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

NCT07562191

/ RecruitingPhase 2IIT

Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial of Inhaled N,N-Dimethyltryptamine (DMT) for Major Depressive Disorder

This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD).
The study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT.
Participants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.

Start Date01 Aug 2026

Sponsor / Collaborator

Universidade Federal do Rio Grande do Norte

[+1]

NCT07317232

/ RecruitingNot ApplicableIIT

Effects of a Single Dose of Ayahuasca or Esketamine on the Menstrual Cycle and Premenstrual Symptoms: a Randomized, Double-Blind Study

Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on premenstrual symptoms.

Start Date20 Dec 2025

Sponsor / Collaborator

University of Sao Paulo

100 Clinical Results associated with Dimethyltryptamine

100 Translational Medicine associated with Dimethyltryptamine

100 Patents (Medical) associated with Dimethyltryptamine

2,799

Literatures (Medical) associated with Dimethyltryptamine

01 Sep 2026·EXPERIMENTAL NEUROLOGY

Therapeutic properties of ayahuasca component N,N-Dimethyltryptamine in a pre-clinical model of Parkinson's disease

Article

Author: Sanz-SanCristobal, Marina ; Calleja-Conde, Javier ; Giné, Elena ; Morales-García, José A ; Bühler, Kora ; López-Moreno, Jose A ; Perez-Castillo, Ana ; Echeverry-Alzate, Víctor ; Alonso-Gil, Sandra

Parkinson's disease is a progressive neurodegenerative disorder with increasing global prevalence, primarily driven by population ageing. A hallmark of the disease is the degeneration of nigrostriatal dopaminergic neurons, accompanied by marked activation of glial cells and a sustained neuroinflammatory response. Current pharmacological treatments are limited to symptomatic relief and do not halt or reverse disease progression. Ayahuasca, a traditional Amazonian psychoactive brew, has attracted growing scientific interest for its potential therapeutic effects in neuropsychiatric and neurodegenerative conditions. Its principal psychoactive compound, N,N-dimethyltryptamine (DMT), acts as an agonist at the 5-HT2A serotonin receptor-responsible for its hallucinogenic properties-and at the sigma-1 receptor, a molecular target implicated in neuroprotection and modulation of inflammation. This study investigates the neuroprotective and anti-inflammatory potential of DMT in a preclinical model of Parkinson's disease. Our findings demonstrate that DMT administration results in molecular changes within the nigrostriatal pathway consistent with reduced neuroinflammation and neuronal preservation. Furthermore, behavioral assessments indicate symptomatic improvements following treatment. These results support the therapeutic potential of DMT as a disease-modifying agent in Parkinson's disease and warrant further investigation.

01 Sep 2026·METABOLIC ENGINEERING

Genome-based optimization of psilocybin and N,N-dimethyltryptamine biosynthetic pathways in E. coli using CRISPR-associated transposases

Article

Author: Sen, Abhishek K ; Sawyer, Lily E ; Jones, J Andrew ; Spezzano, Sean J ; Fried, Niya B ; Cegielski, Evelyn R ; Madsen, Siena M ; Abrahms, Zachary N ; Majdi, Mohammad ; Morton, Chloe J

Stable, high-level biosynthesis of complex natural products requires precise control of heterologous pathway expression, yet transcriptional architectures optimized on plasmids often fail when transferred to the chromosome. Here, we present ePathIntegrate, a genome-centric pathway engineering strategy that leverages CRISPR-associated transposases (CASTs) to integrate and rebalance multigene metabolic pathways in Escherichia coli. Direct genomic transfer of plasmid-optimized psilocybin and N,N-dimethyltryptamine (DMT) pathways resulted in a loss of productivity, driven by context-dependent promoter behavior. To address this, we developed and characterized a library of mutant T7 promoters that restore mid-range transcriptional control on the genome. Applying ePathIntegrate enabled re-optimization of both pathways, yielding genome-encoded strains that achieve 1.88 g/L psilocybin and 1.62 g/L DMT in fed-batch bioreactors. Whole-genome sequencing of CAST-mediated strains further revealed (i) precise on-target integration, (ii) some off-target pathway integrations, and (iii) small mutations in a subset of strains, highlighting both the power and limitations of CAST-mediated strain engineering.

01 Aug 2026·JOURNAL OF NEUROIMMUNOLOGY

Tracking the invisible: Impact of disease-modifying therapies on serum neurofilament light chain and clinical outcomes in treatment-naïve multiple sclerosis

Article

Author: Khedr, Eman M ; Abdelwarith, Ahmed ; El-Deen, Hussein Bahey ; Haridy, Nourelhoda A

BACKGROUND:

Disease-modifying therapies (DMTs) are widely used to manage multiple sclerosis (MS), but their effects on serum neurofilament light chain (sNfL), particularly in drug-naïve patients, remain underexplored. This study aimed to evaluate the effects of different DMT classes on sNfL level and compare these changes with clinical rating scales in drug-naïve MS patients.

METHODS:

In this prospective study, 85 drug-naïve MS patients completed 18-month follow-up after initiating DMTs (high-, moderate-, or first-line efficacy). Clinical assessments included EDSS, the 9-Hole Peg Test (9-HPT), the 25-Foot Walk Test (25-FWT), the MSIS-29, and the Hamilton Depression and Anxiety Scales. sNfL levels were measured via ELISA before and after treatment.

RESULTS:

Baseline sNfL levels were significantly higher in MS patients than controls (66.36 ± 51.32 versus 10.55 ± 8.19 pg/mL, p < 0.001). High- and moderate-efficacy DMTs significantly reduced sNfL by 42.7% and 39.7%, respectively; first-line DMTs showed no significant reduction. Between-group differences were significant (p = 0.010). High-efficacy DMTs demonstrated the greatest reductions in EDSS (p = 0.001) and ARR (p < 0.001; large effect size), with moderate effects on motor performance. Changes in sNfL correlated with EDSS improvement (r = 0.383, p < 0.001) and 9-HPT (r = 0.258, p = 0.022), but not with psychiatric or quality-of-life measures. Age-adjusted analysis confirmed an independent association between sNfL reduction and EDSS change (p = 0.010).

CONCLUSION:

High- and moderate-efficacy DMTs are associated with significant reductions in sNfL and improvements in clinical parameters in drug-naïve MS. Declines in sNfL parallel improvements in disability and motor function but not in psychiatric outcomes, supporting its role as a reliable biomarker of treatment response and neuroaxonal injury. Larger longitudinal studies are warranted to confirm its long-term prognostic and clinical utility.

350

News (Medical) associated with Dimethyltryptamine

20 Jul 2026

·www.fiercebiotech.com

Lilly buys AtaiBeckley for $2.8B upfront to challenge J&J for psychedelic mental health market

Eli Lilly has struck a deal to buy AtaiBeckley for $2.8 billion upfront, continuing its takeover spree to move into a psychedelic mental health sector targeted by companies including Johnson & Johnson. AtaiBeckley’s lead candidate is BPL-003, a fast-acting intranasal formulation of the psychedelic substance 5-MeO-DMT. The substance, which is found in some plants and animals, stimulates the serotonin system that regulates mood. A phase 2b trial linked BPL-003 to statistically significant improvements in patients with treatment-resistant depression (TRD) starting Day 2. The effects were maintained through Day 57. Lilly has agreed to pay $6.75 per share in cash to buy AtaiBeckley, representing a 40% premium over the biotech’s 30-day volume-weighted average trading price. AtaiBeckley’s share price closed Wednesday at $5.36. AtaiBeckley investors could receive a further $2.50 per share if BPL-003 and another candidate, the DMT buccal film asset VLS-01, hit certain milestones. Lilly has tied $1 per share to the start of phase 3 trials of VLS-01, plus another $1 per share to U.S. regulatory approval and rescheduling of the asset. A further 50 cents per share is tied to the approval and rescheduling of BPL-003. Milestones covered by the contingent value right, which Lilly will give AtaiBeckley shareholders, could add $1 billion to the value of the deal. If the programs achieve the milestones, Lilly will become a rival to J&J for the TRD market. J&J’s Spravato is one of two FDA-approved TRD drugs, the other being a fixed-dose combination of two medicines—olanzapine and fluoxetine hydrochloride—that are available individually as generics. The J&J product, an isomer of ketamine, can elicit dissociative effects and requires patients to be monitored for two hours. Most patients taking BPL-003 in the phase 2b trial were ready for discharge after 90 minutes. The discharge timeline positions BPL-003 to fit into the treatment infrastructure established for Spravato. At an investor day in March, AtaiBeckley CEO Srinivas Rao said the company had “essentially taken the lessons from earlier interventional approaches, including Spravato, and designed treatments that retain or possibly even improve upon efficacy while dramatically reducing complexity.” BMO Capital Markets analysts praised the deal in a note to investors. Writing after Bloomberg reported Lilly was in takeover talks, the analysts said the deal “would provide differentiated exposure in psychiatry and reinforce the company’s broader effort to diversify beyond its cornerstone cardiometabolic franchise.” The analysts also noted increasing regulatory support for psychedelic-based mental health treatments. The content above comes from the network. if any infringement, please contact us to modify.

AcquisitionIPO

20 Jul 2026

·healthcare-digital.com

Eli Lilly’s Psychedelic Treatment-Resistant Depression Play

Eli Lilly has completed a series of major acquisitions across multiple therapeutic areas in 2026. Credit: Eli Lilly. Eli Lilly has agreed to purchase biopharmaceutical company AtaiBeckley, which is developing psychedelic-based therapies for treatment-resistant depression Treatment-resistant depression poses some of neuroscience’s most challenging questions. In a bid to expand its neuroscience pipeline and improve treatment of this largely incurable condition, Eli Lilly is set to acquire AtaiBeckley, marking a significant step in the development of next-generation mental health treatments. The deal, which could be worth up to US$3.8bn, marks Eli Lilly’s first foray into the psychedelic-based drug discovery market. “Treatment-resistant depression persists even after multiple treatments have failed. Millions of people are still searching for relief and desperately need a therapy that works,” says Carole Ho, Executive Vice President at Eli Lilly and President at Lilly Neuroscience. “Advancing AtaiBeckley's investigational therapies gives us a real chance to change that.” Carole Ho, Executive Vice President at Eli Lilly and President at Lilly Neuroscience. Credit: Eli Lilly. A novel approach to depression treatment AtaiBeckley is developing a pipeline of rapid-acting neuroplastogens, spanning multiple clinical-stage programmes alongside a discovery platform focused on next-generation compounds. Its lead candidate, BPL-003 (mebufotenin benzoate), is a synthetic formulation of 5-MeO-DMT delivered intranasally for the treatment of treatment-resistant depression, a condition affecting millions of people in the United States. Emerging evidence suggests that treatment-resistant depression and other severe mental health disorders may be associated with impaired synaptic plasticity, which is the brain's ability to form and strengthen neural connections in regions responsible for mood regulation. AtaiBeckley's therapies are designed to restore synaptic connectivity by promoting the growth of new neural connections, representing a fundamentally different approach from conventional antidepressants, which primarily act by modulating neurotransmitter levels. The company's two lead psychedelic-derived candidates, BPL-003 and VLS-01, are both designed as short-acting therapies that complete the entire treatment session in approximately two hours – a significant reduction compared with many other psychedelic therapies, which can require six to 12 hours. Crucially, BPL-003 has been granted Breakthrough Therapy Designation by the US Food and Drug Administration, with Phase 3 activities now being initiated. Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley. Credit: LinkedIn. "Across our portfolio, we're seeking to demonstrate that psychiatric illness is treatable at its biological root, not just its symptoms," says Srinivas Rao, Co-Founder and CEO of AtaiBeckley. "Lilly's expertise and reach are expected to accelerate that work for people whose conditions have not responded to existing treatments." Growing industry interest in psychedelic therapies Eli Lilly's acquisition of AtaiBeckley marks the latest entry by a major pharmaceutical company into the psychedelic therapeutics space. Much of this investment activity was catalysed in April when US President Donald Trump signed an executive order directing US regulators to expedite reviews of psychedelic treatments and increased funding for this emerging therapeutic field. Johnson & Johnson has already launched a ketamine-derived nasal spray designed to combat treatment-resistant depression called Spravato. Last year, AbbVie purchased an experimental psychedelic depression drug from neuroscience biotechnology firm Gilgamesh Pharmaceuticals for US$1.2bn. Analysts estimate the psychedelics industry could reach US$12bn in revenue by 2034. Eli Lilly’s diversifying pipeline Although Eli Lilly is best known for developing and marketing the weight-loss drug Mounjaro, which is now the world's best-selling medicine, the company has pursued a series of major acquisitions across multiple therapeutic areas in 2026. Alongside its acquisition of AtaiBeckley, Eli Lilly has agreed to a US$7.8bn deal for sleep disorder specialist Centessa and a US$7bn takeover of gene therapy oncology company Kelonia Therapeutics. Company portals AbbVie Eli Lilly Johnson & Johnson Executives Carole Ho Executive Vice President and President, Lilly Neuroscience, Eli Lilly and Company

AcquisitionBreakthrough TherapyPhase 3

20 Jul 2026

·pmlive.com

Lilly to acquire AtaiBeckley in deal worth $2.8bn

Eli Lilly has agreed to aquire AtaiBeckley, a clinical-stage biopharmaceutical company developing innovative therapeutics for mental health conditions, in a deal worth 2.8bn. AtaiBeckley is advancing a pipeline of rapid-acting neuroplastogens, including multiple clinical-stage programmes and a discovery pipeline of next-generation compounds. The lead asset, BPL-003 (mebufotenin benzoate), is a synthetic form of 5-MeO-DMT administered intranasally for treatment-resistant depression, which affects millions of people in the US. Emerging research indicates that treatment-resistant depression and other serious mental health conditions may involve a loss of synaptic plasticity, the brain’s ability to form and strengthen connections in regions critical to mood regulation. AtaiBeckley’s therapies are designed to restore synaptic connectivity and aim to promote the growth of new neural connections, offering a distinct mechanism from conventional antidepressants that primarily target neurotransmitter levels. “Treatment-resistant depression persists even after multiple treatments have failed. Millions of people are still searching for relief and desperately need a therapy that works,” said Carole Ho, executive vice president and president, Lilly Neuroscience. “Advancing AtaiBeckley’s investigational therapies gives us a real chance to change that.” In a phase 2b study, BPL-003 demonstrated rapid and durable reductions in depressive symptoms following an in-clinic visit lasting approximately two hours on average, with beneficial effects persisting for months. BPL-003 has been granted Breakthrough Therapy Designation by the US FDA and has initiated phase 3 activities. VLS-01, the second most advanced programme of the pipeline, is a buccal film formulation of DMT advancing in an ongoing phase 2b study. “Across our portfolio, we’re seeking to demonstrate that psychiatric illness is treatable at its biological root, not just its symptoms,” said Srinivas Rao, co-founder and CEO of AtaiBeckley.

Phase 2Breakthrough TherapyClinical Result

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	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	-	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


NCT06094907 (Pubmed \| Neuropsychopharmacology)	Phase 2	Depressive Disorder, Treatment-Resistant	14	Vaporized N,N-Dimethyltryptamine 15 mg	cytgbnyfaq(frrdltqtxc) = vxwwiusphk jdjzfhzoir (vfyvgtjwcd ) View more	Positive	01 May 2025
				Vaporized N,N-Dimethyltryptamine 60 mg	cytgbnyfaq(frrdltqtxc) = nwnowcmumh jdjzfhzoir (vfyvgtjwcd ) View more
NCT02914769 (CTgov)	Phase 1/2	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	35	placebo (Placebo)	dsmqrahdte(byofmlmzpl) = cgvfmfclfh myewwgrmwl (hfaaejfwjh, 7.36) View more	-	06 Apr 2025
				Ayahuasca (Ayahuasca)	dsmqrahdte(byofmlmzpl) = zysgwageka myewwgrmwl (hfaaejfwjh, 7.39) View more
NCT06094907 (Pubmed)	Phase 2	Depressive Disorder, Treatment-Resistant	6	Vaporized DMT 15 mg	enolcykzfl(zpccgyvjye) = ndbzyqjadw huatbqxqju (fanolxwxif )	Positive	01 Mar 2025
				Vaporized DMT 60 mg	enolcykzfl(zpccgyvjye) = bdfozqzdwv huatbqxqju (fanolxwxif )
ACTRIMS2024	Not Applicable	Multiple Sclerosis	15	High or very high efficacy DMT	ltcjfelesu(uouajjdcvn) = zhebvwtant ggsdgywdzc (cpeqqebxtq ) View more	Positive	29 Feb 2024
NCT04673383 (Not provided, Pubmed \| Front Psychiatry)	Phase 1	-	-	SPL026 (DMT fumarate)	jlbkfhchhz(zjmqkxensx) = SPL026 was well tolerated, with an acceptable safety profile, with no serious adverse events bbzlgbbpoo (qpmurzxjer )	-	11 Jan 2024
NCT05553691 (Corporate Publications) Manual	Phase 1	Depressive Disorder, Major	17	SPL026 (SSRI Cohort)	jkwibnzfct(rhqqyhjvla) = iwlpvjggya nxhnicvzpg (kqkufxndvn ) View more	Positive	26 Sep 2023
				SPL026 (Non-SSRI Cohort)	jkwibnzfct(rhqqyhjvla) = joiiktlpbi nxhnicvzpg (kqkufxndvn ) View more
NCT04673383 (Biospace) Manual	Phase 2	Depressive Disorder, Major	34	SPL026 21.5mg + supportive therapy	jrffxxwxzj(ykbalbluqi) = vvmtloyvga wxmbplrjiy (dfyutfrcfq ) Met View more	Positive	25 Jan 2023
				Placebo + supportive therapy	nwgyiuxyrc(uujmjnafpy) = jigvfnkcxz bxlrhqxqwp (tijuxtlrnt )
NCT05573568 (Biospace) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	30	BMND01	prvfugsrfb(dpoehtphbo) = No volunteer presented serious adverse events to the 11 different doses tested. pjwpklxlrx (umrtokdulk )	Positive	04 Nov 2022

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