Early-Stage Translational Research (Pre-Clinical)

2A Biosciences is a drug discovery company developing Serotonergic Anti-Inflammatories (SAIs) — non-hallucinogenic 5-HT2A receptor agonists that harness the peripheral anti-inflammatory properties of psychedelics without behavioural effects. Co-founded by pharmacologists Charles D. Nichols and David E. Nichols, the company's near-term programs target dermatological inflammatory conditions, with a broader platform addressing autoimmune and cardiovascular disease. The company has completed an oversubscribed seed round backed by biotech and psychedelic VCs.

Very small Canadian biotech developing KRN-101, a natural psilocybin formulation for cancer-related psychological distress. Market capitalisation fell below C$300,000 in 2024, with minimal operating activity and limited financing capacity.

The Alexander Shulgin Research Institute (ASRI) was founded in 2021 by Dr. Nicholas Cozzi, Dr. Paul Daley, and the late Ann Shulgin, continuing the legacy of chemist Alexander Shulgin. The institute maintains the Shulgin Vault — a repository of over 500 compounds synthesized by Shulgin and ASRI scientists. Lead candidate ASR-3001 (5-MeO-iPALT) is an orally active, fast-acting tryptamine with a mild internal psychedelic profile and no visual hallucinations, near IND-ready for psychiatric disorders. ASR-2001 is a non-hallucinogenic compound producing mental clarity.

Alvarius Pharmaceuticals is an Irish bio-pharmaceutical company developing 5-MeO-DMT-based therapies for addiction and substance use disorders. Founded in 2021 and based in Dublin, the company conducts preclinical studies in collaboration with University College Dublin, combining acute 5-MeO-DMT administration with guided psychotherapy. Alvarius raised €5.5M in 2023 and has filed one patent.

BetterLife Pharma (CSE: BETR / OTC: BETRF) is a Canadian biotech developing BETR-001, a first-in-class non-hallucinogenic LSD derivative (2-bromo-LSD / BOL-148) for MDD, anxiety, and neuropathic pain. BETR-001 was acquired from Transcend Biodynamics LLC and activates the 5-HT2A receptor at 60% efficacy — sufficient for neuroplastogenic antidepressant effects but below the threshold for hallucinogenic effects. A composition of matter patent was granted January 2025, IND filing projected H1 2026.

Bexson Biomedical is a US private biotech developing BB106, a subcutaneous wearable formulation of ketamine delivered via its proprietary SEVALENT™ platform device. The formulation is designed to provide precise, extended ketamine dosing for chronic pain and depression outside of clinic settings. As of 2023 the company was conducting IND-enabling studies.

Biomia is a Copenhagen-based synthetic biology company developing novel plant-inspired drug candidates for unmet medical needs in pain, addiction, and depression. Using a proprietary AI-assisted drug discovery engine and fermentation-based biomanufacturing platform, the company engineers Monoterpene Indole Alkaloid (MIA) derivatives — a large family of plant-derived bioactive compounds including ibogaine analogs — with optimised halogenation to improve ADME properties and therapeutic profiles.

CB Therapeutics is a Carlsbad, California-based synthetic biology company developing biosynthetic psychedelic compounds and their novel analogues using a proprietary yeast fermentation platform. Founded in 2015, the company has raised $11.62M from investors including Y Combinator, Pioneer Fund, and re.Mind Capital. CB Therapeutics has achieved biosynthesis of psilocybin, psilocin, DMT, and MDMA analogs, holds seven granted patents with twelve pending, and has partnered with atai Life Sciences and Cleveland Clinic for clinical supply. Its PsyVault™ platform houses the largest collection of biosynthetic psychedelics and analogues.

CaaMTech is a US psychedelic drug discovery company based in Issaquah, Washington, focused on novel tryptamine chemistry. Founded around 2018, the company raised $22M in a 2021 Series A and holds a CRADA with NIH/NIDA and a research collaboration with UMass Dartmouth. Its two flagship compound series are Prophoria™ (4-AcO-DMT analogues) and Amphoria™ (4-HO-MiPT analogues), which the company is developing as improved psychedelic therapeutics with potentially more targeted and safer profiles than existing compounds.

Collaborations Pharmaceuticals is a Raleigh, North Carolina-based drug discovery company using generative AI to design novel psychoplastogens for substance use disorders. Its lead candidate DM506 is a non-hallucinogenic, non-cardiotoxic synthetic ibogamine derivative (ibogaminalog) that has shown preclinical efficacy in reducing cue-induced heroin-seeking and modulating prefrontal cortex GABA currents in opioid use disorder models.

Canadian biotech developing biosynthetic psilocybin through its Vocan Biotechnologies subsidiary. Vocan's proprietary fermentation-based process produces pharmaceutical-grade psilocybin without mushroom cultivation. Signed a partnership with Cube Psytech for psychedelic drug development in December 2023.

Delix Therapeutics is harnessing the power of neuroplastogens, a novel class of compounds designed to bring about a new paradigm in brain health therapeutics with treatments intended to be safe, fast-acting, and long-lasting. Through its discovery platform, Delix has identified non-hallucinogenic versions of psychedelic compounds with favorable safety and therapeutic profiles. The company was co-founded in 2019 by David E. Olson and Nick Haft, building upon Olson's discovery at the University of California, Davis, of several novel psychoplastogens that have significant therapeutic potential in preclinical models, without hallucinogenic side effects. Delix's treatments are designed to address the root cause of neuropsychiatric conditions by repairing the underlying synaptic damage through targeted neuroplasticity. To date, the company has synthesized over 2000 novel psychoplastogens, many of which are analogs of known psychedelics such as ibogaine and 5-MeO-DMT. Their lead compound, zalsupindole (DLX-001), produces the same rapid and sustained structural and functional plasticity as ketamine, psilocybin, and DMT, without inducing hallucinations or dissociation. Recent Phase I data have demonstrated that DLX-001 is associated with robust signs of CNS engagement and a favorable safety and tolerability profile, with no serious adverse events reported to date. The company's compounds are tailored for swift neuronal repair and can be taken at-home, providing significant advantages to patients, their loved ones, and healthcare providers. Delix focuses on developing non-hallucinogenic psychoplastogens as scalable alternatives to first-generation hallucinogenic psychoplastogens like ketamine and psilocybin.

Elkedonia is a French neuroplastogen biotech developing novel small molecules targeting the Elk-1 transcription factor, a key regulator of neuroplasticity within neuronal cells. Backed by €11 million in funding, the company is advancing clinical research into next-generation antidepressants that promote neuroplasticity without the adverse effects of traditional treatments, with CEO Delphine Charvin leading the programme.

Empyrean Neuroscience is a New York-based biotech pioneering the use of genetic engineering of fungi and plants to develop novel neuroactive therapeutics for CNS disorders. Founded in 2019, the company launched with a $22M Series A from Spore Partners and uses CRISPR/Cas9 technology licensed from ERS Genomics to genetically modify Psilocybe cubensis, Tabernanthe iboga, and Cannabis sativa. Lead programmes include an encapsulated psilocybin mushroom drug product (IND-enabling studies) and DMT-based therapeutics for MDD, PTSD, and substance use disorders.

Entheos Labs is a Boston-based psychedelic medicines company founded in 2022 by Dr. Jerry Rosenbaum and Tristan Edwards, dedicated to discovering, developing, and deploying novel psychedelic medicines for unmet medical needs. The company is creating a pipeline of new chemical entities derived from overlooked natural psychedelic materials, with its lead candidate ET-01 targeting mood, anxiety, trauma, and substance use disorders.

Enveric Biosciences (NASDAQ: ENVB) is a clinical-stage biotech developing novel non-hallucinogenic neuroplastogenic DMT analogs for depression, anxiety, and addiction via its Psybrary™ discovery platform. Lead candidate EB-003 is a first-in-class compound designed to selectively engage both 5-HT2A and 5-HT1B receptors, delivering fast-acting antidepressant and anxiolytic effects without hallucinations. EB-003 completed pre-IND dose range studies (Aug 2025) and demonstrated positive preclinical PTSD data (July 2025), with IND filing targeted Q3 2025 and clinical initiation by end of 2025.

Equulus Therapeutics (Raleigh, NC) was founded in 2023 to develop non-hallucinogenic, non-cardiotoxic ibogaine analogs for substance use disorders. Lead candidate EQL-101 retains ibogaine’s anti-addictive efficacy while eliminating its hallucinogenic effects and cardiotoxicity (hERG inhibition). The company is advancing EQL-101 through IND-enabling studies targeting first-in-human dosing by Q4 2026. Co-founded by RTI medicinal chemist Bruce Blough and pharmacologist Kevin Murnane (LSU), who received a $2.4M NIH grant for methamphetamine use disorder research.

Journey Colab is a US psychedelic pharmaceutical company developing synthetic mescaline hydrochloride for alcohol use disorder (AUD). Founded in 2020, the company has raised $30.7M from investors including Sam Altman, Apollo Projects, and Drew Houston. Journey Colab has dedicated 10% of its founding equity to a Reciprocity Trust supporting Indigenous communities from which mescaline knowledge originates. The company is partnering with All Points North (APN) for an FDA-authorised Phase 2 clinical trial.

Kuleon Bioscience is a Seattle-based drug discovery company leveraging AI-based technology to identify novel serotonergic drugs for neuropsychiatric diseases. The company specialises in biased serotonin receptor ligands — including the world's first known trifunctional 5-HT2C agonist / 5-HT2A antagonist / 5-HT2B antagonist — designed to deliver therapeutic efficacy without hallucinogenic or cardiotoxic side effects. Its lead programme KB-128 targets alcohol use disorder and is supported by a $2 million NIAAA grant.

Marvel Biosciences is a Calgary-based clinical-stage biotechnology company pursuing a 'drug redevelopment' strategy to create synthetic derivatives of approved drugs with improved therapeutic profiles. Its lead candidate MB-204, a fluorinated derivative of the adenosine A2a receptor antagonist Istradefylline, is advancing through IND-enabling pre-clinical studies targeting autism spectrum disorder, Rett syndrome, and depression, with Phase 1 trials expected to begin in Australia.

Mycrodose Therapeutics is a San Diego-based biotech developing advanced drug delivery systems for psychedelic and controlled-substance therapeutics. One of only a few companies with DEA Schedule I research licences covering psilocybin, LSD, MDMA, and DMT, the company has demonstrated in vitro delivery of psilocin through human skin using a proprietary transdermal patch technology. A second programme involves an oral mucosa delivery system for ketamine targeting cancer-related mucositis. Mycrodose has completed an oversubscribed private placement to expand its patent portfolio.

Negev Labs is a biotech company-building platform founded in 2022 and headquartered in Fort Lee, New Jersey, dedicated to advancing neuroplastogens — non-hallucinogenic compounds that promote neuroplasticity and cellular resilience. The company operates through R&D partnerships with Hadassah Brain Labs Center for Psychedelic Research in Jerusalem, a licensing agreement with the Alexander Shulgin Research Institute (ASRI), and acquired Beckley Psytech's ophthalmology program, targeting psychiatry, neurodegeneration, and retinal degeneration.

Octarine Bio is a Danish synthetic biology company producing psilocybin and other neuroactive compounds via proprietary yeast fermentation. Founded in Copenhagen, the company raised $11M from 13 investors including DSM-Firmenich and has partnered with Clerkenwell Health to supply GMP psilocybin for clinical trials. Octarine Bio's platform is based on engineering yeast to express the biosynthetic pathway for psilocybin and related alkaloids.

PharmAla Biotech (CSE: MDMA) is a Canadian biotech specialising in MDXX-class molecule R&D and GMP MDMA manufacturing. Founded in January 2021 by CEO Nick Kadysh, the company operates two business lines: (1) LaNeo — clinical-grade GMP MDMA supplied to research institutions worldwide under a supply-for-data model, now with a US distribution hub and agreements spanning Mt. Sinai, Yale, UAB, University of Washington, and institutions in Norway and Netherlands; and (2) proprietary drug development led by ALA-002, a patented non-racemic MDMA (70–80% R-MDMA / 20–30% S-MDMA) targeting social anxiety in autism, plus APA-001, a novel non-scheduled MDXX molecule discovered via University of Windsor AI collaboration. ALA-002 holds US Patent No. 12,053,452 (composition of matter, issued 2024), MHRA written guidance that no further preclinical data is needed, and FDA NCE classification. Phase 2a clinical trial drug substance manufacture was contracted with a UK CDMO in December 2025 in preparation for an Australian Phase 2a with University of Sydney (Dr. Adam Guastella). Revenue grew 95% in FY2024 to C$1.04M from MDMA product sales. Note: master list originally classified as private, but is publicly listed on CSE.

PharmaDrug is a Canadian specialty pharmaceutical company focused on the research and development of controlled substances and natural medicines. Through its Sairiyo Therapeutics subsidiary, the company is developing a DMT candidate with FDA Orphan Drug Designation for prevention of ischemia-reperfusion injury in organ transplants, and is also studying DMT for ophthalmic indications. PharmaDrug also distributes medical cannabis in the EU via PharmaDrug Production GmbH.

Psilera is a Florida-based drug discovery company developing non-hallucinogenic psilocybin derivatives and outpatient-compatible psychedelic medicines. Founded in 2019, the female co-founded company has a proprietary compound library of over 1 million novel compounds. Lead candidate PSIL-006 is a non-hallucinogenic psilocybin derivative targeting behavioral variant frontotemporal dementia (bvFTD), with positive preclinical in vivo efficacy data in humanized tau mouse models. Earlier compounds PSIL-001/002 (DMT derivatives) showed improvements in learning and memory.

Psy Therapeutics is a Cambridge, MA-based drug discovery company developing novel small-molecule NCEs for neuropsychiatric and neurological disorders. Founded around 2019 by MGH psychiatrists Jerry Rosenbaum, Roy Perlis, and Maurizio Fava with Brant Binder, the company applies DNA-encoded library screening (via X-Chem) and validated CNS targets. Pipeline includes PSY-05 (anxiety), PSY-06 (MDD), PSY-02 (dementia/tau aggregation), and programs in Parkinson's and chronic pain. Non-hallucinogenic, psychedelic-inspired CNS approach.

Canadian company producing and distributing legal psilocybin magic truffles to adult consumers in the Netherlands under the iMicrodose and Trip brands. Also developing pharmaceutical-grade psilocybin formulations through its Irvine Pharma subsidiary for clinical and research applications.

Remedi Therapeutics is a private biotech company developing a novel oral DMT formulation combined with a best-in-class, ultra-selective monoamine oxidase A inhibitor (RIMA) to create a predictable, convenient ayahuasca-like therapeutic. Unlike traditional ayahuasca, which uses plant-sourced harmine with off-target effects, Remedi's proprietary RIMA avoids gastrointestinal distress, tremors, and hypertensive risk, enabling pharmaceutical-grade oral DMT delivery for neuropsychiatric conditions.

Shortwave Life Sciences is a UK-listed biopharmaceutical company developing a proprietary psilocybin and beta-carboline buccal film formulation for the treatment of anorexia nervosa. The mucoadhesive film delivery system enables improved bioavailability and rapid onset by bypassing first-pass metabolism, and the company has secured an investigator-initiated Phase 2 clinical trial agreement with Sheba Medical Center in Israel — targeting a condition with no FDA-approved pharmacological treatment.

US-listed clinical-stage biotech developing psychedelic and ketamine-based therapies for PTSD and chronic pain. SPC-15 is an intranasal 5-HT4 serotonin receptor agonist for PTSD in IND-enabling GLP studies. SP-26 is a proprietary ketamine implant for fibromyalgia being co-developed with the University of Maryland.

Soneira is a private psychedelic biotech company developing synthetic ibogaine therapies for neuropsychiatric conditions, with a primary focus on traumatic brain injury (TBI). The company has raised $15 million from Sergey Brin's Catalyst4 investment vehicle and is working to advance the first FDA-approvable synthetic ibogaine candidate to clinical trials.

Tactogen is a Palo Alto-based public benefit corporation developing novel MDMA-like entactogens and psychedelic-adjacent molecules for psychiatric disorders. Founded in 2020 by neuroscientist Matthew Baggott and Luke Pustejovsky, Tactogen has built the largest known library of entactogenic compounds. Lead candidate TACT908 is a non-hallucinogenic 5-HT1B/2A agonist for cluster headache, while TACT833 targets alcohol use disorder and eating disorders. Following the 2024 FDA rejection of Lykos's MDMA, Tactogen has pivoted toward its novel NCE pipeline.

Transneural Therapeutics is a Washington-based preclinical biotech spun out from CaaMTech in April 2025, developing AI-engineered non-hallucinogenic neuroplastogens for neuropsychiatric disorders. Lead candidate TN-001 is a dual 5-HT2A partial agonist/5-HT2B antagonist designed to deliver rapid antidepressant efficacy without hallucinations, potentially enabling outpatient dosing. TN-001 is in IND-enabling studies for MDD and PTSD, with preclinical data presented at ACNP 2026. CEO Charmaine Lykins brings experience from Karuna, ACADIA, and MapLight.

Canadian biotech developing standardised ibogaine therapy protocols for opioid use disorder. Filed a Clinical Trial Application (CTA) with Health Canada for a Phase 1 clinical study. The company has undergone management restructuring and faces ongoing financing challenges.

Xylo Bio (formerly Psylo) is an Australian-US biotech developing next-generation neuroplasticity-promoting therapeutics for mental health. Founded in 2021 by Josh Ismin and Sam Banister in Sydney, the company has labs at the University of Colorado Boulder and the University of New South Wales. Its lead candidate PSYLO-100X is a non-hallucinogenic compound designed for home administration without clinical supervision, advancing through IND-enabling studies toward first-in-human trials. Xylo has raised $14.2M including an $8M seed round in June 2024 from Tenmile, Focalpoint Partners, and Palo Santo.