The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to psychedelic drug luvesilocin, from biopharmaceutical developer Reunion Neuroscience, for the treatment of postpartum depression. 

Luvesilocin is a recently-discovered proprietary psychedelic that can produce an acute subjective experience of around 3 to 4 hours shorter than that reported for some classic psychedelics such as LSD. 

It is the ninth psychedelic to receive breakthrough therapy designation by the agency, a qualification meant to to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition, when preliminary clinical evidence shows that the drug could demonstrate a substantial improvement over available therapy. 

The Trial

Postpartum depression affects a substantial portion of people who have recently given birth. Globally, the condition is estimated to occur in roughly 10 % to 20 % of postpartum women.

According to the announcement from last week, Reunion’s clinical trial achieved its primary endpoint, showing a statistically significant reduction in depression seven days after administration.¡

Participants receiving a 30mg dose showed reductions in depressive symptoms as early as Day 1 that were maintained through Day 28 of follow-up, with 70 % of those patients in remission at both Day 7 and Day 28. 

With BTD status, luvesilocin is eligible for benefits associated with the FDA’s Fast Track program and will receive enhanced guidance and engagement with senior FDA leadership.

Reunion Neuroscience has said it plans to initiate a pivotal Phase 3 trial of luvesilocin in postpartum depression in 2026. The company is also enrolling patients in a Phase 2 trial for adjustment disorder related to cancer and other medical conditions, and anticipates beginning a Phase 2 trial in generalized anxiety disorder in early 2026.

What Luvesilocin Is and How It Works

Luvesilocin belongs to a class of molecules known as substituted tryptamines. 

Tryptamines are a family of compounds derived from the amino acid tryptophan, which includes endogenous neurotransmitters like serotonin, as well as classical psychedelic agents such as psilocin and DMT. Many structurally related molecules share the same backbone and interact with serotonin receptors, producing altered perceptions and changes in mood and cognition.

Chemically, luvesilocin is a prodrug of 4-HO-DiPT, meaning the compound is metabolised in the body to release the active serotonin receptor agonist, in a similar way to how psilocybin is metabolized into psilocin, which is the active ingredient producing a psychedelic effect in humans.

The active moiety of luvesilocin, 4-HO-DiPT, itself is part of this broader class and was described in the scientific literature as early as the late 1970s. It differs slightly in structure from psilocin (the active form of psilocybin), which may influence its receptor interactions and subjective effects. 

Unlike many classic psychedelics taken orally, luvesilocin is administered via subcutaneous injection, which contributes to its more predictable and shorter duration.

Clinical updates from Compass Pathways and Helus Pharma from last week marked a significant step forward in the psychedelics development landscape, with new data emerging from late stage and mid stage programs targeting depressive disorders.

Compass reported positive results from its second Phase 3 trial of COMP360, a synthetic psilocybin therapy for treatment resistant depression, meeting the study’s primary endpoint at Week 6. The company said the 25 mg dose produced a statistically significant reduction in depressive symptoms versus a control group, with rapid onset and a safety profile consistent with earlier studies, supporting planned regulatory discussions.

Helus Pharma (formerly Cybin) reported positive results from a mid stage clinical trial of its DMT based therapy, SPL026, in people with moderate to severe depression. Participants who received the treatment showed significantly greater improvements in their symptoms than those given placebo, with effects emerging within a week and lasting for several weeks. No treatment related serious safety issues were reported.

Compass Pathways Posts Second Positive Phase 3 Result in Treatment Resistant Depression

Compass Pathways reported results from its second Phase 3 trial evaluating COMP360, a proprietary synthetic psilocybin formulation, in patients with treatment resistant depression. The study forms part of the company’s pivotal development program and follows earlier positive findings.

The company has advanced COMP360 through a development that now includes two positive Phase 3 trials in treatment resistant depression. The therapy previously received Breakthrough Therapy designation from the U.S. Food and Drug Administration and a comparable innovation pathway designation in the UK. Last month, Compass also announced an acceptance by the FDA of COMP360 for the indication of PTSD.

Recently, CEO Kabir Nath told Psychedelic Health that based on the latest stream of positive clinical results, COMP360 “could potentially be looking at a launch in early 2027,” though the psychedelics spae is still recovering from the rejection of Lykos’ MDMA application in 2024.

According to Compass, the latest trial met its primary endpoint, demonstrating a statistically significant reduction in depressive symptoms compared with control at week 6, as measured by the Montgomery Asberg Depression Rating Scale, or MADRS. Patients receiving a 25 mg dose showed a mean reduction that translated into a 3.8 point difference versus the 1 mg control group at the primary timepoint.

The antidepressant effect was observed rapidly, with separation from control evident as early as the day after administration. Treatment effects were sustained through at least six weeks. In a related Phase 3 study within the same program, a subgroup of participants maintained clinically meaningful reductions in MADRS scores through 26 weeks following one or two dosing sessions. Retreatment in eligible patients appeared to yield consistent response patterns, and no unexpected safety findings were reported across the studies.

Treatment resistant depression remains a major unmet need, defined generally as inadequate response to at least two prior antidepressant therapies. Compass has indicated that it intends to engage with the FDA to discuss next steps, including a potential rolling submission of a New Drug Application. The company has previously guided toward a possible submission timeline in late 2026, contingent on regulatory feedback and completion of required analyses.

Helus Pharma Reports Mid Stage Data Showing Rapid Symptom Improvement in Depression

In parallel, Helus Pharma, formerly known as Cybin, released detailed results from a Phase 2a randomized, placebo controlled study of SPL026, an intravenous formulation of N,N dimethyltryptamine, or DMT, in adults with moderate to severe major depressive disorder. The findings were published in the journal Nature Medicine and reflect one of the more advanced controlled studies of DMT in this indication.

The SPL026 program was previously led by the company Small Pharma, which was acquired by Cybin in 2023. Earlier this year, Cybin announced it would change its name to Helus Pharma, following a recent trend of companies in the psychedelics space rebranding to reflect a more mature subsector within biotech.

By the second week of the study, people who received SPL026 showed significantly greater improvements in their depression symptoms than those who received a placebo. On average, the difference between the two groups was clear and clinically meaningful, with an even larger gap already visible after just one week.

At Week 2, about 35 percent of participants given SPL026 experienced a marked improvement in symptoms, compared with 12 percent of those on placebo. Nearly 29 percent of treated participants saw their symptoms ease to the point of remission, versus 12 percent in the placebo group. In a follow up phase where all participants could receive the treatment, many maintained their improvements for up to three months.

The safety profile was described as manageable, with no treatment related serious adverse events reported in the study population. Acute psychedelic effects were consistent with the pharmacology of DMT and were administered in a controlled clinical setting with psychological support.

Despite the positive data, Helus has indicated that it does not plan to advance SPL026 in its current intravenous format. Instead, the company intends to use the findings to inform development of next generation short acting serotonergic agonists within its broader pipeline. Topline data from a separate Phase 2 program targeting generalized anxiety disorder are anticipated in 2026.

Together, the updates from Compass and Helus reflect continued maturation of the psychedelics field, with one company reporting confirmatory Phase 3 outcomes in treatment resistant depression and another publishing controlled mid stage data in major depressive disorder. Regulatory engagement and strategic portfolio decisions will shape the next phase of development as sponsors seek to translate controlled trial results into potential approvals and commercial pathways.

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One of Britain’s central think tanks for drug policy reform is looking for new partners to join forces in 2026.

Over its five-year history, the group has achieved major milestones, which include consulting with the UK Home Office on a recent call for submissions on barriers to research scheduled substances.

In July 2025 the UK government responded to recommendations by the Advisory Council on the Misuse of Drugs on rescheduling psychedelics for clinical research, agreeing in principle to ease licensing for universities and hospitals and exempt approved clinical trials from Home Office licences.

“I like to think we swayed them with our evidence”, said James Bunn, Head of Operations at Drug Science, the organisation overseeing the group.

The group is currently on the lookout for new members and corporate partners.

“We’ve seen what collaboration can achieve with medical cannabis. Now it’s time to apply that same evidence-based, patient-led approach to psychedelics”, said Drug Science founder Professor David Nutt. 

What Is the Medical Psychedelics Working Group?

The Medical Psychedelics Working Group was established in 2020 in response to growing scientific evidence, shifting regulatory landscapes, and the persistent barriers facing legitimate psychedelic research. 

Following the legalisation of medical cannabis in the UK in 2018, a need emerged for coordinated, interdisciplinary action to ensure psychedelic medicines could be responsibly developed within public health systems.

Created to challenge decades of medical marginalisation, the group seeks to advance a rational and evidence-based approach to psychedelic research and clinical treatment. Its work focuses on generating robust scientific data, supporting regulatory reform, and improving understanding among policymakers, clinicians, researchers, and the wider public. 

Central to this mission is addressing the constraints imposed by Schedule 1 classification, which continues to limit research through cost, complexity, and delay.

“While the legislation did not preclude scientific research with these drugs, it made them significantly more difficult, time-consuming and costly to study”, said Bunn. “Drug Science’s Medical Psychedelics Working Group aims to change this situation for the better.”

Major Achievements and Upcoming Goals

Currently, the group is running an MDMA psychotherapy research trial in collaboration with University College London. The study aims to improve understanding of MDMA-assisted psychotherapy, focusing on how the psychotherapeutic component interacts with the drug’s effects. The project aims to clarify treatment mechanisms and enhance safety and efficacy.

Drug Science Head of Research, Dr. Anne Schlag, says the group is “continuously responding to the government’s call for evidence”.

This includes a recent response to a 2026 ketamine review by the Advisory Council on the Misuse of Drugs, which was commissioned last year to assess harms and legal classification. 

With funding by Norrsken Foundation, the group is running an MCDA (multi-criteria decision analysis) comparing treatments for treatment resistant depression, including psilocybin and ketamine. We can expect results for the analysis before July, says Schlag.

The group is also working closely together with Australian colleagues such as Prof Ranil Gunewardene, to understand, document and publish everything related to the developments in MDMA and psilocybin rescheduling in Australia.

“We hope [it] can serve as an example for the UK and Europe. A very exciting case series of the first fifteen MDMA patients is forthcoming!” says Schlag.

Other key achievements include developing the ARC: a framework for Access, Reciprocity and Conduct in psychedelic therapies, which was published in Frontiers in Psychiatry in 2023; and developing a lexicon for psychedelic research and treatment, described as “a key paper delineating a standardised terminology for clinical development and regulatory classification for psychedelic medicines.”

An upcoming project focused on psilocybin for palliative care will be announced over the summer.

“I would urge any organisation that shares our vision to join us in shaping the future of mental healthcare”, concludes Prof. Nutt.

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