A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of Repeated Doses of VLS-01 Buccal Film in Participants With Treatment Resistant Depression

This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term VLS-01-BU treatment in patients with TRD and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.

Start Date31 Dec 2024

Sponsor / Collaborator

Atai Therapeutics, Inc.

NCT06070649 / Not yet recruitingPhase 1IIT

The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)

This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.

Start Date01 Dec 2024

Sponsor / Collaborator

Yale University

[+1]

NCT06671977 / Not yet recruitingPhase 1IIT

Phase 1 Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans

The goal of this phase 1 study is to investigate the safety and efficacy of dimethyltryptamine (DMT) in individuals with depression and healthy controls. We hypothesize that administration of DMT will result in decreases in depression, associated symptoms, and neuroplastic changes in depressed subjects. We expect that DMT will induce changes in neuroplasticity as indexed using electroencephalographic (EEG) measures and tasks in both depressed individuals and healthy volunteers, though to different degrees. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.

Start Date01 Nov 2024

Sponsor / Collaborator

Yale University

100 Clinical Results associated with Dimethyltryptamine

100 Translational Medicine associated with Dimethyltryptamine

100 Patents (Medical) associated with Dimethyltryptamine

2,267

Literatures (Medical) associated with Dimethyltryptamine

01 Jan 2025·TOXICOLOGY IN VITRO

NDMA enhances claudin-1 and -6 expression viaCYP2E1/ROS in AGS cells

Article

Author: Montaño, Luis F. ; Rendón-Huerta, Erika P. ; García-García, Carlos Abraham ; Cruz-Gregorio, Alfredo ; Montaño, Luis F ; Rendón-Huerta, Erika P ; Pedraza-Chaverri, José

Carcinogenic N-nitroso compounds, especially N-nitroso dimethylamine, increase the risk of gastric cancer development. Cytochrome P450-2E1 metabolizes this compound, thus generating an oxidant microenvironment. We aimed to evaluate in gastric adenocarcinoma cells if its effect on CYP2E1 and ROS affects signaling pathways associated with gastric cancer oncogenesis. The impact of N- nitroso dimethylamine upon CYP2E1 and ROS activation/secretion was evaluated by the DCFDA assay protocol, TER measurements, Stat3, pSTAT3, ERK1/2, and pERK1/2 expression, claudins-1 and -6 expression, and finally mRNA values of IL-1β IL-6, IL-8 and TNFα. Our results showed that exposure to N- N-nitroso dimethylamine disrupts the regulation of Stat3 and Erk1/2, alters the expression of claudin-1 and claudin-6 tight junction proteins, and increases the secretion of pro-inflammatory cytokines. These alterations induce a continuous local inflammatory process, an event identified as a gastric cancer promoter. In summary, N-nitroso dimethylamine can disrupt cell mechanisms associated with gastric cancer oncogenesis.

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.

01 Dec 2024·CURRENT OPINION IN PLANT BIOLOGY

New frontiers in the biosynthesis of psychoactive specialized metabolites

Review

Author: Facchini, Peter J ; Li, Ginny

The recent relaxation of psychedelic drug regulations has prompted extensive clinical investigation into their potential use to treat diverse mental health conditions including anxiety, depression, post-traumatic stress, and substance-abuse disorders. Most clinical trials have relied on a small number of known molecules found in nature, such as psilocybin, or long-known synthetic analogs of natural metabolites, including lysergic acid diethylamide (LSD). Elucidation of biosynthetic pathways leading to several psychedelic compounds has established an opportunity to use synthetic biology as a complement to synthetic chemistry for the preparation of novel derivatives with potentially superior pharmacological properties compared with known drugs. Herein we review the metabolic biochemistry of pathways from plants, fungi and animals that yield the medicinally important hallucinogenic specialized metabolites ibogaine, mescaline, psilocybin, lysergic acid, and N,N-dimethyltryptamine (DMT). We also summarize the reconstitution of these pathways in microorganisms and comment on the integration of native and non-native enzymes to prepare novel derivatives.

210

News (Medical) associated with Dimethyltryptamine

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

21 Oct 2024

·www.biospace.com

Massachusetts Proposal to Legalize Plant-Based Psychedelics Ahead of Science: Experts

iStock/ iQoncept As Massachusetts prepares to vote on a measure that would legalize psilocybin and other plant-based psychedelic substances, researchers raise concerns around safety and a lack of epidemiological data. On Nov. 5, Massachusetts could follow Oregon and Colorado in legalizing certain plant-based psychedelic drugs. However, experts urge caution regarding the safety and purity of such substances. The proposed legislation, Massachusetts’ Question 4: The Natural Psychedelic Substances Act , would establish regulated access to natural psychedelic substances “that show therapeutic potential in increasing well-being and life satisfaction and improving mental health” at licensed therapy centers. If voted into law, Massachusetts residents 21 years and older would be able to legally purchase psilocybin (the active ingredient in so-called magic mushrooms), as well as other plant-based psychedelics, including psilocyn, dimethyltryptamine (DMT), mescaline and ibogaine. A yes vote would set Massachusetts on a similar path to Oregon , which voted to legalize psilocybin in 2020, and Colorado , which in 2022 voted to decriminalize psilocybin, psilocyn, DMT, ibogaine and mescaline. “I admire the sentiment,” Doug Drysdale, CEO of Cybin, a psychedelic drug developer, told BioSpace . “It’s indicative of positive sentiment around use of psychedelic medicines to treat mental health. I think it’s maybe indicative of where the public is leaning as well.” Regulatory efforts going through the FDA have yet to be successful, however. In August, the agency rejected Lykos’ MDMA-assisted therapy for post-traumatic stress disorder (PTSD) and requested that the company conduct an additional Phase III trial to glean more information on the safety and efficacy of MDMA—something former CEO Amy Emerson said at the time “would take several years.” While MDMA is not included in Massachusetts’ proposed legislation, Howard Kornfeld, medical director at Recovery Without Walls, told BioSpace the urgent need for these therapies is the impulse behind such state initiatives. “There’s a sense that the mental health crisis that the country is in, the world is in . . . mandates action now,” he said. Certainly, the need is immense. More than 13 million individuals in the U.S. live with PTSD, 40% to 60% of whom never achieve remission, according to Lykos. Meanwhile, an estimated 21 million American adults had at least one major depressive episode in 2021, and at least 30% of people with major depressive disorder have treatment-resistant depression. PTSD and depression are two of the top indications being pursued by developers of psychedelic therapies. Psychedelics Gaining Momentum With scientific evidence pointing to the therapeutic benefits of psychedelics for these conditions and others, momentum around legalizing—or decriminalizing—these substances is growing. “It’s something that is somewhat happening organically in the United States,” Kornfeld said of efforts to decriminalize psilocybin. For example, in 2022, the San Francisco Board of Supervisors unanimously passed a motion to decriminalize entheogenic, or psychoactive, plants like psilocybin and ayahuasca. The motion calls for San Francisco police to give arrests and investigations related to these substances “the lowest priority,” according to CNN . “So, churches have popped up that are essentially selling or distributing psilocybin with instructions how to use it, and the law enforcement is leaving them alone and letting it cultivate in that way,” Kornfeld said. The phenomenon isn’t limited to San Francisco. “I think that’s going on in certain cities in Massachusetts that sort of led to this momentum of putting this question on the ballot.” Implementation Obstacles All of the experts who spoke to BioSpace advised caution about state-led legalization initiatives. Drysdale questioned the value of legalizing psilocybin in Massachusetts. “I understand the kind of impatience and the urgency . . . but the timelines and the complexities and all this effort, I’m not sure it’s really going to help many patients. It may even create challenges.” One of these challenges is the cost of the drugs, Drysdale said. In Oregon, “you’re seeing patients being charged $3,500 cash for a session because there’s no insurance coverage. Who would go to a mushroom dealer in some center and pay [$3,500] when they can go their doctor and get a prescription and be reimbursed . . . for something that is synthetic?” He also likened the proposed legislation to compounding pharmacies of GLP-1 medicines—a group which was recently hit with an FDA warning . “This is kind of the same thing, isn’t it, in that it’s a way to get around FDA regulations and they may not be happy about it,” he said. Drysdale suggested that even if Massachusetts’ proposal does pass on Election Day, there could be challenges with its adoption. In Oregon, “about 70% of the counties opted out of implementation, and now what you’re seeing . . . is one specific strain of mushrooms only being available in certain centers with licensed facilitators.” Kornfeld expressed concern around the inclusion of ibogaine in the Massachusetts proposal. “Ibogaine is not a simple drug for the cardiovascular system,” he said, noting that in Mexico, where ibogaine is legal, most centers have a cardiology team in place to monitor patients. “I was surprised that the developers of Question 4 would have put ibogaine in there. I think people will emphasize that the ibogaine is more problematic, medically, physiologically, than the other substances.” Paul Summergrad, a professor of psychiatry and medicine at Tufts University School of Medicine and a scientific advisor to Lykos and fellow psychedelic drug developer MindMed, raised concerns about safety. “We don’t have great data on the risks and harms associated with this in clinical populations. Frankly, we don’t have great data on the risks and harms in general populations,” Summergrad told BioSpace . Psychedelic use can lead to “challenging experiences,” which can be “quite meaningful” in an appropriate clinical setting, he said. However, “It’s not clear that anyone will have enough training to really do this well.” The Massachusetts proposal “kind of runs ahead of where the science is right now in terms of which of [these compounds] are effective for what considerations,” Summergrad added. Potential Impact on Drug Development Ultimately, Drysdale said, the safest path to widespread access to psychedelic therapies is FDA approval of purified, synthetically designed molecules through large, randomized controlled trials that would then trigger Drug Enforcement Agency (DEA) rescheduling and enable reimbursement. Drysdale stressed the importance of having synthetic psychedelic drugs. “The goal is to create an FDA-approved, validated, repeatable manufacturing process that yields highly pure active ingredients, as opposed to the natural, self-grown, highly variable sources proposed in Question 4 of the ballot,” he said. For Summergrad, clinical data are the key to bringing psychedelics to the market. “I think the right way to do it is . . . in a way that lets us get data that will be at least reasonably reliable,” he said. “I think from a clinical standpoint, number one, we would want to have really well-conducted clinical trials in well-defined populations with the best opportunities to manage some of the challenges around placebo effects and functional unblinding.” Functional unblinding, which occurs when trial participants are aware of whether they’ve been given the drug or a placebo because of the drug’s immediate effect, was a key concern for the advisory committee considering Lykos’ application. As for how state initiatives like Massachusetts’ Question 4 will affect psychedelic drug development, Kornfeld contends it isn’t an either/or proposition. “I think these things are going to be happening simultaneously,” he said. Given how readily available these natural substances are, “I think there is probably room in the world for both pharma development and for loosening of the prohibitions against these drugs,” he added. Drysdale said the two arenas are “very separate and different.” “I don’t think FDA is going to be paying attention to the state level changes when it comes to reviewing drugs currently in development,” he said. “Once we have one or two of these substances approved and reimbursed, these other local processes become kind of pointless.”

Phase 3

26 Sep 2024

·www.businesswire.com

Enveric Biosciences Presents Data Highlighting Development of EB-003 at European Behavioral Pharmacology Society Biennial Workshop

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced that it is presenting research describing the Company’s identification of EB-003 as its lead development candidate based on preclinical data suggesting the compound exhibits promising anxiolytic and anti-depressant properties without inducing hallucinations, a favorable profile compared with other analogs of N,N-Dimethyltryptamine (DMT). The poster is being presented by Peter Facchini, Ph.D. Chief Innovation Officer of Enveric at the European Behavioral Pharmacology Society Biennial Workshop being held in Banff, Alberta, Canada on September 26, 2024. The presentation titled, “Semi-systematic series of DMT analogs for exploring relationships between hallucination, neuroplastigenicity, and positive behavioural outcomes in mice,” describes the methodology used by Enveric to select EB-003 from a series of 3D-designed analogs based on behavioral outcomes in mouse models for anxiety and depression. The presentation highlights key measures of responses in mice including head twitch response (HTR), which is a behavioral proxy in rodents for human hallucinogenic effects, as well as outcomes of marble burying and sucrose preference, widely used models for anxiety and depression, respectively. These findings provide evidence of beneficial neuroplastogenic responses that are non-hallucinogenic in animal models. “The European Behavioral Pharmacology Society’s Biennial Workshop is an important meeting of researchers dedicated to bringing cutting-edge pharmacology-based interventions for substance use and related mental health disorders to the forefront of medicine,” said Dr. Facchini. “I am proud to be presenting our team’s latest findings on EB-003 to the research community, and we look forward to building upon our continued efforts to move EB-003 to clinical trials.” Enveric recently announced preclinical data confirming the oral bioavailability of EB-003 and its ability to produce brain exposure at therapeutically relevant levels. Enveric expects to file an Investigational New Drug (IND) application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment for psychiatric disorders. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com . Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposes,” “ “budgets,” “schedules,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: negotiate and finalize definitive agreements based on any of its out-licensing term sheets and perform pursuant to the terms thereof; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

100 Deals associated with Dimethyltryptamine

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Treatment-Resistant	Phase 2	BR	Hanalytics Pte Ltd.	09 Mar 2022
Depressive Disorder, Major	Phase 2	GB	Cybin UK Ltd.	04 Feb 2021
Stroke	Phase 1	NL	Algernon Pharmaceuticals, Inc.	13 Jan 2023
Depressive Disorder	Phase 1	US	Atai Therapeutics, Inc.	01 Oct 2022
Smoking Cessation	Phase 1	NL	Entheon Biomedical Corp.	22 Feb 2022
Brain Injuries, Traumatic	Phase 1	-	Algernon Pharmaceuticals, Inc.	-
Alcoholism	Preclinical	IL	Entheon Biomedical Corp.	01 Mar 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACTRIMS2024	Not Applicable	Multiple Sclerosis	15	High or very high efficacy DMT	tjjhgcnebm(ewyuiqltut) = vdutdeiczo cjodmipbsf (xmoqtsvjvd ) View more	Positive	29 Feb 2024
NCT05553691 (Corporate Publications) Manual	Phase 1	Depressive Disorder, Major	17	SPL026 (SSRI Cohort)	xtvwhvorfs(dtqoflnpik) = sshcolvpkr eaxyttxaih (ujegjywuhh ) View more	Positive	26 Sep 2023
NCT05553691 (Corporate Publications) Manual	Phase 1	Depressive Disorder, Major	17	SPL026 (Non-SSRI Cohort)	xtvwhvorfs(dtqoflnpik) = rbwmrtuprd eaxyttxaih (ujegjywuhh ) View more	Positive	26 Sep 2023
NCT04673383 (Not provided, Pubmed)	Phase 1	-	-	SPL026 (DMT fumarate)	ymwwsvoaya(zetlweyted) = SPL026 was well tolerated, with an acceptable safety profile, with no serious adverse events getvsqgdld (ewaazkjqty )	-	01 Jan 2023
NCT05573568 (Biospace) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	30	BMND01	lavrchnrnv(yvwgrpwjsb) = No volunteer presented serious adverse events to the 11 different doses tested. crooysaurn (rhrwwxjgzv )	Positive	04 Nov 2022
ECTRIMS2019	Not Applicable	Multiple Sclerosis	256	Patients treated with immunotherapy until gestation	ulunwjqfwy(stlsdpiblf) = ysajvqmuhq hgcyyqctpa (esefnnjvow )	-	10 Sep 2019
ECTRIMS2019	Not Applicable	Multiple Sclerosis	256	Patients who never had a therapy	ulunwjqfwy(stlsdpiblf) = cuqqlwmzbv hgcyyqctpa (esefnnjvow )	-	10 Sep 2019
ECTRIMS2018	Not Applicable	Brain atrophy	520	DMT	vtwopcioju(gkrqeerwwa) = ocmahaanar atltgxrfmy (ongglqbbtg ) View more	-	09 Oct 2018

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis