Compass Pathways is one of the companies spearheading clinical development of synthetic psilocybin, the compound naturally found in psilocybin mushrooms. 

Founded in 2016, Compass Pathways built its company around COMP360, a proprietary synthetic psilocybin formulation. Currently ready to begin a second phase 3 trial in treatment-resistant depression, Compass is expecting to potentially lead the first approval of a classic psychedelic by the U.S. FDA.

Psychedelic Health sat down with Compass Pathways CEO Kabir Nath, to discuss the company’s most recent milestones and plans for the future, ahead of the company’s stage appearance at PSYCH Symposium: London 2025, happening at Conway Hall, December 4.

In its most recent quarterly call, Compass emphasized the successful primary endpoint in its first Phase 3 trial, positioning COMP360, as the first psychedelic treatment to reach this milestone in treatment-resistant depression. 

The company reported plans to accelerate commercial readiness, expand provider education, and continue learning from their clinical delivery collaborations to support regulatory submission and launch timelines, underscoring its transition from experimental research toward potential market entry.The company recently announced that based on recent successes and developments, it’s pulling forward the projected launch date for COMP360 by about one year.

“We had a good discussion with the FDA about the potential for a rolling submission and rolling review, which for the psychiatry division would definitely be something they have not historically done,” said Nath.

These measures could put the drug in a fast track status with the FDA, allowing it to reach the market sooner than previously expected.

Nath says that because Compass has already completed enrollment in their second psilocybin study, they’re now looking to have a significant data release in the first quarter of next year.

“That suggests we could potentially be looking at a launch in early 2027,” he said, which would mean a pull forward of roughly one year from previous projections of a launch in 2028.

“We have runway into 2027, so we have cash to see us through all of our phase 3 readouts,” he said.

In its most recent financial results, the company reported having $185.9 million USD (£140.7 million) in cash or cash equivalents.

Dealing With Lykos Therapeutics’ FDA Rejection

Last year, the U.S. FDA rejected an application from Lykos Therapeutics, formerly MAPS, for the approval of MDMA therapy. The event marked a low point in the history of the recent psychedelic renaissance, taking many activists and investors to wonder when one of these compounds would finally reach approval by a major regulating body.

Nath made a point to separate Compass’ pipeline from that of Lykos.

“MDMA is not a classic psychedelic, MDMA is more of a pathogen, and so the therapy component is really important for MDMA, the actual dialog, the interaction with a therapist. For classical psychedelics like psilocybin or LSD, that’s not the case” he said.

While Lykos were trying to get a drug/therapy combination approved, Compass is trying to get a drug with monitoring and support approved. This marks a major difference from how the two companies present their results to the FDA.

Since Lykos was a spin-off from MAPS, which is an NGO working for decades to gather data on MDMA treatment, this could have led to issues around “some of the basics around safety, safety reporting, and collection of adverse events,” said Nath.

While Compass is looking at the U.S. market first, it has designed its studies with scientific advisors from Europe and the UK.

“We know that if these studies are successful, they would meet regulatory standards in Europe, but obviously that would be a separate application,” Nath said.

How Does Compass See Its Role and Influence As a Market Leader?

If COMP360 becomes approved, it will invariably influence the broader psychedelics space since it would be the most significant event since psychedelics came back into mainstream attention for healthcare use, starting in the early 2000s.

How does Compass see its ability to influence the broader market and levels of excitement moving investors and the general audience to become interested in these drugs?

“We are focused on executing this ourselves and, getting COMP360 across the finish line. But I completely recognize that, because we are likely to be the first, by some way, what we do and how we set about commercializing and being successful, is going to influence how others do,” says Nath.

Still, Nath is sure to point out that “the infrastructure that’s already been established for Spravato is actually the infrastructure that most of us in psychedelics will be plugging into.”

That means that treatment with COMP360 could potentially be provided by the same clinics currently providing treatment with ketamine, which means the drug could count with an existing infrastructure of thousands of clinics across the U.S., the UK and Europe ready to provide its treatment.

Ambio Life Sciences, a company known for its physician-led ibogaine therapy programmes, has been thrust into the global spotlight with the release of In Waves and War on Netflix, a documentary filmed at one of its treatment facilities, while simultaneously announcing the opening of its first European clinic in Malta. 

Ambio is a clinical organisation that offers medically supervised ibogaine programmes focused on trauma recovery, neuroregeneration and substance use disorders. The company’s leadership will be part of PSYCH Symposium: London 2025, occurring at London’s Conway Hall on December 4.

 In Waves and War 

The new Netflix documentary follows several former U.S. Navy SEALs as they confront the psychological and neurological scars of combat, including post-traumatic stress and traumatic brain injury, through ibogaine-assisted therapy. Filmed partly at Ambio’s clinic in Mexico, the film presents a rare, direct view of what such treatment entails and how it fits into the broader debate about the role of psychedelics in addressing mental health and substance use disorders.

In the film, Ambio showcases a clinical model that departs from the underground or informal settings that have long characterised ibogaine use. The company’s approach, grounded in medical oversight and structured aftercare, contrasts sharply with earlier practices and aligns with emerging calls for regulated, evidence-informed psychedelic care.

Ambio Life Sciences CEO and Co-Founder Jonathan Dickinson said to Psychedelic Health that the film’s timing is both urgent and consequential. “It is now 24 years after the start of the Global War on Terrorism, and rates of veteran suicide continue to rise. This film is being released to a global audience at a crucial time. The good news is, ibogaine is uniquely capable of addressing the intersection of mental health challenges, neurocognitive injury, and substance use,” he said. “Over the past five years, ibogaine in Mexico has quietly become the treatment of choice for the operator community, many describing immediate and lasting relief, often after years of failed conventional treatments.”

The documentary also foregrounds patient voices. Retired Navy SEAL and Ambio patient DJ Shipley, one of the film’s central figures, described his experience: “Ibogaine allowed me to become a better, more well-rounded version of myself, someone with more empathy, more compassion, but without losing my edge. I’m incredibly proud of my castmates and the directors. They did a beautiful job telling our story. I truly hope this film changes lives and helps people find strength in its vulnerability.”

The New Malta Clinic

Alongside the film’s debut, Ambio announced the launch of its new clinic in Malta, described as Europe’s first physician-led ibogaine facility. According to the company’s release, the centre offers a structured residential programme that combines medical screening, 24-hour physician supervision and integrated therapeutic support. Treatments will take place in a medically equipped environment with on-site emergency protocols, a full-time medical team, and facilities designed for private accommodation and holistic therapies such as breathwork and somatic work.

The Malta site marks Ambio’s first expansion beyond North America and establishes a strategic base for patients from Europe, Canada and the eastern United States. By creating a clinic that operates under formal medical oversight, Ambio seeks to raise safety standards and expand accessibility in a field that has often been criticised for its lack of regulation.

Ambio Life Sciences, founded by clinicians with experience treating addiction and trauma through ibogaine, positions itself as a provider of evidence-based, medically supervised psychedelic care. The company’s work has focused on neuroregenerative and trauma-related conditions, with a particular emphasis on veterans and first responders.

The combination of global media exposure and clinical expansion underscores Ambio’s role in shaping the public perception and practical delivery of ibogaine treatment. As both scrutiny and interest in psychedelic medicine intensify, Ambio’s visibility through In Waves and War and its new European operations will test how far the treatment can move toward mainstream medical acceptance.

Picture courtesy of Ambio Life Sciences.

Last week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to 5-MeO-DMT, also known as toad venom, in a significant advancement for psychedelic medicine.

The designation was given to BPL-003, a novel intranasal formulation of 5-MeO-DMT developed by Atai Life Sciences and Beckley Psytech. 

The decision by the regulatory body aims to expedite the development of BPL-003 as a treatment for adults with treatment-resistant depression (TRD), a condition affecting up to 30% of the 280 million individuals worldwide living with depression.

The FDA’s decision follows promising results from a Phase 2b clinical trial, which demonstrated that a single dose of BPL-003 led to rapid and sustained reductions in depressive symptoms within 24 hours, with effects lasting up to eight weeks. Notably, the majority of participants were ready for discharge just 90 minutes post-treatment, highlighting the potential for a scalable, in-clinic treatment model.

5-MeO-DMT is a naturally occurring psychedelic compound found in several species. It is most famously present in the venom of the Incilius alvarius (Sonoran Desert toad), as well as in other Bufo toads. It also occurs in certain plants, including Virola species and Anadenanthera peregrina.

The companies state that BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short therapeutic experience. The Breakthrough Therapy Designation facilitates intensive FDA guidance to support the advancement of BPL-003, with Phase 3 trials expected to initiate in the second quarter of 2026, subject to alignment with the FDA.

Other Breakthrough Therapy Designations in Psychedelic Compounds

The FDA has previously granted Breakthrough Therapy Designations to other psychedelic compounds, underscoring the growing recognition of psychedelics in mental health treatment:

• Psilocybin: In 2018, the FDA granted Breakthrough Therapy Designation to psilocybin for the treatment of treatment-resistant depression. A second designation followed in 2019 for major depressive disorder. 
• MDMA: In 2017, the FDA designated MDMA as a Breakthrough Therapy for the treatment of post-traumatic stress disorder (PTSD). 
• LSD: In March 2024, the FDA granted Breakthrough Therapy Designation to an LSD compound for the treatment of generalized anxiety disorder (GAD), based on Phase 2b trial data showing rapid and sustained improvements in anxiety symptoms.

Global 5-MeO-DMT Research Landscape

Beyond BPL-003, several organizations are exploring 5-MeO-DMT’s therapeutic potential:

• The Usona Institute has completed a phase 1 study of 5-MeO-DMT and is currently analyzing the results.
• GH Research is currently studying a 5-MeO-DMT compound for treatment-resistant depression and is in phase 2 trials.

These initiatives reflect a global interest in harnessing the therapeutic potential of 5-MeO-DMT for various mental health conditions.

The FDA’s Breakthrough Therapy Designation for BPL-003 marks a pivotal moment in the development of psychedelic-based treatments for mental health disorders. With ongoing clinical trials and increasing regulatory support, 5-MeO-DMT is emerging as a promising candidate in the evolving landscape of psychiatric medicine.

Original picture by Alan Schmierer on Wikimedia Commons. Edited using AI tools.