Psychedelics

LOS ANGELES – The Food and Drug Administration is preparing to overhaul its evidence requirements for new drug approvals, making a single well-designed Phase 3 trial the standard rather than the exception. This adjustment, outlined by agency Commissioner Marty Makary, could streamline paths to market for therapies in mental health, including experimental psychedelic treatments for post-traumatic stress disorder (PTSD), depression, and anxiety. Makary emphasized the scientific foundation for the change. "You can achieve the same statistical power with one trial as you would with two trials when it’s designed and controlled appropriately," he said. The policy update, expected within three to six months, builds on existing flexibility. In 2024, 66% ...

LOS ANGELES – Federal health officials under the Trump administration have begun to signal stronger backing for psychedelic therapies, setting the stage for possible FDA approvals of MDMA and psilocybin treatments within the next 18 months, according to recent conversations with regulators, lawmakers, and industry executives. This shift comes as developers ramp up lobbying efforts and states introduce dozens of reform measures, though persistent concerns over clinical trial integrity continue to test the sector's progress. Health and Human Services Secretary Robert F. Kennedy Jr. has taken a direct role in championing these substances, testifying before Congress in June that his department aims to enable clinical access to psychedelic options for ...

WASHINGTON – A group of House and Senate lawmakers from both parties unveiled legislation to permit physicians to deliver Schedule I substances, including MDMA and psilocybin, to individuals grappling with terminal illnesses or severe mental health disorders. The Freedom to Heal Act, sponsored by Senators Cory Booker (D-N.J.) and Rand Paul (R-Ky.) alongside Representatives Madeleine Dean (D-Pa.) and Nancy Mace (R-S.C.), would carve out an exemption in the Controlled Substances Act to align these treatments with the existing federal Right to Try framework. Under the proposal, eligible patients [those who have exhausted standard FDA-approved options] could receive supervised administration of investigational therapies after a Phase 1 clinical trial demonstrates basic ...

NEW YORK – Psyence BioMedical Ltd. disclosed its entry into longevity science with a new program probing psilocybin's influence on key aging indicators. The initiative, conducted alongside South African academics, marks the company's first foray beyond mental health applications and establishes it as the sole public firm pursuing this angle on the Schedule I substance. At its core, the project deploys an accelerated preclinical framework to track shifts in cellular stress, inflammatory responses, mitochondrial efficiency, and telomere length following psilocybin exposure. Early lab work underpinning the effort points to psilocin [the compound's active form] prolonging survival rates in elderly rodents and boosting the viability of human skin and lung cells ...

TRENTON – New Jersey lawmakers advanced a bill that would allow supervised access to psilocybin for adults facing certain health challenges, establishing a regulated psilocybin therapy framework approved by the Assembly Health Committee. Assemblymember Anthony Verrelli, a Democrat and co-sponsor of the measure, framed the legislation during testimony as a targeted response to unmet mental health needs. "This bill gives another option for people to heal and get better," Verrelli said. "And by getting them better, it gives them the opportunity to make their communities, their families, and life in general better to break that cycle of trauma, however it looks." The bill, designated A3852 in the Assembly and S2283 ...

BERLIN – Switzerland's long-standing framework for psychedelic treatments has set a course for its neighbors, as Germany and the Czech Republic roll out their own programs to address stubborn mental health conditions. These steps mark a cautious expansion of therapies using psilocybin, with Switzerland also permitting limited use of LSD and MDMA, signaling a shift toward regulated access across the region. In Switzerland, the Federal Office of Public Health issued 723 authorizations for psychedelic-assisted therapy in 2024 alone [348 for psilocybin, 245 for MDMA, and 130 for LSD] administered by roughly 100 licensed physicians at 80 private practices and 15 institutions, including university hospitals. This builds on a program dating ...

CHICAGO – AbbVie Inc. disclosed in a recent securities filing that it handed over $900 million in cash at the outset of its acquisition of bretisilocin, the experimental psychedelic compound acquired from Gilgamesh Pharmaceuticals aimed at treating major depressive disorder (MDD). The revelation, uncovered in the company's Q3 2025 report, fills in a key blank from the $1.2 billion transaction announced in August and closed last month, showing that three-quarters of the value flowed immediately to the seller. That cash portion exceeds what deal watchers had anticipated for a Phase 2 asset in the nascent field of psychedelic medicines, where upfront payments often hover below 50% to hedge against clinical ...

LONDON & NEW YORK – Compass Pathways reported Q3 2025 financial results and signaled a faster path to market for its lead psilocybin-based therapy in treatment-resistant depression (TRD). The biotechnology firm now targets commercialization readiness 9 to 12 months ahead of schedule, a shift driven by completed enrollment in its second Phase 3 trial and encouraging feedback from U.S. regulators. The update comes as Compass wraps up the COMP006 study, which enrolled 585 patients to evaluate a single dose of COMP360 psilocybin therapy paired with psychological support. This follows positive topline results from the first Phase 3 trial, COMP005, in June, where the treatment showed statistically significant symptom reductions at ...

PHOENIX – State officials in Arizona have authorized and financed what amounts to the country's initial controlled study of whole psilocybin mushrooms as a treatment for post-traumatic stress disorder (PTSD) among police officers, firefighters, and military veterans, marking a significant step forward in regulated psychedelic research. The trial, set to begin in November, will enroll 24 participants evenly divided among the three groups, with each receiving a 30-milligram dose derived from roughly 4.5 grams of cultivated mushrooms in a supervised setting. Supported by the Arizona Department of Health Services (ADHS) and led by the Scottsdale Research Institute (SRI), the effort draws on a $5 million allocation from a 2023 state ...

TORONTO – Cybin Inc., a clinical-stage biopharmaceutical company focused on psychedelic-based treatments for mental health disorders, disclosed a $175 million registered direct offering, drawing commitments from a roster of established biotech investors. The deal, priced at $6.51 per share or pre-funded warrant, stands as the biggest capital infusion in the psychedelics field [!] this year, outpacing Compass Pathways' $150 million public offering from January. The transaction involves roughly 22.3 million common shares and accompanying warrants, exercisable at $8.14 per share through mid-2027 or earlier based on trial milestones for Cybin's lead candidate, CYB003, a deuterated psilocin analog targeting major depressive disorder. Participants include Venrock Healthcare Capital Partners, OrbiMed, Point72, Deep ...

NEW YORK – A former narcotics prosecutor who once enforced drug laws now argues that New York must open the door to psilocybin-assisted therapy, framing it as a necessary step toward treating chronic pain and mental health disorders with evidence-based care. In an opinion piece, Victoria Cvitanovic, a Louisiana-trained attorney now practicing in psychedelic medicine, draws on her shift from courtroom adversary to patient advocate. She describes prosecuting drug cases in New Orleans, where she witnessed laws trap suffering individuals in cycles of arrest rather than recovery. A personal crisis [a severe back injury] plunged her into unrelieved pain, depression, and despair. Standard treatments offered no lasting relief until she ...

DALLAS – Former Texas Governor Rick Perry called for broader access to ibogaine, a psychedelic compound derived from the African iboga shrub, during a panel discussion following a screening of documentary clips on Thursday night. The event, held at Cinépolis Luxury Cinemas, underscored Perry's growing role in pushing for clinical trials of the substance as a treatment for addiction, post-traumatic stress disorder (PTSD) and traumatic brain injuries (TBIs) among veterans. Perry, who served as Texas governor (2000-2015) and later as U.S. energy secretary under President Donald Trump, shared his personal encounter with ibogaine during the discussion. In 2023, he traveled to a clinic near Tijuana, Mexico, for a 12-hour session. ...

LOS ANGELES – A compound long associated with visionary experiences in plants like ayahuasca may hold untapped value in treating one of medicine's toughest challenges: brain damage from strokes. Hungarian researchers report that N,N-dimethyltryptamine, or DMT [a naturally occurring psychoactive substance found in various plants, animals, and humans] can shield neural tissue from further harm after a stroke. In experiments with rats and human cell cultures, DMT cut the size of damaged brain areas by up to 50%, curbed swelling and restored the blood-brain barrier, which often breaks down during such events and lets in toxins. The work, detailed in the journal Science Advances, points to DMT's action on sigma-1 ...

LOS ANGELES – A new systematic review of clinical studies underscores psilocybin's potential to deliver quick and lasting reductions in depressive symptoms, offering a targeted option for patients who see little benefit from standard medications. The analysis, published this month in journal Acta Neuropsychiatrica, examined 20 studies involving more than 850 participants with major depressive disorder or treatment-resistant depression. Researchers found that psilocybin, the active compound in psilocybin-containing [or so-called “magic”] mushrooms, produced large antidepressant effects, often measured by drops in scores on scales like the Montgomery-Åsberg Depression Rating Scale, after just one or two guided sessions. Effect sizes reached Cohen's d-values of 2.5 in some trials, indicating strong clinical ...

SALEM – State health officials in Oregon are seeking participants for a rules advisory committee that will shape permanent guidelines on the temporary use of licensed Psilocybin Service Centers, as applications close in less than two weeks. The Oregon Psilocybin Services section of the Oregon Health Authority (OHA) announced the opportunity on October 1, with submissions due by October 13. The committee will convene virtually on November 5 to review proposed changes to administrative rule OAR 333-333-4300, which governs hours of operation and authorized temporary activities at service centers. These amendments aim to codify a temporary measure adopted in late August, which restricts such uses to between 6 am and ...

LOS ANGELES – Former U.S. Senator Kyrsten Sinema of Arizona shared details of her personal encounter with ibogaine during a recent appearance on CNN. Speaking with Jake Tapper, Sinema highlighted her push for expanded research into the drug's potential to address traumatic brain injuries (TBIs) and neurodegenerative conditions. She credited a former staffer's positive outcome with the substance for prompting her own decision. "I had a colleague who had experienced traumatic brain injury, and they tried ibogaine and had remarkable results," Sinema told Tapper. Her motivation stemmed from family history: her grandmother's death from dementia a few years prior. Sinema, who left the Senate in January 2025 after switching her affiliation ...

LOS ANGELES – A recent study published in the Journal of the American Medical Association (JAMA) on September 4, suggests that a single dose of lysergic acid diethylamide (LSD) may significantly reduce symptoms of generalized anxiety disorder (GAD) for up to 12 weeks. Conducted by MindMed, a biotech company focused on psychedelic-based treatments, the research offers new insights into the therapeutic potential of LSD, a substance historically associated with recreational use but now gaining attention for its medical applications. The phase 2b clinical trial involved 198 adults aged 18 to 74 with moderate-to-severe GAD, a condition affecting nearly 5.7% of U.S. adults, according to the National Institutes of Mental Health. ...

WASHINGTON, D.C. – Newt Gingrich, a Former House Speaker, has drawn attention to ibogaine, a psychedelic compound derived from the African iboga shrub, calling it a potential game-changer for treating addiction, post-traumatic stress disorder (PTSD), and traumatic brain injuries (TBI). During the recent "Newt's World" podcast episode, the Georgia Republican sat down with W. Brian Hubbard, executive director of Americans for Ibogaine, who highlighted ibogaine’s ability to disrupt opioid addiction cycles, often with a single dose, based on his work in Kentucky. A subsequent discussion with Dr. Nolan Williams, a Stanford University psychiatrist, cited a January 2024 study published in Nature Medicine. The study tracked 30 U.S. military veterans treated ...

LOS ANGELES – A scientific review published in the journal Brain Sciences has outlined how psilocybin, the active compound in psychedelic mushrooms, might support recovery for individuals with traumatic brain injuries. The analysis, released in late May 2025, draws from nearly 30 studies to suggest that the substance could reduce inflammation, encourage new neural connections, and ease related mental health issues. Researchers from Hackensack Meridian School of Medicine examined psilocybin's mechanisms, noting its ability to lower markers of inflammation like TNF-α and IL-6, which often exacerbate brain damage after injury. The compound also appears to boost neuroplasticity, as seen in animal models where it increased synaptic density in the prefrontal ...

NEW YORK – A recent report by Research and Markets reveals the current global psychedelic drugs market is valued at $7.4 billion and is projected to hit $22.6 billion by 2033, exhibiting a substantial compound annual growth rate (CAGR) of 15%. This anticipated expansion underscores growing acceptance of psychedelics in addressing mental health challenges, driven by clinical advancements and shifting regulatory frameworks. The report points to rising demand for innovative treatments for conditions like depression, post-traumatic stress disorder (PTSD), and anxiety as a primary growth driver. Psychedelic compounds like psilocybin, MDMA, and ketamine have demonstrated promising results in controlled clinical settings, often providing rapid and sustained relief where conventional therapies ...

BOSTON – In a groundbreaking development for psychedelic policy reform, the Massachusetts Psychiatric Society (MPS) has publicly endorsed legislation to decriminalize psilocybin, marking the first time a branch of the American Psychiatric Association (APA) has supported such a measure. The endorsement, announced during a legislative hearing, signals a significant shift in the psychiatric community's stance on psychedelics, highlighting their potential as a public health tool. Dr. Jhilam Biswas, representing the MPS, testified in favor of four bills [H.1624, H.1726, H.1858, and S.1113] before the Massachusetts Joint Committee on the Judiciary. These bills aim to reduce penalties for psilocybin possession and establish frameworks for its supervised therapeutic use. “We are encouraged ...

BENTONVILLE – In the heart of Northwest Arkansas, a group of dedicated activists is pushing to reshape the legal landscape for psychedelics. Decriminalize Nature NW Arkansas, founded in 2023, is leading the charge to decriminalize naturally occurring entheogenic plants and fungi, such as psilocybin mushrooms, in Bentonville and beyond. Their efforts signal a growing movement to rethink psychedelic policy in a state known for its conservative stance. On July 26, 2025, Decriminalize Nature NW Arkansas hosted a one-day summit at the Bentonville Public Library, drawing community members, policymakers, and experts to discuss the legal, therapeutic, and spiritual dimensions of psychedelics. Co-founders Jessica Fitzmaurice and Beth Day, both longtime Bentonville residents, ...