This study investigates DDH-LSD, a novel LSD-like compound expected to have a shorter duration of action than LSD. In healthy volunteers, pharmacokinetics, safety, and subjective effects, will be assessed and compare with LSD in a controlled cross-over study.

Start Date06 Mar 2026

Sponsor / Collaborator-

NCT05477459

/ RecruitingPhase 2IIT

Efficacy and Safety of Minidosing Lysergic Acid Diethylamide (LSD) for Chronic Cluster Headache: a Randomized Placebo-controlled Study

This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH).
It is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period.
Primary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH.
Additional objectives:
* To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH.
* To explore the exposure-response relationship of 25μg LSD in cCH.
* To explore cost-effectiveness of treatment with LSD in cCH.
* To evaluate the efficacy of LSD on health-related quality of life.

Start Date16 Apr 2025

Sponsor / Collaborator

Radboud University Medical Center

[+2]

NCT06941844

/ Active, not recruitingPhase 3

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Emerge

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Major Depressive Disorder - Emerge

Start Date14 Apr 2025

Sponsor / Collaborator

Definium Therapeutics US, Inc.

100 Clinical Results associated with Lysergic acid diethylamide

100 Translational Medicine associated with Lysergic acid diethylamide

100 Patents (Medical) associated with Lysergic acid diethylamide

4,996

Literatures (Medical) associated with Lysergic acid diethylamide

01 Jun 2026·ADDICTIVE BEHAVIORS

Lifetime psychedelic use and opioid use disorder severity in a National Survey: the roles of psychedelic type and mental health

Article

Author: Ehmann, Sebastian ; Jones, Grant ; Allen, John J B ; Hager, Nathan M ; Regier, Paul S

BACKGROUND:

Opioid use disorder (OUD) remains a major public health crisis in the United States, with mental health disorders substantially increasing risk severity. Emerging evidence suggests psychedelics may relate to reduced OUD risk. This exploratory study examined associations between lifetime psychedelic use and OUD severity and tested whether these associations varied by mental health impairment.

METHODS:

Structural equation modeling of the cross-sectional 2023 U.S. National Survey on Drug Use and Health with multiple-group moderation (n = 45,133 adults). OUD severity was the primary outcome. Independent variables were two psychedelic factors derived from factor analysis: mescaline/peyote (Psychedelic_F1) and LSD/psilocybin/MDMA/DMT (Psychedelic_F2). Mental health impairment was modeled as a latent construct and used to define high vs. low impairment groups. Covariates included age, sex, and income.

FINDINGS:

Psychedelic_F1 associated with lower OUD severity (β = -0.34, p = 0.001), whereas Psychedelic_F2 associated with higher severity (β = 0.60, p < 0.001). Mental health impairment positively associated with OUD severity (β = 0.21, p < 0.001). Moderation analyses indicated Psychedelic_F1 related to lower OUD severity only in the high mental health impairment group (β = -0.15, p = 0.041), while the positive association for Psychedelic_F2 was attenuated among those with high impairment (β = 0.38, p < 0.001, vs. β = 0.48, p = 0.004).

CONCLUSIONS:

Psychedelic use patterns showed divergent associations with OUD severity. Mescaline/peyote use was linked to lower severity, whereas LSD/psilocybin/MDMA/DMT use was linked to higher severity, with effects differing by mental health impairment. Contextual and motivational factors underlying psychedelic use warrant further investigation.

01 Apr 2026·PSYCHIATRY RESEARCH

Real-world effectiveness and safety of psychedelic-assisted psychotherapy: Outcomes from a large-scale compassionate use cohort in Switzerland

Article

Author: Zullino, D ; Amberger, C ; Seragnoli, F ; Mabilais, C ; Iuga, R ; Penzenstadler, L ; Buchard, A ; Szczesniak, L ; Furtado, L ; Briefer, J-F ; Aboulafia-Brakha, T ; Sabé, M ; Alaux, S ; Thorens, G

BACKGROUND:

Classic serotonergic psychedelics such as LSD and psilocybin show promising antidepressant effects in controlled trials, but real-world data from routine clinical care remain limited.

METHODS:

This study retrospectively analysed routine data from adults with treatment-resistant depressive and/or anxiety disorders who received a first standardized Psychedelic-assisted Psychotherapy (PAP) cycle with 100 µg LSD or 25 mg psilocybin at a Swiss university hospital (May 2024-October 2025). Self-reported depression (BDI) and trait anxiety (STAI-T) were assessed at screening, one month before treatment, and 1-3 months post-treatment. In a subset of participants, cognitive emotion regulation (CERQ) was assessed pre- and post-treatment. Subjective drug effects and adverse events were recorded on the treatment day.

RESULTS:

The sample consisted of 115 patients (56.5 % female; Mean age = 47.5 years). Depressive and anxiety symptoms significantly decreased over time (BDI: F(2178) = 63.50, p < 0.001, partial η² = 0.42; STAI-T: F(1.74,145.9) = 16.97, p < 0.001, partial η² = 0.17), with no main effect of substance. CERQ analyses indicated reduced self-blame, rumination and catastrophizing, and increased positive refocusing and reappraisal. Perceived intensity followed distinct temporal profiles for LSD and psilocybin, but comparable subjective drug effects and clinical outcomes. Adverse events were mostly mild and transient, with no serious complications or treatment discontinuations.

CONCLUSIONS:

In this compassionate-use real-world cohort, a first fully-active dose PAP session with LSD or psilocybin was well tolerated and associated with significant improvements in depressive and anxiety symptoms. These findings support the feasibility and effectiveness of PAP in specialised routine care.

01 Apr 2026·NEUROSCIENCE

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

Review

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

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

209

News (Medical) associated with Lysergic acid diethylamide

14 Mar 2026

·www.sciencedaily.com

A lab mistake at Cambridge reveals a powerful new way to modify drug molecules

Cambridge scientists have discovered a light-powered chemical reaction that lets researchers modify complex drug molecules at the final stages of development. Unlike traditional methods that rely on toxic chemicals and harsh conditions, the new approach uses an LED lamp to create essential carbon–carbon bonds under mild conditions. This could make drug discovery faster and more environmentally friendly. The breakthrough was uncovered unexpectedly during a failed laboratory experiment.Researchers at the University of Cambridge have created a new technique that uses light instead of toxic chemicals to change complex drug molecules. The discovery could speed up drug development and make the process of designing medicines more efficient. The study, published on March 12 in Nature Synthesis, introduces what the team calls an "anti-Friedel-Crafts" reaction. Traditional Friedel-Crafts chemistry requires powerful chemicals or metal catalysts and harsh laboratory conditions. Because of these requirements, the reaction normally takes place early in drug manufacturing and is followed by many additional chemical steps to produce the final medicine. The new Cambridge method turns that process around by allowing researchers to make changes to drug molecules much later in development. LED Powered Reaction Forms Key Chemical Bonds Instead of relying on heavy metal catalysts, the reaction is activated by an LED lamp at ambient temperature. When the light triggers the reaction, it sets off a self sustaining chain process that forms carbon-carbon bonds under mild conditions without toxic or costly reagents. In practical terms, this approach lets chemists adjust complex molecules near the end of the drug development process rather than dismantling them and rebuilding them piece by piece -- something that can otherwise take months. "We've found a new way to make precise changes to complex drug molecules, particularly ones that have been exceptionally difficult to modify in the past," said David Vahey, first author and a PhD researcher at St John's College, Cambridge. "Scientists can spend months rebuilding large parts of a molecule just to test one small change. Now, instead of doing a multistep process for hundreds of molecules, scientists can start with their hit and make small modifications later on." "This reaction lets scientists make precise adjustments much later in the process, under mild conditions and without relying on toxic or expensive reagents. That opens chemical space that has been hard to access before and gives medicinal chemists a cleaner, more efficient tool for exploring new versions of a drug." Faster Drug Discovery With Less Waste Reducing the number of synthesis steps lowers chemical use, cuts energy consumption and shrinks the environmental footprint of drug development. It also saves researchers valuable time. The reaction is highly selective, allowing chemists to change one specific part of a molecule without disturbing other sensitive areas. This precision is important because even small structural changes can influence how a medicine works in the body, how it behaves biologically or whether it produces side effects. At its core, the breakthrough addresses a fundamental chemical challenge: forming carbon-carbon bonds. These bonds create the backbone of countless substances including fuels, plastics and complex biological molecules. The technique also shows what chemists describe as "high functional-group tolerance." That means it can modify one region of a molecule while leaving other functional groups untouched. This makes the reaction particularly useful for late-stage optimization, a stage of drug discovery where scientists fine tune molecules to improve how medicines perform. Because the approach avoids heavy metals, harsh reaction conditions and lengthy synthesis pathways, it could also reduce toxic waste and energy consumption in pharmaceutical manufacturing. These environmental benefits are increasingly important as the chemical industry works to reduce its environmental impact. Inspired by Sustainable Chemistry Research Vahey works in the research group led by Professor Erwin Reisner at Cambridge. Reisner's team is known for developing chemical systems inspired by photosynthesis. Their research explores ways to use sunlight to convert waste materials, water and the greenhouse gas carbon dioxide into useful chemicals and fuels. Reisner, Professor of Energy and Sustainability in the Yusuf Hamied Department of Chemistry and lead author of the study, said the significance of the work lies in expanding what chemists can achieve under practical conditions while also moving toward greener manufacturing techniques. "This is a new way to make a fundamental carbon-carbon bond and that's why the potential impact is so great. It also means chemists can avoid an undesirable and inefficient drug modification process." The researchers tested the reaction on a broad range of drug like molecules and showed that it could also be adapted for continuous flow systems commonly used in industrial chemical production. Collaboration with AstraZeneca helped evaluate whether the technique could meet the practical and environmental requirements of large scale pharmaceutical manufacturing. "Transitioning the chemical industry to a sustainable industry is arguably one of the most difficult parts of the whole energy transition," explained Reisner. Breakthrough Emerges From a Failed Experiment The discovery began with an unexpected laboratory result, similar to many famous scientific breakthroughs including X-rays, penicillin, Viagra and modern weight loss medications. "Failure after failure, then we found something we weren't expecting in the mess -- a real diamond in the rough. And it is all thanks to a failed control experiment," Vahey said. He had been testing a photocatalyst when he removed it during a control experiment and discovered that the reaction worked just as well and sometimes even better without it. At first the unusual product appeared to be a mistake. Instead of ignoring it, the researchers chose to investigate further. According to Reisner, recognizing the significance of unexpected results is an important part of scientific discovery. "Recognizing the value in the unexpected is probably one of the key characteristics of a successful scientist," he said. AI Helps Predict New Chemical Reactions "We generate enormous amounts of data, and increasingly we use artificial intelligence to help analyze it. We have an algorithm that can predict reactivity. AI helps because we don't need chemists to do endless trial and error, but an algorithm will only follow the rules it has been given. It still takes a human being to look at something that appears wrong and ask whether it might actually be something new." In this case, Vahey recognized the potential importance of the unexpected result and explored it further. "David could have dismissed it as a failed control," Reisner said. "Instead, he stopped and thought about what he was seeing. That moment, choosing to investigate rather than ignore it, is where discovery happens." After uncovering the chemistry behind the reaction, the team introduced machine learning models developed with Trinity College Dublin to predict where the reaction would occur on entirely new molecules that had never been tested in the laboratory. By learning patterns from known chemical reactions, the AI system can simulate possible outcomes before experiments are performed. This allows researchers to identify promising molecules more quickly and with far less trial and error. For Vahey, the discovery provides scientists with a valuable new capability for drug discovery and development. He said: "What industry and other researchers do with it next -- that's where the future impact lies. For us, the lab is mostly average to bad days. The good days are very good days." Reisner added: "As a chemist, you only need one or two good days a year -- and those can come from a failed experiment." 10 Famous Accidental Scientific Discoveries 1. X-rays (1895) Wilhelm Conrad Röntgen discovered X-rays while studying electrical currents flowing through glass tubes. He noticed that a nearby screen began glowing unexpectedly, revealing a new type of radiation that allowed doctors to see inside the human body without surgery. 2. Radioactivity (1898) Marie Curie observed that certain uranium minerals produced much more radiation than uranium alone could explain. This surprising finding led to the discovery of polonium and radium and helped establish the field of nuclear physics and chemistry. 3. Vulcanized rubber (1839) Charles Goodyear discovered vulcanization when a mixture of natural rubber and sulphur accidentally fell onto a hot surface. Instead of melting, the rubber became strong and elastic. The process made rubber practical for industrial uses and eventually enabled the development of tires and many other products. 4. Penicillin (1928) Alexander Fleming discovered penicillin after mould accidentally contaminated a laboratory dish and killed surrounding bacteria. The discovery led to the first widely used antibiotic and transformed modern medicine. 5. Teflon (1938) Chemist Roy Plunkett accidentally created Teflon while experimenting with refrigerant gases. The unexpected material proved extremely slippery and heat resistant and later became widely used in nonstick cookware and industrial applications. 6. Super glue (1942) Harry Coover was attempting to develop transparent plastics when he instead created a substance that bonded instantly to nearly any surface. Later marketed as super glue, it became widely used in homes, manufacturing and medicine. 7. LSD (1943) Swiss chemist Albert Hofmann accidentally absorbed a small amount of a compound he had synthesized and experienced its powerful psychological effects. The substance, lysergic acid diethylamide (LSD), later played an important role in neuroscience research and became controversial in popular culture. 8. Pulsars (1967) Graduate student Jocelyn Bell Burnell noticed repeating radio signals while analyzing telescope data. Initially believed to be interference, the signals turned out to be the first evidence of pulsars, rapidly spinning neutron stars that opened a new field of astrophysics. 9. Viagra (1990s) Researchers at Pfizer were studying a drug intended to treat angina when participants reported an unexpected side effect. The compound was later developed as Viagra and is now widely prescribed for erectile dysfunction. 10. Weight loss injections (2021) Scientists developing treatments for Type 2 diabetes discovered that drugs mimicking the hormone GLP-1 also caused significant weight loss. Medications such as Ozempic and Mounjaro, originally created for diabetes, were later developed to treat obesity, marking a major shift in approaches to weight management.

Radiation Therapy

09 Mar 2026

·www.prnewswire.com

CNS Drug Developers Add Pharma Veterans as Sector Nears First FDA Decisions

Issued on behalf of Cybin D/B/A Helus Pharma USANewsGroup.com News Commentary VANCOUVER, BC, March 9, 2026 /PRNewswire/ -- The central nervous system therapeutics sector is approaching a commercial inflection point as multiple candidates advance through late-stage trials and regulatory milestones accumulate1. The Drug Enforcement Administration raised its 2026 production quotas for controlled research compounds by 67%, reflecting expanding clinical trial activity across the therapeutics landscape2. Five companies are working to translate that momentum into approved treatments: Helus Pharma (NASDAQ: HELP), Compass Pathways (NASDAQ: CMPS), AtaiBeckley (NASDAQ: ATAI), Definium Therapeutics (NASDAQ: DFTX), and GH Research (NASDAQ: GHRS). The World Health Organization estimates that depression and anxiety cost the global economy more than $1 trillion annually in lost productivity3. Treatment-resistant depression alone affects roughly 30% of patients diagnosed with major depressive disorder, fueling demand for novel mechanisms that can deliver rapid, durable therapeutic responses where traditional antidepressants have failed4. The pipeline is moving to meet it, and pharmaceutical capital is following. Helus Pharma™ (NASDAQ: HELP) is a clinical-stage pharmaceutical company developing novel serotonergic agonists for serious mental health conditions, including major depressive disorder and generalized anxiety disorder. Helus announced topline results from a Phase 2 signal detection study evaluating HLP004 as a potential adjunctive treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing standard-of-care antidepressant therapy. GAD affects more than 20 million adults in the United States, and no adjunctive pharmacologic treatment for the condition has ever been approved. In the study, 36 patients were randomized to HLP004 20 mg or 2 mg and received two intramuscular doses three weeks apart. Patients receiving 20 mg adjunctive to standard of care achieved a mean HAM-A reduction of 10.4 points (p<0.0001) at six weeks. At six months, the pooled study population showed 67% responders and 39% remitters. Acute drug effects lasted approximately 90 minutes, with most participants ready for discharge within three hours. "Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments," said Michael Cola, CEO of Helus Pharma. "We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients." "These Phase 2 results support the continued development of HLP004, and I am encouraged by the magnitude of improvement observed over standard of care treatments, together with the rapid onset and short in-clinic treatment experience for this patient population with limited options," noted Dr. Andrew Cutler, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Senior Advisor to Helus Pharma. Helus also recently appointed Dr. Freda Lewis-Hall to its Board of Directors and as Chair of the company's Scientific Advisory Committee. Lewis-Hall served for more than a decade on Pfizer's Executive Leadership Team as Executive Vice President and Chief Medical Officer. During her tenure, she helped lead the spinout of SpringWorks Therapeutics, which was later acquired by Merck KGaA for approximately $3.4 billion. "What distinguishes Helus Pharma is its disciplined approach at the intersection of rigorous science, a thoughtfully advancing clinical portfolio, and focused execution in areas of significant unmet need in mental health," said Dr. Lewis-Hall. Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026 and began trading on the NASDAQ under the ticker HELP. The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041. The company's lead asset HLP003, a proprietary oral compound granted FDA Breakthrough Therapy Designation, is advancing through two pivotal Phase 3 studies for the adjunctive treatment of major depressive disorder. Phase 2 data on HLP003 demonstrated 100% response rates and 71% remission at 12 months after just two 16 mg doses, with an approximately 23-point reduction in MADRS scores. The APPROACH pivotal Phase 3 study has topline data anticipated in Q4 2026, while the complementary EMBRACE Phase 3 study and EXTEND long-term extension study continue to progress. Helus reported US$195.1 million in cash as of December 31, 2025, supporting continued advancement across its multi-asset clinical pipeline. CONTINUED… Read this and more news for Helus Pharma at: In other industry developments and happenings in the market include: Compass Pathways (NASDAQ: CMPS) reported positive results from two pivotal Phase 3 trials evaluating COMP360, a synthetic psilocybin compound, in patients with treatment-resistant depression. The larger trial, COMP006, enrolled 581 participants and demonstrated a highly statistically significant reduction in symptom severity, with a p-value below 0.001 and a mean treatment difference of 3.8 points on the MADRS depression scale at Week 6. The results replicate findings from the first Phase 3 trial, COMP005, which showed a mean difference of 3.6 points (p<0.001). "COMP360 has demonstrated a highly differentiated profile for treatment-resistant depression, with rapid and durable effects in patients facing significant unmet need," said Kabir Nath, CEO of Compass Pathways. Across both Phase 3 studies, 39% of participants receiving the 25 mg dose achieved a clinically meaningful reduction in depression scores at Week 6, with durable effects observed through 26 weeks after just one or two administrations. Most treatment-emergent adverse events were mild or moderate, resolving within 24 hours. COMP360 is the first classic psychedelic to achieve two highly statistically significant Phase 3 readouts in treatment-resistant depression. The company has submitted a request to the FDA to discuss a rolling New Drug Application submission beginning in Q4 2026. AtaiBeckley (NASDAQ: ATAI) announced a successful FDA End-of-Phase 2 meeting for BPL-003, clearing the path for Phase 3 initiation in treatment-resistant depression targeted for Q2 2026. The FDA provided clear guidance aligning with the company's Breakthrough Therapy Designation granted in October 2025, enabling a Phase 3 program designed for real-world interventional psychiatry with two-hour in-clinic sessions and few treatments per year. "This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 and firmly positions us to advance a robust Phase 3 clinical program," said Srinivas Rao, M.D., Ph.D., Co-Founder and CEO of AtaiBeckley. BPL-003, a nasal spray formulation, demonstrated statistically significant antidepressant effects at 8 mg and 12 mg doses in Phase 2b trials, with rapid and durable responses sustained out to Week 8. The company, formed through the 2025 merger of atai Life Sciences and Beckley Psytech, also expects topline data in H2 2026 from its Phase 2 study of VLS-01, a DMT buccal film for treatment-resistant depression, enrolling 142 patients. AtaiBeckley recently redomiciled to the United States, was added to the NASDAQ Biotechnology Index, and reports a cash runway extending into 2029, providing financial stability through multiple anticipated clinical catalysts. Definium Therapeutics (NASDAQ: DFTX), formerly MindMed, reported full-year 2025 financial results, highlighting $411.6 million in cash, cash equivalents, and investments sufficient to fund operations into 2028. The company rebranded in January 2026 to reflect its focus on a late-stage psychiatry pipeline anchored by DT120 ODT, a lysergide tartrate compound that holds FDA Breakthrough Therapy Designation for generalized anxiety disorder. "With our first Phase 3 MDD trial, Emerge, now fully enrolled and advancing toward topline data, and our Phase 3 GAD studies rapidly progressing, 2026 represents a monumental year for Definium," said Rob Barrow, CEO of Definium Therapeutics. The Emerge study in major depressive disorder is fully enrolled with topline data expected in late Q2 2026. The Voyage and Panorama trials in generalized anxiety disorder are advancing toward enrollment completion, and the company plans to start the Ascend study in major depressive disorder in early to mid-2026. Across the DT120 program, at least three Phase 3 readouts are anticipated in 2026. Definium also dosed the first patient in a Phase 2a study of DT402 (R(-)-MDMA) for autism spectrum disorder, with initial data expected this year. R&D expenses rose to $117.7 million for 2025, up from $65.3 million in 2024, driven by the DT120 program expansion across multiple indications. GH Research (NASDAQ: GHRS) announced that the FDA lifted the clinical hold on its Investigational New Drug application for GH001, a mebufotenin (5-MeO-DMT) therapy for treatment-resistant depression, enabling U.S. patient enrollment and clearing the path for global Phase 3 initiation in 2026. The FDA had placed a clinical hold in 2023 due to insufficient risk assessment information; the company submitted a complete response in June 2025 after completing the required toxicology studies. "This is a major milestone for GH001 as a potential ultra-rapid, durable treatment for treatment-resistant depression," said Dr. Velichka Valcheva, CEO of GH Research. The company's Phase 2b trial demonstrated a placebo-adjusted MADRS reduction of -15.5 points at Day 8 (p<0.0001), with 57.5% of patients achieving remission at Day 8 and 73% at six months with approximately four treatments on average. GH001 features a short median psychoactive exposure of 11 minutes, requires no psychotherapy, and showed no serious treatment-related adverse events, with 99% of participants discharge-ready within one hour. The company plans to seek FDA alignment on a global Phase 3 program design replicating the Phase 2b trial protocol. Article Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for Helus Pharma advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of Helus Pharma, and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of Helus Pharma but reserve the right to buy and sell, and will buy and sell shares of Helus Pharma at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of Helus Pharma by CDMG; this is a paid advertisement, we currently own shares of Helus Pharma and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES: Logo: 21% more press release views with Request a Demo

Phase 2Breakthrough TherapyClinical ResultPhase 3Executive Change

27 Feb 2026

·www.prnewswire.com

Psychedelic Biotechs Push Toward Phase 3: Five Companies Advancing CNS Treatments

Issued on behalf of Helus Pharma VANCOUVER, BC, Feb. 27, 2026 /PRNewswire/ -- Equity-Insider.com News Commentary — Psychedelic compounds are edging closer to regulatory approval as pivotal trials in treatment-resistant depression and anxiety advance through late-stage development[1]. The sector is shedding its countercultural reputation as biotech firms reposition serotonergic and psychedelic-derived therapies as mainstream pharmaceutical candidates[2]. Five companies are building the clinical programs to get there: Helus Pharma (NASDAQ: HELP), AtaiBeckley (NASDAQ: ATAI), Definium Therapeutics (NASDAQ: DFTX), GH Research (NASDAQ: GHRS), and LB Pharmaceuticals (NASDAQ: LBRX). A consensus statement from the U.S. National Network of Depression Centers published in The Lancet outlined considerations for integrating psychedelic into routine clinical practice, a signal that academic medicine is preparing for what the trials may deliver[3]. The clinical infrastructure is expanding, and the investment thesis is following. Helus Pharma (NASDAQ: HELP) is a clinical-stage pharmaceutical company developing treatments for depression and anxiety. Its approach centers on novel serotonergic agonists, synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026, pronounced "Heal-Us," and began trading on the NASDAQ under the ticker HELP. The name reflects its transition toward a commercial-ready pharmaceutical operation. The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041. It operates across Canada, the United States, the United Kingdom, and Ireland. Recently, Nature Medicine published results from a randomized, placebo-controlled Phase 2a trial of SPL026 in patients with moderate-to-severe major depressive disorder. The study enrolled 34 participants across three clinical sites in the United Kingdom. The study met its primary endpoint. Participants receiving a single 21.5 mg dose showed a mean MADRS difference of -7.35 versus placebo (p=0.023), with effects appearing within one week (p=0.002). Response rates at two weeks reached 35% versus 12% for placebo. Remission rates were 29% versus 12%. Effects were sustained for up to three months, with some participants maintaining improvements for up to six months. No treatment-related serious adverse events were reported. "The findings provide clinical proof-of-concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility," said Michael Cola, CEO of Helus Pharma. HLP004, a proprietary intramuscular compound informed by the SPL026 clinical insights, is now in Phase 2 for generalized anxiety disorder. Helus expects topline data from that study this quarter. The company's lead asset HLP003, a proprietary oral compound granted FDA Breakthrough Therapy Designation, is advancing through two pivotal Phase 3 studies for the adjunctive treatment of major depressive disorder. Phase 2 data on HLP003 demonstrated 100% response rates and 71% remission at 12 months after just two 16 mg doses, with an approximately 23-point reduction in MADRS scores. The APPROACH pivotal Phase 3 study has topline data anticipated in Q4 2026, while the complementary EMBRACE Phase 3 study and EXTEND long-term extension study continue to progress. Helus reported US$195.1 million in cash as of December 31, 2025, supporting continued advancement across its multi-asset clinical pipeline. CONTINUED… Read this and more news for Helus Pharma at: In other industry developments: AtaiBeckley (NASDAQ: ATAI) in January outlined its 2026 pipeline strategy ahead of the J.P. Morgan Healthcare Conference, reporting that its lead candidate BPL-003, a mebufotenin benzoate nasal spray for treatment-resistant depression, met its primary and all key secondary endpoints in Phase 2b. The company expects Phase 3 guidance in the first quarter and trial initiation by mid-year, with financial resources supporting operations into 2029. "Following the strategic combination of atai Life Sciences and Beckley Psytech completed last year and the recent corporate redomiciliation to the United States, we enter 2026 with meaningful momentum and a clear vision for the impact AtaiBeckley can deliver for people living with difficult-to-treat mental health conditions," said Dr. Srinivas Rao, Co-Founder and CEO of AtaiBeckley. The company's broader pipeline includes VLS-01, a DMT buccal film for treatment-resistant depression with Phase 2 data expected in the second half of 2026, and EMP-01, an oral R-MDMA compound for social anxiety disorder with Phase 2a results anticipated this quarter. AtaiBeckley was added to the NASDAQ Biotechnology Index in December following its formation through the merger of atai Life Sciences and Beckley Psytech. A new patent granted in December covering its R-MDMA compound extends exclusivity through 2043. Definium Therapeutics (NASDAQ: DFTX) in January completed its rebrand from MindMed, signaling its transition from a psychedelic research platform to a late-stage psychiatry company. Its lead candidate DT120, an LSD-derived orally disintegrating tablet with FDA Breakthrough Therapy Designation for generalized anxiety disorder, has three Phase 3 readouts expected in 2026. The company also dosed its first patient in a Phase 2a study of DT402 in autism spectrum disorder. "We are unwavering in our mission to forge a new era of psychiatry by applying scientific rigor to psychedelics," said Rob Barrow, CEO of Definium Therapeutics. "With three Phase 3 readouts expected in 2026, we are uniquely positioned to validate the strength of our science, advance care for patients, and continue delivering long-term value for our shareholders." The three trials include Voyage for generalized anxiety disorder in the second quarter, Emerge for major depressive disorder at mid-year, and Panorama for generalized anxiety disorder in the second half. A fourth Phase 3, Ascend, targeting major depressive disorder, is planned for mid-year initiation. Generalized anxiety disorder and major depressive disorder together affect over 50 million people in the United States. The ticker changed from MNMD to DFTX effective January 13. GH Research (NASDAQ: GHRS) in January announced that the FDA lifted the clinical hold on GH001, its proprietary inhaled mebufotenin (5-MeO-DMT) formulation for treatment-resistant depression, clearing the path for U.S. subject enrollment. The compound's Phase 2b trial met its primary endpoint with a 15.5-point placebo-adjusted MADRS reduction on Day 8 (p<0.0001). The hold had paused U.S. enrollment while the company continued advancing its European clinical program. "The FDA clearance is a major milestone and positions us to advance GH001 as a potential ultra-rapid and durable treatment option for TRD patients," said Dr. Velichka Valcheva, CEO of GH Research. "We continue to expect initiation of our global pivotal program in 2026." The global Phase 3 program is expected to replicate the Phase 2b design, targeting initiation in 2026. GH001 is administered via proprietary inhalation in a clinical setting, with sessions lasting under an hour. The Dublin-based company's approach to treatment-resistant depression differs from oral psychedelic programs in that it targets 5-HT receptor subtypes through a rapid-onset delivery mechanism. The company has positioned GH001 as a potential practice-changing option for the roughly one-third of depression patients who do not respond to standard antidepressants. LB Pharmaceuticals (NASDAQ: LBRX) in January initiated its Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression, enrolling approximately 320 patients across 30 U.S. sites. LB-102 is a novel once-daily oral benzamide antipsychotic targeting D2, D3, and 5-HT7 receptors, with Phase 2 schizophrenia data showing statistically significant benefit at all doses studied. "The initiation of this Phase 2 trial in patients with bipolar depression marks an important step in our strategy to expand the potential of LB-102 for the treatment of mood disorders," said Heather Turner, CEO of LB Pharmaceuticals. "We look forward to a number of late-stage clinical catalysts, including results from this Phase 2 trial in the first quarter of 2028, as well as from our planned Phase 3 trial in schizophrenia which remains on track to initiate this quarter." The company closed a $100 million private placement in February, with participation from institutional investors including Balyasny, Deep Track, and Nantahala. LB-102 could become the first benzamide antipsychotic approved in the United States, addressing a market of approximately 7 million bipolar patients domestically and 40 million worldwide. Phase 2 data in schizophrenia showed low rates of extrapyramidal symptoms and minimal sedation, differentiating LB-102 from existing antipsychotics. Article Source: CONTACT: EQUITY-INSIDER [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by Equity-Insider on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for Helus Pharma advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of Helus Pharma, and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of Helus Pharma but reserve the right to buy and sell, and will buy and sell shares of Helus Pharma at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of Helus Pharma by CDMG; this is a paid advertisement, we currently own shares of Helus Pharma and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES: (25)00450-X/fulltext Logo - 21% more press release views with Request a Demo

Phase 2Phase 3Clinical ResultBreakthrough Therapy

100 Deals associated with Lysergic acid diethylamide

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KEGG	Wiki	ATC	Drug Bank
-	Lysergic acid diethylamide	N	DB04829

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 3	United States	Definium Therapeutics US, Inc.	14 Apr 2025
Generalized anxiety disorder	Phase 3	United States	Definium Therapeutics US, Inc.	29 Jan 2025
Generalized anxiety disorder	Phase 3	Czechia	Definium Therapeutics US, Inc.	29 Jan 2025
Generalized anxiety disorder	Phase 3	France	Definium Therapeutics US, Inc.	29 Jan 2025
Generalized anxiety disorder	Phase 3	Germany	Definium Therapeutics US, Inc.	29 Jan 2025
Generalized anxiety disorder	Phase 3	Poland	Definium Therapeutics US, Inc.	29 Jan 2025
Generalized anxiety disorder	Phase 3	United Kingdom	Definium Therapeutics US, Inc.	29 Jan 2025
Depressive Disorder	Phase 2	Switzerland	Universitätsspital Basel	09 Jun 2024
Fear	Phase 2	Switzerland	Universitätsspital Basel	09 Jun 2024
Pain	Phase 2	Switzerland	Universitätsspital Basel	09 Jun 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03866252 (Pubmed \| Med)	Phase 2	Depressive Disorder, Major Adjuvant	-	LSD 100 μg + 200 μg	xbotgiwfsc(nbdmsmxlye) = Adverse events were comparable between groups bdzkihffkx (wqhjdxmlza )	Positive	01 Sep 2025
				LSD 25 μg + 25 μg
NCT05200936 (CTgov)	Phase 2	Attention Deficit Disorder	53	Placebo (Arm 1- Placebo)	jtetcvjupd(jmwvozgxpe) = sfsccgxsww opbvgefcni (aigkknfuvs, 5.24) View more	-	13 Apr 2025
				MM120 (Arm 2- MM120)	lbkhpckznx(vzijvprgik) = rggbcthgik exozebuypb (whjhmhluaw, zyzvoeyggl - qilkeffyxq) View more
NCT05407064 (MMED008, CTgov)	Phase 2	Generalized anxiety disorder	198	Placebo (Arm 1- Placebo)	ivhfazmdpd(eitfgtswpv) = ievurdyvqy jmziejwwnz (wmehtiftcb, vbmkppjaqg - dynvltxdic) View more	-	20 Mar 2025
				MM120 (Arm 2- 25 μg MM120)	xdtrpahqmc(rgfsgrkons) = vcyccqkmqv kiivtkkyix (xztoeconwh, fwgvndzhgi - vivjknrwhi) View more
NCT05398484 \| NCT05214417 \| NCT05883540 \| NCT05403086 (Pubmed \| Cochrane Database Syst Rev)	Phase 2/3	Anxiety Disorders \| Moderate depression Adjuvant	149	Psychedelic-assisted therapy with classical psychedelics (psilocybin, LSD)	ugwmekwgpc(sbydtnokuu) = xpsaphjgyf jkkqkhtbjc (ksarfcmdjv, -12.92 to -3.89) View more	Positive	12 Sep 2024
				Psychedelic-assisted therapy with 3,4-methylenedioxymethamphetamine (MDMA or 'Ecstasy')	ugwmekwgpc(sbydtnokuu) = fwbrrdjyxo jkkqkhtbjc (ksarfcmdjv, -29.45 to 0.05) View more
NCT05407064 (MMED008, BusinessWire) Manual	Phase 2	Generalized anxiety disorder	198	MM120 100 µg	gcigupbwtb(yhbsddlskt) = nfsgknglpj mtjksxujtv (rkdpcubsal ) View more	Positive	07 Mar 2024
				placebo	gcigupbwtb(yhbsddlskt) = lgviztrvfh mtjksxujtv (rkdpcubsal )
NCT05407064 (MMED008, BusinessWire) Manual	Phase 2	Generalized anxiety disorder	198	MM-120 (100 μg or 200 μg)	bzdpcdhiue(tjwnezpukf) = temhujrogz jxjwuknosi (jhklkmnmmt ) View more	Positive	14 Dec 2023
				MM-120 (100 μg)	eaitbvdenh(ogzdxdalwx) = cvkineoozi todxfyqyki (solzpshqrp ) View more
NCT04227756 (Pubmed \| Neuropsychopharmacology)	Phase 1	-	32	Mescaline 300 mg	edtruonuyi(utigqvzdmk) = hzvheljcuo vrwhvwutil (zapwitviju ) View more	-	25 May 2023
				Mescaline 500 mg	edtruonuyi(utigqvzdmk) = adoqcnmaug vrwhvwutil (zapwitviju ) View more
NCT03153579 (LSD-assist, SOBP2022) Manual	Phase 2	Anxiety Disorders	42	Lysergic Acid Diethylamide	gmrriooeji(xqaxmpforu) = bwobrehnum imicrouhbf (okesjuldgs ) View more	Positive	02 Sep 2022
				Placebo	gmrriooeji(xqaxmpforu) = rxwgljysif imicrouhbf (okesjuldgs ) View more
NCT00920387 (CTgov)	Phase 2	Anxiety Disorders	12	Therapy+200 mcg LSD (Full Dose LSD (200 mcg))	nfkecnachu(otnjhqklzs) = beqgjaoimr upldmpqqth (cslshrlfkv, 4.7) View more	-	08 Dec 2021
				Therapy+20 mcg LSD (Active Placebo LSD (20 mcg))	nfkecnachu(otnjhqklzs) = yefakhhfcd upldmpqqth (cslshrlfkv, 7.7) View more
NCT02308969 \| NCT01878942 (Pubmed \| Clin Pharmacokinet)	Early Phase 1	-	-	LSD 100 µg	hykqfmcjok(upscmhrjgg) = wwewqblmzu nzkkggmymm (lbpgfscsyn, 2.1) View more	-	01 Oct 2017
				LSD 200 µg	hykqfmcjok(upscmhrjgg) = uflbbmjhkr nzkkggmymm (lbpgfscsyn, 1.7) View more

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