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-ResistantBipolar II disorder+ [39]

Inactive Indication

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

Originator Organization-

Active Organization

Compass Pathways Plc

Apex Labs Ltd.Startup

MYND Life Sciences, Inc.

+ [30]

Inactive Organization

Beckley Psytech Ltd.Startup

Cybin, Inc.

Drug Highest PhasePhase 3

First Approval Date-

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

Structure/Sequence

Molecular FormulaC12H17N2O4P

InChIKeyQVDSEJDULKLHCG-UHFFFAOYSA-N

CAS Registry520-52-5

243

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

NCT06801041

/ Not yet recruitingPhase 2IIT

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

Start Date01 Jun 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

ACTRN12624000816550

/ Not yet recruitingPhase 2IIT

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 May 2025

Sponsor / Collaborator

University of Otago

100 Clinical Results associated with Psilocybin

100 Translational Medicine associated with Psilocybin

100 Patents (Medical) associated with Psilocybin

2,416

Literatures (Medical) associated with Psilocybin

01 Dec 2025·Current Pain and Headache Reports

Pain and Perception: Exploring Psychedelics as Novel Therapeutic Agents in Chronic Pain Management

Review

Author: Strand, Natalie H ; Gomez, Diego ; Leathem, James ; Viswanath, Omar ; Whitney, Madeline ; Johnson, Brooks ; Attanti, Sumedha ; Maloney, Jillian ; Misra, Lopa ; Dunn, Tyler ; Emami, Eric

PURPOSE OF REVIEW:

Chronic pain affects approximately 1.5 billion people worldwide, representing the leading cause of disability and a significant financial burden on healthcare systems. Conventional treatments, such as opioids and non-steroidal anti-inflammatory drugs, are frequently linked to adverse effects, including dependency and gastrointestinal issues, and often offer limited long-term relief. This review explores the potential of psychedelics, including psilocybin, LSD, and ketamine, as alternative therapeutic agents in chronic pain management.

RECENT FINDINGS:

These substances modulate pain perception through actions on serotonergic and glutamatergic systems and may promote neuroplasticity, offering novel pathways for pain relief. Specifically, the review details the pharmacologic actions of psychedelics, their effects on chronic pain syndromes such as cancer pain, migraines, and neuropathic pain, and their clinical implications. The safety profiles, patient responses, and analgesic properties of these compounds are examined, highlighting the need for further research to validate their efficacy and optimize their therapeutic use in pain management.

01 Dec 2025·Current Pain and Headache Reports

Exploring the Potential of Psychedelics in the Treatment of Headache Disorders: Clinical Considerations and Exploratory Insights

Review

Author: Henderson, Isabella ; Duarte, Robert A ; Vadhan, Nehal P ; Chan, Gabriel ; Elsaadany, Ronnie ; Goodman, Sadie ; Grunstein, Michael ; Duarte, Diana ; Bajaj, Vikram

PURPOSE OF REVIEW:

Exploration of the potential of serotonergic psychedelic drugs, such as psilocybin and LSD, as potential treatments for headache disorders. This review addresses the need for well-informed physician guidelines and discusses mechanisms, safety, and efficacy of these treatments. Further research, including the consideration of combination with psychotherapy, is needed.

RECENT FINDINGS:

Psychedelics demonstrate promising outcomes as treatments for headache disorders. Recent findings indicated that some patients who underwent brief periods of treatment with psychedelics experienced a reduction in headache attack frequency, severity, or duration. When prescription medications are ineffective at treating headache disorders, or are habit-forming, patients often turn to alternative options. There is anecdotal evidence that psychedelic drugs like LSD and psilocybin can effectively treat and prevent pain in patients with headache disorders, such as migraine or cluster headache. It is vital that physicians treating patients who self-treat with psychedelics be well-informed about the mechanisms and their effects to best advise their patients and coordinate their care well. This is a review assessing the literature on the mechanisms, safety, and efficacy of psychedelic drugs as a headache management intervention. We believe there is evidence that may support further investigation into the clinical use of psychedelic medications to treat cluster headache and migraine, including the consideration of use in conjunction with other interventions like cognitive behavioral therapy or acceptance and commitment training.

01 Mar 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Mice lacking the serotonin transporter do not respond to the behavioural effects of psilocybin

Article

Author: Wilson, Carey ; Gattuso, James J ; Hannan, Anthony J ; Renoir, Thibault ; Li, Shanshan

BACKGROUND AND PURPOSE:

Psilocybin is a serotonergic psychedelic with therapeutic potential for several neuropsychiatric disorders, including depression and anxiety disorders. Serotonin transporter (5-HTT) knockout mice (KO) are a well-validated mouse model of anxiety/depression and are relevant to both chronic treatment with serotonin transporter reuptake inhibitors (SSRIs) and polymorphisms in the serotonin transporter-linked polymorphic region (5-HTTLPR) associated with depression/anxiety and resistance to classic antidepressant treatments. However, there is yet to be a study assessing the effect of psilocybin in 5-HTT KO mice.

EXPERIMENTAL APPROACH:

We investigated the effects of a single dose of psilocybin (1 mg/kg) on locomotor activity and the head-twitch response as well as anxiety- and depressive-like behaviour in KO versus wild-type (WT) mice using the light-dark box and Porsolt swim test respectively.

KEY RESULTS:

We found that both the psilocybin-induced head-twitch and hyperlocomotor responses observed in WT mice were completely absent in KO animals. In female WT mice only, psilocybin was also able to block the weight loss observed one day after intraperitoneal injection. While psilocybin did not alter anxiety- and depression-like behaviours for both genotypes, we revealed a genotype-specific trend for a main effect of treatment for WT females (p = 0.054) in the Porsolt swim test. Finally, we found that only female KO mice exhibit anhedonia-like behaviour in the saccharin-preference test.

CONCLUSION AND IMPLICATIONS:

Our findings highlight the complexity of psilocybin's effects and suggest that functional integrity of 5-HTT is essential for psilocybin's acute behavioural effects. This could also have implications for pharmacogenetics, including individuals with polymorphisms or mutations in 5-HTT.

931

News (Medical) associated with Psilocybin

03 Feb 2025

·www.biopharmadive.com

Shares of psychedelics biotech nearly double on depression data

In a little more than a weeks time, a drug developed by a small psychedelics company was able to significantly curb hard-to-treat depression in a mid-stage clinical trial.Thats according to high-level results announced Monday. The trial recruited 81 people with treatment-resistant depression and evaluated them via a widely used, 60-point scale where larger scores mean more severe depressive symptoms. The drug, from Ireland-based GH Research, hit the studys main goal by showing that participants taking it had their scores drop 15.5 points more than those who were given a placebo.GH Research said its drug was well-tolerated. No serious adverse events had been reported as of Jan. 22. All treatment-emergent adverse events were mild or moderate, and investigators found no evidence the drug led to flashbacks, suicidal thoughts or behavior, or changes in heart activity. Almost all participants were discharge-ready within an hour of getting their last doses.Additionally, GH Research called the drug ultra-rapid, providing relief just eight days into treatment. By that time, 58% of patients in the drug arm were in remission, compared with 0% in the placebo group. Among 54 patients who then completed an extension portion of the study in which everyone knowingly got the drug the remission rate was 78% at the six-month mark.A novel treatment with such a large and rapid effect, particularly one that may require only infrequent, short 1-3 hours clinic visits, has the potential to be a practice changing treatment, Michael Thase, a psychiatry professor at University of Pennsylvania and a GH Research scientific adviser, said in a statement from the company.The drug is an inhalable form of mebufotenin, one member in a diverse family of molecules that also includes serotonin, melatonin and a psychedelic chemical found in some mushrooms. GH Research studied it in bipolar II disorder as well, and has a different, injectable version of it that went through a small trial of healthy volunteers.The newly released results look highly compelling and the best-in-class for a psychedelic targeting treatment-resistant depression, according to Paul Matteis, an analyst at the investment bank Stifel. While the experiment was not large, and the lack of any signal in the placebo group could be from patients deciphering what arm they were assigned to, Matteis still thinks the study was well run and had no oddities or red flags.Overall, the data look remarkably consistent and are essentially a best-case scenario for GH Research, he wrote in a note to clients.Shares of GH Research nearly doubled on the news. By late Monday morning they were up 81%, trading at over $19 apiece.Biotechnology investors have viewed psychedelics, much like the broader neuroscience field, as a high-risk, high-reward area of medical research. Theres mounting evidence these drugs can be valuable therapies for common conditions like depression, anxiety and addiction.Last year, psychedelics developers Lykos Therapeutics and Reunion Neuroscience each closed fundraising rounds worth more than $100 million.The hope is that these investments lead to products like Johnson & Johnsons Spravato, a form of ketamine used in treatment-resistant depression as well as certain cases of major depression. Sales from Spravato last year totaled almost $1.1 billion. (Matteis, notably, said his team was struck that GH Researchs drug looks much better than Spravato monotherapy in treatment-resistant depression, where the latter therapy showed a roughly 7-point decline in depressive symptoms after 28 days.)Still, the journey to market remains perilous. Psychedelics trials are exceedingly difficult, in part because the mind-altering effects of these drugs can tip off participants to the therapy theyve received, possibly skewing results.This was a key issue for the Food and Drug Administration when it reviewed a request from Lykos to approve MDMA better known to some as the party drug ecstasy for the treatment of post-traumatic stress disorder.The FDA went on to reject Lykos application, leading the company to lay off about three quarters of its employees. '

Clinical ResultClinical Study

22 Jan 2025

·www.pharmaceutical-technology.com

J&J’s Spravato receives FDA label expansion for depression monotherapy

Major depressive disorder (MDD) is characterised by characterised by depression and inability to feel pleasure. Credit: Justin Paget via Getty Images. Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder (MDD) in adults who do not respond to two oral antidepressants. The US Food and Drug Administration’s (FDA’s) decision makes Spravato the first-ever standalone treatment for adults with treatment-resistant depression. Initially approved in 2019 for use alongside oral antidepressants, this label expansion follows a priority review from the FDA. The approval was based on data from the Phase IV TRD4005 study (NCT04599855), which demonstrated a significant reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) total score within 24 hours after the initial dose, with effects sustained for at least four weeks. Spravato’s safety profile aligns with existing data for oral antidepressants, with no new safety concerns detected. The standard-of-care for MDD typically involves selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) as first-line treatments, often in combination with psychotherapy. However, these therapies can take weeks to exert an effect, and many patients do not respond adequately, leading to a need for innovative alternatives. Spravato targets the brain’s N-methyl-D-aspartate (NMDA) receptor. Unlike traditional MDD therapies that usually take weeks to work, J&J says this drug delivers rapid action. MDD is a severe, chronic mood disorder characterised by depression, inability to feel pleasure, guilt, low energy, and impairments in essential functioning. The global MDD market, valued at $8.8bn in 2019, is expected to grow to $16.2bn in 2029, according to a GlobalData report. GlobalData is the parent company of Pharmaceutical Technology. GlobalData notes that growth will be driven by the rising patient share of newly approved drugs, including J&J’s Spravato. Generating $689m in 2023 – nearly double its 2022 revenue of $374m – the drug’s sales are projected to reach $2.6bn by 2030. Another key contributor to this growth is Axsome Therapeutics’ Auvelity (dextromethorphan and bupropion). The company submitted a new drug application for Auvelity to the FDA for the treatment of MDD, which was accepted under priority review in April 2021. The FDA then approved Auvelity extended-release tablets in August 2022. Axsome’s drug is forecast to generate $1.9bn by 2030. With researchers looking for alternative treatments for mental health conditions, psychedelics have gained investor attention in recent years after demonstrating success in clinical trials. Psilocybin, a psychedelic prodrug compound found in more than 200 species of fungi, is currently in a Phase III programme for treatment-resistant depression with Compass Pathways .

Phase 3Clinical ResultDrug ApprovalPriority ReviewPhase 2

21 Jan 2025

·www.filament.health

Filament Health Announces Shipment Of Botanical Psilocybin To The University of Wisconsin-Madison

UW-Madison, a globally recognized psychiatric research institution, will study Filament’s botanical psilocybin drug candidate, PEX010, in two clinical trials exploring neuroplasticity Vancouver, British Columbia, January 21, 2025 – Filament Health Corp. (OTCQB:FLHLF) (Cboe CA:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced that it has shipped its botanical psilocybin drug candidate, PEX010, to the University of Wisconsin–Madison (UW–Madison) for investigation in two clinical trials. Both trials are United States Food and Drug Administration (FDA)-authorized and will study the effects of psilocybin on neuroplasticity. “Our goal with this research is to examine how psilocybin’s effects on neuroplasticity may impact participants’ wellbeing and their ability to understand the world around them,” said Charles L. Raison, MD, principal investigator of both clinical trials and professor of psychiatry at the University of Wisconsin School of Medicine and Public Health in Madison, Wis. Research has shown that psilocybin can improve neuroplasticity — the brain's ability to reorganize and form new neural connections — which may contribute to psilocybin’s therapeutic effects. At UW–Madison, the first clinical trial studying PEX010, titled The ENHANCE Study, is being funded by the Tiny Blue Dot Foundation. Tiny Blue Dot Foundation is dedicated to advancing scientific research to help individuals understand the concept of Perception Box™, a metaphor, developed by Founder Elizabeth R. Koch which represents the internal beliefs, experiences, and biases that shape how individuals view the world and engage with others. By expanding these boundaries, individuals can reduce suffering, foster greater self-acceptance and empathy for others, and reframe trauma or challenges as opportunities for personal growth. The ENHANCE Study will dose 100 healthy volunteers to examine whether strategies that enhance psychedelic-induced neuroplasticity and increase the long-term salience of the psychedelic experience may also enhance the ability of psychedelics to support long-term enlargement of the Perception Box. The second clinical trial, titled The RECAP2 Study, will examine the proposition that the neuroplastic effects of psychedelics such as psilocybin underlie their long-term effects on wellbeing. This premise will be investigated in a cohort of 60 physically healthy volunteers with slight decline in wellbeing. “The University of Wisconsin–Madison is an internationally recognized leader in psychiatric research,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “We are proud that Dr. Raison and his team have selected Filament’s drug candidate for clinical trials of this calibre and we’re pleased to support their important research.” Both clinical trials at UW–Madison are expected to begin dosing in Q1 2025. PEX010 is authorized for investigation in 41 clinical trials worldwide for 14 mental health indications. ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS) Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates. Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn. MEDIA RELATIONS Anna Cordon Vice President, Marketing & Communications anna@filament.health INVESTOR RELATIONS ir@filament.health FORWARD LOOKING INFORMATION Certain statements and information contained herein may constitute “forward‐looking statements” and “forward‐looking information,” respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements. Forward‐looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including status of patent applications and the ability to secure patents. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐ looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws. ‍

Clinical Study

100 Deals associated with Psilocybin

External Link

KEGG	Wiki	ATC	Drug Bank
-	Psilocybin	-	DB11664

R&D Status

10 top R&D records.

to view more data

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


NCT04433858 (Pubmed \| J Affect Disord)	Phase 2	Depressive Disorder, Treatment-Resistant	15	Psilocybin 25 mg	ntvsaforcp(tutvtlhkez) = deshntituv luxsdyohsb (ygnmlloafx ) View more	Positive	01 Jan 2025
NCT03429075 (Psilodep-RCT, CTgov)	Phase 2	Depressive Disorder, Major	59	Psilocybin + Placebo (Psilocybin)	ftwrnxvrab(bkxekyfxxo) = toqisguvzv hlrslgwxhy (juearjgxhv, jweinxgboe - xthvfvwdqh) View more	-	24 Oct 2024
NCT03429075 (Psilodep-RCT, CTgov)	Phase 2	Depressive Disorder, Major	59	Psilocybin + Escitalopram (Escitalopram)	ftwrnxvrab(bkxekyfxxo) = gwejstraum hlrslgwxhy (juearjgxhv, prvjzztjmf - rgtvpobqjm) View more	-	24 Oct 2024
NCT03429075 (Literature) Manual	Phase 2	Major depressive disorder, moderate (MDD)	59	Psilocybin combined with psychological support	jjiazzlgpi(bnjkujacpw): 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	allucgilfn(qxlhymcnfq) = 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. hwylqgzibh (slyrrxbntt )	Positive	01 Jul 2024
NCT05434156 (GlobeNewswire) Manual	Phase 1/2	Depressive Disorder, Major	-	ELE-101	zvidqabryo(epydcgwxjb) = 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. togairlttz (cjpmtukkoe )	Positive	20 Jun 2024
NCT05312151 (GlobeNewswire) Manual	Phase 2	Stress Disorders, Post-Traumatic	22	COMP360 psilocybin	twhleazthq(atwvspmnrd) = There were no treatment-emergent serious adverse events. bbgjwskqfx (qrbgnfndkf ) Met View more	Positive	08 May 2024
NCT04593563 (Pubmed \| Cancer)	Phase 2	-	-	Psilocybin-assisted therapy	yelpwqqwzc(nugqgsebvr) = e.g., nausea, headache dzhqjdbsvf (bxbfrgpzef )	-	01 Apr 2024
Psi-GAD1 (NEWS) Manual	Phase 2	Generalized anxiety disorder	72	Psilocybin	auxqubcout(tjbdvibqvj) = ohwupvancn pbitxejcgc (uscthvjksx ) Met	Positive	28 Feb 2024
Psi-GAD1 (NEWS) Manual	Phase 2	Generalized anxiety disorder	72	Placebo	auxqubcout(tjbdvibqvj) = qtyznqomiv pbitxejcgc (uscthvjksx ) Met	Positive	28 Feb 2024
GlobeNewswire Manual	Phase 2	Stress Disorders, Post-Traumatic	22	COMP360 25mg	tihskzxkke(vmbrvhwnqd) = COMP360 was well-tolerated and the safety profile was as expected, with no treatment emergent serious adverse events recorded. eobxaeichv (ihirqmkfge )	Positive	19 Dec 2023
NCT04593563 (Literature) Manual	Phase 2	Depressive Disorder, Major Adjuvant	30	Psilocybin	yoglwsbkil(ofjzdvafsq) = hlijyekviu sejszlqwwn (pcikqujbco, 22.3 to -16.0)	Positive	18 Dec 2023

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