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.

A newly published systematic review titled on psilocybin’s effects on obsessive‑compulsive behaviours provides an up-to-date synthesis of research into the compound’s potential for treating OCD and related disorders. 

The study integrates findings from both animal models and early human trials, drawing attention to a consistent signal: reductions in obsessive or compulsive behaviours following psilocybin administration.

The review shows that in preclinical models (for example mice with altered grooming behaviours) psilocybin (or its active metabolite) produced marked reductions in compulsive-like behaviours, sometimes lasting beyond the immediate administration period. 

Clinically, although data remain limited, participants in early trials or case reports experienced rapid reductions in symptom severity (for example within hours or days) after single doses. The authors emphasise that while the mood-disorder applications of psilocybin are more advanced, this compulsive-behaviour indication is an important frontier.

In humans, single doses of psilocybin led to rapid symptom reductions. For example, in an open‑label study of nine treatment‑resistant OCD patients, reductions of 23 % to 100 % on the Y‑BOCS scale were recorded between 4 and 24 hours after dosing. A pilot trial in body dysmorphic disorder (a related OCRD) using a 25 mg psilocybin dose reported sustained improvements over 12 weeks in 58.3 % of participants. 

Mechanistically, the review highlights that psilocybin’s effects on compulsivity may not map exactly onto its classic psychedelic mechanism (5-HT₂A receptor activation). Some animal data suggest alternate or additional pathways (for instance 5-HT₇ receptor involvement, synaptic protein modulation) may underpin the anti-compulsive outcomes. The authors call for more robust, placebo-controlled human trials, ideally with neuroimaging and circuit-level biomarkers, to validate these early signals and clarify therapeutic protocols. 

The authors of the review emphasise that while the findings are promising, the evidence remains early stage. Key limitations include small clinical sample sizes, lack of placebo‑controls, short follow‑up intervals and heterogeneity in doses and models. They call for larger, double‑blind, placebo‑controlled trials incorporating neuroimaging of fronto‑striatal circuits, to more precisely map psilocybin’s effect in OCRDs. 

The authors propose that psilocybin may one day serve as a treatment for disorders characterised by repetitive, intrusive behaviours, not just mood disorders.

Are companies developing psilocybin-based treatments for OCD?

Several biotechnology companies are advancing psilocybin-based therapies for obsessive-compulsive disorder (OCD), signalling growing clinical interest in this area. 

Ceruvia Lifesciences has received U.S. FDA approval for an Investigational New Drug application to begin a Phase 2 trial using its synthetic psilocybin compound, SYNP-101, for OCD. The multicentre, randomised, double-blind, placebo-controlled study will administer a single oral dose and monitor participants for 12 weeks to assess symptom reduction, making it one of the most advanced OCD-focused psilocybin programmes.

Filament Health is developing PEX010, a botanical psilocybin drug exported to Israel for a trial investigating treatment-resistant OCD and PTSD.

MycoMedica Life Sciences lists OCD among its target indications, though its programmes remain early stage, while Compass Pathways is exploring broader psychiatric uses for COMP360, including potential applications in OCD.

Photo by Mélissa Jeanty on Unsplash.

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.