Psilocybin continues to gain momentum as a possible alternative to mental health treatments that leave large numbers of patients without recovery. 

Shortwave Life Sciences is a company that’s currently working on a feasibility study to prove whether psilocybin can be delivered safely, accepted by patients and integrated smoothly into clinical practice, for the treatment of anorexia.

The company will be presenting its most recent findings at PSYCH Symposium: London 2025, on December 4 at London’s Conway Hall, in the panel “Designing Breakthroughs: A New Human Study for Anorexia Treatment.”

Shortwave is a neuroscience-focused biopharma company looking to target severe treatment-resistant anorexia nervosa through a psilocybin-based buccal film formulation.

According to the company’s CEO, anorexia nervosa carries the highest mortality of all psychiatric disorders, driven by both medical complications and suicide.

The Lack of Treatment Options for Anorexia

Dr. Nadya Lisovoder, CEO at Shortwave, told Psychedelic Health that “the illness itself is exceptionally complex” because “it is a multifactorial condition that involves emotional, cognitive and physiological mechanisms at the same time.”

For that reason, not much therapeutic innovation has been seen in trying to combat the condition since developing a single medicine that can influence all of these layers has been extremely difficult.

“Most traditional treatments focus on one pathway only. In anorexia, that is rarely enough. The psychological patterns, the fear circuits, the rigid thinking styles and the metabolic consequences all reinforce each other. Treating just one aspect does not shift the illness in a meaningful way,” says Lisovoder.

That has led Shortwave to develop an integrated perspective. 

“Our approach aims to engage several relevant receptor systems and neural pathways simultaneously, addressing the mental and emotional dimensions of anorexia in a more complete way,” she told us.

By doing so, Shortwave aims to create conditions that can also support improvement in the underlying physiology, because in this illness the mental state and the physical state are deeply interconnected.

Scientific evidence may support Shortwave’s thesis. A systematic review published on the British Medical Journal in 2024 found that psilocybin could be as effective as escitalopram, a selective serotonin reuptake inhibitor (SSRI), in treating depressive symptoms.

“Psilocybin is considered a promising candidate for conditions defined by rigid cognition and compulsive patterns because it can temporarily soften the fixed neural networks that shape these behaviours,” said Lisovoder.

Research also shows that it creates an increase in neuroplasticity, allowing the brain to form new associations and to respond more flexibly to emotional and environmental cues. In disorders where people become locked into narrow patterns of thought or behaviour, like anorexia, this short period of increased adaptability may provide a meaningful therapeutic opportunity.

These same principles are relevant to anorexia nervosa, where inflexible thinking, heightened fear responses and avoidance-driven routines play a central role. 

“Even a modest shift in these underlying circuits can support change when combined with the right clinical framework,” says Lisovoder.

Shortwave’s plan is to build on the known effects of psilocybin but not rely on it alone. Its formulation includes an additional component intended to influence complementary pathways, reflecting the company’s view that complex psychiatric and neurological conditions are best approached through more than one mechanism.

Shortwave’s Feasibility Study On Psilocybin for Anorexia

A safe and credible feasibility study in anorexia nervosa must begin with a clear focus on safety, the CEO says.

The first aim is to confirm that the treatment can be given without harm, with careful monitoring and a responsible medical framework. Because anorexia involves both medical fragility and deeply rooted cognitive and emotional behaviours, the protocol has to keep the burden on participants as low as possible, supported by a psychiatric and nutritional environment that understands the condition well.

Recruitment is often challenging in this field, which makes partnerships with established eating disorder centres essential. The company is in partnership with Sheba Medical Centre in Israel, whose eating disorders unit is recognised internationally for its clinical and research expertise, with a large and diverse patient population and a highly experienced psychiatric and medical team.

“Having an established collaboration with such a centre allows us to design studies with real clinical insight, consult with leading clinicians, and recruit participants more efficiently and responsibly,” said Lisovoder.

The company is also partnering with MSICS Pharma, a company that manufactures natural psilocybin at full pharmaceutical GMP quality. Their product is already being used in active clinical trials, supported by strong preclinical data and careful pharma grade characterisation.

The exec is hopeful for the treatment, beyond the results of the feasibility trial. She says there is a possibility that this line of research could help shift the way we think about eating disorders more broadly.

“For many years, these illnesses have been approached mainly through behavioural and psychological frameworks, which are important but do not fully reflect the underlying biology. The emerging science suggests that patterns of fear, avoidance, cognitive rigidity and altered reward processing all play a role, and that these patterns can be influenced at the neurocircuit level. If we can show that targeted modulation of these circuits contributes to meaningful change, it may open the door to a more integrated model of care,” she told us.

Such a shift would not replace psychological treatment, but rather add a biological dimension that has been missing, concludes the CEO.

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.

A new study in The Journal of Neuroscience has shed light on how the psychedelic N,N-Dimethyltryptamine, or DMT, changes brain activity during its most intense psychological effects.

The research focuses on a key experience reported by many users of the drug, the temporary disappearance of the sense of self, often called ego-dissolution.

DMT is known for producing rapid, vivid and immersive psychedelic states that unfold within minutes. The study, led by Mona Irrmischer and colleagues, set out to identify what happens in the brain during this altered state, and how those changes relate to subjective feelings of becoming “less of a person,” or losing individual identity.

Dr Christopher Timmermann, one of the study’s co-authors, will be a panelist at the upcoming PSYCH Symposium: London 2025, on December 4 at London’s Conway Hall, where key figures in the psychedelics space will meet to discuss the future of policy, research and patient roll out.

To investigate this, the researchers used electroencephalography, EEG, which records electrical activity from the scalp. Twenty-seven healthy volunteers took part in two separate clinical sessions. In one, they were injected with DMT. In the other, they received a placebo saline injection. Neither participants nor experimenters were told which session was which at the time. EEG was recorded before and after injection, and participants later rated their subjective experience, including whether they felt the boundaries of their self dissolve.

The team measured what they call “criticality,” a property of brain activity that reflects the balance between order and randomness. A near-critical brain is thought to be versatile, able to shift fluidly between different states. It maintains patterns across long periods of time, which helps organize thought, perception and the experience of continuous identity. When the brain moves away from this balance, signals may become either too rigid or too chaotic.

To quantify this, the researchers used two tools. One, detrended fluctuation analysis, or DFA, measures how consistent brain rhythms remain over longer timescales. Higher values indicate more structured, temporally coherent activity. Lower values show more noise and unpredictability. The other measure, the functional excitatory-inhibitory ratio, distinguishes whether changes push the brain toward suppressed subcritical states or toward unstable supercritical activity.

Under DMT, DFA values dropped significantly across several frequency bands, especially alpha rhythms. This means brain signals became less temporally organized and more entropic. The effect was widespread, not limited to a small region, indicating a broad shift in how neural networks behave over time.

The excitatory-inhibitory analysis provided further clarity. Rather than showing runaway excitation, the changes suggested that DMT pushed brain dynamics toward subcritical states, especially in parietal and occipital regions. These parts of the brain help integrate sensory information and support internal models that anchor a person’s sense of being a continuous self. Under DMT, their activity became less structured and less stable.

Critically, these neural shifts were directly tied to how people felt. Participants who reported stronger ego-dissolution also showed the biggest reductions in criticality, particularly in theta and alpha bands. This correlation suggests that the breakdown of long-range, temporally organized brain activity is closely linked to the subjective loss of self.

The authors emphasize that these effects do not resemble unconsciousness. Instead, they reflect a brain that cannot maintain its usual long-term patterns of self-representation. Without the steady temporal scaffolding that normally supports identity, experience becomes immediate, immersive and unanchored.

The study challenges a simple picture of psychedelics as increasing brain flexibility by moving closer to a balanced critical state. Under DMT, entropy does increase, but the rhythms most involved in self-processing move away from balanced dynamics. The result is not random chaos but a specific weakening of the neural patterns that hold the self together.

By showing how a psychedelic alters the brain in real time, the research provides a clearer biological explanation for one of the most mysterious psychedelic effects. It points to ego-dissolution not as a vague spiritual idea, but as a measurable change in how the brain organizes its activity over time.

Image made using AI tools.