atai Life Sciences has announced positive initial results for their Phase I clinical trial of KUR-101
Mindset Pharma has announced that it has developed a novel, patent-pending, intranasal platform formulation technology expected to deliver improved central nervous system (CNS) penetration of first and subsequent generations of psychedelic medicines. The proof of concept of this novel formulation demonstrates improved CNS penetration compared to standard formulations of 5-MeO-DMT.
A first-of-its-kind trial exploring MDMA-assisted therapy in a group setting being led by MAPS is about to commence following the resolution of a clinical hold placed by the US Food and Drug Administration (FDA) that paused progress for several months.
Congressional interest in psychedelics continues as a manager’s amendment to legislation covering the Department of Health and Human Services contains two sections addressing the therapeutic potential of psychedelics.
Officials at two agencies within the National Institutes of Health (NIH) have acknowledged in a letter to two U.S. senators that federal prohibition makes it harder to study the benefits of psychedelics, requiring researchers to jump through additional regulatory hoops.
MAPS Public Benefit Corporation (MAPS PBC) announced today that it has selected the contract research organisation (CRO), MMS Holdings (MMS), as its CRO for the development of a New Drug Application (NDA) for MDMA-assisted therapy for PTSD. MMS will support the NDA submission by providing regulatory strategy, biostatistics, statistical programming, medical writing, medical review, publishing, and submission project ...
Psychedelics’ latest feature in The New York Times explores the work of four Veterans Affairs clinicians, frustrated with existing treatments for addiction and PTSD, and have turned to psychedelic medicine to help veterans get the treatment they need.
Cybin has announced that it has received a “may proceed letter” and Investigational New Drug Application clearance from the U.S. FDA for its Phase I/IIa first-in-human clinical trial evaluating CYB003. CYB003 is a proprietary deuterated psilocybin analogue that is being developed for the potential treatment of major depressive disorder. This milestone marks the industry’s first-ever ...
Enosis Therapeutics has announced the successful completion of the world’s first study on the synergistic application of VR and psychedelics. The study, led by researchers and co-founders of Enosis Therapeutics, Agnieszka Sekula and Prash Puspanathan, was conducted in the Netherlands and in collaboration with Swinburne University of Technology and the Psychedelic Society Belgium.
Mydecine has announced that the U.S. Food and Drug Administration has cleared MYCO-001 in a recent Investigational New Drug (IND) application, marking the first clearance of the company’s drug product.
Braxia Scientific has announced positive preliminary results from the first Health Canada Approved, Phase II, randomized clinical trial to evaluate the feasibility, safety, tolerability, and efficacy of multi-dose psilocybin-assisted therapy for treatment-resistant depression. Preliminary results indicate strong feasibility with adequate recruitment including 159 individuals who were referred to the study and clinically meaningful improvements in ...
PAREA is a non-profit, multistakeholder and multidisciplinary partnership bringing together patient organizations, medical associations, scientific societies, psychedelic foundations, and the for-profit sector in an effort to change perceptions about psychedelic-assisted therapies, raise awareness of the scientific advances and, ultimately, bring better health to European citizens.
Cybin has announced that it has received Institutional Review Board approval to begin the first-in-human Phase I/IIa clinical trial evaluating CYB003, its proprietary deuterated psilocybin analogue, for the treatment of major depressive disorder.
Psychedelics feature in the BBC yet again. This time, Clare Tweedy dissects how psychedelics can help to treat depression.
The former chief of the Australian defence force, Chris Barrie, is campaigning to remove barriers stymying doctors from using MDMA to treat veterans suffering post-traumatic stress disorder and depression, saying he hopes “common sense is going to prevail”.
Tripp has raised $11.2 million in funding to help it continue to create meditation apps that power the “mindful metaverse.”
Cybin has announced the team of 28 esteemed faculty and advisors who will lead the Company’s EMBARK Psychedelic Facilitator Training Program. Recognizing the crucial importance of supporting psychedelic study facilitators with quality training, Cybin has brought together recognized leaders and senior psychedelic-assisted psychotherapy trainers from leading universities and psychedelic research and training organizations.
Awakn Life Sciences has announced that they have initiated a larger behavioral addiction study investigating ketamine as a treatment for Gambling Disorder. The larger study announced today will include 42 patients who are suffering from Gambling Disorder and will see participants undergo a memory reactivation procedure, which is designed to weaken the link between reward and ...
Ehave Inc. has announced that its KetaDASH subsidiary will begin using precision medicine to improve patient outcomes through its partnership with Entheon Biomedical Corp.’s wholly-owned subsidiary, HaluGen Life Sciences. KetaDASH will become one of the first psychedelic companies to use precision medicine to test patients by using HaluGen’s expanded psychedelics genetic testing panel, which analyzes ...
Lennham Pharmaceuticals has announced that the United States Patent & Trademark Office issued U.S. Patent No. 11,344,564 with an expiration date of December 2041. This patent covers methods of treating neurological or psychiatric disorders in patients having reduced monoamine oxidase A (MAO-A) activity by administering a below-normal dose of psilocybin or psilocin.
Cybin has announced that it has submitted an Investigational New Drug application to the U.S. FDA for its Phase I/IIa first-in-human clinical trial evaluating CYB003, a proprietary deuterated psilocybin analogue, for the treatment of major depressive disorder.
Optimi Health has been engaged by Filament Health to supply psilocybin mushrooms cultivated in Optimi’s recently inaugurated 20,000 square foot EU-GMP Princeton, British Columbia facility in the form of whole, dried mushroom fruiting bodies for potential drug development, testing, and analysis by Filament’s research team.
In this piece for The Guardian, Josiah Hesse gives us an insight into exactly what went on at “The Psychedelic House of Davos.”
Albert Labs has announced Sara Tai, Senior Lecturer in Clinical Psychology from Manchester University, as Principal Investigator for its upcoming trial. The trial will evaluate the safety and efficacy of KRN-101, a psilocybin-based medicine, for the treatment of cancer-related distress.
Based on a positive pre-IND meeting with the U.S. FDA, Ceruvia Lifesciences has submitted an Investigation New Drug (IND) application to begin a Phase II clinical trial for the treatment of obsessive-compulsive disorder with psilocybin Preliminary results from the Ceruvia funded pilot Phase II study taking place at Yale School of Medicine demonstrate rapid and robust improvement ...
Clerkenwell Health has announced the addition of Dr David Erritzoe, Dr Dea Siggaard Stenbæk, Dr Kim Kuypers and Dr James Stone to its advisory board from Danish, Dutch and British universities.
The Oregon Health Authority (OHA) has adopted the first subset of rules related to psilocybin products, testing and training programs. These rules are needed to implement ORS chapter 475A, the Oregon Psilocybin Services Act. The rules specify curriculum requirements for programs planning to train people interested in facilitating psilocybin services in Oregon, as well as initial ...
This great article from Jason Silva for Forbes details what exactly is happening at the World Economic Forums’ annual meeting in Davos in relation to psychedelic medicine.
Researchers at the University of California, Davis, and the University of Colorado Anschutz Medical Campus plan to screen hundreds of compounds to discover new, non-hallucinogenic treatments for substance use disorders. The research is funded by a $2.7 million grant from the US National Institute on Drug Abuse.
COMPASS Pathways has presented positive data from the largest randomised, controlled, double-blind study of psilocybin therapy ever completed, at the American Psychiatric Association annual meeting in New Orleans. The study showed that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after ...
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