treatment. This prevented patients and researchers from distinguishing the study drug from the control. Through this method, the study found that treatment led to a rapid and sustained drop in depression symptoms.
Though this study isn’t in the April 18 executive order, researchers noted the growing pool of evidence as justification for further investigation.
Scientific design may be demanding, but the direction is clear. Psychedelic-assisted treatment is inching closer to mainstream medicine.
The Companies Developing Psychedelic-based Prescriptions
The FDA has awarded Commissioner’s National Priority Vouchers to several companies developing psychedelic-based therapies for mental health disorders. The program is designed to accelerate regulatory review timelines for treatments addressing major public health needs.
Compass Pathways
Compass Pathways is a U.K.-based biotechnology company focused on developing psychedelic therapies for mental health conditions.
Its lead drug candidate, COMP360, is a synthetic formulation of psilocybin being studied as a treatment for patients with treatment-resistant depression who have not responded to existing therapies.
The FDA granted COMP360 a Commissioner’s National Priority Voucher, potentially reducing the agency’s review timeline to one to two months following a formal application submission. The designation follows Phase 3 clinical trials involving patients with treatment-resistant depression.
The Usona Institute
Usona Institute is a U.S.-based nonprofit medical research organization investigating psychedelic-assisted therapies
The organization is developing a medical-grade psilocybin formulation for major depressive disorder. Usona Institute is studying psilocybin for major depressive disorder more broadly rather than for treatment resistant depression.
Usona received a Commissioner’s National Priority Voucher from the FDA, giving the program access to an expedited review pathway. The company is in late-stage clinical development and has announced plans to submit a formal drug application to regulators.
Otsuka America Pharmaceuticals / Transcend Therapeutics
Otsuka America Pharmaceuticals acquired Transcend Therapeutics and its psychedelic drug pipeline in a deal valued at approximately $1.225 billion.
Transcend is developing TSND-201, a synthetic compound derived from methylone, a psychoactive substance chemically related to MDMA. The treatment is being studied for post-traumatic stress disorder.
The FDA granted the program a Commissioner’s National Priority Voucher, accelerating its regulatory review timeline. The designation followed results from a Phase 2 study published in JAMA Psychiatry. The company is currently enrolling patients in Phase 3 clinical trials.
DemeRx NB
DemeRx NB is a clinical-stage biotechnology company developing treatments for substance use disorders.
The company is investigating DMX-1001, a synthetic therapy based on noribogaine, a metabolite of the psychoactive compound ibogaine.
The FDA recently cleared the company’s application to begin an early-stage U.S. clinical trial evaluating the treatment for alcohol use disorder. This authorization marks the first time federal regulators allowed a domestic clinical study involving an ibogaine-related compound for the condition.
