The God Molecule Heads to Phase 3 FDA Trials: Have Psychedelics Fully Arrived?

5-MeO-DMT is not your everyday psychedelic. It’s called the “God Molecule” for a reason. Users describe experiences of rapid ego death or merging with pure consciousness. Some call it an obliteration, not a hallucination. Yet, even with this intense profile, 5-MeO has taken a major step into the mainstream. 

Psychedelic drug developers Beckley Psytech and Atai Life Sciences have reported positive Phase 2b results in patients with treatment-resistant depression, showing rapid and durable antidepressant effects. These results prompted Atai to acquire Beckley in a multi-million dollar deal, with plans to advance the program into Phase 3 FDA trials. 

If a compound as potent and historically fringe as 5-MeO-DMT is now progressing through advanced FDA clinical studies, it suggests that the whole range of psychedelic therapies are becoming an accepted part of the conventional therapeutic ecosystem.

If 5-MeO-DMT can make it to the medical mainstream — have psychedelics finally fully arrived?

The God Molecule: 5-MeO-DMT

The God Molecule. It says a lot. A close chemical cousin of DMT (the active compound in ayahuasca), 5-MeO-DMT is a short-acting but intensely powerful molecule that induces ego-dissolution and non-dual states of consciousness often described as mystical or even spiritual in nature. 

5-MeO-DMT has a long history of ritual use in Central and South America, primarily through inhaled snuffs made from Anadenanthera and Virola seeds. These powders were mixed with ash or lime and blown into the nose using tubes made of bone or wood. Archeological finds show that this practice dates back thousands of years and was widespread across the region. Indigenous use of these snuffs for spiritual and healing ceremonies continued into the colonial era. 

Although 5-MeO-DMT occurs naturally in certain plants and fungi, today it’s most famously derived from the Sonoran Desert Bufo alvarius toad, an amphibian native to the arid regions of the southwestern U.S. and northern Mexico. 

To extract the psychedelic compound, people harvest the toad’s glandular secretions, a milky substance that contains 5-MeO-DMT along with other chemicals. While the toads often survive the process, conservationists warn that growing interest in the substance has added stress to an already vulnerable species. As interest grows, researchers are shifting their focus to synthetic versions of 5-MeO-DMT that can be safely produced in labs. 

To get more context on the God Molecule, we spoke to Joel Brierre, co-founder of 5-MeO Tandava Retreats and F.I.V.E. training programs.

“5-MeO-DMT could be considered the most powerful known psychedelic experience. What makes 5 (5-MeO) different from other psychedelics is that rather than a subjective experience of going on a journey, users may experience a complete cessation of sense of individual self, a merging with something infinite and boundless.”

Unlike psilocybin or LSD, 5-MeO is not known for classic hallucinations or colorful imagery. Instead, its effects are more existential — described as “whiteout” experiences or total dissolution of the self. 

The entire experience typically lasts 15 to 45 minutes, making it potentially more manageable in a clinical setting than longer-acting psychedelics. However, its sheer intensity has historically limited its clinical exploration and kept it on the fringes of psychedelic medicine.

Until now.

Major Study Shows Positive Results for Severe Depression

In July 2025, Beckley Psytech and Atai Life Sciences announced positive topline results from a Phase 2b trial of BPL-003, an intranasal formulation of 5-MeO-DMT. 

The Phase 2b study was the largest ever controlled study, with 193 patients suffering from treatment-resistant depression (TRD). The results were compelling: a single dose of 5-MeO-DMT produced significant and meaningful reduction in depression scores for up to 8 weeks. In addition, Beckley reported rapid onset of antidepressant effects within hours of dosing, a key differentiator from traditional antidepressants, which can take weeks to become effective. 

The trial also revealed a favorable safety profile, with no serious adverse events reported. This is critical, given the compound’s reputation for overwhelming intensity. 

In February, psychedelic medicine competitor GH Research reported similarly positive results for its own Phase 2b study, using an inhaled 5-MeO-DMT drug for treatment-resistant depression.

Joel Brierre has seen similar results from people attending his retreats: 

“We have seen remarkable results with depression. However we have found that effects lasting beyond 4-6 weeks are limited when done outside of a container, one that includes and emphasizes structured support during the integration process.”

An important reminder that purely clinical results are not on their own a guarantee of long-term healing. Popping a 5-MeO pill at the doctor’s office is not the likely path to success. 

But by developing a standardized, pharmaceutical-grade delivery option for 5-MeO, these companies are turning a ceremonial or underground tool into a legitimate medical intervention that could help a larger number of people.

Millions in Investment Follow 5-MeO Success

The strong Phase 2b results didn’t just impress researchers — they moved markets. Atai Life Sciences, a major player in the psychedelic medicine space, had already entered into a partnership with Beckley Psytech, but the release of the study data provided a green light for something bigger. In June of this year, Atai announced its intention to fully acquire Beckley Psytech — if the 5-MeO-DMT Phase 2b results were sufficiently positive. 

With the positive results, the acquisition and merger will be taking place (the deal placed a value on Beckley and its 5-MeO program at approximately $390 million).

The acquisition shows how seriously investors are now taking psychedelic compounds, even lesser-known drugs like 5-MeO. It also marks the first time a major pharmaceutical acquisition has been driven entirely by the clinical success of 5-MeO-DMT. The merger will consolidate Beckley’s research and development pipeline under Atai’s larger infrastructure, accelerating its path to Phase 3 trials and potentially, FDA approval.

If 5-MeO-DMT Is Invited to the Party, Psychedelics May Have Fully Arrived

For years, the psychedelic renaissance has largely revolved around more familiar compounds like psilocybin and MDMA — substances that already had some cultural acceptance and extensive safety profiles. But 5-MeO-DMT has always been the outlier: more intense, less studied, and associated with underground ceremonies rather than clinical protocols.

We asked Joel Brierre about this. 5-MEO is not your usual psychedelic. It’s the God Molecule. Yet it’s now moving to Phase 3 FDA trials and getting millions in biotech investment. Does this mean that psychedelics have fully arrived?

“5-MeO is an accelerant to deep emotional processing, and after a long time without effective valves for catharsis, humanity is in need of a good letting go,” said Brierre. “If the most profound, unpredictable, and paradigm-dissolving compound goes mainstream, then we may be in store for something even greater than a psychedelic renaissance,” 

We’re no longer trying to convince the medical establishment to cautiously entertain your garden-variety magic mushrooms. We are now talking about bringing a toad-derived, ego-annihilating compound into mainstream psychiatric clinics.

A potentially seismic shift.

A Medical and Commercial Tipping Point

The implications of this go beyond one molecule or one company. The successful entry of 5-MeO-DMT into late-stage clinical trials signifies that psychedelics have crossed a critical threshold of credibility. The medical world is paying attention. The investment world is betting big. And the cultural narrative has shifted from curiosity to acceptance.

Socially, there is now a broader openness to exploring altered states as tools for healing. What was once seen as dangerous or indulgent is now viewed by many as a deeply healing, even sacred, experience. Commercially, top biotech investors are putting their money on the line based on these results. Medically, psychedelics are being evaluated by the same rigorous standards as SSRI anti-depressants — and they’re passing the test. 

“If a treatment with this profile were available today, it would immediately become my treatment of choice for treatment-resistant depression.” — said Dr David Feifel, Professor Emeritus of Psychiatry at the University of California, after seeing the results from Beckley’s 5-MeO study

The Director of a respected Neuropsychiatry Institute saying this about a rare psychedelic. 

And the momentum is self-reinforcing. The success of 5-MeO-DMT may encourage other companies to explore lesser-known or more powerful compounds. It may also push regulators to fast-track additional psychedelic therapies, especially as mental health disorders continue to pose a growing global burden.

It also sends a message: this is no longer fringe science. It’s a viable part of the future of mental health care.

With Phase 3 trials on the horizon and millions of investment dollars continuing to come in, the so-called God Molecule is no longer just a spiritual metaphor. It’s becoming a medical and therapeutic reality.