The Psychedelics Drug Development Tracker

Developed by Michael Haichin, PharmD.

New: Visualise this tracker as a 🎯 Bullseye Chart.

New: Visualise this tracker as a
🎯 Bullseye Chart.

Mapping Drug Development in Psychedelics

This overview seeks to map out drug discovery & development activity in psychedelics. Candidates currently undergoing clinical trials are presented first, while those that are at the discovery or preclinical stage are catalogued in the latter half of this page.

Due to the large amount of data presented on this page, we recommend you explore this resource on a desktop device. If you’re visiting this page on mobile, you may wish to email it to yourself to revisit when you’re on a device with a larger screen: click here to do so.

Those unfamiliar with the drug development and approval process may wish to review our Primer before continuing…

Discovery

The very first stage of the drug development process is the discovery of one or multiple suitable molecules that have therapeutic potential for improving certain diseases. The discovery process includes screening many molecules in the laboratory to identify those with desired properties before they are considered to be lead candidates that may progress to preclinical studies.

Preclinical

The preclinical stage involves lab and animal testing to identify one or more lead compounds and determine if they are safe for human testing.

Phase I

Phase I clinical trials are intended to establish initial safety in humans. The drug is given to a small number of healthy volunteers to test for possible side effects and determine what the safe dosing range is.

Phase II

Phase II clinical trials are the first in which the drug is tested in a small group of patient volunteers with the disease it is meant to treat. Phase II studies assess the safety and efficacy of the drug across a range of doses. Due to the small number of patients involved, conclusions about overall efficacy cannot be drawn, however Phase II trials provide guidance on how to optimally design larger Phase III trials to confirm the drug’s safety and efficacy.

Phase III

Phase III trials, also known as pivotal trials, demonstrate a drug’s safety and efficacy in a large group of patients. Typically, at least two successful Phase III trials are required in order to provide sufficient evidence of efficacy. Given the large number of patients required, Phase III trials are most often multi-centre, international trials.

Approval

At this stage, pharmaceutical companies can submit applications for drug approval. Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States, review the data generated in all the studies (from preclinical to phase III), and after weighing the benefits and risk of the potential medicine, decide whether to grant approval.

Clinical Trials

The below companies are in the process of stewarding their drug candidates through clinical trials. Each drug and target indication are afforded their own row. As such, some companies and drugs appear more than once.

Following successful Phase III trials, a company may submit an application for drug approval. Regulators review data generated across all studies when deciding whether to grant approval. It can take up to 10 months for the FDA, for example, to approve a New Drug Application.

Approved

Treatment-Resistant Depression; Acute Suicidal Ideation & Behaviour in Major Depressive Disorder | Spravato (Esketamine) | Approved

Phase 3

Compass Pathways logo colour

Treatment-Resistant Depression | COMP360 (Psilocybin) | Phase 3

Usona Institute logo

Major Depressive Disorder | Psilocybin | Phase 3

Cybin

Major Depressive Disorder | CYB003 (Deuterated Psilocybin Analog) | Phase 3

MindMed Logo

Generalized Anxiety Disorder | MM-120 (LSD D-tartrate ODT) | Phase 3

Awakn Life Sciences

Alcohol Use Disorder | Ketamine | Phase 3

Lykos Logo

Post-Traumatic Stress Disorder | MDMA | Phase 3

Phase 2

GH Research Logo 2025

Treatment-Resistant Depression; Bipolar II Disorder; Postpartum Depression | GH001 (5-MeO-DMT) | Phase 2

Beckley Psytech Logo

Treatment-Resistant Depression; Alcohol Use Disorder | BPL-003 (5-MeO-DMT) | Phase 2

Post-Traumatic Stress Disorder | TSND-201 (Methylone) | Phase 2

MindMed Logo

Major Depressive Disorder | LSD D-tartrate ODT | Phase 2

Major Depressive Disorder | MSP-1014 (Psilocybin-Like NCE) | Phase 2

Cybin

Generalized Anxiety Disorder | CYB004 (IM Deuterated DMT Analog) | Phase 2

Major Depressive Disorder | FREE001 (Ketamine & Temsirolimus) | Phase 2

Major Depressive Disorder | GM-2505 (5-HT2A Agonist & 5-HT Releaser) | Phase 2

Reunion Logo

Post-Partum Depression | RE104 (4-OH-DiPT Prodrug Subcutaneous Injection) | Phase 2

Depression & Anxiety With PTSD; Depression with PTSD | APEX-52 / 90 (Psilocybin) | Phase 2

Major Depressive Disorder (MDD) | GM-1020 (Oral NMDAR Antagonist) | Phase 2

Restart Life Sciences

Fragile X Syndrome | Psilocybin | Phase 2

Alcohol Use Disorder | SYNP-101 (Psilocybin) | Phase 2

Tryp Therapeutics

Fibromyalgia; Binge Eating Disorder; IBS | TRP-8802 (Psilocybin) | Phase 2

Beckley Psytech Logo

Major Depressive Disorder | ELE-101 (IV Psilocin) | Phase 2

Filament Health invite

Methamphetamine Use Disorder; Opioid Use Disorder | PEX010 (Psilocybin) | Phase 2

Incannex

Generalized Anxiety Disorder | Psi-GAD (Psilocybin) | Phase 2

Psyence Biomed Logo

Adjustment Disorder | Psilocybin | Phase 2

Diamond Therapeutics

Generalized Anxiety Disorder | Psilocybin | Phase 2

Demoralization Syndrome | RSTP-1000 (Psilocybin) | Phase 2

Tactogen

Post-Traumatic Stress Disorder | MDMA + Citalopram | Phase 2

Social Anxiety in Autism Spectrum Disorder | ALA-002 (Non-Racemic MDMA) | Phase 2

Mindbio Logo

Major Depressive Disorder; Existential Distress in Cancer Patients | MB22001 (LSD) | Phase 2

Treatment-Resistant Depression (TRD) | BMND01 (DMT) | Phase 2

Seelos Therapeutics

PTSD; Acute Suicidal Ideation & Behaviour in MDD | SLS-002 (Intranasal Ketamine) | Phase 2

Clexio Biosciences

Major Depressive Disorder (MDD) | CLE-100 (Esketamine) | Phase 2

Depression & Anxiety In Alzheimer's | BMND08 (Sublingual 5-MeO-DMT) | Phase 2

Generalised Anxiety Disorder | RE02 (5-MeO-DMT) | Phase 1/2

Cocaine Use Disorder | RE01 (DMT & Harmine) | Phase 1/2

ATAI Life Sciences Logo

Opioid Use Disorder | IBX-210 (IV Ibogaine) | Phase 1/2

Phase 1

DemeRx Logo

Alcohol Use Disorder | DMX-1001 (Noribogaine) | Phase 1

Substance Use Disorders | 5-MeO-DMT | Phase 1

Usona Institute logo

Undisclosed | 5-MeO-DMT | Phase 1

ATAI Life Sciences Logo

Social Anxiety Disorder | EMP-01 (R-MDMA) | Phase 1

Relmada Logo

Metabolic Disease | REL-P11 (Psilocybin) | Phase 1

ATAI Life Sciences Logo

Treatment-Resistant Depression | VLS-01 (Buccal Film DMT) | Phase 1

GH Research Logo 2025

Psychiatric/Neurological Disorders | GH002 (IV 5-MeO-DMT) | Phase 1

Mycomedica Logo

Opioid Use Disorder; Obsessive Compulsive Disorder; Premenstrual Dysphoric Disorder; Neuropsychiatric Disorders | MLS101 (Psilocybin) | Phase 1

Ceruvia Lifesciences

Headache Disorder; Obsessive Compulsive Disorder | SYNP-101 (Psilocybin) | Phase 1

Major Depressive Disorder; CNS Disorders | TSND-201 (Methylone) | Phase 1

MindMed Logo

Autism Spectrum Disorder | MM-402 (R(-)-MDMA) | Phase 1

Ceruvia Lifesciences

Headache Disorders | NYPRG-101 (BOL-148) | Phase 1

Undisclosed | DMT & Beta-Carboline | Phase 1

Algernon Logo

Stroke | AP-188 (IV DMT) | Phase 1

Awakn Life Sciences

Alcohol Use Disorder | AWKN-002 (Esketamine OTF) | Phase 1

Clexio Biosciences

Depression in Bipolar Disorder | CLE-100 (Esketamine) | Phase 1

Obesity | BMND06 (Mescaline-Based) | Phase 1

Journey Colab

Alcohol Use Disorder | JOUR-5700 (Mescaline HCl) | Phase 1

Alcohol Use Disorder | CMND-100 (MEAI) | Phase 1

Major Depressive Disorder | DLX-001 (AAZ-A-154) | Phase 1

Mindstate Design

Undisclosed | MSD-001 (5-MeO-MiPT) | Phase 1

Parkinson's | BMND09 | Phase 1

Lophora

Treatment-Resistant Depression | LPH-5 (Novel Phenethylamine) | Phase 1

Discovery & Preclinical​

The very first stage of the drug development process is the discovery of one or multiple suitable molecules that have therapeutic potential for improving certain diseases. The discovery process includes screening many molecules in the laboratory to identify those with desired properties before they are considered to be lead candidates that may progress to preclinical studies.

The preclinical stage involves lab and animal testing to identify one or more lead compounds and determine if they are safe for human testing. If the lead compound(s) are found to be safe for human testing, clinical trials may commence.

Seaport Therapeutics Logo

Mood & Neuropsychiatric Disorders | SPT-348 (Non-Hallucinogenic Neuroplastogen)

Depression | XYL-1001 (Non-Hallucinogenic 2A-Preferring Full Agonist)

Depression | XYL-400X (Non-Hallucinogenic)

Anxiety | XYL-1002 (Non-Hallucinogenic Multi-Target 2A Preferring Agonist)

Substance Use Disorders | XYL-300X (Non-Hallucinogenic)

Depression, Anxiety, and Others | GM-5022 (Neuroplastogens)

Opioid Use Disorder, PTSD, Traumatic Brain Injury | GMX-3009 (Ibogaine Analogs)

Undisclosed | Various NCEs (Mindset)

Intra-Cellular Therapies

Mood & Neuropsychiatric Disorders | ITI-1549 (Non-Hallucinogenic Neuroplastogen)

Neuropsychiatry | DLX-159 (Tryptamine Neuroplastogen)

Substance Use Disorders | DLX-007 (Tabernanthalog)

Inflammatory Diseases & Others | Various NCEs

GH Research Logo 2025

Psychiatric/Neurological Disorders | GH003 (Nasal 5-MeO-DMT)

Tactogen

Cluster Headache | TACT908

Alcohol Use Disorder; Eating Disorders | TACT411/833

Beckley Psytech Logo

Neuropsychiatry | NCEs

Sensorium Therapeutics Logo

Social Anxiety Disorder | SENS-01

Psy Therapeutics

Undisclosed | NCE Discovery

Undisclosed | Various NCEs

Undisclosed | ASR-3001 (Short-Acting Tryptamines)

Undisclosed | ASR-2001 (Phenethylamine)

Anxiety Disorders | PSIL-025 (Non-Hallucinogenic)

Undisclosed | PSIL-020 (Non-Hallucinogenic 5-HT6 Agonist)

Frontotemporal Dementia | PSIL-006 (Tryptamine)

Bright Minds Biosciences

Neurology, Neuropsychiatry, Obesity & Feeding Disorders | BMB-XXX (5-HT2A/C Agonist)

Depression | BMB-202 (5-HT2A Agonist)

Treatment-Resistant Depression | BMB-201 (Psychoplastogen)

Undisclosed | NCE Discovery

Major Depressive Disorder | CT-4201 (Psilocin Prodrug)

Arcadia Logo

Major Depressive Disorder | AM-1004 (Psychoactive & Empathogen)

Substance Use Disorders | AM-1006 (Psychoactive NCE)

PTSD | AM-1002 (Non-Racemic MDMA)

Lophora

Alcohol Use Disorder | LPH-48 (Novel Phenethylamine; LPH-5 Analog)

Undisclosed | 5-HT2AR Active Compounds

Reunion Logo

Undisclosed | RE245 (Neuroplastogen)

ATAI Life Sciences Logo

Undisclosed | EGX-121 (Non-Tryptamine NCE)

Undisclosed | NCEs

Cacti Logo

Pain & Headache | NCEs

Cybin

CNS Disorders | CYB005 (Phenethylamine Derivative)

Opioid Use Disorder | Psychoplastogens

Bexson Biomedical

Undisclosed | NMDA Receptor Antagonists

Acute Pain Management & Mental Health Indications | BB106 (Ketamine)

Mindstate Design

Undisclosed | Various

Undisclosed | NCEs

Equulus Logo

Substance Use Disorders | Non-Hallucinogenic Ibogaine Derivative

Major Depressive Disorder; Anxiety Disorder; Neuropathic Pain | BETR-001 (BOL-148)

Soneira Logo

Traumatic Brain Injury | Ibogaine

Pharmadrug Logo

Glaucoma | DMT

Enveric Biosciences

Anxiety, Depression & Other Disorders | EB-003 (DMT Analog)

Remedi Therapeutics Logo

Undisclosed | DMT & RIMA

Undisclosed | 5-MeO-DMT Analogs

Undisclosed | ET-01

Substance Use Disorders | BMND03

Fibromyalgia | BMND02 (5-MeO-DMT)

Chronic Pain | BMND05 (5-MeO-DMT)

Major Depressive Disorder | BMND07 (5-MeO-DMT)

Terran Biosciences Logo

Undisclosed | NCEs

Undisclosed | ABA Family (MBDB)

Undisclosed | APA-01 (NCE)

Undisclosed | NCE Discovery

Major Depressive Disorder; PTSD | Psi-X (Non-Hallucinogenic)

Major Depressive Disorder | Psi-D+

Anorexia Nervosa | Psilocybin & Beta-Carboline

Tryp Therapeutics

IBS; Binge Eating Disorder; Fibromyalgia | IV Psilocin

Awakn Life Sciences

Substance Use & Mental Health Disorders | Aminoindane NCEs

Substance Use Disorders | MDMA Zydis

Suggestions & Comments

Psychedelic Alpha reserves its right to exercise editorial judgement regarding the inclusion of drug development projects on this page, and does not claim that this resource is definitive. For example, due to the variability in data ownership and rights, investigator-initiated trial (IITs) are omitted from this tracker. As with all of our resources, this should not inform investment decisions.

If you would like to suggest an addition or amendment to The Psychedelic Drugs Development Tracker, or discuss obtaining a more detailed version of this dataset, you are welcome to contact us at industry@psychedelicalpha.com.

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