Drug Developers

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.

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.

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.

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.

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.

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.

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.

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.

Canadian psychedelic biotech developing conjugated psilocin formulations for treatment-resistant conditions. Spun out its proprietary Conjugated Psilocin™ technology to Cynaptec Pharmaceuticals in April 2025 via an $8.46 million financing round. Lead programme L-130 targets cluster headache disorder.

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.

Canadian biotech using AI-assisted drug discovery at the University of Alberta to develop novel psilocybin and MDMA analogues for mental health and addiction treatment. Pipeline compounds MYCO-003 through MYCO-007 represent a library of psychedelic-inspired molecules at preclinical stage.

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.

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.

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.

Seaport Therapeutics is a Boston-based biopharmaceutical company developing neuropsychiatric medicines using its proprietary Glyph™ lymphatic delivery platform. The Glyph technology bypasses first-pass hepatic metabolism by routing drugs through the lymphatic system, improving oral bioavailability. Its lead candidate SPT-348 (Glyph2BLSD™) is a prodrug of BOL-148 (2-bromo-LSD), a non-hallucinogenic neuroplastogen targeting headache disorders and TRD. The company raised $325M across a $100M Series A (2024) and $225M Series B (2024–2025), backed by PureTech Health, ARCH Venture Partners, Third Rock Ventures, and General Atlantic.

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.

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.

Xylo Bio (formerly Psylo, rebranded January 2025) is an Australian drug discovery company developing next-generation neuroplastogens — non-hallucinogenic 5-HT2A agonists that promote neuroplasticity without the psychedelic experience. Lead candidate XYL-1001 is a selective 5-HT2A agonist advancing toward first-in-human trials planned for mid-2026. The company has raised $15.4M and uses computational drug discovery and structure-based design.

Algernon Pharmaceuticals (also known as Algernon Health / Algernon NeuroScience) is the first company in the world to test DMT as an emergent treatment for ischemic stroke and traumatic brain injury. Their lead candidate AP-188 uses sub-hallucinogenic IV DMT to promote neuroplasticity and neuroprotection. Phase 1 completed at the Centre for Human Drug Research in Leiden; Phase 2a stroke trial planned.

Arcadia Medicine is a San Francisco-based biotech developing safe entactogens for mental health disorders. Their lead candidate AM-1002 is a patented non-racemic MDMA formulation that received FDA IND clearance in October 2025 for Phase 1 trials in generalized anxiety disorder. Backed by investors including Sam Altman and Coinbase co-founder Fred Ehrsam.

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.

DemeRx is a clinical-stage biotech developing noribogaine (DMX-1001), a non-psychedelic active metabolite of ibogaine, as a treatment for alcohol use disorder. DMX-1001 promotes neuroplasticity to repair neural circuits damaged by chronic alcohol use. Phase 1b completed with favorable safety; Phase 2 AUD trial planned for 2026, supported by a $1.7M NIH SBIR grant.

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.

Lophora ApS is a Danish biotech developing next-generation selective 5-HT2A receptor agonists for psychiatric disorders. Their lead compound LPH-5, a novel cyclized phenethylamine, is in Phase 1 trials at Biotrial in Rennes, France. LPH-5 shows exceptional 5-HT2A selectivity and can produce antidepressant effects at sub-psychedelic doses. Secondary candidate LPH-48 is being explored for alcohol use disorder.

Mindstate Design Labs is a San Francisco-based biotech using AI (the Osmanthus platform, trained on 70,000+ psychedelic experience reports) to design precision psychedelic therapeutics. Their lead compound MSD-001 (5-MeO-MiPT) completed Phase 1 in July 2025, confirming safety and novel non-hallucinogenic psychoactive effects. The company is now advancing fixed-dose combinations for targeted therapeutic states.

MycoMedica Life Sciences PBC is a public benefit corporation developing low-dose psilocybin medicines for psychiatric and neurological disorders. Their lead candidate MLS101 is in Phase 1 clinical development, with PMDD as the lead indication and OUD and OCD as additional targets. Based in Shelton, Washington.

Neurala Biosciences is a Melbourne-based clinical-stage biotech developing second-generation DMT–harmala alkaloid neuromedicines for mental health and addiction. Emerging from over a decade of research at the University of Melbourne, their Phase 1 proof-of-concept study was published in Scientific Reports (2025). Lead candidate NBX-100 targets substance use disorder; NBX-200 targets depressive illness.

Scottsdale Research Institute (SRI) is an Arizona-based research organization conducting the world's first controlled clinical trial of whole psilocybin mushrooms. Their FDA-approved Phase 1 study tests naturally-grown whole mushrooms (30mg psilocybin dose) for PTSD in first responders and military veterans, funded by $5M from the Arizona Legislature. The study explores the entourage effect hypothesis compared to isolated synthetic psilocybin. Led by Dr. Sue Sisley.

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.

Clearmind Medicine is an Israeli-American biotech developing CMND-100, a proprietary oral MEAI (5-methoxy-2-aminoindane) formulation for alcohol use disorder. First patient dosed in June 2025 in their multinational Phase 1/2a trial across Yale, Johns Hopkins, and Hadassah Medical Center. Positive first cohort top-line results reported November 2025.

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.

Canadian biotech developing psilocybin formulations for substance use disorders and neurological conditions. Lead programme is an oral psilocybin thin-film strip in a Phase I/II clinical trial for methamphetamine use disorder, with approximately 50% enrolment completed. Also conducting preclinical research on psilocybin for stroke recovery and inflammation.

AbbVie (NYSE: ABBV) is a global biopharmaceutical company and one of the first large pharma entrants in next-generation psychedelic medicine. In May 2024, AbbVie partnered with Gilgamesh Pharmaceuticals ($65M upfront, up to $1.95B in milestones) to develop novel CNS therapies including neuroplastogens. In August 2025, AbbVie acquired bretisilocin (GM-2505) — a short-acting IV serotonergic psychedelic (DMT analog) from Gilgamesh — for up to $1.2B, marking one of the largest psychedelic drug deals in history. Bretisilocin's Phase 2a data showed a -21.6 point MADRS reduction at Day 14 (p=0.003). AbbVie continues to collaborate with Gilgamesh Pharma Inc. (Gilgamesh's spin-off) on earlier-stage programmes.

Apex Labs Ltd. is a private Canadian clinical-stage company developing psilocybin treatments for depression, anxiety, and PTSD, with a focus on the Veteran community. The company is advancing two parallel Phase 2b programmes: APEX-52 (take-home oral microdose psilocybin, the first of its kind in a Phase 2b trial) and APEX-90 (in-clinic macrodose psilocybin with assisted psychotherapy). Trials are running across Canada, the US (Yale School of Medicine PK study), and Israel (Tel Aviv University Sagol Brain Institute + Be'er Yaakov Mental Hospital, approved June 2025).

AtaiBeckley is a clinical-stage biopharmaceutical company listed on NASDAQ (ATAI), formed in November 2025 through the strategic combination of atai Life Sciences and Beckley Psytech. Incorporated in Delaware with headquarters in New York, the company develops rapid-acting, durable psychedelic-based treatments for serious mental health conditions with significant unmet need. Its lead asset, BPL-003, is a proprietary intranasal formulation of 5-MeO-DMT (mebufotenin benzoate) that received FDA Breakthrough Therapy Designation for treatment-resistant depression and delivered compelling Phase 2b results. The merger was approved by approximately 98% of atai shareholders in an all-share transaction valued at around $390 million, creating a pipeline spanning three active Phase 2 programmes. AtaiBeckley holds a strong IP portfolio with granted US patents through 2043 and reported cash runway into 2029.

Bright Minds Biosciences (NASDAQ: DRUG) is a Vancouver-based biotech developing highly selective serotonergic agonists for neurological and psychiatric disorders. Lead asset BMB-101, a 5-HT2C agonist, is in Phase 2 for drug-resistant epilepsy (BREAKTHROUGH study, positive Phase 2 results January 2026). BMB-201 is a 5-HT2A/2C agonist showing preclinical efficacy in pain and migraine models (outperformed sumatriptan, Sept 2025). BMB-202 is a selective 5-HT2A agonist with antidepressant profile in development for MDD.

Ceruvia Lifesciences is a US-based clinical-stage biopharmaceutical company founded in 2017 by philanthropist Carey Turnbull, focused on developing neurotransformational medicines for neurological and psychiatric disorders. The company was the world's first producer of cGMP-certified LSD and its non-hallucinogenic analogue BOL-148. Ceruvia is advancing SYNP-101 (synthetic psilocybin) through Phase 2 trials for OCD, alcohol use disorder, and migraine/headache disorders, and NYPRG-101 (BOL-148) for cluster headache. Collaborators include Yale University, the Heffter Research Institute, Usona Institute, NYU, and Clusterbusters.

Clairvoyant Therapeutics is a Canadian clinical-stage biotech developing synthetic psilocybin for alcohol use disorder (AUD). The company ran a fully randomized, double-blinded Phase IIb multi-country trial in the EU and Canada enrolling 154 participants, with topline data anticipated in early 2025. Founded in 2021 in Vancouver, a proposed acquisition by Psyence Biomed (Nasdaq: PBM) for $500K in September 2024 fell through following due diligence.

Entropy Neurodynamics Limited (formerly Tryptamine Therapeutics Limited, renamed November 2025; ASX: ENP, OTC: TYPTF) is an Australian clinical-stage company developing psilocin-based therapies for conditions with major unmet need including fibromyalgia, binge eating disorder, and IBS. Its two-pronged strategy uses TRP-8802 (oral psilocybin) to establish clinical proof-of-concept, then advances TRP-8803 (proprietary IV psilocin formulation) for precision dosing. Phase 2a fibromyalgia and BED trials showed strong results; the world's first IV psilocin neuropsychiatric trial (TRP-8803 in BED) dosed its first patient on December 1, 2025 at Swinburne University.

Freedom Biosciences is a Yale University spin-out developing next-generation combination therapies for treatment-resistant depression. Co-founded by Yale psychiatry chair Dr. John Krystal (CSO) and Dina Burkitbayeva (CEO, PsyMed Ventures), the company raised $10.5M seed financing in August 2022. Its lead asset FREE001 combines ketamine with temsirolimus (an mTOR inhibitor and prodrug of sirolimus) to extend the antidepressant duration of ketamine from the standard 2–7 days to approximately 14 days. FDA cleared the IND for the Phase 2a study in April 2024, and the trial (FREE001-TRD-201, n≥100) is underway.

Gilgamesh Pharma Inc. is the post-spinoff successor of Gilgamesh Pharmaceuticals, created in October 2025 when AbbVie acquired Gilgamesh's lead asset bretisilocin (GM-2505) for up to $1.2B. Launched with over $100M in funding and retaining the original team, Gilgamesh Pharma is advancing a pipeline of rapid-acting, durable psychiatric therapeutics including blixeprodil (GM-1020), a first-in-class oral NMDA receptor antagonist. Positive Phase 2a data for blixeprodil were announced January 6, 2026, and late-stage development is planned for 2026. The company also retains an ongoing AbbVie collaboration on non-hallucinogenic neuroplastogens.

MSICS Pharma is an Israeli biotechnology company that operates a GMP production facility for naturally-sourced psilocybin. Their lead candidate MSX-06, a naturally-sourced psilocybin formulation, is in Phase 2 clinical development targeting treatment-resistant depression and obsessive-compulsive disorder.

MindBio Therapeutics is a clinical-stage biotechnology company developing MB22001, a proprietary titratable form of LSD designed for take-home microdosing. The company's Phase 2B trials in major depressive disorder and advanced-stage cancer distress have reported strong antidepressant effects, with Phase 2a data showing a 72% reduction in depressive symptoms and 58% remission at six months. MindBio is listed on the Canadian Securities Exchange and the Frankfurt Stock Exchange.

Canadian drug discovery company focused on next-generation psilocybin and DMT analogues, acquired by Otsuka Pharmaceutical in October 2023 for approximately C$80 million. Lead compound MSP-1014, a novel psilocin prodrug, received MHRA approval for a Phase 2 clinical trial in the UK for major depressive disorder.

Otsuka Pharmaceutical Co., Ltd. is a Japanese multinational pharmaceutical company (parent: Otsuka Holdings, TYO: 4578) with a core focus on neuropsychiatry, oncology, and cardiovascular/renal medicine. It entered the psychedelic medicine space by acquiring Canadian biotech Mindset Pharma for ~CAD $80M (~USD $59M) in September 2023, giving it exclusive rights to MSP-1014 and a broader pipeline of novel 5-HT2A agonists. The deal was seeded by an earlier $5M joint development agreement between Mindset and the McQuade Center for Strategic Research and Development (an Otsuka R&D vehicle). MSP-1014 is a Phase 2 psilocin prodrug for MDD, with trials underway in the UK.

Reset Pharma is a US clinical-stage biotechnology company developing psilocybin-based treatments for patients with life-altering diseases. Its lead candidate RSTP1000 (oral psilocybin) targets demoralization syndrome in cancer patients — a condition with no approved treatments. In November 2023 the company received FDA IND clearance to initiate a Phase 2b multicenter, randomized, dose-ranging trial. The company holds an exclusive worldwide licence from NYU Langone Health and licenses drug supply from Filament Health Corp. Reset has raised $11.1M led by Merida Capital Partners.

Canadian biotech (formerly Nova Mentis Life Science, renamed November 2024) developing psilocybin therapy for Fragile X Syndrome and autism spectrum disorder. Lead candidate NM-1001 received Health Canada authorisation for a Phase IIA clinical trial, making it one of the few psilocybin programmes targeting neurodevelopmental 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.

Terran Biosciences is a New York-based drug discovery platform company developing transformative therapeutics for neurological and psychiatric diseases. Founded by CEO Samuel Clark, the company holds over 200 patent applications covering novel formulations of psychedelic compounds including LSD, DMT, psilocybin, and MDMA, and operates clinical programs in schizophrenia and depression. Its AI-enabled neuromelanin MRI software platform NM-101 has received FDA clearance.

Australian biotech (formerly Tryp Therapeutics, relisted on ASX following Exopharm acquisition in May 2024) developing psilocybin and psilocin formulations for treatment-resistant conditions. TRP-8802 (oral psilocybin) completed Phase 2a trials for fibromyalgia and binge eating disorder. TRP-8803 (IV psilocin) has entered Phase 1 with first-in-human dosing.

Xpira Pharmaceuticals is a Toronto-based private biotech developing psilocybin-assisted therapy for anorexia nervosa (AN), a condition with no currently approved pharmacological or psychotherapeutic treatments. Founded in 2020 by leaders from the Canadian and Dutch pharmaceutical industries, the company received FDA IND approval in September 2022 for a Phase 2a clinical trial. Xpira is a portfolio company of Origin Therapeutics Holdings. Dr. Allan Kaplan of CAMH and the University of Toronto serves as VP of Clinical Development.

UK-based biopharmaceutical company developing ketamine and esketamine-based treatments for alcohol use disorder and addiction. AWKN-001 (IV ketamine combined with cognitive behavioural therapy) is in Phase 3 clinical trials in the UK for alcohol use disorder. AWKN-002, an esketamine oral thin film formulation, is in pre-IND development for the US market.

Compass Pathways is a London-based, NASDAQ-listed clinical-stage mental health company developing COMP360 — a proprietary synthetic psilocybin formulation — as a potential first-in-class treatment for psychiatric conditions. Led by CEO Kabir Nath, Compass has built the largest psilocybin clinical programme in history, treating over 1,000 participants across multiple studies. COMP360 holds FDA Breakthrough Therapy Designation and UK ILAP (Innovative Licensing and Access Pathway) designation for treatment-resistant depression (TRD). In June 2025, the first Phase 3 trial (COMP005) met its primary endpoint with a highly significant reduction in MADRS scores (p<0.001, -3.6 difference vs placebo). The second Phase 3 trial (COMP006) also met its primary endpoint in February 2026, using two 25 mg doses three weeks apart. Compass has held a positive Type B FDA meeting and plans a rolling NDA submission in Q4 2026, targeting commercial launch readiness by end of 2026 — which would make COMP360 the first classic psychedelic approved in the US. A Phase 2b/3 trial in PTSD was greenlit in early 2026 following FDA IND acceptance, supported by Phase 2 open-label data showing substantial reductions in CAPS-5 scores.

Definium Therapeutics (formerly Mind Medicine / MindMed) is a late-stage clinical biopharmaceutical company headquartered in New York, founded in 2019 and rebranded in January 2026. Led by CEO Robert Barrow, the company applies scientific rigor to psychedelic-derived molecules to develop accessible, rapidly-acting psychiatric treatments. Its lead asset, DT120 ODT (formerly MM-120) — a pharmaceutically optimised formulation of lysergide D-tartrate (LSD) as an orally disintegrating tablet — has received FDA Breakthrough Therapy Designation for generalised anxiety disorder (GAD) and delivered compelling Phase 2b results: 65% clinical response rate and 48% remission at 12 weeks following a single dose. Three Phase 3 trials are currently underway: Voyage and Panorama (GAD) and Emerge (MDD, fully enrolled). Topline data from all three studies is expected in 2026, potentially positioning Definium for the first-ever FDA approval of an LSD-derived therapy. A second pipeline asset, DT402 (formerly MM402) — an MDMA-related compound — is in Phase 1 development for autism spectrum disorder.

GH Research plc (NASDAQ: GHRS) is a clinical-stage biopharmaceutical company founded in 2018 and headquartered in Dublin, Ireland, developing novel mebufotenin (5-MeO-DMT) therapeutics for treatment-resistant depression, bipolar II disorder, and postpartum depression. Its lead asset GH001 — an inhaled mebufotenin formulation — met the primary endpoint of its Phase 2b TRD trial in February 2025 with striking results: -15.5 point MADRS reduction vs placebo (p<0.0001) and 57.7% remission vs 0%. With a single-day dosing paradigm requiring no structured psychotherapy, GH001 is positioned as a differentiated asset; Phase 3 global initiation is planned for 2026 following FDA clinical hold lift. GH002 (IV mebufotenin) completed Phase 1 in healthy volunteers.

Helus Pharma is the commercial operating name of Cybin Inc., a clinical-stage biopharmaceutical company developing proprietary Novel Serotonergic Agonists (NSAs) — synthetic deuterated molecules designed to activate serotonin pathways and promote neuroplasticity. Operating across Canada, the US, UK, and Ireland, Helus holds over 100 granted patents and 250+ pending applications across its NSA portfolio. Its lead asset, HLP003 (formerly CYB003, a deuterated psilocin analogue), has received FDA Breakthrough Therapy Designation for the adjunctive treatment of major depressive disorder and is in two concurrent Phase 3 trials: APPROACH™ (topline data Q4 2026) and EMBRACE™. A key differentiator is its adjunctive design — allowing patients to continue background antidepressant medications without washout. HLP004 (a deuterated DMT analogue for intramuscular use) posted encouraging Phase 2 topline results in GAD in March 2026: 10.4-point HAM-A reduction at 6 weeks, 67% responders at 6 months, and an ~90-minute in-clinic session window. US composition-of-matter patent coverage through at least 2041.

Reunion Neuroscience is a private, Toronto-based clinical-stage biopharmaceutical company focused on short-duration, serotonergic psychedelic therapies for postpartum depression, adjustment disorder, and anxiety. Spun out of Field Trip Health in 2022, the company raised a $103M Series A in May 2024 (co-led by Novo Holdings and MPM BioImpact) and went private under CEO Greg Mayes. Its lead asset RE104 (luvesilocin) — a subcutaneous prodrug of 4-OH-DiPT, a psilocybin-like 5-HT2A agonist with shorter duration than psilocybin — met the primary endpoint of its RECONNECT Phase 2 trial for PPD (Aug 2025) and received FDA Breakthrough Therapy Designation on February 23, 2026. A single pivotal Phase 3 trial is planned for 2026.

Solvonis Therapeutics plc (LSE: SVNS) is a London-listed, clinical-stage biopharmaceutical company developing evidence-based treatments for addiction and mental health disorders. Formed through the rebranding of Graft Polymer (UK) PLC and the acquisition of Awakn Life Sciences Corp (NEO: AWKN, completed May 2025), Solvonis inherited Awakn's lead programme SVN-001 — IV ketamine combined with manualised CBT — now in Phase 3 for severe alcohol use disorder, co-funded by the UK NIHR. The company also advances SVN-002 (buccal/sublingual esketamine for US AUD) and SVN-SDN-14 (novel SDN receptor modulators for PTSD at preclinical stage), plus an AI-driven CNS discovery engine.

Transcend Therapeutics is a private, New York-based clinical-stage company developing TSND-201 (methylone), a rapid-acting neuroplastogen for PTSD and other neuropsychiatric conditions. Founded in 2021 by Blake Mandell (CEO), Kevin Ryan (AlleyCorp), and Dr. Benjamin Kelmendi (Yale), the company raised $41.5M from investors including the US Department of Defense. TSND-201 is non-hallucinogenic (no 5-HT2A activity) and requires no structured psychotherapy. Its Phase 2 IMPACT-1 trial met the primary endpoint (March 2025, published JAMA Psychiatry Feb 2026) and the FDA granted Breakthrough Therapy Designation in July 2025. Phase 3 programme is planned for 2026.

Usona Institute is a US-based 501(c)(3) non-profit medical research organisation (MRO) headquartered in Madison, Wisconsin. Co-founded in 2014 by Bill Linton (CEO of Promega Corporation) and Malynn Utzinger, M.D., Usona was established after Linton witnessed the profound impact of a Johns Hopkins psilocybin study on a terminally ill friend. Unlike commercial drug developers, Usona operates as a mission-driven MRO — conducting and supporting pre-clinical and clinical research on psilocybin and other consciousness-expanding medicines, with the goal of developing accessible, affordable treatments. Its research leadership includes Dr. Charles Raison (Director of Clinical and Translational Research, UW-Madison psychiatrist) and Dr. Alexander Sherwood (medicinal chemist). Usona's psilocybin programme received FDA Breakthrough Therapy Designation for major depressive disorder in 2019. After completing the Phase 2 PSIL201 study (the largest Phase 2 randomised controlled trial of psilocybin for MDD at the time), the Institute launched the Phase 3 uAspire trial in 2024 — a 240-participant, randomised, double-blind, multicentre study comparing 25 mg psilocybin vs placebo in adults with MDD. Usona is also exploring 5-MeO-DMT in early-stage research.

NRx Pharmaceuticals is a US-based NASDAQ-listed biopharmaceutical company developing NRX-100, a proprietary preservative-free formulation of intravenous ketamine, for the acute treatment of suicidal ideation in patients with depression including bipolar depression. Unlike most commercially available ketamine products, NRX-100 omits the benzethonium chloride preservative, whose safety profile in repeated dosing has not been established. Rather than running a traditional Phase 3 trial, NRx is pursuing NDA approval based on already-completed government-funded controlled trials (demonstrating 55–63% response/remission vs 30–31% for comparators), expanded access data, and — in a regulatory first — de-identified real-world evidence from over 70,000 US patients treated with IV or intranasal ketamine, licensed and submitted to the FDA in January 2026. The FDA granted Fast Track Designation to NRX-100 for suicidal ideation in depression in August 2025, and the company has applied for a Commissioner’s National Priority Voucher (CNPV) review, which could reduce review time to 1–2 months. The NDA filing is underway, with PDUFA date expected 2025–2026. A parallel generic pathway (KETAFREE™ ANDA) targets the broader ketamine market, with a Q2 2026 GDUFA date anticipated.

Resilient Pharmaceuticals (formerly Lykos Therapeutics, formerly MAPS PBC) is a US-based public benefit corporation developing MDMA-assisted therapy for PTSD. It was founded in 2014 by MAPS (Multidisciplinary Association for Psychedelic Studies) as a commercial spinout to carry MAPS’ three decades of MDMA research through late-stage trials and regulatory approval. After completing two Phase 3 trials and filing an NDA in 2024, the FDA issued a Complete Response Letter (CRL) in August 2024, citing concerns about functional unblinding, durability of response, safety reporting at two trial sites, and the challenge of blinding psychedelic studies. The CRL requested a third Phase 3 trial. Following the rejection, the company laid off approximately 75% of staff. In May 2025, billionaire investors Antonio Gracias (Gracias Foundation) and Sir Christopher Hohn (TCI Fund) led a $50 million Series B recapitalisation, installing new leadership: CEO Mike Burke and CMO Javier Muniz. Rick Doblin, MAPS’ founder, remains supportive of the new direction. The company rebranded from Lykos Therapeutics to Resilient Pharmaceuticals on 28 August 2025, and continues to negotiate a path to FDA approval for MDMA-assisted therapy for PTSD.

Australian clinical-stage biotech pioneering psychedelic-assisted therapies. In 2025, Emyria became the first company in the world to commercially deliver MDMA-assisted psychotherapy for PTSD, with insurance funding secured from Medibank. Also operates a clinical trial division and an MDMA analogue discovery program in collaboration with the University of Western Australia.

Canadian specialty pharmaceutical company focused on ketamine-based therapies for psychiatric and neurological conditions. KETARX™ (racemic ketamine IV) received FDA approval in August 2025, making PharmaTher one of the first Canadian companies to achieve US regulatory approval for a ketamine product. Also developing KETABET, a proprietary combination of ketamine and betaine.