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Last update 03 Nov 2026

Dimethyltryptamine

Last update 03 Nov 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

2-(3-indolyl)ethyldimethylamine, 3-(2-dimethylaminoethyl)indole, 3-[2-(dimethylamino) ethyl] indole

+ [11]

Target

5-HT receptor

Action

modulators

Mechanism

5-HT receptor modulators(Serotonin (5-HT) receptor modulators), Neurons modulators

Therapeutic Areas

Other DiseasesNervous System DiseasesCardiovascular Diseases

Active Indication

Depressive Disorder, MajorDepressive Disorder, Treatment-ResistantAlcohol Use Disorder+ [5]

Inactive Indication

Cognition

Originator Organization-

Active Organization

Entheon Biomedical Corp.

Yale UniversityAtai Therapeutics, Inc.

+ [10]

Inactive Organization

Cybin UK Ltd.

University of Basel

License Organization

Eli Lilly & Co.

Grey Matters Health, Inc.Atai Beckley, Inc.

+ [1]

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States)

Structure/Sequence

Molecular FormulaC12H16N2

InChIKeyDMULVCHRPCFFGV-UHFFFAOYSA-N

CAS Registry61-50-7

Clinical Trials associated with Dimethyltryptamine

NCT07893912

/ Enrolling by invitationEarly Phase 1IIT

Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study

Open-label trial with healthy adults

Start Date01 Oct 2026

Sponsor / Collaborator

University of Sao Paulo

NCT07693257

/ Not yet recruitingPhase 1IIT

Neural Effects of Continuous Intravenous Infusion of N,N-dimethyltryptamine (DMT)

This study examines how the psychedelic substance DMT affects the human brain when administered by the intravenous (IV) route. DMT is a naturally occurring chemical in the body that is thought to help improve mood when ingested in a continuously monitored medical setting. Previous research has shown that a single IV injection of DMT can be given safely, but its effects, which include changes in perception, emotions, and thinking, usually wear off within 15-20 minutes.
To better understand what happens when DMT's effects last longer, researchers have developed a method to give DMT slowly and continuously through an IV, which safely extends its effects for up to an hour or more. In this study, healthy volunteers who have prior experience using DMT will receive low and medium doses of DMT in this extended manner through an IV for 1 hour while undergoing a brain scanning technique known as functional magnetic resonance imaging (fMRI). These scans allow researchers to see changes in brain activity and blood flow in real time.
Participants will complete psychological assessments before and after receiving DMT, and additional brain scans without DMT will be used for comparison. The researchers will also use advanced computer techniques to help identify brain patterns linked to the visual experiences people report during DMT.
Overall, the goal of the study is to better understand how DMT affects the brain during an extended experience and to learn more about the biological processes behind its psychological effects.

Start Date01 Sep 2026

Sponsor / Collaborator

University of California San Diego

CTIS2025-521605-40-00

/ RecruitingPhase 1IIT

Research into the effects of the drug DMT in healthy volunteers

Start Date21 Aug 2026

Sponsor / Collaborator

Centre for Human Drug Research

100 Clinical Results associated with Dimethyltryptamine

100 Translational Medicine associated with Dimethyltryptamine

100 Patents (Medical) associated with Dimethyltryptamine

2,922

Literatures (Medical) associated with Dimethyltryptamine

01 Mar 2027·Value in Health Regional Issues

Cost-Effectiveness of Universal Newborn Screening and Disease-Modifying Therapies for Spinal Muscular Atrophy in Taiwan

Article

Author: Hsieh, Hui-Min ; Chen, Huey-Fen ; Prosser, Lisa A ; Jong, Yuh-Jyh ; Chiang, Wan-Ling ; Chen, Chung-Yu

OBJECTIVES:

Spinal muscular atrophy (SMA) is a rare neuromuscular disorder and an important genetic cause of infant mortality. Universal newborn screening (NBS) enables presymptomatic disease-modifying therapy (DMT) but increases upfront costs. This study evaluated the cost-effectiveness of universal SMA NBS in Taiwan.

METHODS:

This study built a state-transition simulation model for a hypothetical SMA birth cohort using local epidemiology and costs and published clinical inputs. Strategies were as follows: (1) NBS with presymptomatic DMTs and (2) clinical identification (CI) with symptomatic DMTs. DMTs included nusinersen, onasemnogene abeparvovec, and risdiplam (reimbursed by Taiwan's National Health Insurance). Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were estimated over 10-year and lifetime (90-year) horizons from Taiwan's payer and societal perspectives. The willingness-to-pay (WTP) threshold was 3 times Taiwan's 2022 GDP per capita (New Taiwan Dollar (NTD) 2 917 650/QALY). One-way, probabilistic sensitivity, and scenario analyses assessed uncertainty.

RESULTS:

All ICERs were below WTP threshold. From the payer perspective, ICERs for NBS with presymptomatic DMT versus CI with symptomatic DMT were NTD 1 157 970 (USD 38 599) /QALY (10 years) and NTD 2 108 499 (USD 70 283)/QALY (lifetime). From the societal perspective, ICERs were NTD 261 789 (USD 8726)/QALY (10 years) and NTD 1 494 002 (USD 49 800)/QALY (lifetime). Results were most sensitive to DMT costs (particularly nusinersen and risdiplam) and health-state utility values.

CONCLUSIONS:

Universal SMA NBS with presymptomatic DMT is likely cost-effective in Taiwan from both payer and societal perspectives under the WTP threshold, supporting earlier treatment to slow progression and improve quality of life.

01 Jan 2027·WASTE MANAGEMENT

Assessing the environmental benefits of textile waste valorization via methanolysis

Article

Author: Ajalogun, Abdulganiyu O ; Del Carmen Munguía-López, Aurora

The increase in textile production and disposal has contributed to the accumulation of textile waste in the environment. Identifying sustainable methods to valorize PET textile waste can help reduce the environmental impacts associated with this waste stream. Methanolysis is a chemical recycling method that enables the depolymerization of PET textiles into their constituent monomers, dimethyl terephthalate (DMT) and ethylene glycol (EG), which can then be used to produce PET again or for other applications. Assessing the environmental benefits of methanolysis over fossil-based production of these monomers is essential for deploying this technology. In this work, we propose a computational framework that integrates process modeling and life cycle assessment (LCA) to evaluate the benefits of producing PET monomers via methanolysis over their production from fossil sources. We analyze two methanolysis process variants (subcritical and vapor phase), considering a mass allocation scenario and a combined mass scenario, evaluating the climate change, energy or resource use, and water use metrics. Our results reveal that the subcritical and vapor phase processes can provide environmental benefits over the fossil-based production of DMT and EG, but the benefits vary depending on the scenario and the metric evaluated. Overall, both process variants can achieve lower or similar impacts to the fossil-based alternative when the combined mass scenario is considered. Our analysis also provides insights into which components of the methanolysis processes drive the total impacts.

01 Jan 2027·PSYCHIATRY RESEARCH

Adverse reactions to psychedelics in naturalistic settings are associated with current psychopathology and well-being: A correlational study

Article

Author: Borkel, Lucas F ; Henríquez-Hernández, Luis Alberto ; Quintana-Hernández, Domingo J ; Santana Del Pino, Ángelo ; Rojas-Hernández, Jaime

This study examines acute and delayed adverse reactions reported in naturalistic psychedelic use, focusing on their associations with substance-use patterns, contextual variables, and user motivations. Using an online survey incorporating the Psychedelic Use Scale, data were collected from a large naturalistic sample (N = 1022) to analyze patterns of self-reported adverse reactions. Acute adverse reactions were consistently associated with similar delayed adverse reactions, suggesting continuity between immediate and subsequent self-reported adverse experiences. Furthermore, most acute adverse reactions, with the exception of vomiting, which showed an opposite pattern, were associated with higher current psychopathology and lower well-being. Self-reported lifetime use of individual psychedelics (e.g., DMT, MDMA, and LSD) and combined substances (e.g., alcohol, caffeine, and cannabis) showed participant-level associations with specific self-reported adverse-reaction categories, while MDMA use was also associated with poorer current psychological indicators. Adverse reactions were also associated with contextual variables, including setting, type of companionship, and user motivations. Younger age and higher current frequency of psychedelic consumption were associated with higher odds of reporting adverse reactions. Because the study is cross-sectional and retrospective, and adverse reactions were not linked to specific substances or psychedelic episodes, the findings should be interpreted as correlational, hypothesis-generating co-reporting patterns rather than as substance-specific attribution. Nevertheless, they provide an empirical basis for future prospective, longitudinal, and clinical studies aimed at clarifying temporal relationships and informing harm reduction strategies.

359

News (Medical) associated with Dimethyltryptamine

21 Oct 2026

·www.globenewswire.com

Psyence BioMed Completes PsyLabs Investment as Ibogaine Milestones Are Met

Ibogaine regulatory readiness pack completed and U.S. cGMP manufacturing agreement concluded with DEA-registered Benuvia in Texas; investment supports PsyLabs’ intended supply of pharmaceutical-grade ibogaine for the planned U.S. development programNEW YORK, Oct. 21, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced that both milestones attached to its backstop subscription commitment in Psyence Labs Ltd. (“PsyLabs”) have been achieved and that the Company, through its wholly-owned subsidiary Psyence Biomed II Corp., has completed its additional investment in PsyLabs of US$2,599,896. The milestones include the completion of an ibogaine regulatory readiness documentation package and the execution of a U.S. current Good Manufacturing Practice (“cGMP”) manufacturing agreement with Benuvia Operations, LLC (“Benuvia”), representing important progress in advancing the Company’s planned U.S. pharmaceutical-grade ibogaine development program. As previously announced on September 23, 2026, Psyence BioMed agreed to invest up to US$5 million in PsyLabs, comprising an irrevocable commitment of US$2.4 million (936 PsyLabs ordinary shares at US$2,564 per share) under its pro rata pre-emption entitlement in PsyLabs’ current financing round and a backstop commitment of up to US$2.6 million to subscribe for shares in that financing round not taken up by other PsyLabs shareholders, payable in up to two tranches of up to US$1.3 million each upon the achievement of specified milestones. The backstop tranches were required to be called and completed by December 31, 2026. Key Development Milestones Achieved Regulatory Readiness Documentation PsyLabs has completed its ibogaine regulatory readiness pack, a documentation package intended to support future regulatory interactions relating to pharmaceutical-grade ibogaine hydrochloride (HCl). The completion of this documentation represents an important preparatory step in supporting the regulatory development activities contemplated under the Company’s U.S. ibogaine program. U.S. cGMP Manufacturing Agreement A manufacturing services agreement has been entered into with Benuvia by Texas Ibogaine Research Corporation (“TIRC”), the Company’s wholly-owned Texas subsidiary. Benuvia operates a controlled-substance manufacturing facility in Round Rock, Texas registered with the U.S. Drug Enforcement Administration (“DEA”). As previously announced on October 5, 2026, the agreement is intended to support the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient (“API”) under cGMP standards, subject to applicable regulatory requirements. The agreement establishes a U.S. manufacturing relationship intended to support future nonclinical and clinical development activities. Advancing a Coordinated U.S. Ibogaine Development Strategy In structuring the planned U.S. manufacturing program, the Company and PsyLabs agreed that the Benuvia agreement would be entered into by TIRC rather than by PsyLabs. TIRC was established to carry out the manufacturing, nonclinical and regulatory development work required before any human clinical trial could be proposed in the United States, and, as a U.S. developer, may be positioned to pursue domestic funding and grant opportunities that may be available for that work. This structure is intended to allow PsyLabs to remain focused on cultivating, extracting and supplying pharmaceutical-grade ibogaine HCl. Under the binding term sheet between TIRC and PsyLabs announced on September 28, 2026, PsyLabs is expected to serve as TIRC’s exclusive ibogaine supplier for the United States, subject to the conclusion of a definitive agreement, which the parties have agreed to conclude on or before November 30, 2026. Additional Investment in PsyLabs Completed Following certification by the PsyLabs board of directors that both development milestones had been achieved, PsyLabs called both backstop tranches ahead of the December 31, 2026, deadline. Psyence Biomed II Corp. subscribed for 1,014 ordinary shares of PsyLabs at US$2,564 per share, reflecting the US$54 million pre-money equity valuation set for the financing round, for aggregate subscription proceeds of US$2,599,896. Immediately prior to the investment, the Company held approximately 41.13% of PsyLabs’ issued and outstanding shares. Following completion of the investment, and after giving effect to the previously announced share exchange which closed October 1, 2026, the Company holds approximately 43.37% of PsyLabs’ issued and outstanding shares. The investment was funded from the Company’s existing cash resources. Management Commentary “Achieving both milestones well ahead of the December 31 deadline is a clear signal that the ibogaine program is moving from planning into execution,” said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed and TIRC. “PsyLabs now has the regulatory documentation and additional capital to support the supply of pharmaceutical-grade ibogaine, and TIRC has a U.S. cGMP manufacturing partner in place to support the development work we are planning. Each company is doing what it is best equipped to do, which we believe is the right structure for building long-term value for our shareholders.” Related-Party Transaction PsyLabs is a related party of the Company and a significant shareholder of Psyence BioMed. The investment, including the backstop commitment, was reviewed and approved by a special committee of the Company’s independent directors and by its audit committee, in accordance with the Company’s related-party transaction policies and applicable Nasdaq requirements. ABOUT PSYENCE BIOMED Psyence Biomedical Ltd. (Nasdaq: PBM) is a Nasdaq-listed company with its wholly-owned subsidiary, Texas Ibogaine Research Corporation, headquartered in Texas. It is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in neuroplastogen-based therapeutics and the manufacture of pharmaceutical-grade drug candidates. It is the first life sciences biotechnology company focused on developing nature-derived, non-synthetic psilocybin and ibogaine-based neuroplastogen medicine to be listed on Nasdaq. The Company is dedicated to addressing unmet mental health needs and is committed to an evidence-based approach to developing safe, effective and FDA-approved nature-derived neuroplastogen treatments across a range of mental health disorders. ABOUT PSYLABS PsyLabs is a neuroplastogen active pharmaceutical ingredient development company, federally licensed in its operating jurisdiction to cultivate, extract and export psilocybin mushrooms and other neuroplastogen compounds, including psilocybin, psilocin, mescaline, ibogaine and dimethyltryptamine, to lawful medical and research markets. PsyLabs operates from an ISO 22000 and GMP-compliant facility, with a focus on natural compound purification, regulatory support and global distribution. www.psylabs.life CONTACTS Psyence Biomedical Ltd. ir@psyencebiomed.com media@psyencebiomed.com info@psyencebiomed.com · +1 416-477-1708 Investor contact: Michael Kydd, Investor Relations Advisor — michael@psyencebiomed.com FORWARD-LOOKING STATEMENTS This communication contains “forward-looking statements” within the meaning of applicable securities laws, including the U.S. Private Securities Litigation Reform Act of 1995. These include statements regarding the investment by Psyence BioMed in PsyLabs, including the achievement and certification of the related milestones and the anticipated effects of the investment; the application of the proceeds of that investment; the resulting shareholding of Psyence BioMed in PsyLabs; the completion and effects of the previously announced share exchange; the manufacturing services agreement between TIRC and Benuvia, including the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient and the timing, scale and cost of such manufacture; the capitalization, funding and intended role of TIRC, including its ability to access U.S. funding and grant opportunities; the expected conclusion of a definitive license and supply agreement between TIRC and PsyLabs, including PsyLabs’ expected role as TIRC’s exclusive ibogaine supplier; the Company’s ability to secure pharmaceutical-grade drug substance and the regulatory documentation required to support a United States program; the evaluation, funding, design, timing and conduct of any clinical trial in Texas; the Company’s ability to obtain and maintain required registrations, permits, quotas and licenses; its ability to participate in federal or state ibogaine programs; and its expected role in future research, development and commercialization activities relating to ibogaine. Forward-looking statements may be identified by words such as “will,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates” and similar expressions. These statements are based on assumptions regarding government policy, continued interest in regulated neuroplastogen research, the availability of lawful development pathways, and the Company’s ability to maintain licenses, permits, supply arrangements and third-party relationships, as well as assumptions that PsyLabs will apply the investment proceeds as intended and maintain its licenses, permits and facility standards; that Benuvia will perform its obligations under the manufacturing services agreement; that required DEA and other regulatory authorizations will be obtained on a timely basis; and that the Company will have access to sufficient financing to fund TIRC’s development activities. These assumptions may prove incorrect. Risks and uncertainties that could cause actual results to differ materially include: that the anticipated benefits of the investment in PsyLabs are not realized, or that PsyLabs does not apply the investment proceeds as intended; that the regulatory readiness documentation completed by PsyLabs does not support, or is not accepted by regulatory authorities in connection with, any future regulatory submission; that required board, shareholder, regulatory or stock exchange approvals are not obtained; that the previously announced share exchange is not completed, or is completed on terms that differ from those announced; that the cash investment and the other arrangements with PsyLabs are transactions between related parties, and that the terms agreed may differ from those that would be agreed between unrelated parties; that the valuation used to price the cash investment is not indicative of realizable value, and that the Company’s interest in PsyLabs, a privately held company, is illiquid; the reduction in the Company’s cash resources resulting from the investment; that a definitive agreement between TIRC and PsyLabs is not concluded by November 30, 2026, or at all, or is concluded on terms that differ from the term sheet; the Company’s dependence on PsyLabs, a related party, as exclusive supplier of ibogaine, and the risk of any interruption or failure in that supply; that DEA import permits, quotas, registrations or other regulatory approvals are delayed, limited or refused; that the Benuvia arrangements are terminated, not performed or do not proceed as intended; reliance on a single manufacturing partner and manufacturing, analytical or supply-chain failures; the capital commitments, regulatory obligations and contractual liabilities assumed by TIRC under the manufacturing services agreement and the Company’s ability to fund them; that U.S. funding or grant opportunities are not available to TIRC or are not obtained; changes in law, regulation or enforcement priorities in the United States, Southern Africa or elsewhere; the continuing status of ibogaine as a controlled substance; clinical, regulatory and approval risk; competition and market adoption risk; financing risk; and the Company’s ability to maintain compliance with Nasdaq continued listing standards. This list is not exhaustive. These risks should be considered together with the risk factors described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2026 and in the Company’s other filings with the U.S. Securities and Exchange Commission. 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. Readers should not place undue reliance on forward-looking statements, which speak only as of the date made. Except as required by law, the Company undertakes no obligation to update such statements. The Company makes no medical, treatment or health benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada and other regulatory authorities have not approved ibogaine or the Company’s other neuroplastogen compounds for therapeutic use, and their safety and efficacy have not been established through authorized clinical research. Rigorous scientific research and clinical trials are required. Any references to ibogaine stock, inventory or doses are the Company’s best estimates only. References to GMP-compliant or cGMP mean production in a facility designed, operated and controlled in accordance with applicable Good Manufacturing Practice standards, and do not themselves constitute a representation of formal certification or approval by any regulatory authority unless expressly stated. Information regarding Benuvia and its facility is based on information provided by Benuvia and has not been independently verified by the Company. References to a planned clinical trial describe an activity under evaluation only; no trial has been commenced, and no regulatory application in respect of it has been filed or accepted. This communication is not an offer to sell or a solicitation of an offer to buy any securities.

License out/in

07 Oct 2026

·www.fiercepharma.com

Scaling psychedelics comes with uncertainty ‘baked into the sauce’

Two years ago, the psychedelic bubble was all but bursting. Lykos’ long-awaited FDA evaluation had just flopped. Regulators picked apart the study design behind the company’s phase 3 trials of an MDMA-assisted therapy for post-traumatic stress disorder, ultimately rejecting the application amid concerns about efficacy and safety. But that one failure triggered a multitude of strategic shifts across the industry that, combined with extremely favorable policy changes, have helped ring in a banner year for the field in 2026. Over just five months, the Trump administration directed the FDA to prioritize certain psychedelic drugs through an executive order and the agency finalized clear guidance for clinical trial design, a historic stumbling block for psychedelic developers. Compass Pathways’ COMP360 was put under rolling review with the FDA, with the potential for approval by year’s end. And Eli Lilly made a multibillion-dollar buy into the industry with the purchase of psychedelic drug developer AtaiBeckley. If the FDA’s Sept. 14 public hearing on the future of psychedelics is any indication, the possibility of psychedelic therapies for PTSD or treatment-resistant depression in the U.S. has never been greater. But even as the industry inches closer to an FDA go-ahead, the pathway to commercialization remains riddled with unknowns. From regulatory guidelines and credentialing to manufacturing and delivery, the realities of approved psychedelic medicine are far from decided. And the onus is on the drugmakers furthest down the pipeline to lead the way. Even with an FDA approval in the bag, regulatory pressures on psychedelic treatments will continue to be steep. Foremost, psychedelics—or at least the approved variety—must be rescheduled by the DEA. Currently, all psychedelics are Schedule 1, a category the DEA uses for substances that have a high potential for abuse, no medicinal value and lack safety even under medical supervision. No approved drug can go to market while its still Schedule 1, and the transition process could take months to years if a psychedelic approval comes through. The federal process for scheduling a newly FDA-approved drug is expedited under current law, though the timing would depend on when the DEA receives the necessary FDA and HHS recommendations. It’s also unclear exactly how the DEA would schedule an approved psychedelic product and its active ingredient. Johnson & Johnson’s Spravato, which contains the S-enantiomer of ketamine, was placed in Schedule III when it was approved in 2019. Ketamine was already a Schedule III controlled substance. While ketamine and esketamine are not true psychedelics, they’re dissociative anesthetics that cause patients to dissociate rather than hallucinate, and their regulatory trajectory may provide some framework for how formerly illicit substances can be repurposed into medicine. Dane Stevens, CEO at Optimi Health, a psychedelic manufacturer and distributor in Canada, is hoping U.S. psychedelic treatments score a similar Schedule III designation or Schedule IV classification, which carries a lower potential for abuse than Schedule III. In either case, that rescheduling process “could take a while,” Emma Wille, senior analyst at Norstella’s Citeline, a consultancy that helps pharma developers identify unmet needs, told Fierce in an interview. Though the current administration’s favor could accelerate that process, as it has with the FDA. From there, the rules that shape the nascent psychedelic industry will likely be product-specific, taking shape around whichever candidate makes it through the FDA first, said Benjamin Yudkoff, M.D., a psychiatrist and co-founder of Lumin, a Boston-based ketamine and Spravato clinic that also plans to offer psychedelic treatment if it becomes available. Many peg U.K.-based Compass Pathways as the regulatory frontrunner. The drugmaker’s lead asset, a synthetic formulation of psilocybin called COMP360, has shown significant success against treatment-resistant depression and is the first classic psychedelic to report phase 3 efficacy data. Per Compass’s two phase 3 trials, a single dose of 25 mg of COMP360 significantly reduced symptom severity for patients whose depression was otherwise treatment-resistant. And two doses of COMP360 given three weeks apart produced a clinically meaningful reduction in depression severity in 39% of patients, with those patients continuing to experience the benefit 26 weeks after treatment. That data is currently under FDA review as part of Compass’ rolling new drug application. The drugmaker is expected to finalize its NDA in the fourth quarter of 2026, with a possible approval and launch in the first half of 2027. If Compass does snag the first psychedelic approval, it will go on to shape the industry’s “hard logistics,” like square footage requirements, a risk evaluation and mitigation strategy, how clinics enroll patients, and how treatment is ultimately scheduled and billed, Yudkoff said. Compass, or whichever company leads the way, will likely even shape the language. “Do we call it a trip?” he asked, “or do we talk about outcomes?” For its part, Compass Pathways has already partnered with five training organizations that will build curriculum to train healthcare providers to deliver COMP360 in the event of an approval. “They’re sort of building from the clinic up,” Wille said. Every obstacle they’re able to smooth is a win for the products behind them. The race toward psychedelic approval and commercialization really is a “group project,” for which Compass shoulders a lot of the burden, she said. Approving psychedelic drugs themselves isn’t the only regulatory battle. Perhaps the biggest concern expressed by speakers at the FDA’s recent public hearing revolved around who would administer the new medicines and how the psychedelic workforce will be trained and regulated, should the drugs eventually pass muster with U.S. regulators. By nature, psychedelic treatments are labor-intensive. Treatment sessions for the drugs furthest down the pipeline last anywhere from five to eight hours. However the FDA ultimately establishes staffing requirements during treatment sessions will have huge implications for cost and accessibility. In Australia, where authorized psychiatrists can prescribe psilocybin for treatment-resistant depression and MDMA for PTSD under a special access framework, regulators require a treatment team of at least two members. The two medicines cost between 200 and 500 Australian dollars ($140 to $350) per dose, Stevens at Optimi, which manufactures the medications used in Australia, said. But the labor involved, including the cost of a facility and two monitoring providers, ramps up the cost to between 10,000 and 15,000 Australian dollars ($7,000 to $10,000) per visit, he said. “But a lot of that is being reimbursed by insurance now,” Stevens told Fierce. In an effort to minimize staffing hurdles, drug developers like Compass Pathways and Definium have moved away from the traditional combination of psychedelics and talk therapy. Instead, their study designs rely on dosing session monitors or other forms of psychological support, licensed healthcare professionals who monitor the session for safety but don’t provide therapy. This was a point of controversy at the FDA hearing, where several speakers condemned the psychedelic industry’s departure from talk therapy, calling it a crucial part of patient progress. On the other hand, Wille said, including talk therapy as part of the treatment gets complicated, because “the FDA doesn’t regulate psychotherapy and no one really wants them to.” There’s also much debate about what qualifies someone to deliver psychedelic treatment. Some stakeholders at the hearing pushed for a psychedelic medicine workforce overseen exclusively by psychiatrists. Others, many of whom come from the cottage industry that has assembled around psychedelic training, say a range of nurses and practitioners are sufficient, but the FDA needs to standardize training requirements and affirm a credentialing body. Several at the hearing said the FDA needs to draw lines in the sand and clarify specific roles for individual team members: nursing staff, prescribers and therapists. Staff requirements will likely prove to be a balancing act between broad access and maximum patient safety. And what the agency decides will have direct effects on how psychedelic drugs scale post-launch. If these drugs are even half as effective as the data suggest, then access is the mandate, Yudkoff said. A “training program needs to keep in mind that it can only be so burdensome. And the threshold to entry needs to be low enough to make these medications accessible,” he said. Once a psychedelic medicine is approved, rescheduled and equipped with guidelines, the next challenge will be delivering it at scale, a process some experts think will take the better part of a decade. Optimi’s Stevens said staffing and supply shortages are to be expected as the field scales. In Australia, prescribing was initially limited because there were too few credentialed psychedelic medicine providers and staff. He expects a similar bottleneck in the U.S. if an approval comes. And corresponding slowdowns on the supply side are also in the offing. Optimi is equipped to supply hundreds of thousands of patients, he said. But as long as these compounds remain Schedule I, manufacturers are unlikely to invest in the infrastructure needed to scale production early on. There’s no clear home for these treatments either. From Yudkoff’s perspective, psychedelic treatments will fit the mission of many Spravato providers, but there’s little practical overlap. An eight-hour COMP360 treatment, for instance, “won’t just slot into the esketamine clinics,” where typical appointments are just two hours, Wille said. Facilities will need dedicated rooms and staff for the longer trips. The more labor and space needed, the more prohibitive the costs could be for both practitioners and patients. The lengthy intervention followed by three to six months of recovery is more like a “surgical model than anything done in traditional psychiatry,” Yudkoff said. For that reason, he believes flexibility will be the key for any early psychedelic delivery sites. One exception, Wille and Yudkoff agree, could be AtaiBeckley’s BPL-003 and VLS-01, two DMT candidates acquired by Eli Lilly as part of its purchase of the company. Both candidates are being tested in treatment resistant depression, and unlike many of the other psychedelic candidates, DMT is a fast-acting. BPL-003 is delivered intranasally while VLS-01 dissolves under the tongue, and both are designed to fit within a roughly two-hour in-clinic treatment window. The delivery approach could square nicely with existing infrastructure and have real commercial advantages. Still, potential commercialization is a ways out for either asset as Lilly awaits phase 3 and phase 2b results for BPL-003 and VLS-01, respectively. The real-world value of psychedelic treatments may come down to durability, or how much relief patients get out of one of these expensive and intensive treatments. If the benefits last so that patients only need two to four visits each year, the model may prove financially sustainable. Still, insurance coverage will be critical. In Oregon, where psilocybin clinics are cash-pay, the cost of a single session runs between $1,000 and $3,000. The clientele inevitably skews wealthy and white. And still, the network of psilocybin clinics that sprang up after the Oregon Psilocybin Services Act passed in 2020 is contracting under financial pressure. Roughly one-third of psilocybin service centers have closed their doors or surrendered their licenses since the program’s inception amid high operational costs. The statewide program is funded in part through hefty fees, with service centers generally paying $10,000 annually for a license. This summer, the Oregon Health Authority introduced a proposal that could have significantly increased licensing fees, but the agency abandoned the proposed increases in September. While the Oregon program may offer some proof of concept, it’s also concrete evidence that access and infrastructure for future psychedelic treatments will hinge on payers’ involvement. If drugmakers can show that their psychedelic compounds benefit a significant population, “then usually [they] have significant evidence to get it paid for,” said Kyle Sampson, an attorney at King & Spalding who specializes in clients with FDA-regulated products. Coverage would likely follow, but limits should be expected, too. These treatments will be “very expensive” for payers, Yudkoff said, noting that pharma middlemen will almost certainly take a restrictive approach as they look to maximize value and minimize overtreatment. “How rollout looks on day one will be different than how rollout looks at year 2, and it will be very different from how rollout looks at year 10,” Yudkoff said. “And tolerating that uncertainty is baked into the sauce.”

Phase 3AcquisitionPhase 2Clinical Result

05 Oct 2026

·www.biospace.com

Psyence BioMed Partners with DEA-Registered Benuvia Operations to Establish U.S. Manufacture of Pharmaceutical-Grade Ibogaine

Partnership intended to establish a Texas-based manufacturing pathway for pharmaceutical-grade ibogaine as TIRC advances its planned U.S. development program HIGHLIGHTS Texas Ibogaine Research Corporation (“TIRC”), the wholly-owned Texas subsidiary of Psyence BioMed, enters manufacturing partnership with Benuvia Operations, LLC for the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient (“API”) Benuvia operates an 83,000-square-foot, DEA-registered controlled-substance manufacturing facility in Round Rock, Texas, with capabilities spanning development through commercial-scale production Partnership is intended to connect TIRC’s planned exclusive U.S. access to PsyLabs’ pharmaceutical-grade ibogaine under TIRC’s previously announced binding term sheet with PsyLabs, with U.S.-based controlled-substance manufacturing capabilities The partnership represents another step in Psyence BioMed’s strategy to build an integrated U.S. supply, manufacturing and regulatory development platform for ibogaine through TIRC NEW YORK, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced that its wholly-owned Texas subsidiary, Texas Ibogaine Research Corporation (“TIRC”), has entered into a manufacturing services agreement with Benuvia Operations, LLC (“Benuvia”) of Round Rock, Texas, establishing a manufacturing partnership for the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient (“API”) under current Good Manufacturing Practice (“cGMP”) standards. The manufacturing partnership builds upon TIRC’s previously announced binding term sheet with Psyence Labs Ltd. (“PsyLabs”), a significant shareholder of Psyence BioMed and in which Psyence BioMed holds an ownership interest, for an exclusive U.S. license, supply and wholesale distribution arrangement covering PsyLabs’ pharmaceutical-grade ibogaine. The term sheet is to be superseded by a definitive agreement, which the parties have agreed to conclude on or before November 30, 2026. PsyLabs’ material is supported by a regulatory-readiness package that includes GMP-compliant production, an Investigator’s Brochure and certificates of analysis. Benuvia operates an approximately 83,000-square-foot pharmaceutical manufacturing facility in Round Rock, Texas, registered with the U.S. Drug Enforcement Administration (“DEA”), with capabilities spanning controlled-substance API development and manufacturing, analytical development, stability programs and regulatory support. According to Benuvia, it currently holds approximately half of the U.S. aggregate production quota for ibogaine, providing an established foundation for potential domestic production. Applications for the import permit and procurement quota required for the planned production are being advanced with the DEA by Benuvia. Because Benuvia’s commercial-scale manufacturing infrastructure is already in place, the Company believes that the timing and scale of any U.S. ibogaine production will be governed primarily by applicable DEA quotas, controlled-substance import requirements and other regulatory authorizations. “Benuvia brings a DEA-registered U.S. facility with the quota, systems and track record required to manufacture controlled substances to pharmaceutical standards,” said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed and TIRC. “Combined with our planned licensed supply, we believe this has the potential to create an end-to-end pathway from pharmaceutical-grade source material through U.S.-based manufacturing.” “Benuvia brings more than 10 years of experience in the development and commercial manufacturing of DEA Schedule I–V controlled substances to rigorous pharmaceutical standards,” said Terry Novak, Chief Executive Officer of Benuvia. “Our Round Rock facility was purpose-built for controlled-substance manufacturing and provides the infrastructure, regulatory capabilities, and commercial-scale capacity required for complex programs like ibogaine. While ibogaine has been discussed for decades, pharmaceutical-grade manufacturing capacity in the United States has remained extremely limited. Through our partnership with TIRC and Psyence BioMed, we believe we have an opportunity to change that — manufacturing ibogaine in America, to exacting specifications and at the scale this program will require if and as DEA quota expands. We have the experience, the facility, and the team in place. We are ready to begin.” “For a regulated ibogaine development program, manufacturing is inseparable from the regulatory strategy,” said Dr. John Thorne, Project Lead, TIRC. “Establishing a U.S.-based manufacturing pathway is intended to strengthen chain-of-custody controls, batch consistency and the chemistry, manufacturing and controls work required to support future regulatory submissions. We believe Benuvia’s capabilities give us an experienced U.S. manufacturing platform on which to build that work.” Psyence BioMed views this manufacturing partnership as more than a manufacturing milestone; it is part of a broader effort to advance the clinical and regulatory work required to develop potential ibogaine-based therapies for patients facing significant unmet needs, including opioid use disorder, other substance use disorders and mental health conditions affecting veterans. The Company believes that the combination of pharmaceutical-grade supply at source and Texas-based cGMP manufacturing would position TIRC to support regulated research and clinical programs if and when applicable quotas are expanded. If compliant U.S. production capacity is established, the Company believes it would be better positioned to support the research and clinical development programs that could ultimately underpin future regulatory approvals and patient access. ABOUT PSYENCE BIOMED Psyence Biomedical Ltd. (Nasdaq: PBM) is a Nasdaq-listed company with its wholly-owned subsidiary, Texas Ibogaine Research Corporation, headquartered in Texas. It is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in neuroplastogen-based therapeutics and the manufacture of pharmaceutical-grade drug candidates. It is the first life sciences biotechnology company focused on developing nature-derived, non-synthetic psilocybin and ibogaine-based neuroplastogen medicine to be listed on Nasdaq. The Company is dedicated to addressing unmet mental health needs and is committed to an evidence-based approach to developing safe, effective and FDA-approved nature-derived neuroplastogen treatments across a range of mental health disorders. ABOUT PSYLABS PsyLabs is a neuroplastogen active pharmaceutical ingredient development company, federally licensed in its operating jurisdiction to cultivate, extract and export psilocybin mushrooms and other neuroplastogen compounds, including psilocybin, psilocin, mescaline, ibogaine and dimethyltryptamine, to lawful medical and research markets. PsyLabs operates from an ISO 22000 and GMP-compliant facility, with a focus on natural compound purification, regulatory support and global distribution. CONTACTS Psyence Biomedical Ltd. · ir@psyencebiomed.com · media@psyencebiomed.com · info@psyencebiomed.com · +1 416-477-1708 Investor contact: Michael Kydd, Investor Relations Advisor — michael@psyencebiomed.com FORWARD-LOOKING STATEMENTS This communication contains “forward-looking statements” within the meaning of applicable securities laws, including the U.S. Private Securities Litigation Reform Act of 1995. These include statements regarding the manufacturing partnership with Benuvia and its intended scope, benefits and timing; the planned U.S. manufacture of pharmaceutical-grade ibogaine API; the timing and outcome of import permit, procurement quota and other DEA applications and authorizations; the ability to manufacture material to specification and on schedule; the potential for future increases in DEA quotas; the conclusion of a definitive agreement with PsyLabs in accordance with the previously announced binding term sheet and the rights to be granted to TIRC under it; the Company’s strategy to build an integrated U.S. supply, manufacturing and regulatory development platform for ibogaine through TIRC; the planned U.S. development program and any future clinical, regulatory or commercial activities; and the Company’s ability to support regulated research and clinical programs. Forward-looking statements may be identified by words such as “will,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates” and similar expressions. These statements are based on assumptions regarding government policy, continued interest in regulated neuroplastogen research, the availability of lawful development pathways, and the Company’s ability to maintain licenses, permits, supply arrangements and third-party relationships. These assumptions may prove incorrect. Risks and uncertainties that could cause actual results to differ materially include that import permit, quota, registration or other regulatory approvals are delayed, limited or refused; that the arrangements with Benuvia are terminated, are not performed or do not proceed as intended; reliance on a single manufacturing partner and the consequences of any interruption; manufacturing, analytical or supply-chain failures; that a definitive agreement with PsyLabs is not concluded by November 30, 2026, or at all, or is concluded on terms that differ from the term sheet; dependence on PsyLabs, a related party, as exclusive licensor and supplier; changes in law, regulation or enforcement priorities in the United States or elsewhere; the continuing status of ibogaine as a controlled substance; clinical, regulatory and approval risks; financing risk; and the Company’s ability to maintain compliance with Nasdaq continued listing standards. This list is not exhaustive. These risks should be considered together with the risk factors described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2026 and in the Company’s other filings with the U.S. Securities and Exchange Commission. 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. Readers should not place undue reliance on forward-looking statements, which speak only as of the date made. Except as required by law, the Company undertakes no obligation to update such statements. The Company makes no medical, treatment or health benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada and other regulatory authorities have not approved ibogaine or the Company’s other neuroplastogen compounds for therapeutic use, and their safety and efficacy have not been established through authorized clinical research. Rigorous scientific research and clinical trials are required. Information in this communication regarding Benuvia, including its facility, capabilities, DEA registration and quota allocations, has been provided by Benuvia and has not been independently verified by the Company. Any references to ibogaine stock, inventory or doses are the Company’s best estimates only. References to GMP-compliant mean production in a facility designed, operated and controlled in accordance with applicable Good Manufacturing Practice standards, and do not themselves constitute a representation of formal certification or approval by any regulatory authority unless expressly stated. References to a planned clinical trial describe an activity under evaluation only; no trial has been commenced, and no regulatory application in respect of it has been filed or accepted. This communication is not an offer to sell or a solicitation of an offer to buy any securities.

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KEGG	Wiki	ATC	Drug Bank
D13141	Dimethyltryptamine	-	DB01488

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Treatment-Resistant	Phase 2	Brazil	Hanalytics Pte Ltd.	09 Mar 2022
Depressive Disorder, Major	Phase 2	United Kingdom	-	04 Feb 2021
Alcohol Use Disorder	Phase 1	United States	Yale University	04 Aug 2025
Stroke	Phase 1	Netherlands	Grey Matters Health, Inc.	13 Jan 2023
Depressive Disorder	Phase 1	-	ATAI Life Sciences AG	05 Oct 2022
Smoking Cessation	Phase 1	Netherlands	Entheon Biomedical Corp.	22 Feb 2022
Cognition	Phase 1	Switzerland	University of Basel	01 Dec 2020
Brain Injuries, Traumatic	Phase 1	Canada	Algernon NeuroScience	-
Brain Injuries, Traumatic	Phase 1	-	Grey Matters Health, Inc.	-
Alcoholism	Preclinical	Israel	Entheon Biomedical Corp.	01 Mar 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECTRIMS2026	Not Applicable	-	39,168	High-efficacy treatments (HET)	kfptnjeoqf(zgsdsdergs) = rckwbjmxog yvehxcnnkw (fbsokaxeas ) View more	Negative	23 Sep 2026
				Intravenous (IV) therapies	kfptnjeoqf(zgsdsdergs) = orvjllqazc yvehxcnnkw (fbsokaxeas ) View more
ECTRIMS2026	Not Applicable	Multiple Sclerosis	7,220	Continued DMT	gkjimtebsm(vhxjaqdzat) = fzaksgfsfn gxxwvajcdi (wpkdpvizur, 12.8 - 15.3) View more	Positive	23 Sep 2026
				Discontinued DMT	gkjimtebsm(vhxjaqdzat) = zopxyxgoki gxxwvajcdi (wpkdpvizur, 6.8 - 17.5) View more
ECTRIMS2025	Not Applicable	-	563	DMT (Discontinuation group)	wxxednazsx(ddqdqntlcz): HR = 0.99 (95.0% CI, 0.56 - 1.72), P-Value = >0.9 View more	Positive	24 Sep 2025
				DMT (Continuation group)
NCT06094907 (Pubmed \| Neuropsychopharmacology)	Phase 2	Depressive Disorder, Treatment-Resistant	14	Vaporized N,N-Dimethyltryptamine 15 mg	pxbwosdeid(ywkagmevrq) = vmzryyemge heorravvqm (hryxtqrhhe ) View more	Positive	01 May 2025
				Vaporized N,N-Dimethyltryptamine 60 mg	pxbwosdeid(ywkagmevrq) = tqjsolfzwz heorravvqm (hryxtqrhhe ) View more
NCT02914769 (CTgov)	Phase 1/2	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	35	placebo (Placebo)	ieokurysjm(zqcntelrwh) = ogrjdrvhdu udjsbmlibg (tkettyxpys, 7.36) View more	-	06 Apr 2025
				Ayahuasca (Ayahuasca)	ieokurysjm(zqcntelrwh) = ijnjbiekzq udjsbmlibg (tkettyxpys, 7.39) View more
NCT06094907 (Pubmed)	Phase 2	Depressive Disorder, Treatment-Resistant	6	Vaporized DMT 15 mg	ppqcynnchi(wxaqgqxiut) = ioisijpnlh wrxkflkhyw (vwgsxgbhxd )	Positive	01 Mar 2025
				Vaporized DMT 60 mg	ppqcynnchi(wxaqgqxiut) = czyjnmcjtm wrxkflkhyw (vwgsxgbhxd )
ACTRIMS2024	Not Applicable	Multiple Sclerosis	15	High or very high efficacy DMT	nllgrxwlbp(wkccbfxyrl) = lfcyjwwjif ffqywuwggp (gejqjqnakr ) View more	Positive	29 Feb 2024
NCT04673383 (Not provided, Pubmed \| Front Psychiatry)	Phase 1	-	-	SPL026 (DMT fumarate)	afzqqrupzq(wiwrrbgqki) = SPL026 was well tolerated, with an acceptable safety profile, with no serious adverse events otuwhikobr (zuqjxqhgwh )	-	11 Jan 2024
NCT05553691 (Corporate Publications) Manual	Phase 1	Depressive Disorder, Major	17	SPL026 (SSRI Cohort)	zwnsmysupo(soimtykcnv) = hsazlpheil pmpeuovsir (czysyqiutg ) View more	Positive	26 Sep 2023
				SPL026 (Non-SSRI Cohort)	zwnsmysupo(soimtykcnv) = hhyvidhaje pmpeuovsir (czysyqiutg ) View more
NCT04673383 (Biospace) Manual	Phase 2	Depressive Disorder, Major	34	SPL026 21.5mg + supportive therapy	xncgsgtvyz(qnyeijsjht) = ciqjgahjse rzzoaedcvl (psffdyjocu ) Met View more	Positive	25 Jan 2023
				Placebo + supportive therapy	jlvcwfywkc(dklwpaousd) = gnjxhmqtgg ueeebcofet (vycfjdfeab )

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