The Food and Drug Administration (FDA) has announced the winners of national priority vouchers to study the therapeutic effects of psychedelic drugs, less than a week after PresidentDonald Trumpsigned anexecutive orderpaving the way for more research.
In aFriday, April 24, announcement,the agency said that three companies had been given the green light to further explore, develop and test two different serotonin-2A agonists, a class of psychedelic medications, and related products. Another company was also granted permission to begin clinical trials on a third psychedelic drug.
“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 abuse conditions,” said FDA Commissioner Dr. Marty Makary in a statement. "We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”
The move drew praise from industry leaders like Eric So, interim CEO ofHelus Pharma, which was granted a voucher and appeared in the White House's initial press release about the order.
"This voucher program does draw attention to the space and hopefully takes and starts to educate people away from the war on drugs attitude that they had towards these compounds, which was really unjustified because ultimately, these are things that are not addictive and have therapeutic benefit," he told USA TODAY.
Skepticism also followed, with some saying expedited timelines may compromise the scientific process for drug approvals. Others, like Dan Troy, former FDA chief counsel and current managing director atBerkeley Research Group, said that the White House giving priority directives to the FDA is an unprecedented move that could raise doubts as to the agency's independence and dedication to a historically rigorous and apolitical process.
"There are many people who think that this avenue shows promise in the mental health space," he told USA TODAY. "I think the concern that some of us have is whether or not the White House should be telling the FDA which medicines to prioritize and which medicines not to prioritize. Because historically, that's been something that has been more the province of the scientists."
What are psychedelics?
"Psychedelics" is a broad term often used colloquially to refer to a variety of hallucinogens, or drugs that cause non-ordinary mental states. The term often conjures images of hippies "tripping" on LSD or rave-goers popping colorful MDMA pills.
In reality, psychedelics are a subcategory of hallucinogenic drugs that alter consciousness, often creating what is described as an otherworldly experience, according to theCleveland ClinicandGoodRx.They bind to certain serotonin receptors in the brain to affect the senses and cause auditory, visual and psychological hallucinations or sensations.
Being under the influence of a psychedelic is frequently called "tripping" or "going on a trip," and the experience is often associated with spiritual, mystical and emotional growth or clarity.
Most compounds categorized as hallucinogens or psychedelics are illegal in the U.S. and under UN conventions. Currently, the only legal drug commonly referred to as a psychedelic in the U.S. is ketamine, which can be administered medicinally but not recreationally.
Ketamine therapy has shown promise in mental health treatment, especially for treatment-resistant disorders, or those for which traditional medications and interventions do not work. The category of drugs has garnered newfound attention in recent years as anecdotal evidence and preliminary research have found potential benefits for the treatment of serious mental health disorders, according to GoodRx.
Which drugs are being studied and what do they do?
The FDA issued national priority vouchers to three organizations - biotech company Compass Pathways, nonprofit Usona Institute and pharmaceutical company Transcend Therapeutics - studying the following:
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Psilocybin for treatment-resistant depression and major depressive disorder.
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Methylone for post-traumatic stress disorder (PTSD).
It likewise greenlit an early-phase clinical study ofnoribogaine hydrochlorideby biopharmaceutical company DemeRx NB, primarily for the treatment of alcohol use disorder.
Psilocybin
What it is: Ever heard of "magic mushrooms"? Then you've heard of psilocybin. Naturally occurring and derived from certain types of fungi, psilocybin turns into psilocin in the body, where it then binds to serotonin receptors and possibly interacts with the Default Mode Network, a brain network associated with memory, daydreaming and a sense of space, time and self,according to GoodRx.
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What it does:People who use psilocybin often describe a "traditional" or "classic" psychedelic experience, including a sense of mysticism, loss of sense of space and time and visual and auditory hallucinations.
What it could do:Psilocybin has been indicated for potential use in treating major depressive disorder, specifically for people who have tried and failed traditional routes of treatment, like SSRIs and talk therapy. Compass Pathways hasalready provided the FDA with datafrom its Phase 3 clinical trials for treatment-resistant depression, which says patients can see symptom relief in as little as one day and for up to six months with only one or two doses.
Researchers and pharmaceutical companies like Helus Pharma look to extract and repackage these compounds in a way that can produce a therapeutic event while eliminating known side effects, explained So, such as stabilizing the otherwise unstable molecule of psilocin and allowing it to better enter the brain and produce the desired effect.
Methylone
What it is:Methylone is a common, synthetic drug that imitates the effects of MDMA (3,4-methylenedioxymethamphetamine). While it was popularized in a recreational manner beginning in the 2000s, it was first synthesized with therapeutic intent in 1996, specifically for the treatment of depression and Parkinson's, according to a2023 study publishedin the journal Frontiers of Pharmacology.
What it does:It is an entactogen and stimulant drug, meaning it tends to affect users differently than other, more "classic" psychedelics. Entactogens increase levels of serotonin, norepinephrine, dopamine and oxytocin in the brain, creating a more "energized" experience and enhancing pleasant emotions like love, connection, openness and trust, explains the same study and GoodRx.
What it could do:This relaxed, open and introspective attitude can be conducive to therapeutic breakthroughs for long-time mental health patients, allowing them to revisit and work through traumatic experiences that may otherwise be too frightening or upsetting to address.
"What MDMA (and similar drugs) does is it allows you to talk about things that are triggering," said Dr. Martin Polanco, founder of theMission to Live FoundationandMission Within. "For example, if somebody suffered a violent assault, often they can't even talk about it without their heart rate going up or losing their breath or just feeling activated. So with MDMA, it causes this sense of empathy and love and just relaxation, where they can talk and go back and talk about the trauma for the first time."
Noribogaine hydrochloride
What it is:Noribogaine hydrochloride is a derivative of ibogaine, a psychoactive substance that comes from plants, specifically the African Tabernanthe iboga shrub.
What it does:It is especially potent and produces a "trip" that lasts for several hours, often associated with "revisiting" memories formed throughout life, said Polanco. It has a complex effect on the human nervous system, impacting neurotransmitters of multiple kinds. Ibogaine has been administered therapeutically in other countries, including Mexico, for years, but comes with more significant risks than other popular psychedelics, including heart issues and severe drug interactions.
Focus has been placed on the derivative noribogaine hydrochloride, as opposed to ibogaine as a whole, as researchers aim to explore and extract the therapeutic effects of the substance while limiting or removing components that cause the associated risks. Before the 2026 executive order, Texas allocated $50 million in 2025 for clinical research on ibogaine to develop FDA-approved treatments for several substance use disorders. It has never before been approved for testing in the U.S.
What it could do:Early testing has indicated that ibogaine and its derivatives have the potential to help treat addiction. "Ibogaine is probably one of the strongest psychedelic medicines in existence," said Polanco, who has administered ibogaine therapeutically in Mexico for 25 years. "I think the funding dollars that the executive order provides for will allow for an acceleration of research into ibogaine because of its enormous efficacy for both PTSD, traumatic brain injury, and, actually, most commonly known, opiate and alcohol addiction."
What happens now?
Having priority doesn't necessarily mean drugs will come to the market or speed through the necessary trials exponentially faster. While the voucher program has purported to truncate the process by months, it all depends on the status of existing trials and what the data shows.
"The FDA’s decision allows the study to proceed and does not mean the drug has been approved or found to be safe or effective," FDA said in a statement. "The agency will continue to review data as it becomes available and support efforts to develop new treatments for alcohol use disorder and other mental health conditions."
While Markay said in the same statement that some drugs could hit the market as soon as the summer or fall, their availability will depend on factors ranging from insurance coverage and price to distribution and regulation.
Then, there is the matter of trust.
"I think FDA would run its normal drug approval process and would make the science-based decisions that it traditionally has made," said Dan Troy. "I think the concern is that, let's say they approve the medicine. Are people going to trust that this medicine has gone through the same approval process that has had the same standards applied to it as every other medicine? Because this medicine has had the president of the United States weigh in for it."
For now, researchers will continue to explore what some believe could be a turning point for mental health treatment in America.
This article originally appeared on USA TODAY:What psychedelics did FDA approve for study, and what do they do?
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