Will psilocybin ever be approved by the FDA?

Despite promising research, there’s no realistic timeline for when, or if, psilocybin will ever be approved by the FDA.

All three experts interviewed by Healthline stress that the substance can be dangerous for a host of different reasons if administered incorrectly.

“It will only be administered in a clinic by specially trained and certified therapists, physicians. It’s never gonna be available out on the street where people can sell it or take too much, or take too many of their pills from a prescription,” Greer said.

Psilocybin affects the cardiovascular system and can lead to increased blood pressure or irregular heartbeat.

It also has the potential to cause serious and permanent psychological problems.

“Psilocybin is a lot more psychologically dangerous than cannabis, and it’s especially dangerous for a small percentage of the population who have had an episode of psychosis or mania, manic episode, or even, say, a close family member whose had those problems, because it can trigger a psychosis or manic episode in a person who is vulnerable to that,” Greer said.

And there’s always the chance of a “bad trip,” or negative experience while taking the drug. There are rare but documented cases of individuals jumping to their deathsTrusted Source or otherwise behaving erratically in such a way that endangers themselves or those around them.

As Grob puts it: “Taken in uncontrolled settings, honestly, all bets are off. You don’t know what you’re gonna get.”

But psilocybin therapy is nothing like taking shrooms at a party. It’s meant to be a meticulously controlled environment to ensure that nothing unexpected happens.

“You name the risk, and we have really good mechanisms for addressing it,” Johnson said.

He further explained, “There are risks, but they are dramatically reduced in medical research and potentially in approved medical use, and I would argue that those risks and our ability to address them fairs very reasonably compared to many procedures that are routinely used in medicine.”

Nonetheless, the safety and efficacy of psilocybin treatment must still be satisfactorily proved to the FDA, which, thus far, it has not.

While some are optimistic that psilocybin may follow in the footsteps of MDMA therapy and potentially even have approval within the next 5 to 10 years, its pathway is far from clear and very uncertain.

When asked if there’s a realistic timeline for approval, Grob told Healthline, “I don’t think so. Even though the research we’re talking about has by and large been very positive and encouraging, there hasn’t been enough research.”

“There needs to be more FDA-approved clinical research with psychedelics,” he added, “exploring both how to optimize their therapeutic potential but also trying to get a better understanding of the range of medical effects, which may be problematic… There’s still some questions that need to be answered.”