5-HT1A receptor antagonists(Serotonin 1a (5-HT1a) receptor antagonists), 5-HT2A receptor agonists(Serotonin 2a (5-HT2a) receptor agonists), 5-HT2C receptor agonists(Serotonin 2c (5-HT2c) receptor agonists)

Therapeutic Areas

Other DiseasesNeoplasmsImmune System Diseases+ [6]

Active Indication

Depressive Disorder, MajorDepressive Disorder, Treatment-ResistantStimulant abuse+ [37]

Inactive Indication

Major depressive disorder, moderate (MDD)Mild depressionModerate depression+ [1]

Originator Organization-

Active Organization

Apex Labs Ltd.Startup

MYND Life Sciences, Inc.

NeonMind Biosciences, Inc.

+ [25]

Inactive Organization

Cybin, Inc.

Beckley Psytech Ltd.Startup

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (US), Orphan Drug (US), Innovative Licensing and Access Pathway (GB), Orphan Drug (EU)

Structure

Molecular FormulaC12H17N2O4P

InChIKeyQVDSEJDULKLHCG-UHFFFAOYSA-N

CAS Registry520-52-5

224

Clinical Trials associated with Psilocybin

NCT06005662 / SuspendedPhase 2IIT

Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial

This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood.

Start Date01 Apr 2027

Sponsor / Collaborator

The Johns Hopkins University

NCT06367738 / Not yet recruitingPhase 1IIT

Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults

The investigators will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults. The investigators will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose. Dose response will be assessed. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. The investigators will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect.

Start Date01 Apr 2025

Sponsor / Collaborator

University of California, Berkeley

ACTRN12624000816550 / Not yet recruitingPhase 2

Feasibility Study of the Effect of Psilocybin in Response to Brief Psychological Input with Psychological Flexibility as a Mediating Factor on adults with Mild to Moderate Depression or Anxiety.

Start Date01 Feb 2025

Sponsor / Collaborator

University of Otago

100 Clinical Results associated with Psilocybin

100 Translational Medicine associated with Psilocybin

100 Patents (Medical) associated with Psilocybin

1,818

Literatures (Medical) associated with Psilocybin

01 Jan 2025·JOURNAL OF AFFECTIVE DISORDERS

The association between study design and antidepressant effects in psychedelic-assisted therapy: A meta-analysis

Review

Author: Liang, Chih-Sung ; Li, Jia-Ru ; Yang, Fu-Chi ; Kao, Yu-Chen ; Hsu, Tien-Wei ; Chiang, Kuo-Tung ; Yu, Chia-Ling

Different study designs of psychedelic trials may impact the blinding and expectance, leading to biased treatment effects. This study aimed to examine the association between antidepressant efficacy and study designs in psychedelic trials. Six databases were systematically searched. Eligible trials were required to investigate the efficacy of psychedelics (psilocybin, lysergic acid diethylamide [LSD], 3,4-Methylenedioxymethamphetamine [MDMA], and ayahuasca) in adult patients with depressive symptoms. We only considered oral psychedelic-assisted therapy without concomitant use of antidepressants. The primary outcome was the change in depressive symptoms. There were five study designs of psychedelic trials, including non-active-drug-as-placebo, active-drug-as-placebo, waitlist-as-control, fixed-order, and pre-post designs. In non-active-drug -as-placebo design, psilocybin (k = 4, Hedges' g [g] = 0.87, 95 % confidence intervals[CIs] = 0.58 to 1.16) and MDMA (k = 2, g = 0.65, 95%CIs = 0.26 to 1.05) were associated with large and medium effect sizes, respectively. In active-drug-as-placebo design, both psilocybin (k = 2, g = 0.71, 95%CIs = -0.01 to 1.43) and MDMA (k = 3, g = 0.53, 95%CIs = -0.23 to 1.28) were not statistically significant. In pre-post single-arm (k = 3, g = 2.51, 95%CIs = 1.00 to 4.02) and waitlist-as-control (k = 1, g = 2.88, 95%CIs = 1.75 to 4.00) designs, psilocybin showed a large effect size of antidepressant effect. Ayahuasca also showed a large effect size in both pre-post (k = 2, g = 1.88, 95%CIs = 1.18 to 2.57) and non-active-drug-as-placebo (k = 1, g = 1.60, 95%CIs = 0.84 to 2.36) designs. LSD was associated with a significant antidepressant effect only in non-active-drug-as-placebo design (k = 1, g = 1.49, 95%CIs = 0.80 to 2.17) but not in active-drug-as-placebo design (k = 1, g = 0.44, 95%CIs = -0.90 to 1.78). The antidepressant effects of psychedelics may be overestimated in studies with pre-post single-arm, non-active-drugs-as placebo, and waitlist-control designs. Restricted sample size, difficulty with establishing blinding for participants, and over expectancy limit the estimation of the antidepressant effect of psychedelic-assisted therapy.

01 Jan 2025·PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY

Psychedelic-related deaths in England, Wales and Northern Ireland (1997–2022)

Article

Author: Penttinen, Jenni ; Kopra, Emma I. ; Copeland, Caroline S. ; Copeland, Caroline S ; Kopra, Emma I ; Rucker, James J ; Rucker, James J.

BACKGROUND:

Psychedelic drugs are increasingly visible in society once more, but their risks and adverse effects have received less attention than perhaps they should. While fatalities associated with psychedelics appear rare, a systematic approach to characterising their aetiology is required to inform harm minimisation efforts.

AIMS:

This study aimed to analyse prevalence and characteristics of psychedelic-related deaths in England, Wales, and Northern Ireland, between 1997 and 2022.

METHODS:

We analysed coroner reports submitted to the National Programme on Substance Use Mortality where psychedelic serotonergic agonist drugs were involved in the death, and conducted a thematic framework analysis to explore potential factors associated with their occurrence.

RESULTS:

We identified 28 cases where psychedelics were implicated (75 %, N = 21) or potentially implicated (25 %, N = 7) in the death; 19 of these involving psychedelic tryptamines (LSD 39 %, N = 11; Psilocybin 21 %, N = 6; DMT 7 %, N = 2), and 9 psychedelic phenethylamines (incl. NBOMes 18 %, N = 5). Most deaths were deemed accidental by the coroner (86 %, N = 24), including both traumatic injuries and drug toxicities; most cases involved multiple implicated drugs (68 %, N = 19); and most of the deceased were under 30 years of age (82 %, N = 23). Thematic framework analysis identified nine themes in the deaths across three categories. 'Polysubstance use' was the most common theme (82 % of cases, N = 23/28), followed by a suboptimal 'physical environment' (70 % of cases where this information was available, N = 14/20).

CONCLUSIONS:

The profound and often unpredictable effects of psychedelics pose a unique profile of risks and adverse reactions. Nevertheless, psychedelic-related deaths remain very rare in comparison to other recreational drugs, and frequently involve polydrug use. Implications for harm reduction and policy are discussed.

02 Dec 2024·PHILOSOPHICAL TRANSACTIONS OF THE ROYAL SOCIETY B-BIOLOGICAL SCIENCES

Psilocybin-assisted neurofeedback for the improvement of executive functions: a randomized semi-naturalistic-lab feasibility study

Article

Author: Lietz, M. ; Krc, J. ; O’Higgins, F. J. ; Enriquez-Geppert, S.

Executive function deficits, common in psychiatric disorders, hinder daily activities and may be linked to diminished neural plasticity, affecting treatment and training responsiveness. In this pioneering study, we evaluated the feasibility and preliminary efficacy of psilocybin-assisted frontal-midline theta neurofeedback (NF), a neuromodulation technique leveraging neuroplasticity, to improve executive functions (EFs). Thirty-seven eligible participants were randomized into an experimental group ( n = 18) and a passive control group ( n = 19). The experimental group underwent three microdose sessions and then three psilocybin-assisted NF sessions, without requiring psychological support, demonstrating the approach’s feasibility. NF learning showed a statistical trend for increases in frontal-midline theta from session to session with a large effect size and non-significant but medium effect size dynamical changes within sessions. Placebo effects were consistent across groups, with no tasks-based EF improvements, but significant self-reported gains in daily EFs—working memory, shifting, monitoring and inhibition—showing medium and high effect sizes. The experimental group’s significant gains in their key training goals underscored the approach’s external relevance. A thorough study with regular sessions and an active control group is crucial to evaluate EFs improvement and their specificity in future. Psilocybin-enhanced NF could offer significant, lasting benefits across diagnoses, improving daily functioning. This article is part of the theme issue ‘Neurofeedback: new territories and neurocognitive mechanisms of endogenous neuromodulation’.

847

News (Medical) associated with Psilocybin

31 Oct 2024

·www.prnewswire.com

B.More Collaborator, Dr. Michael Bogenschutz, Awarded $15 Million NIDA Grant for Landmark Psilocybin Study in Opioid Use Disorder

GREENWICH, Conn. , Oct. 31, 2024 /PRNewswire/ -- B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company dedicated to the development of psychedelic medicines for substance abuse disorders, is pleased to announce that its collaborator, Dr. Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, has been awarded a grant of $3 million per year for a total of 5 years dependent on progress during the first 2 years, from the National Institute of Drug Abuse (NIDA). This funding will support the first clinical trial to evaluate psilocybin's efficacy as a treatment for Opioid Use Disorder (OUD). If successful, the trial will provide the basis for a full-scale drug development program aimed at achieving FDA approval for psilocybin as a treatment for OUD. The NIDA-funded, double-blind, multi-site, phase 2 randomized controlled clinical trial will assess psilocybin's therapeutic potential to reduce opioid cravings and improve emotional well-being in individuals struggling with OUD but who continue to use non-prescribed opioids despite adherence to methadone treatment. Conducted across four treatment centers in New York and New Mexico, the trial plans to enroll 240 participants, including OUD patients with co-occurring substance use and psychiatric disorders. With participants drawn predominantly from low-income minority populations, the study marks a significant shift toward diversity in psychedelic research, addressing a critical knowledge gap with respect to underrepresented groups. Participants will receive manualized, non-directive clinical support and will be randomly assigned to receive a single administration of psilocybin 30 mg (high dose), psilocybin 20 mg (medium dose), or psilocybin 1 mg (low-dose control condition). Weekly urine drug screens and continuous self-report of opioid and other drug use will be collected for 24 weeks after psilocybin administration, along with measures probing OUD-related neuropsychopathology and functional outcomes. Unlike previously reported psychedelic trials, the study will include prospective assessment of pre-randomized patient expectancies along with post-treatment patient beliefs regarding treatment assignment, providing data for modelling the contribution of expectancy effects on reported outcomes. B.More, which will license the trial data for commercial development, will supply cGMP psilocybin for the study and will also fund other support for the goal of an eventual New Drug Application (NDA). "This trial is a vital step toward understanding psilocybin's therapeutic potential in Opioid Use Disorder," said Carey Turnbull, Co-founder, and CEO of B.More Inc. "In working with Dr. Bogenschutz, our goal is to create a treatment pathway that's accessible, effective, and safe, opening new avenues for psychedelic-assisted therapy as an FDA-approved tool in the fight against addiction. This NIDA funded OUD trial taking place in substance abuse treatment centers pairs nicely with NYU's previously announced NIH funded alcohol use disorder trial being conducted within the Silver Hill rehab center, adding to their expertise in the treatment of substance abuse using psilocybin." According to Dr. Bogenschutz, "In addition to providing a rigorous test of safety and efficacy, this trial will provide information regarding the feasibility of implementing psilocybin-assisted treatment for OUD within the existing system of care. If psilocybin is found to be safe and effective, this model would provide a new option for OUD patients who are receiving treatment but continue to struggle with illicit opioid use." About B.More Founded in 2017 by Carey and Claudia Turnbull, B.More is a 501(c)(3) non-profit, clinical-stage biopharmaceutical company with a mission to develop better treatment options for those struggling with alcohol use disorder and other substance use disorders. With researchers at the NYU Grossman School of Medicine, B.More is advancing clinical research to help these individuals, and their loved ones, live a better tomorrow. For more information, please visit Logo - SOURCE B.More Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2

31 Oct 2024

·www.globenewswire.com

Revive Therapeutics Provides Update on Research Study Evaluating Bucillamine for Nerve Agent Exposure

TORONTO, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures, announced today an update on the research study evaluating Bucillamine as a potential treatment for nerve agent exposure, in partnership with Defence R&D Canada – Suffield Research Centre (“DRDC”), an agency of the Canadian Department of National Defence. The DRDC is investigating pharmacological compounds, including Bucillamine, that can mitigate nerve agent induced brain injury. The DRDC conducted an additional control study to achieve optimal dosing. The research study is progressing and is now expected to be completed with final results by the end of calendar 2024. The results from this research study, if promising, will determine further studies to facilitate FDA and Health Canada approvals for the use of Bucillamine in nerve agents or organophosphate pesticide poisoning and explore its potential for traumatic brain injury caused by concussive or explosive forces and viral infections. Nerve agents are chemicals that affect the nervous system. Nerve agents are highly toxic regardless of the route of exposure. The main chemical nerve agents that are man-made and manufactured for use in chemical warfare are sarin, soman, tabun and VX. These nerve agents are known to be present in military stockpiles. Exposure to nerve agents can occur due to chemical warfare or accidental release from a military storage facility. Exposure to nerve agents can cause tightness of the chest, excessive salivation, abdominal cramps, diarrhea, blurred vision, tremors, and death. Recent studies have shown that antioxidant compounds such as n-acetylcysteine (“NAC”) could be beneficial in limiting seizure activity and improving the anticonvulsant efficacy of GABA-mediating drugs such as diazepam. Bucillamine is a significantly more effective antioxidant than NAC and has the potential to provide increased efficacy against seizure activity while limiting the anticoagulant and bleeding event liability observed with NAC. The overall objective of the research project is to investigate pharmacological means for neuroprotection of GABA(A) receptors, which are required for the effectiveness of currently fielded anticonvulsant therapies. Bucillamine and NAC will be evaluated to determine the effect on GABA(A) receptor endocytosis and the effect on diazepam effectiveness in terminating seizures. Any additional antioxidant effects on seizure activity and survival will also be assessed. About Revive Therapeutics Ltd. Revive Therapeutics is a life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com. For more information, please contact: Michael FrankChief Executive OfficerRevive Therapeutics Ltd.Tel: 1 888 901 0036Email: mfrank@revivethera.comWebsite: www.revivethera.com Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the year ended June 30, 2024 ("MD&A"), dated October 25, 2024, which is available on the Company's profile at www.sedarplus.ca.

Orphan DrugFast TrackClinical Study

31 Oct 2024

·www.globenewswire.com

Psyence Biomedical Announces Closing of Previously Announced Acquisition of Psyence Group’s Stake in PsyLabs

PsyLabs develops and produces certified pharmaceutical-grade nature-derived psychedelics for applications in mental health and well-being Psyence Biomedical has issued common shares to Psyence Group pursuant to a debt-for-equity swap agreement NEW YORK, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced the successful closing of its previously announced acquisition of Psyence Group's 11.13% stake in privately held PsyLabs. PsyLabs is focused on the cultivation and production of psychedelic active pharmaceutical ingredients (APIs) and extracts for use in research, clinical trials and drug development. As previously announced, Psyence Biomed and PsyLabs have an existing strategic partnership whereby PsyLabs has granted Psyence Biomed a worldwide, exclusive, royalty-bearing IP licensing agreement to supply pharmaceutical-grade, EU GMP nature-derived (non-synthetic) psilocybin to be evaluated in future clinical trials as a potential treatment for Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs) and for commercialization of the licensed product. "We are very pleased to have acquired a direct interest in PsyLabs through this acquisition and intend to capitalize on the benefits of being one of the world’s few vertically integrated developers of psychedelic-based regulatory-approved therapeutics,” said Dr. Neil Maresky, Chief Executive Officer of Psyence Biomed. Tony Budden, Chief Executive Officer of PsyLabs, said, “We welcome Psyence Biomed as our newest shareholder as we continue to develop our proprietary process and drug candidate, suitable for human clinical trials, in support of Psyence Biomed's pipeline of therapeutics to treat additional high-value mental health conditions, including AUD and other SUDs.” Debt-for-Equity Swap AgreementPsyence Group and Psyence Biomed have entered into a debt-for-equity swap agreement (the "Debt Swap Agreement"), pursuant to which Psyence Biomed has agreed to issue 845,394 Psyence Biomed common shares at a deemed price of US$0.50 per common share to Psyence Group, in exchange for the discharging of the balance of the debt repayment obligation due under a promissory note, dated January 25, 2024, issued by Psyence Biomed to Psyence Group in connection with Psyence Biomed's listing of its common shares on the NASDAQ in January 2024 ("Debt Swap"). In the event that the average VWAP of Psyence Biomed common shares for the ten trading days prior to January 15, 2025 is lower than US$0.50, Psyence Biomed will be required to make a "make whole payment" in cash or common shares, as set forth in the Debt Swap Agreement. Psyence Biomed has agreed to register the resale of the common shares within 60 days of the issuing of such common shares. The Debt Swap Agreement contains customary representations, warranties and covenants of the parties. Psyence Group’s board of directors has, subject to the appropriate recusal of interested directors who are also directors of Psyence Biomed, approved the Debt Swap Agreement and no materially contrary view or abstention was expressed or made by any director in relation to the Debt Swap. Psyence Group will not file a material change report in respect of the Debt Swap at least 21 days before anticipated closing of the Debt Swap, as Psyence Group wishes to close on an expedited basis for sound business reasons. About PsyLabs:PsyLabs is a psychedelic Active Pharmaceutical Ingredient (API) development company that is federally licensed to cultivate and export psilocybin mushrooms and other psychedelic compounds, including psilocin, mescaline, ibogaine and dimethyltryptamine (DMT) to the legal medical and research markets. PsyLabs has been able to successfully demonstrate, at laboratory scale, purification of natural psilocybin to levels not seen before in the industry using its proprietary extraction and purification technologies. It is in the process of scaling to full scale commercial production of Psilocybin and into a fully formulated product, with the accompanying regulatory approvals. This work is being done in collaboration with the largest U.K. owned contract manufacturing organization. Learn more at www.psylabs.life Contact InformationGeneral Information: tony@psylabs.life About Psyence Biomed: Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the world’s few vertically integrated biopharmas with a focus on psychedelic-based pharmaceutical therapeutics. The first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq, Psyence is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, FDA-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn. Contact Information for Psyence GroupEmail: ir@psyence.comMedia Inquiries: media@psyence.comGeneral Information: info@psyence.comPhone: +1 416-477-1708 Contact Information for Psyence BiomedEmail: ir@psyencebiomed.comMedia Inquiries: media@psyencebiomed.comGeneral Information: info@psyencebiomed.comPhone: +1 416-477-1708 Investor Contact:Jeremy FefferManaging DirectorLifeSci Advisorsjfeffer@lifesciadvisors.com Forward-Looking Statements This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning. Forward-looking statements in this communication include statements regarding the benefits of the Acquisition, the advancement of PsyLabs and Psyence Biomed's respective drug development and clinical trial strategies and the progress of Psyence Biomed's existing Phase IIb clinical trial. These forward-looking statements are based on a number of assumptions, including the assumption that Psyence Biomed will be able to capitalize on the benefits of the Acquisition and that PsyLabs' drug development programme will be successfully executed. There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the inability of Psyence Biomed to recognize the anticipated benefits of the Acquisition (ii) changes in applicable laws which may impact drug development, clinical trials and/or the conducting thereof; (iii) the inability of PsyLabs to develop a drug candidate suitable for human clinical trials; (iv) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the final prospectus (File No. 333-282468) filed with the Securities and Exchange Commission on October 10, 2024 and other documents filed by Psyence Biomed from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, neither Psyence Group nor Psyence Biomed intends to update these forward-looking statements. Neither of the parties referenced in this news release make any medical, treatment or health benefit claims about the proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Neither of the parties referenced in this news release has conducted clinical trials for the use of the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that any of the parties referenced in this news release verified such in clinical trials or that such parties will complete such trials. If the parties cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on such parties' performance and operations.

License out/inAcquisitionPhase 2

100 Deals associated with Psilocybin

External Link

KEGG	Wiki	ATC	Drug Bank
-	Psilocybin	-	DB11664

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 3	US	Usona Institute	05 Mar 2024
Depressive Disorder, Treatment-Resistant	Phase 3	US	Compass Pathways Plc	19 Jan 2023
Stimulant abuse	Phase 2	-	Filament Health Corp.	01 Jan 2025
Opioid abuse	Phase 2	-	Filament Health Corp.	01 Dec 2024
Irritable Bowel Syndrome	Phase 2	US	Tryp Therapeutics, Inc.	17 Jan 2024
Borderline Personality Disorder	Phase 2	US	Usona Institute	01 Nov 2023
Tobacco Use Disorder	Phase 2	US	The University of Alabama at Birmingham	01 Nov 2023
Fibromyalgia	Phase 2	US	Tryp Therapeutics, Inc.	27 Sep 2023
Fibromyalgia	Phase 2	US	University of Michigan	27 Sep 2023
Neoplasms	Phase 2	US	Sunstone Medical LLC	07 Jul 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03429075 (Psilodep-RCT, CTgov)	Phase 2	Depressive Disorder, Major	59	Psilocybin + Placebo (Psilocybin)	ovkfarcdvz(pokwotexjq) = nbiyxfinpn glxmoozpjb (kvpmbtwntv, gxboklgrxh - qvbpzomcrt) View more	-	24 Oct 2024
NCT03429075 (Psilodep-RCT, CTgov)	Phase 2	Depressive Disorder, Major	59	Psilocybin + Escitalopram (Escitalopram)	ovkfarcdvz(pokwotexjq) = bqvttnaidz glxmoozpjb (kvpmbtwntv, ycaehqhrzr - atltdqtzmr) View more	-	24 Oct 2024
NCT03429075 (Literature) Manual	Phase 2	Major depressive disorder, moderate (MDD)	59	Psilocybin combined with psychological support	scnkdfxidm(gmvgbtnaov): Difference = 1.51 (95% CI, -1.35 to 4.38), P-Value = 0.311 View more	Positive	21 Sep 2024
NCT03429075 (Literature) Manual	Phase 2	Major depressive disorder, moderate (MDD)	59	Escitalopram combined with psychological support		Positive	21 Sep 2024
NCT04661514 (Pubmed)	Phase 1	Anorexia Nervosa	10	Psilocybin	zqvpgmbrfm(uufvhuxuik) = Two participants developed asymptomatic hypoglycemia at post-treatment, which resolved within 24 h. No other clinically significant changes were observed in laboratory values. All AEs were mild and transient in nature. ynepqufovt (efgsrnvlct )	Positive	01 Jul 2024
NCT05434156 (GlobeNewswire) Manual	Phase 1/2	Depressive Disorder, Major	-	ELE-101	vmlegfvotg(hmtuqzbxae) = Was well-tolerated with no serious or severe adverse events (AE) reported, and an AE profile which is consistent with other compounds in this class. olmqbsasip (iikwsyucgr )	Positive	20 Jun 2024
NCT05312151 (GlobeNewswire) Manual	Phase 2	Stress Disorders, Post-Traumatic	22	COMP360 psilocybin	crourjpzuk(qqajgtgrkt) = There were no treatment-emergent serious adverse events. ryqyekpegz (zimjojwhax ) Met View more	Positive	08 May 2024
Psi-GAD1 (NEWS) Manual	Phase 2	Generalized anxiety disorder	72	Psilocybin	pimkrkdmhc(dljxtglpnt) = zhbxrazwnd ofarkdehrp (kfbnytpqes ) Met	Positive	28 Feb 2024
Psi-GAD1 (NEWS) Manual	Phase 2	Generalized anxiety disorder	72	Psilocybin	pimkrkdmhc(dljxtglpnt) = sjkujfazst ofarkdehrp (kfbnytpqes ) Met	Positive	28 Feb 2024
GlobeNewswire Manual	Phase 2	Stress Disorders, Post-Traumatic	22	COMP360 25mg	gpxxldermg(nvzxugjatz) = COMP360 was well-tolerated and the safety profile was as expected, with no treatment emergent serious adverse events recorded. niqzskngtv (dzzjaycfsp )	Positive	19 Dec 2023
NCT04593563 (Literature) Manual	Phase 2	Depressive Disorder, Major Adjuvant	30	Psilocybin	vdaiskodci(qcfqkxjjfl) = bxsbflnavy rdbdmdzbjt (utguaqkumr, 22.3 to -16.0)	Positive	18 Dec 2023
NCT04593563 (Pubmed)	Phase 2	Neoplasms \| Depressive Disorder, Major	-	Psilocybin-assisted therapy	cnetmdbafd(vxvncwvtlb) = e.g., nausea, headache aedqxxbhyc (hojmyczpyn )	-	18 Dec 2023
GlobeNewswire Manual	Phase 2	Bipolar II disorder	15	psilocybin 25mg	ucovfyuqtz(ilslhdqpeu) = utqzgnkouf zttgoiuzrq (hlqopzecbh ) View more	Positive	06 Dec 2023

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