Psychedelics

LOS ANGELES- Silo Pharma, Inc. a developmental stage biopharmaceutical company, has announced an exclusive global license agreement with Columbia University to develop, manufacture, and commercialize its lead drug candidate, SPC-15. This intranasal treatment targets stress-induced affective disorders and PTSD. Exclusive License for SPC-15 Development Silo Pharma has entered into an exclusive, global license agreement with Columbia University to further develop SPC-15, a novel treatment for PTSD and anxiety. This agreement allows Silo to advance its efforts in creating effective treatments for these disorders. Regulatory Progress and FDA Interaction Earlier this month, Silo submitted a pre-IND briefing package and meeting request for SPC-15 to the U.S. Food and Drug Administration (FDA). ...

LOS ANGELES- Clearmind Medicine Inc., a clinical biotech company specializing in psychedelic-derived therapeutics, has announced a significant advancement in its MEAI-based binge behavior regulator program. The company received patent approval from the Hong Kong Patent Office for its innovative use of primary amine aminoindan compounds to regulate binge behavior. The patent covers the use of these compounds, including the company's flagship molecule, 5-methoxy-2-aminoindan (MEAI). This latest addition extends Clearmind's intellectual property portfolio, which now includes 28 granted patents across 18 patent families in key jurisdictions such as the US, Europe, China, India, and Hong Kong. MEAI is designed to reduce the desire to consume alcohol while providing a mild euphoric ...

LOS ANGELES- Americans are increasingly curious about microdosing, a practice involving minimal consumption of psychedelics or cannabis over extended periods, according to a study by the University of California San Diego published in JAMA Health Forum. The study reveals a 1250% increase in Google searches about microdosing from 2015 to 2023, with over three million searches in 2023. Kevin Yang, M.D., a psychiatry resident at UC San Diego School of Medicine, led the research. Yang's study highlights how legislative changes on substance use influence public behavior and interest. The study correlates the rising curiosity about microdosing with relaxed local, federal, and state laws on recreational cannabis and therapeutic psychedelic use. ...

LOS ANGELES- Incannex Healthcare Inc. a clinical-stage pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to commence a Phase 2 clinical trial for its psilocybin pharmaceutical formulation, PSX-001, in combination with psychotherapy for patients with generalized anxiety disorder in the United States and the United Kingdom. The FDA completed its review of Incannex's Investigational New Drug (IND) application, submitted on June 26, 2024, within the designated 30-day period. The regulatory body has deemed the trial, named PsiGAD2, safe to proceed following an evaluation of the trial protocol, lead investigator, and a risk-benefit analysis of the trial and prospective drug product. The PsiGAD2 trial will enroll ...

LOS ANGELES- Arizona Governor Katie Hobbs has signed a bill into law that enables firefighters and peace officers with post-traumatic stress disorder (PTSD) to receive workers' compensation coverage for MDMA therapy, contingent upon federal legalization. While Governor Hobbs vetoed a separate proposal to legalize psilocybin service centers earlier this week, she approved legislation authorizing the Industrial Commission of Arizona to provide compensation for a one-course treatment of MDMA for public safety officials with PTSD if the drug receives approval from the Food and Drug Administration (FDA). The bill's enactment follows a recent recommendation by an FDA advisory committee against approving a new drug application for MDMA-assisted therapy, drawing criticism from ...

LOS ANGELES- Canadian psychedelics firm MindBio Therapeutics Corp. on Friday released durability results from its Phase 2A trial for its patented take-home microdose version of lysergic acid diethylamide (LSD), designed to treat depression with "sub-hallucinogenic" doses. The trial found the drug "is a safe and effective drug for treating depression with a psychedelic medicine to patients out in the community." The second trial reinforced findings from an earlier one, the company said in a press release, supporting the potential for the commercial debut of the drug for depression patients. The company's model posits that its product, formally called MB22001, in the take-home version can be a more cost-effective psychedelic treatment ...

LOS ANGELES- Arizona Governor Katie Hobbs vetoed a bill on June 18 that would have permitted the use of psilocybin in designated treatment centers. The vetoed House Bill 1570 proposed $5 million in annual funding for psilocybin therapy, overseen by the Department of Human Services, which would have regulated therapy centers and facilitators. The bill also sought to establish the Arizona Psilocybin Advisory Board to develop the program and conduct studies. Governor Hobbs explained her decision, citing the need for more evidence before supporting widespread clinical expansion. “The state’s psilocybin research advisory board established last year recently issued its annual report, with a clear message: although psilocybin may be a ...

LOS ANGELES- A recent study available through the National Library of Medicine provides new insights into the use of psilocybin for treating psychiatric disorders and its potential in psychedelic-assisted psychotherapy. This study is the first to explore reinforcement learning with psilocybin. Researchers conducted a probabilistic cue-reward task, presenting participants with emotional cues—either neutral or fearful faces—both consciously and subconsciously. The goal was to examine how psilocybin affects learning processes when interacting with emotional stimuli. The findings showed that across various dosages, psilocybin maintained learning effects and performed comparably to a placebo, suggesting that psilocybin does not impair reinforcement learning. Participants displayed higher exploratory behavior under psilocybin, indicating potential enhanced cognitive flexibility. ...

LOS ANGELES- Older individuals who have used psychedelics exhibit better cognitive functioning and fewer depressive symptoms compared to those who have not, according to new research published in Gerontology & Geriatric Medicine. However, psychedelic usage was not linked to improvements in episodic memory. Psychedelics are substances that alter perception, mood, and cognitive processes, often inducing hallucinogenic or introspective experiences. Popular psychedelics include LSD, psilocybin (found in certain mushrooms), and ecstasy (MDMA). Historically, some psychedelics have been used in cultural and religious rituals to induce spiritual experiences and enhance self-awareness. In modern times, psychedelics are considered illicit substances in most jurisdictions. However, studies in recent decades have indicated that they can ...

LOS ANGELES- A psilocybin therapy bill introduced by California Senators Brian W. Jones and Josh Becker on June 6 seeks to establish a three-year pilot program for military veterans and first responders. Senate Bill 803, known as the Heal Our Heroes Act, proposes the creation of this program in San Francisco County, Santa Cruz County, and San Diego County, pending legislative approval. The bill, an amendment to an unrelated bill, aims to facilitate psilocybin or psilocyn therapy by approved facilitators, including licensed medical and mental health professionals. Data collection would begin after the program's second year, with the goal of evaluating the treatment's effectiveness for participants suffering from conditions such ...

LOS ANGELES- Optimi Health Corp, a Health Canada licensed GMP psychedelics pharmaceutical manufacturer specializing in controlled substances such as botanical psilocybin and MDMA, has announced several significant milestones in its international psychedelic supply operations and corporate marketing strategy. Optimi has successfully completed its first international shipment of in-house manufactured MDMA active pharmaceutical ingredient (API) to the Institute for Psychedelic Research at Tel Aviv University (IPR-TLV) in Israel. This was facilitated by the necessary Export Permit from Health Canada, marking a pivotal step in Optimi’s mission to support global psychedelic research and innovation. “Completing our first international export of MDMA to Israel is an important milestone for the company,” said Bill ...

LOS ANGELES- Beckley Psytech, a private psychedelics medicine company, announced on Monday the commencement of a new research study investigating the neurophysiological effects of BPL-003, its novel synthetic intranasal formulation of 5-MeO-DMT, on the human brain. The study, funded by Beckley Psytech, is being conducted at Imperial College London. The study's initiation follows a recent update from the company regarding its ongoing Phase IIa study of BPL-003 in patients with treatment-resistant depression. Dr. Rob Conley, chief scientific and medical officer at Beckley Psytech, expressed pride in supporting the research at Imperial College London. He noted that literature suggests a link between the intensity of psychedelic experiences and positive treatment effects, ...

LOS ANGELES- Filament Health, a psychedelic drug development company, has received authorization from Health Canada and the United States Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial of its botanical psilocybin drug candidate, PEX010, for the treatment of methamphetamine use disorder (MAUD). This marks the first clinical trial to investigate the safety and efficacy of botanical psilocybin in treating MAUD. The urgent need for new interventions to address MAUD is underscored by the absence of FDA-approved pharmacotherapies and the limited effectiveness of existing options. A comprehensive approach, potentially involving psychedelic-assisted psychotherapy, is suggested to address the complexities of MAUD, including reducing stimulant overdose and relapse. Dr. ...

LOS ANGELES- Earlier today, staff from the U.S. Food and Drug Administration (FDA) expressed concerns regarding the interpretation of data from trials on the psychedelic drug MDMA for treating post-traumatic stress disorder (PTSD). These concerns emerged ahead of an upcoming meeting of the agency’s advisory panel. The comments have set the stage for in-depth discussions on the benefits and risks of this therapy by the FDA’s advisory panel, scheduled for Tuesday. This marks the first time the FDA is reviewing the therapeutic use of MDMA, a substance commonly known as ecstasy or molly. The FDA is seeking recommendations from its advisers on a capsule version of MDMA developed by Lykos ...

NEW YORK-  Numinus Wellness Inc.  announced that its research site, Cedar Clinical Research (CCR), has been chosen for Cybin's Phase 3 clinical trial of CYB003, aimed at treating Major Depressive Disorder (MDD). This selection highlights a significant step in transforming mental health care. The inclusion of CCR, located in Murray, Utah, among 15 U.S. sites for this trial underscores Numinus's commitment to advancing innovative behavioral health treatments. This collaboration aims to explore new therapies that could significantly impact patient care. Cybin's Phase 2 trial results were promising, with 75% of participants achieving remission from depression symptoms four months after dosing with CYB003. These results led the U.S. Food and Drug ...

LOS ANGELES- A proposal from an Atlanta City Council member is under consideration, aiming to include coverage for psilocybin and ketamine as mental health treatments in the city's healthcare plan for firefighters, police, and other government workers. The legislation, supported by 11 of the Council's 16 members, highlights the limited effectiveness of traditional mental health treatments for some individuals and points to recent research demonstrating the potential efficacy of alternative therapies like ketamine-assisted and psilocybin-assisted treatments. Councilmember Liliana Bakhtiari, the lead sponsor, emphasized the importance of providing a broad range of mental health services to city employees, particularly first responders. Bakhtiari recounted meeting a West Virginia police officer who used ...

LOS ANGELES- The U.S. Department of Veterans Affairs (VA) is strategizing the rapid deployment of psychedelic treatments for mental health disorders, should such therapies receive FDA approval. A planning document, reportedly reviewed by The Intercept, outlines the responsibilities of the “Psychedelic Medicine Integrated Project Team” within the VA. The document includes regular tasks such as advising VA Under Secretary for Health Shereef Elnahal and providing strategic direction for the deployment of psychedelic medicine within the Veterans Health Administration (VHA). The VA has declined to comment on the circulated document. Upcoming FDA Hearing on MDMA This development comes ahead of an FDA advisory committee meeting scheduled for June 4, which includes ...

Following the recent failure of a state bid to legalize psychedelic treatment centers, California advocates are considering a state ballot measure to address psychedelics reform in 2026, according to a report by KQED. State Senator Scott Weiner (D), who authored the recently failed proposal, expects the issue to appear on the 2026 ballot if state lawmakers do not take action beforehand. “We are not giving up, whether that means introducing a new bill or ballot measure, this issue is not going away. We know these substances are helping people turn their lives around,” Weiner told KQED. Last year, Governor Gavin Newsom (D) vetoed a proposal to decriminalize certain psychedelic substances, ...

LOS ANGELES- New York legislation Assembly Bill 10375, introduced by Assembly Health Committee Chair Amy Paulin, aims to legalize psilocybin service centers. If passed, the bill would create a regulatory framework for licensing these centers and allow patients to receive treatment for a variety of medical conditions. Framework and Regulation The bill proposes amendments to public law to promote health and well-being through regulated adult use, support services, and cultivation of psilocybin-containing fungi. The Department of Health (DoH) would oversee regulations, including cultivator licenses and psilocybin service center approvals. A "Regulated Psilocybin Advisory Board" with 13 members would be established to study federal laws and policies regarding psilocybin and provide ...

LOS ANGELES- In a significant setback for advocates of psychedelic-assisted therapy, California's proposal to legalize treatment centers for supervised access to substances like psilocybin and MDMA has been halted. The Senate Appropriations Committee dropped Senate Bill 1012, leaving proponents disappointed but hopeful for future progress. Senate Bill 1012, known as the “Regulated Psychedelic Facilitators Act,” was introduced to establish treatment centers where adults over 21 could receive supervised sessions involving psychedelic substances such as psilocybin, psilocin, DMT, MDMA, and mescaline. Sponsored by state Senator Scott Wiener, the bill aimed to integrate alternative mental health therapies into mainstream medical practice.The initiative was driven by increasing evidence of the therapeutic potential of ...

LOS ANGELES-Silo Pharma, Inc., a biopharmaceutical company specializing in novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, has announced new research findings indicating promising advances in depression remission and relapse prevention. Innovative Drug Formulation The study, conducted under Silo Pharma's sponsored research agreement with Columbia University, explored a new drug formulation targeting previously unexplored biochemical pathways associated with mood regulation. The results demonstrated significant improvements in patient mood stability without the common side effects associated with current antidepressants. “The recently completed study demonstrated marked improvements in mood stability, which we see as a potentially significant development for combatting depression and preventing relapse,” said Silo CEO Eric ...

LOS ANGELES- The proposal to legalize psychedelic treatment centers in California has been shelved for the year. The initiative was developed in response to concerns raised by Governor Gavin Newsom (D) after he vetoed a prior proposal to decriminalize certain naturally occurring psychedelics. The California Senate Appropriations Committee, dominated by Democrats, dropped Senate Bill 1012, also known as the "Regulated Psychedelic Facilitators Act," alongside hundreds of other bills, as reported by the LA Times. This bill, sponsored by state Senator Scott Wiener (D), aimed to legalize treatment centers where adults aged 21 and over could access psychedelic substances such as psilocybin, psilocin, DMT, MDMA, and mescaline under supervision. Senator Wiener ...

LOS ANGELES- A new study from Johns Hopkins University, published in the Journal of Psychoactive Drugs, indicates that a single psilocybin experience is unlikely to change an atheist's belief in God or alter a person's sense of free will. However, the study found that psilocybin may lead to increased perceptions of consciousness in animals, plants, and even inanimate objects like rocks and robots. The research surveyed hundreds of individuals who planned to use psilocybin outside a laboratory setting. Participants were asked about their beliefs before and at two points after their experiences. While there were minor shifts in how participants perceived consciousness—such as attributing consciousness to primates and insects—their religious ...

LOS ANGELES- Reunion Neuroscience Inc., a developer of psychedelic drug treatments, has successfully raised $103 million in a Series A financing round. The round was co-led by MPM BioImpact and Novo Holdings, with additional participation from various healthcare investment firms including Arkin Bio Capital and Mitsui & Co. Global Investment. This funding marks a pivotal step for Reunion, which was initially spun out from Field Trip Health, a network of ketamine clinics. The capital will primarily fuel the advancement of RE104, Reunion’s leading drug candidate. RE104 is designed as a fast-acting, short-duration therapy aimed at treating mental health conditions. Distinct from traditional psychedelic therapies that can last up to eight ...

LOS ANGELES- A recent study conducted by researchers in the United Kingdom has found promising results for psilocybin, the active psychedelic compound in "magic mushrooms," as a treatment for depression. The study, which was reported by Medical News Today and published in The BMJ, involved a systematic review and meta-analysis of seven randomized controlled trials. The research concluded that psilocybin was more effective than niacin (Vitamin B), microdoses of other psychedelics, and a placebo in alleviating symptoms of depression. These trials also included the use of psychotherapy, allowing researchers to isolate the effects of psilocybin from those attributable to psychotherapeutic interventions. Dr. Akanksha Sharma, a neurologist and neuro-oncologist at the ...