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.

Arcadia Medicine, a San Francisco-based biotech startup developing MDMA-like empathogens, this month closed roughly $9.25 million in seed financing and won FDA clearance to begin human testing of an “safer” alternative to MDMA.

In recent years, MDMA-assisted psychotherapy has made substantial progress toward becoming an FDA-approved treatment for PTSD. In 2017, the FDA granted Breakthrough Therapy Designation to a PTSD program run by MAPS. Two Phase III trials were conducted, and in December 2023 MAPS (now Lykos Therapeutics) filed a New Drug Application for MDMA-assisted psychotherapy, the step before a drug is approved greenlit.

The FDA initially accepted the application but an advisory committee raised concerns about study design, blinding, safety follow-up, and ultimately delayed the decision in lack of sufficient data.

While Lykos is currently addressing the FDA’s concerns, other companies like Arcadia are pushing towards developing MDMA-like compounds foe mental health.

Arcadia’s flagship compound, known as AM-1002 is a patented formulation engineered to deliver MDMA-style therapeutic effects with reportedly fewer stimulant and cardiovascular risks.

On surface, Arcadia’s pipeline is but another push within the broader pipeline for psychedelic medicines. Yet several names stand out as company backers: a small but prominent group of Silicon Valley founders including Sam Altman (OpenAI co-founder and CEO), Coinbase co-founder Fred Ehrsam, and Figma’s Dylan Field are listed among investors. 

Arcadia’s official release includes a direct endorsement from Altman himself: “Arcadia’s innovative work in developing a safer form of MDMA is an important step towards a potentially transformative psychiatric treatment.” 

Come meet the leaders shaping the future of psychedelic medicine. Join PSYCH Symposium: London 2025, December 4 at Conway Hall.

What is Altman’s involvement in the company?

Publicly available records and the company’s release identify Altman as an investor and vocal supporter rather than a manager or board member. 

The press release contains his endorsing line but does not list a formal operational role. 

Secondary reporting from news sources repeats the same facts: local press and sector outlets describe Altman as a backer and, in some pieces, as an early or founding investor, but those outlets trace back to the company announcement for the underlying claim. 

Altman has previously described personal psychedelic experiences, saying to Fortune that taking psychedelics ‘significantly changed’ his mindset, helping him overcome anxiety and other mental health issues.

Why Altman’s backing matters to the psychedelics field

Sam Altman’s name carries heavy value for a clinical-stage startup in the forms of capital, messaging, and network. First, Altman’s net worth itself makes additional funding easier to raise because other investors can treat a credible tech founder’s participation as a due-diligence shortcut.

Second, Altman’s public endorsement functions as a reputational wedge: his quote frames Arcadia’s work as “transformative,” which helps normalize the idea of psychedelic therapeutics among skeptical audiences like clinicians, philanthropists, and foundations who may otherwise view MDMA derivatives as high-risk or fringe. 

Third, his network. Altman’s ties across AI, venture capital and elite philanthropy can open introductions to strategic partners, CROs (contract research organizations), and subsequent investors, all practical advantages for a company moving from IND to Phase 1. 

Tech leaders and psychedelics: a broader pattern

Arcadia’s investor mix is not an isolated case. Over the past several years, high-profile tech figures have repeatedly shown up in psychedelic financing rounds and philanthropic funding. Examples include Peter Thiel’s early backing of Atai Life Sciences and Sergey Brin’s $15 million funding of research into ibogaine-related programs through the company Soneira. These commitments have ranged from direct venture investments to philanthropic grants and have helped bankroll both discovery-stage firms and clinical programs. 

Yet the presence of celebrity or tech capital does not substitute for rigorous clinical validation: AM-1002 still faces standard regulatory hurdles before any therapeutic claims can be tested in patient-outcome trials. Arcadia’s IPO, licensing deals, or strategic partnerships will depend on Phase 1 readouts and subsequent efficacy demonstrations, milestones where scientific data, not endorsements, will determine value.

Picture from Wikimedia Commons. The background has been edited using AI tools.