An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics and Safety of GH001 Administered Via a GH001 Aerosol Delivery System in Healthy Subjects

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration.

Start Date01 Apr 2026

Sponsor / Collaborator

GH Research Plc

NCT07444788

/ RecruitingPhase 1IIT

Acute Subjective Effects, Physiological Effects, and Pharmacokinetics of Intravenous 5-MeO-DMT Infusions in a Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Participants

Participation in this study lasts approximately two weeks and includes three on-site study visits: a screening visit (approximately 2 hours), a study drug administration visit (approximately 4 hours), and a follow-up visit approximately one week later (approximately 2 hours).
If participants decide to take part in the study and meet the inclusion and exclusion criteria, they will be randomly assigned to one of two groups: an experimental group or a control group. Participants will not be informed of your group assignment. Participants in the experimental group will receive the investigational substance 5-MeO-DMT at a dose of 0.2, 0.4, 0.6, or 0.8 mg/min for a total infusion duration of 30 min. Participants in the control group will receive a placebo that is indistinguishable in appearance from the investigational substance. Following substance administration, participants will be repeatedly asked to describe their subjective experiences. Blood pressure and heart rate will be monitored regularly, and blood samples will be collected via an intravenous catheter.

Start Date31 Mar 2026

Sponsor / Collaborator-

NCT06810765

/ WithdrawnPhase 2IIT

Trifecta Research Study: Examining Hormone Replacement Therapy, Magnetic e-Resonance Therapy, Ibogaine, and 5-MeO-DMT in the Treatment of Posttraumatic Stress Disorder and Traumatic Brain Injury-related Cognitive Symptoms

The Special Operations Care-Fund (SOC-F) will sponsor the application of four treatments - hormone replacement, magnetic resonance brain stimulation, ibogaine, and 5-Meo-DMT - to Special Operations Forces veterans with a history of combat deployments, traumatic brain injury, and problems with mental health and cognitive functioning. An observational study will be conducted in parallel by the Johns Hopkins Center for Psychedelic and Consciousness Research to determine the effectiveness and safety of each treatment, primarily through measuring post-treatment changes in PTSD symptoms and cognitive functioning.

Start Date01 Sep 2025

Sponsor / Collaborator

The Johns Hopkins University

100 Clinical Results associated with 5-MeO-DMT

100 Translational Medicine associated with 5-MeO-DMT

100 Patents (Medical) associated with 5-MeO-DMT

898

Literatures (Medical) associated with 5-MeO-DMT

01 Jun 2026·NEUROPHARMACOLOGY

Beyond the toad's kiss: Mapping acute 5-MeO-DMT effects on brain connectivity across sex and dose using awake rat neuroimaging

Article

Author: Ortiz, Richard ; Madularu, Dan ; Akins, David ; Ferris, Craig F ; Soltanpour, Sima ; Nasseef, Md Taufiq ; Kulkarni, Praveen P ; Cavallaro, Noah ; Rai, Priya

BACKGROUND:

5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a potent serotonergic psychedelic with rapid therapeutic potential for depression and anxiety disorders. Despite growing clinical interest, the neurobiological mechanisms underlying 5-MeO-DMT's acute brain effects remain poorly understood, and potential sex differences in response have not been investigated. We conducted the first functional MRI study of 5-MeO-DMT in awake, drug-naïve rats using BOLD imaging.

METHODS:

Male (n = 24) and female (n = 24) rats received I.P. injections of vehicle or 5-MeO-DMT (0.01, 0.1, or 1.0 mg/kg) during scanning sessions. BOLD signal changes and resting-state functional connectivity were assessed across 169 brain regions. Negative and positive BOLD volume activations were quantified during acute (1-10 min) and sustained (11-20 min) time windows post-injection, with sex-stratified analyses performed.

RESULTS:

Females demonstrated markedly enhanced sensitivity to low-dose 5-MeO-DMT (0.1 mg/kg), exhibiting extensive negative BOLD responses that were largely absent in males at the same dose. The 1.0 mg/kg dose induced widespread negative BOLD responses across multiple brain regions in both sexes during the acute window (1-10 min post-injection), with effects substantially diminishing thereafter. Global functional connectivity was significantly reduced across all doses (p < 0.0001), with regional specificity observed in hypothalamic and cerebellar networks. Temporal analysis revealed peak neurobiological effects within the first 10 min, consistent with 5-MeO-DMT's known rapid pharmacokinetics.

CONCLUSION:

To our knowledge, this is the first fMRI characterization of 5-MeO-DMT in any species, and it reveals a previously unreported sex difference in psychedelic response. The rapid onset and brief duration of peak effects align with 5-MeO-DMT's unique pharmacological profile and clinical reports.

01 Apr 2026·NEUROSCIENCE

Hallucinogenic Therapy in Alzheimer’s Disease targeting Mitochondria-Associated Membranes

Review

Author: Vargas-Perez, Hector ; Minauro-Sanmiguel, Fernando

Mitochondrial dysfunction is increasingly recognized as a central driver of Alzheimer's disease (AD), contributing to neuroinflammation, synaptic failure, and energy collapse.Emerging preclinical evidence suggests that classic hallucinogens, such as psilocybin, lysergic acid diethylamide (LSD), N,N-dimethyltryptamine (DMT), mescaline, may restore mitochondrial integrity by activating Serotonin 2A (5-HT2A) and sigma-1(Sig-1R) receptors. In experimental models, these pathways are associated with enhanced mitochondrial biogenesis, reduced oxidative stress, and preservation of ER-mitochondrial coupling. DMT and 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) specifically engage Sig-1R at mitochondria-associated membranes, improving calcium homeostasis and cellular resilience. While these mechanisms are mechanistically compelling, evidence for clinical efficacy in AD remains limited and largely preclinical. Accordingly, this framework is presented as a hypothesis-generating model suggesting that mitochondrial-centered psychedelic mechanisms warrant further investigation,provided that neuropsychiatric safety, patient selection, and translational feasibility are carefully addressed.

01 Mar 2026·CNS DRUGS

Safety and Efficacy of Monoamine Oxidase Inhibitors in Patients Who Use Psychoactive Substances: Potential Drug Interactions and Substance Use Disorder Treatment Data

Review

Author: Gillman, Peter Kenneth ; Barnett, Brian S ; Rached, Gaëlle ; Nguyen, Christine ; Van den Eynde, Vincent ; Fiani, Dimitri ; Campana, Anna

Monoamine oxidase inhibitors (MAOIs) remain an important option for patients with treatment-resistant depression (TRD) and other psychiatric conditions, despite potentially serious drug-drug interactions and associated dietary tyramine restrictions. However, they are rarely prescribed in patients with comorbid substance use disorders (SUDs) due to concerns about potential drug interactions and limited research in these populations. This narrative review investigates the use of MAOIs in patients who use psychoactive substances, exploring potential interactions while summarizing the relatively scant literature on using MAOIs as treatments for SUDs. It synthesizes data from 219 peer-reviewed publications investigating MAOI/psychoactive substance interactions or the use of MAOIs to treat SUDs or psychiatric conditions in patients with comorbid SUDs, including 20 randomized controlled trials, 18 non-randomized interventional trials, 32 observational studies/case series, 56 case reports, 85 preclinical studies, and 8 reviews, with publication years spanning from 1955 to 2025. Data from 28 non-peer-reviewed user-submitted reports from drug use/harm reduction forums are also included. Suspected cases of serotonin toxicity have been reported for MAOIs in combination with amphetamine, dextromethorphan, 3,4-methylenedioxymethamphetamine (MDMA), meperidine (pethidine), methadone, and tramadol. Hypertensive urgency/emergency has been reported for MAOIs in combination with alcohol (varieties containing significant amounts of tyramine), amphetamine, cocaine, dextroamphetamine, khat, methamphetamine, and psilocybin mushrooms. Other notable adverse events associated with MAOIs in combination with psychoactive substances include agitation (4-bromo-2,5-dimethoxyphenethylamine [2C-B] 5-methoxy-N,N-dimethyltryptamine [5-Meo-DMT]), N,N-dimethyltryptamine [DMT]), delirium/confusion (DMT, propoxyphene, and tramadol), edema (chlordiazepoxide), intracranial hemorrhage (amphetamine, khat, and methamphetamine), mania/psychosis (DMT), rhabdomyolysis (5-MeO-DMT, DMT, and propoxyphene), and sedation/stupor/loss of consciousness (amobarbital, amphetamine, cocaine, dextroamphetamine, and propoxyphene). Fatalities have been reported for MAOIs in combination with 5-MeO-DMT, amphetamine, dextroamphetamine, dextromethorphan (in overdose), MDMA, methamphetamine, meperidine, and tramadol (in overdose). Based on our findings, some substances, such as alcoholic beverages containing significant tyramine quantities (uncommon today), amphetamines, opioids with significant serotonergic reuptake inhibition, and some hallucinogens such as the empathogen/entactogen MDMA, can pose potentially fatal risks in combination with MAOIs. However, MAOI treatment of patients who use alcoholic beverages low in tyramine, caffeine, cannabis, nicotine, sedatives, some (primarily classic) hallucinogens, and some other substances can likely be appropriately managed with careful monitoring, although psychoactive substance dose and route of administration are important safety considerations. While there was initially hope MAOIs might effectively treat some SUDs, there are no robust human data to support their efficacy in this context. Given growing levels of substance use and an increasing number of novel illicit compounds being produced, more research on MAOI safety in patients with psychiatric conditions and comorbid psychoactive substance use/misuse is essential to determining their appropriateness in this complex patient population.

144

News (Medical) associated with 5-MeO-DMT

20 Apr 2026

·www.globenewswire.com

GH Research Welcomes White House Executive Order to Accelerate Medical Treatments for Serious Mental Illness

DUBLIN, April 20, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today issued a statement welcoming the White House Executive Order, signed on April 18, 2026, to accelerate medical treatments for serious mental illness, including innovative psychedelic medical treatments (the Executive Order). The Executive Order directs coordinated federal action to accelerate the development of, and expand patient access to, innovative therapies for serious mental illness. GH Research continues to advance GH001, its proprietary inhaled mebufotenin product candidate, toward initiation of a global pivotal Phase 3 program in treatment-resistant depression (TRD) in 2026. “We commend the Administration for recognizing the magnitude of the mental health crisis and the urgent need for innovative, evidence-based therapies for patients with serious mental illness. The Executive Order’s emphasis on scientific rigor and cross-agency coordination is well aligned with the approach required to deliver practice-changing treatments, and we remain focused on advancing GH001 toward a global pivotal Phase 3 program,” said Dr. Velichka Valcheva, Chief Executive Officer of GH Research. About GH Research PLC GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC’s initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with TRD. About GH001 Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has the potential to change the way TRD is treated today. Forward-Looking Statements This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding the potential impact of the Executive Order on the regulatory environment and on the development of psychedelic medical treatments, including our mebufotenin product candidates, and our plans and expectations with respect to the initiation, timing, progress and design of our global Phase 3 pivotal program for GH001, are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, the risk that the Executive Order may not be implemented as anticipated, may be modified, delayed, challenged, rescinded or superseded, and may not, in practice, accelerate the development or approval of psychedelic medical treatments, including our mebufotenin product candidates; the risk that we may not be able to initiate or complete our global Phase 3 pivotal program for GH001 on the timelines we are targeting or at all; the risk that we may not obtain FDA alignment on the pivotal program design on favorable terms or at all; and those other risks described in our filings with the U.S. Securities and Exchange Commission from time to time. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Relations Julie RyanGH Research PLCinvestors@ghres.com

20 Apr 2026

·www.pharmaceutical-technology.com

Trump backs psychedelics for mental health in new executive order

Trump’s executive order aims to accelerate the review time for psychedelics, while supporting research into the drug class. Credit: Tasos Katopodis/Stringer via Getty Images. US President Donald Trump has signed an executive order focused on accelerating the route of psychedelics to the market, adding momentum to a field garnering growing pharma and public interest. Through the order, Trump is directing the US Food and Drug Administration’s (FDA) commissioner, Marty Makary, to award expedited regulatory timelines to psychedelics that have already received breakthrough therapy designation or have completed a Phase III trial. This will specifically be managed through the Commissioner’s National Priority Voucher (CNPV) scheme, which has caused a stir within the industry due to the “unclear” nature of how and why vouchers are provided. Trump’s directive also places a key focus on psychedelic research, meaning the FDA will work in tandem with the Department of Health & Human Services (HHS) to boost psychedelic clinical trial participation, while allocating $50m to fund further research into the drug class. Alongside these research and regulatory efforts, the order aims to boost the availability of investigational drugs, namely ibogaine compounds, to eligible patients who haven’t responded to existing treatment options through the Right to Try Act. To enforce this, the FDA will work in tandem with the Drug Enforcement Administration (DEA) to create a suitable access pathway. Plugging gaps in mental health care Trump’s executive order comes as over 14 million adults live with a serious mental illness in the US. Despite the burden of these diseases on the population, conditions like treatment-resistant depression (TRD) and post-traumatic stress disorder remain challenging to treat, with few treatment options available to patients. According to Compass Pathways – developer of COMP360, an investigational psilocybin based therapy for TRD – psychedelic medicines could help bridge the gap, with the company’s CEO, Kabir Nath, noting that the order marks an “important step forward in accelerating access, without compromising science.” Since COMP360’s double Phase III win , Compass is working on a rolling submission with the FDA for the drug in TRD. If US regulators approve COMP360, it could become the first classic psychedelic to secure the regulatory greenlight for any mental health indication. AtaiBeckley is also eyeing the TRD market with its mebufotenin benzoate nasal spray, which is progressing to pivotal trials after triggering a 13.7-point reduction in depression scores from baseline after 12 weeks at the Phase II stage. Dr Hans Eriksson, CMO of HMNC Brain Health, previously told Pharmaceutical Technology’s sister publication, Clinical Trials Arena , that psychedelic medicines show great promise in the realm of psychiatry – potentially offering patients treatment durability not previously observed with traditional therapies on the market. Psychedelic researchers are also touting the potential of these drugs in inflammatory and headache disorders, suggesting their therapeutic reach and market potential could be broad.

14 Apr 2026

·www.globenewswire.com

AtaiBeckley to Participate in Upcoming Needham Healthcare Conferences

Dr. Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley, will participate in the 25th Annual Needham Virtual Healthcare Conference (April 13 - 16) and the Needham Virtual Psychedelics Forum (April 27)NEW YORK, April 14, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced that Dr. Srinivas Rao, Co-Founder and Chief Executive Officer, will participate in a fireside chat at the 25th Annual Needham Virtual Healthcare Conference (April 13 – 16) and a panel discussion at the Needham Virtual Psychedelics Forum (April 27). Topics for the panel will focus on late-stage clinical development strategy, FDA and DEA regulatory considerations, payer economics, and the long-term commercial adoption of psychedelic-based therapies such as BPL-003, AtaiBeckley’s intranasal formulation of mebufotenin benzoate which holds FDA Breakthrough Therapy Designation and is on track to enter Phase 3 studies in Q2 2026 following a successful End-of-Phase 2 meeting with the FDA. Event Details 25th Annual Needham Virtual Healthcare Conference Participation: Fireside chat and one-on-one meetingsFireside chat date and time: Thursday, April 16, 12:45 PM ETWebcast link: https://event.summitcast.com/view/cCMfZsH5ZqrwSNTwfC9JDv/WwXAbe4vkjvTnYCnmiytCm Needham Virtual Psychedelics Forum Participation: Panel and one-on-one meetingsPanel title: Clinical Risk, Regulatory Reality, and the Path to ScalePanel date and time: Monday, April 27, 11:00 AM ETPlease contact your Needham representative for access to the panel presentation Live webcasts of available events will be available on the investor section of the AtaiBeckley website, under Events. The archived webcasts will be available for at least 30 days after the event. About AtaiBeckley Inc.AtaiBeckley is a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 ((R)-MDMA HCI) for social anxiety disorder. BPL-003 is in Phase 3 planning, VLS-01 and EMP-01 are in Phase 2 clinical development. The Company is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create breakthroughs in mental health through transformative interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X. Contact Information:Investors: Jason Awe, PhDVP, Investor RelationsIR@ataibeckley.com Media: Charlotte ChorleyAssociate Director, CommunicationsPR@ataibeckley.com

100 Deals associated with 5-MeO-DMT

External Link

KEGG	Wiki	ATC	Drug Bank
-	5-MeO-DMT	-	DB14010

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild cognitive disorder	Phase 2	Argentina	Biomind Labs, Inc.	15 Dec 2024
Anxiety Disorders	Phase 2	Argentina	Biomind Labs, Inc.	21 Oct 2024
Depressive Disorder	Phase 2	Argentina	Biomind Labs, Inc.	21 Oct 2024
Alcohol Use Disorder	Phase 2	United Kingdom	Beckley Psytech Ltd.	30 May 2023
Bipolar II disorder	Phase 2	Germany	GH Research Plc	06 Apr 2023
Bipolar II disorder	Phase 2	Netherlands	GH Research Plc	06 Apr 2023
Bipolar II disorder	Phase 2	United Kingdom	GH Research Plc	06 Apr 2023
Depressive Disorder, Major	Phase 2	Germany	GH Research Plc	06 Apr 2023
Depressive Disorder, Major	Phase 2	Netherlands	GH Research Plc	06 Apr 2023
Depressive Disorder, Major	Phase 2	United Kingdom	GH Research Plc	06 Apr 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05660642 (Company_Website) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	12	BPL-003 10 mg	uunuvxiaou(lcpkppttrd) = mclngoxrtl qphkjfungj (szdsqsmzyg ) View more	Positive	17 Mar 2026
NCT05870540 (GlobeNewswire) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	-	BPL-003 12 mg（first 0.3 mg）	cagdftzvbe(ldhozmcdxz) = ssxzgcimkh iptdnxtpws (wogkrzljzl )	Positive	10 Nov 2025
NCT05870540 (GlobeNewswire) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	-	BPL-003 12 mg（first 8mg）	cagdftzvbe(ldhozmcdxz) = cnmvutivzd iptdnxtpws (wogkrzljzl ) View more	Positive	10 Nov 2025
NCT05660642 (Company_Website) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	12	BPL-003	utzylofdys(mcakxiwfke) = yipwwhfywu yidtbfgzkn (ubvrjukuvn ) View more	Positive	23 Sep 2025
NCT05753956 (NEWS)	Phase 1	Depressive Disorder	-	GH002	vhgzgokyyx(zybjshcojl) = None xiqnhuslwd (pcaaorzuue ) View more	Positive	07 Aug 2025
NCT05660642 (GlobeNewswire) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	12	BPL-003 + SSRIs	nggugdkfza(ygydzgxofn) = gdarsrmxal sntvmrmtub (qrmlytgric ) View more	Positive	20 May 2025
NCT05800860 (GH001-TRD-201, Company_Website 1 \| Company_Website 2 \| Company_Website 3 \| Company_Website 4) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	81	GH001	kyfhqyzzdt(txwzpfrvvw) = eniigckira dyhjihizzq (zbqsafvsuj ) Met View more	Positive	03 Feb 2025
	Phase 2	Depressive Disorder, Treatment-Resistant	81	Placebo	kyfhqyzzdt(txwzpfrvvw) = cavvvfwxyf dyhjihizzq (zbqsafvsuj ) Met View more	Positive	03 Feb 2025
NCT05839509 (Company_Website) Manual	Phase 2	Bipolar II disorder	6	GH001	piwhjohtcx(drjcjfpjks) = bynwvnhgcu rsvkicichj (nxsmxynrth ) Met View more	Positive	10 Jan 2025
NCT05804708 (Company_Website) Manual	Phase 2	Depression, Postpartum	10	GH001	wncuspbthq(kzzboptmpz) = jvlxqizkev dniiodlqst (btckrtrhec ) Met View more	Positive	10 Jan 2025
NCT05660642 (Corporate Publications) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	11	BPL-003 10mg	atufhvqeep(vhbhslegea) = pzwtxtdppq efwkwxhmba (nogpjybvgn ) View more	Positive	27 Mar 2024
BusinessWire Manual	Phase 2	Alzheimer Disease \| Depressive Disorder \| Anxiety Disorders	40	BMND08 12mg	vyqpspyxbh(nqzjplmfkq) = ovdwepugfu wllezilbtj (vkupwuovup ) View more	Positive	29 Feb 2024
BusinessWire Manual	Phase 2	Alzheimer Disease \| Depressive Disorder \| Anxiety Disorders	40	BMND08 9mg	vyqpspyxbh(nqzjplmfkq) = uqvpqulutl wllezilbtj (vkupwuovup )	Positive	29 Feb 2024

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