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

Nervous System DiseasesNeoplasmsImmune System Diseases+ [5]

Active Indication

Depressive Disorder, Treatment-ResistantDepressive Disorder, MajorStress Disorders, Post-Traumatic+ [41]

Inactive Indication

Abnormalities, Drug-InducedAmnesiaBinge-Eating Disorder+ [10]

Originator Organization-

Active Organization

Compass Pathways Plc

Filament Health Corp.

APeT Holding B.V.

+ [35]

Inactive Organization

Revive Therapeutics Ltd.

Ceruvia Lifesciences LLC.

Beckley Psytech Ltd.

+ [2]

License Organization

Revive Therapeutics Ltd.

Psyence Biomedical Ltd.

Psirenity

+ [17]

Drug Highest PhaseApproved

First Approval Date

Australia (01 Sep 2025),

Depressive Disorder, Treatment-Resistant

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Innovative Licensing and Access Pathway (United Kingdom), Commissioner's National Priority Voucher (United States)

Structure/Sequence

Molecular FormulaC12H17N2O4P

InChIKeyQVDSEJDULKLHCG-UHFFFAOYSA-N

CAS Registry520-52-5

326

Clinical Trials associated with Psilocybin

NCT06102434

/ SuspendedEarly Phase 1IIT

Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder

The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and subjective (e.g., mood) effects. The study's subject population consists of men and women between the ages of 21 and 55 from the Los Angeles area that meet criteria for cocaine use disorder and express an interest in ceasing cocaine use. 25 mg oral psilocybin will be administered to 10 individuals (separately) during a single laboratory visit. The laboratory visit will take place from 9 am until 3 pm within a comfortable, living room like environment. Within this study session room, participants will be accompanied by two clinicians. Participants will then consume the psilocybin capsule, and thereafter will be encouraged to lie down on a couch and introspect on the experience. At one-hour intervals following ingestion, participants will be tested briefly for changes in heart rate, blood pressure, and subjective effects. No blood draws, behavioral assessments, or neuroimaging is included in the study. Following the laboratory visit, investigators will check-in on participants remotely, after 48 hours, and 10, 50, and 90 days from the psilocybin session.

Start Date01 Feb 2029

Sponsor / Collaborator

University of California, Los Angeles

NCT06005662

/ WithdrawnPhase 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

NCT07566104

/ Not yet recruitingPhase 2IIT

Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder

This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.

Start Date01 Jan 2027

Sponsor / Collaborator

University of California, Los Angeles

100 Clinical Results associated with Psilocybin

100 Translational Medicine associated with Psilocybin

100 Patents (Medical) associated with Psilocybin

2,658

Literatures (Medical) associated with Psilocybin

01 Nov 2026·JOURNAL OF AFFECTIVE DISORDERS

Changes in anxiety, quality of life, and functioning following psilocybin-assisted therapy in veterans with treatment-resistant depression

Article

Author: Kelly, Carlton M ; Aaronson, Scott ; Bostian, Catherine M ; Ellis, Sara ; Fradet, Mathieu ; Suppes, Trisha ; Donnelly, Anna ; Ostacher, Michael

BACKGROUND:

Psilocybin has demonstrated promise for improving depressive symptoms in treatment-resistant depression, but its effects on anxiety, quality of life, functioning, and posttraumatic stress symptoms are less well studied. This study reports exploratory findings from an open-label trial in Veterans with TRD.

METHODS:

Participants received a single 25-mg dose of psilocybin administered with psychological support. The primary endpoint was assessed 3 weeks post-dose, with follow-up extending to 12 months. Outcomes included anxiety severity (GAD-7), quality of life (Q-LES-Q-SF), functional impairment (WSAS), and posttraumatic stress disorder symptoms (PCL-5). Experiential outcomes were measured with the Mystical Experience Questionnaire (MEQ), Challenging Experiences Questionnaire (CEQ-30), and Emotional Breakthrough Inventory (EBI). Mixed-effects models were used to evaluate longitudinal changes, and correlation analyses examined associations between measures and changes in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale.

RESULTS:

Fifteen participants were included, with ten completing long-term follow-up. GAD-7 scores demonstrated sustained improvements through 12 months, with a 59% reduction from baseline at Week 3. Q-LES-Q-SF gains were significant through Week 12, with a 24% increase at Week 3, and WSAS improvements persisted through Month 6 before declining, with a 46% reduction at Week 3. These effects were no longer statistically significant after accounting for improvements in depression. Unadjusted PCL-5 reductions were observed at all timepoints. Exploratory analyses of acute subjective experiences did not correlate to treatment response.

LIMITATIONS:

This study is limited by its small sample size and open-label design.

CONCLUSIONS:

Psilocybin with psychological support was associated with improvements in anxiety, quality of life, functioning, and PTSD symptoms which largely correlated to concurrent improvements in depressive symptoms.

CLINICAL TRIAL:

NCT04433858.

01 Oct 2026·JOURNAL OF PSYCHIATRIC RESEARCH

Psychedelics and autism spectrum disorder: Mechanistic insights, translational evidence and ethical challenges

Review

Author: Lodetti, Guilherme ; Gonçalves, Cinara Ludvig ; Rico, Eduardo Pacheco ; Bolan, Sofia Januário ; Claudino Dos Santos, Júlio César ; Viana, Germano Lapa

Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition characterized by persistent deficits in social communication and interaction, restricted and repetitive patterns of behavior, and sensory processing alterations, frequently accompanied by anxiety, emotional dysregulation, and other psychiatric comorbidities. Despite advances in behavioral and pharmacological interventions, effective treatments for core ASD symptoms remain limited. Psychedelic compounds have recently emerged as potential therapeutic agents in psychiatry because of their ability to modulate serotonergic and glutamatergic signaling, enhance neuroplasticity, reorganize large-scale brain networks, and influence neurobiological pathways implicated in ASD. In this narrative review, we examine the mechanistic rationale supporting psychedelic-based approaches in ASD, including 5-HT2A receptor activation, oxytocin-serotonin interactions, excitation-inhibition dynamics, functional connectivity, and glutamatergic modulation associated with ketamine and related compounds. We also summarize current clinical and preclinical evidence involving substances such as psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine, and ketamine. Particular attention is given to the distinction between core ASD symptoms and associated symptom domains. Current evidence does not support the direct treatment of core social communication deficits or restricted and repetitive behaviors; however, psychedelics may hold greater potential for dimensions such as social anxiety, emotional dysregulation, cognitive rigidity, and co-occurring mood symptoms. Ethical, regulatory, and developmental safety considerations are also discussed, particularly regarding neurodivergent populations and the absence of robust pediatric evidence. Although direct clinical studies in ASD remain scarce, psychedelic-assisted interventions represent a promising translational avenue that warrants further rigorous investigation through carefully designed clinical trials.

01 Sep 2026·INTERNATIONAL JOURNAL OF DRUG POLICY

Balancing safety and access in Oregon’s psilocybin services

Article

Author: Yaden, David B ; Cheung, Katherine ; Propes, Caleigh

As jurisdictions across the U.S. consider enacting policies that facilitate access to psychedelics, they must determine how the desire to expand access to these substances should be weighed against the need to adequately protect safety. Oregon's psilocybin services program offers an important early case study of this balance in practice. Under the Psilocybin Services Act, adults over 21 are permitted to access psilocybin in Oregon at licensed service centers under facilitator supervision, with no referral from a medical practitioner, or clinical supervision, needed. Drawing on the first full year of data published by the Oregon Health Authority, this commentary examines how safety and access are being balanced through Oregon's policy. Reported adverse reactions in 2025 were relatively uncommon: however, Oregon's reporting framework sets a high threshold for reportable events. Access also remains limited, with most clients being of high-income and from outside Oregon. At the same time, the program has expanded supervised psilocybin use beyond strictly medical uses, with a proportion of clients reporting using psilocybin services for general health and wellness. Others report using psilocybin services for more medical-type motivations, such as for depression and anxiety. Overall, we argue that Oregon's broad eligibility criteria and supervision requirements may raise several safety concerns, particularly when clients with clinical symptoms seek services.

1,274

News (Medical) associated with Psilocybin

8 hours ago

·www.einpresswire.com

Scottsdale Research Institute Announces Submission of Investigational New Drug (IND) Application to FDA for Ibogaine HCl

We appreciate FDA's acceptance of our IND application for review and assignment of IND 183727. This is a step toward rigorously evaluating ibogaine hydrochloride under the FDA's regulatory framework.” — Dr. Sue Sisley PHOENIX, AZ, UNITED STATES, July 29, 2026 / EINPresswire.com / -- Ibogaine HCl is an investigational neuroplastogen designed to promote neuroplasticity and restore neural function disrupted by psychological trauma, traumatic brain injury, and substance use disorders. The active pharmaceutical ingredient (API) will be supplied by Psygen (Canada) utilizing Scottsdale Research Institute’s DEA Schedule I Importer Registration. PTSD, TBI, and opioid use disorder affect millions of Americans—including military veterans and first responders—for whom existing treatment options remain inadequate. If authorized by the FDA and Institutional Review Board (IRB), the planned Phase 1 clinical trial is expected to begin in early 2027 and will support advancement into Phase 2 clinical development. Scottsdale Research Institute/Field to Healed Foundation (SRI/F2H), a nonprofit clinical research organization dedicated to advancing innovative therapies for military veterans, first responders, and others living with post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and substance use disorders, today announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ibogaine Hydrochloride (Ibogaine HCl) , an investigational neuroplastogen being developed for the treatment of PTSD, TBI, and opioid use disorder (OUD). Acceptance of the IND application for review represents an important regulatory milestone in the clinical development of ibogaine as an FDA-regulated investigational medicine. Subject to FDA and IRB authorization, Scottsdale Research Institute anticipates initiating its Phase 1 clinical trial in early 2027 to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effects of Ibogaine HCl in military veterans and civilians living with PTSD and TBI. “We appreciate the FDA’s acceptance of our IND application for review and the assignment of IND 183727,” said Dr. Sue Sisley, MD, President and Principal Investigator of Scottsdale Research Institute. “This submission represents an important step toward rigorously evaluating ibogaine hydrochloride under the FDA’s regulatory framework. Millions of individuals living with PTSD, traumatic brain injury, opioid use disorder, and related conditions continue to face significant unmet medical needs. We are proud of the scientific and clinical team that made this milestone possible and look forward to working collaboratively with the FDA as we advance this important research program.” Ibogaine HCl represents a novel therapeutic approach that combines neuroplasticity with a unique polypharmacologic mechanism of action. By interacting with multiple neurotransmitter systems, ibogaine has demonstrated the potential in preclinical and early clinical studies to induce neuroplastic changes that may help restore neural circuits affected by psychological trauma, traumatic brain injury, and chronic substance use. Unlike currently available therapies that primarily target individual symptoms, Ibogaine HCl is being investigated for its potential to address underlying neurological dysfunction that contributes to PTSD, TBI, opioid use disorder, depression, anxiety, and cognitive impairment. Scottsdale Research Institute’s Phase 1 clinical trial is designed to generate critical safety, pharmacokinetic, cardiac safety, and dose-ranging data that will inform future Phase 2 studies evaluating the efficacy of Ibogaine HCl. SRI is collaborating with Brian Anderson, M.D., Associate Professor at the University of California, San Francisco (UCSF), to advance the clinical development program. In addition, SRI is building collaborative relationships with Native American Tribes and tribal partners to support culturally informed and ethically responsible psychedelic research. These relationships form the foundation of an emerging Psychedelic Research Tribal Consortium, led by Michelle Driver, which will help integrate indigenous knowledge and ethical stewardship into the program’s research and development. About Scottsdale Research Institute Scottsdale Research Institute (SRI) is a nonprofit clinical research organization dedicated to developing innovative therapies for PTSD, traumatic brain injury, chronic pain, and substance use disorders through FDA-regulated clinical trials. Working in collaboration with leading academic medical centers, tribal partners, and scientific experts, SRI is committed to generating high-quality clinical evidence that expands treatment options for military veterans, first responders, and patients with serious unmet medical needs. SRI is also advancing HRTT21, an FDA-authorized Investigational New Drug consisting of whole natural psilocybin mushrooms. The Phase 1 clinical trial is expected to conclude in August 2026, with submission of the Phase 2 IND application anticipated shortly thereafter. Upon authorization, HRTT21 is expected to qualify as an Eligible Investigational Drug (EID) under applicable federal Right to Try provisions. ### Dr. Sue Sisley Scottsdale Research Institute +1 480-326-6023 SueSisleyMD@srilaboratory.com Visit us on social media: LinkedIn Instagram Facebook X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 1IND

31 Jul 2026

·www.globenewswire.com

Rose Hill Life Sciences and Control Z Sign Letter of Intent to Advance Clinically Structured Psilocybin-Assisted Therapy for PTSD

Partnership establishes the framework for the first regulated psychedelic therapy program in the Commonwealth, uniting Rose Hill’s pharmaceutical-grade Psychedelic Therapeutic Intervention (PTI)™ protocol with Control Z’s comprehensive care model to serve veterans, first responders and civilians failed by conventional treatment (pending state licensure)BOSTON, July 31, 2026 (GLOBE NEWSWIRE) -- Rose Hill Life Sciences ("Rose Hill" or "the Company"), a clinical-stage biotechnology company advancing psychedelic therapeutics for neurological and psychiatric conditions, announced that it has signed a Letter of Intent (LOI) with Control Z, a Massachusetts healthcare public benefit corporation redefining psychedelic care through a holistic medical model, to advance a structured, clinically grounded psilocybin-assisted therapy program for post-traumatic stress disorder (PTSD) through Rose Hill’s Psychedelic Therapeutic Intervention (PTI)™ program. Post-traumatic stress disorder affects an estimated 13 million Americans annually, with current pharmacological and psychotherapeutic options leaving a substantial proportion of patients without adequate relief. The condition imposes significant individual, social, and economic burdens, and the medical community has increasingly looked to novel mechanisms of action to expand available treatment options. Upon receiving state approval and licensing, the collaboration will position both organizations among the first to deliver a fully regulated, medically supervised psychedelic therapy program in the state using Rose Hill’s PTI clinical framework. The collaboration unites Rose Hill's scientific and regulatory infrastructure with Control Z's advanced bio-psycho-social care delivery model. Control Z's approach integrates medically guided psychedelic sessions with biotherapeutics, physical training, nutrition, breathwork, and mindfulness; a multi-modal framework that complements Rose Hill's emphasis on pharmaceutical-grade quality, structured therapeutic protocols, and responsible development. PTI builds on an earlier iteration of this model that Rose Hill has already delivered through a veteran retreat in Jamaica — combining preparation, a supervised psilocybin experience, and structured integration — operational experience that now informs PTI's clinical framework, safety systems, and U.S. implementation approach. “This agreement reflects our conviction that meaningful outcomes in psychedelic medicine require more than a compound,” said Jama Pitman, CEO of Rose Hill Life Sciences. “They require a rigorously validated protocol, a disciplined clinical environment, and a delivery partner committed to the same standards of care. Control Z shares that commitment, and together we intend to demonstrate what responsible, scalable psychedelic-assisted therapy can look like at the clinical level.” “Control Z was built on the belief that psychedelic care, done properly, demands the same scientific discipline as any other advanced medicine,” said Colin Beatty, CEO and co-founder of Control Z. “Partnering with Rose Hill gives us a protocol grounded in that principle and a pathway to bring genuinely clinical-grade psilocybin-assisted therapy to the Massachusetts patients — many of them veterans and first responders — who have been failed by conventional treatment.” The Control Z collaboration advances Rose Hill’s PTI program for PTSD, one of four active clinical-stage development efforts. The company’s lead program — conducted in exclusive partnership with Johns Hopkins University — represents the world’s first clinical trial investigating psilocybin for post-stroke motor recovery, targeting a $46 billion market with no current psychedelic competition. Rose Hill’s pipeline also includes programs in depression and autism spectrum disorder. Psilocybin-assisted therapy has emerged as one of the most actively studied investigational approaches across multiple psychiatric indications. Direct evidence for psilocybin specifically in PTSD remains early-stage, comprising small, open-label, and feasibility-focused studies that support continued development rather than established efficacy. Psilocybin remains an investigational compound and is not approved by the FDA for the treatment of PTSD or any other indication outside of regulated research settings. "As a psychiatrist at the VA Boston Healthcare System, I see firsthand how many veterans are living with PTSD that have not responded to any available treatment. This partnership represents exactly the kind of clinically leading-edge, medically grounded approach that this population deserves — and has been waiting for." said Dr. Edwin Raffi, Control Z’s Chief Medical Officer. The LOI between Control Z and Rose Hill supports the strategy of building delivery partnerships that extend clinical infrastructure into regulated markets, creating pathways from research to patient access grounded in pharmaceutical-grade quality and evidence-based protocol design, consistent with Rose Hill's staged approach to evaluating feasibility, safety, and outcomes before advancing efficacy claims. About Rose Hill Life Sciences: Rose Hill Life Sciences is a clinical-stage biotechnology company advancing psilocybin-based therapeutics for neurological and psychiatric conditions. The Company holds an exclusive worldwide license with Johns Hopkins University supporting the world's first clinical trial investigating psilocybin for post-stroke motor recovery, and maintains active research collaborations across four clinical programs targeting stroke recovery, depression, autism spectrum disorder, and PTSD. Rose Hill's vertically integrated operations — spanning cultivation and extraction in Jamaica, formulation and manufacturing, and clinical development partnerships across the United States and Canada — support pharmaceutical-grade quality, supply chain control, and scientific rigor from source to patient. As the world's inaugural legal exporter of psilocybin, Rose Hill is committed to advancing evidence-based treatments and setting new standards for safety, efficacy, and responsible development in psychedelic medicine. For more information, visit rosehill.life. Rose Hill Life Sciences is wholly owned by Rose Hill Health Holdings LLC. About Control Z Control Z is an advanced psychedelic mental health and physical resilience treatment company delivering personalized, comprehensive bio-psycho-social care pathways designed to promote deep healing, mental resilience, and sustainable transformation. Control Z integrates medically guided psychedelic sessions with cutting-edge biotherapeutics, physical training, health diagnostics, nutrition, breathwork, and mindfulness in a licensed medical facility setting. For more information, visit www.controlzhealth.com. Media Contact:Rose Hill Life Sciencesrosehill@kcsa.comControl Zmedia@controlzhealth.com

Clinical Study

30 Jul 2026

·www.fiercebiotech.com

Chutes & Ladders—Legend CEO departs without successor in place

Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the industry. Please send the good word—or the bad—from your shop to Darren Incorvaia, Zoey Becker, or Will Maddox and it will be featured here at the end of each week. Legend Biotech CEO departs without successor in place Legend Biotech CEO Ying Huang , Ph.D., has left the company suddenly, without a predecessor in place. Huang was elevated from CFO to CEO in 2020 after a Chinese customs investigation was opened on founding CEO Fangliang Zhang , Ph.D. Legend’s board appointed Carvykti President Alan Bash to fill Huang’s shoes until a permanent successor can be named. Bash joined the company in 2024 and has been managing the Johnson & Johnson-partnered multiple myeloma CAR-T therapy, which is the lead drug in Legend’s portfolio. Legend’s SEC filing said that Huang’s resignation “was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices or the Company’s financial statements or internal controls over financial reporting.” Huang will remain as an advisor through August to support the transition. Story Sarepta snags Severino as new CEO Sarepta Therapeutics Michael Severino , M.D., is the successor to Sarepta Therapeutics CEO Doug Ingram, effective this past Tuesday, July 28th. Severino hails most immediately from Flagship Pioneering’s Tessera Therapeutics, where he served as CEO for the past four years. At Tessera, Severino helped to advance its first in vivo gene-editing therapy, TSRA-196, now being co-developed and commercialized with Regeneron, into the clinic. Prior to Tessera, he served as vice chairman and president at North Chicago-based AbbVie. Here he helped steer R&D efforts for numerous drugs including Rinvoq, Skyrizi, and Venclexta. Under his leadership, AbbVie built leading franchises in hematologic oncology, immunology, and neuroscience. “It is a privilege to join Sarepta, the leader in precision genetic medicine for rare diseases, and a company driven by an extraordinary purpose: bringing innovative therapies, hope and possibility to patients and families facing serious and life-threatening diseases,” Severino said. He also held leadership roles at both Merck and Amgen, where he logged a total of more than 15 years, before his tenure at AbbVie. Story . Nasus sniffs out new CEO in former Teva exec Israel-based Nasus Pharma is swapping out its CEO Dan Teleman with an experienced exec who previously worked in leadership roles at another major Israeli pharma. Succeeding Teleman, Brendan O’Grady joins Nasus as CEO following a stint as the chief executive at Assertio Holdings, which was bought out by Zydus Pharma earlier this year. Before that, O’Grady spent 21 years at Teva Pharmaceuticals in roles of increasing responsibility, culminating as president and CEO of Teva’s U.S. business. At Nasus, the executive is expected to bring “strategic vision, extensive experience in payors and reimbursement, and proven commercial leadership,” board chair Udi Gilboa explained. O’Grady will be tasked with leading Nasus’ next phase of growth and stirring up the maximum commercial potential of its Nasax intranasal technology platform and lead candidate NS002, an epinephrine treatment for type 1 allergic reactions. The asset could address a “significant unmet need” and make for a “growing $2 billion market opportunity,” O’Grady commented. Release > Amgen vet Debra Jeske Zack , M.D., Ph.D., is bringing her 25 years of experience in drug development for immune-mediated diseases to Spero Therapeutics as its new chief medical officer. Release > 37 years after joining Ionis Pharmaceuticals as a founding scientist, chief scientific officer Frank Bennett , Ph.D., is set to hang up the gloves in February 2027, with research head Eric Swayze , Ph.D., taking on his responsibilities. Release > Spruce Biosciences is branching out with the appointment of experienced executive Adrian Quartel , M.D., as its new chief medical officer. Release > In vivo CAR T-cell company Liberate Bio appointed BMS and Regeneron alum Steven Bernstein , M.D., as new CMO to help bring their leading in vivo CAR-T program to the clinic. Release . > Machine learning and AI-focused Recursion welcomed 15-year Microsoft veteran Hoifung Poon , Ph.D., as first Chief AI Officer. Linkedin . > Boston-based psychedelic therapeutics company Rose Hill tapped former Takeda and Deciphera regulatory strategy expert Jama Pitman as new CEO to advance their psilocybin drug pipeline. Release . > Ashlins Pharmaceuticals has named Andres Gutierrez , Ph.D., as its new chief medical officer. He brings more than two decades of experience in oncology, including senior roles at Ayala Pharmaceuticals, Oncolytics Biotech, Bristol Myers Squibb and more. LinkedIn > Terence Rooney , M.D., has been appointed chief medical officer of Kymera Therapeutics, a clinical-stage immunology biotech. He succeeds Jared Gollob , M.D., who will retire after eight years and remain as an advisor through the end of the year. Release > Secretome Therapeutics has named Teji Singh , M.D., as chief medical officer and transitioned Marshelle Smith , M.D., to the role of chief development officer. Singh most recently led clinical development at Sarepta Therapeutics. Release > Linda Shapiro Manning , M.D., Ph.D., has been named the new chief medical officer of Ambrosia Biosciences. She brings more than 30 years of leadership experience in obesity and cardiometabolic disease at Novo Nordisk, Boehringer Ingelheim and Rhythm Pharmaceuticals. Release

Executive Change

100 Deals associated with Psilocybin

External Link

KEGG	Wiki	ATC	Drug Bank
-	Psilocybin	-	DB11664

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Depressive Disorder, Treatment-Resistant	Australia	Optimi Health Corp.	01 Sep 2025

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Stress Disorders, Post-Traumatic	Phase 3	-	Compass Pathways Plc	01 Sep 2026
Depressive Disorder, Major	Phase 3	United States	Usona Institute	13 Mar 2024
Peripheral Nervous System Diseases	Phase 2	United States	The University of Texas MD Anderson Cancer Center	04 Nov 2026
Parkinson Disease	Phase 2	United States	Yale University	01 Jul 2026
Low Back Pain	Phase 2	United States	Yale University	01 Jun 2026
Gambling	Phase 2	France	Nantes University Hospital	01 Apr 2026
Stuttering	Phase 2	United States	NYU Langone Health	15 Jan 2026
Breast Cancer	Phase 2	Australia	Psyence Australia Pty Ltd.	01 Oct 2025
Endometrial Carcinoma	Phase 2	Australia	Psyence Australia Pty Ltd.	01 Oct 2025
Kidney Neoplasms	Phase 2	Australia	Psyence Australia Pty Ltd.	01 Oct 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05523401 (Pubmed \| Neuropsychopharmacology)	Phase 1	-	24	2C-B 10mg	vkmvsgywjf(osznpetute) = Only psilocybin induced 'bad drug effects' and 'anxiety' compared with placebo dvpyalagwl (pvwoabocpv ) View more	Positive	01 Jul 2026
NCT05523401 (Pubmed \| Neuropsychopharmacology)	Phase 1	-	24	MDMA 125mg		Positive	01 Jul 2026
NCT03289949 (NeuroPharm2, Pubmed \| J Psychopharmacol)	Phase 1	Cluster Headache	11	Psilocybin (Chronic Cluster Headache)	xawtfnzjqo(hsbfjranac) = zkysuwbnwp fxgubzoohy (lnnetchsdi )	Positive	29 May 2026
NCT06835699 (Open Label Psilocybin Brain Stimulation and Imaging Pilot Study, Pubmed \| Psychopharmacology (Berl))	Phase 1	Syncope, Vasovagal	1	Psilocybin 25 mg	rgblrpscdr(yjbeunaxyl) = aztrzwsuxo gwxuetlfla (pyydgnekjo )	Positive	28 May 2026
NCT05227612 (CTgov)	Phase 1	Depressive Disorder, Major	16	psilocybin	vmucwbyqps(xajmvugsfv) = btskulyejs kxfqwhnofe (vlluydqhpq, 2.2) View more	-	19 May 2026
NCT02037126 (CTgov)	Phase 2	Cocaine-Related Disorders	40	Psilocybin (Psilocybin Administration)	rbgakrwfjb(deekbftrzf) = iottushtyy ngpextulio (hemnmzqgjm, 1.01) View more	-	18 May 2026
NCT02037126 (CTgov)	Phase 2	Cocaine-Related Disorders	40	Diphenhydramine (Diphenhydramine Administration)	rbgakrwfjb(deekbftrzf) = etzpfynuzm ngpextulio (hemnmzqgjm, 5.25) View more	-	18 May 2026
NCT03300947 (Pubmed \| J Psychopharmacol)	Phase 1	Obsessive-Compulsive Disorder	15	High-dose psilocybin	qmxwfwmpcq(chueuvzrfu) = yyxptfqtmo isqwwnppgn (wqxtesqtzb ) View more	Positive	01 May 2026
NCT03866174 (CTgov)	Phase 2	Depressive Disorder, Major	347	Set and Setting (SaS) Protocol+Psilocybin (Psilocybin)	xxotlpomxr(sihrmcalif) = fievlvgudp pvmrovqtzs (nljrfaccpk, 1.8) View more	-	22 Apr 2026
NCT03866174 (CTgov)	Phase 2	Depressive Disorder, Major	347	Set+Niacin (Niacin)	xxotlpomxr(sihrmcalif) = itlsylcwxj pvmrovqtzs (nljrfaccpk, 1.9) View more	-	22 Apr 2026
NCT05259943 (Pubmed \| BJPsych Open)	Phase 2	Depressive Disorder, Major	40	Microdosing psilocybin	phloilivvq(mtdzpkvlsh) = pgevqffdvt egjrvkjygd (tiikmpotfz ) View more	Positive	01 Mar 2026
NCT04950608 (PATH, CTgov)	Phase 2	Advanced cancer	15	Psilocybin	ayhoyqkfeq = wawpplaghh qauxriqacn (rppgllciqu, mongqdnaje - jkwdmhcvcr) View more	-	02 Sep 2025
NCT04424225 (CTgov)	Phase 1	Psychedelic \| Perceptual Disorders \| Visual Suppression	10	Psilocybin (Psilocybin)	dwaxahmhze(ylzveuodqn) = dxfanhqajg izmjlvnjnp (nfosdtguzg, .11731) View more	-	27 Jun 2025
NCT04424225 (CTgov)	Phase 1	Psychedelic \| Perceptual Disorders \| Visual Suppression	10	Niacin (Niacin)	dwaxahmhze(ylzveuodqn) = ceeamwvqzu izmjlvnjnp (nfosdtguzg, .04398) View more	-	27 Jun 2025

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