Psychedelics Drug Development Tracker

Developed by Michael Haichin, PharmD

Mapping Drug Development in Psychedelics

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

Clicking on a company logo will present a brief summary of the related drug development activity, plus a link to the ClinicalTrials.gov entry for the relevant drug candidate, where available.

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.

Reminder: click on logos to learn more about the drug under development.

Regulatory Review

Lykos

Post-traumatic stress disorder (PTSD) | MDMA | NDA

Phase 3

Compass Pathways logo colour

Treatment-resistant depression (TRD) | COMP360 (Psilocybin) | Phase 3

Awakn Life Sciences

Alcohol use disorder (AUD) | Ketamine | Phase 3

Phase 2

GH Research

Treatment-resistant depression (TRD) | GH001 (5-MeO-DMT) | Phase 2b

MindMed Logo

Generalized Anxiety Disorder (GAD) | MM-120 (LSD) | Phase 2b

B More Logo

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

Apex Labs Logo

Depression & Anxiety With PTSD | APEX-52 (Psilocybin) | Phase 2b

Apex Labs Logo

Depression WIth PTSD | APEX-90 (Psilocybin) | Phase 2b

GH Research

Bipolar Disorder II (BDII) | GH001 (5-MeO-DMT) | Phase 2

GH Research

Postpartum Depression (PPD) | GH001 (5-MeO-DMT) | Phase 2

Nova Mentis logo

Fragile X Syndrome | NM-1001 (Psilocybin) | Phase 2a

Beckley Psytech Logo

Treatment-resistant depression (TRD) | BPL-003 (5-MeO-DMT) | Phase 2b

Usona Institute logo

Major Depressive Disorder (MDD) | Psilocybin | Phase 2

Tryp Therapeutics

Fibromyalgia | TRP-8802 (Psilocybin) | Phase 2a

Compass Pathways logo colour

Anorexia Nervosa | COMP360 (Psilocybin) | Phase 2

Compass Pathways logo colour

Post-traumatic stress disorder (PTSD) | COMP360 (Psilocybin) | Phase 2

Braxia Scientific

Treatment-resistant depression (TRD) | Psilocybin | Phase 2

Janssen logo

Major Depressive Disorder (MDD) | Spravato (Esketamine) | Phase 2

Seelos Therapeutics

Post-Traumatic Stress Disorder (PTSD) | SLS-002 (Ketamine) | Phase 2

MindMed Logo

Cluster Headaches | LSD | Phase 2

Incannex

Generalized Anxiety Disorder (GAD) | Psilocybin | Phase 2

Clexio Biosciences

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

ClairvoyantLogo2

Alcohol Use Disorder (AUD) | Psilocybin | Phase 2

Ceruvia Lifesciences

Obsessive Compulsive Disorder (OCD) | SYNP-101 (Psilocybin) | Phase 2

Psyence

Adjustment Disorder | Psilocybin | Phase 2

Beckley Psytech Logo

Alcohol Use Disorder (AUD) | BPL-003 (5-MeO-DMT) | Phase 2

Cybin

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

Cybin

Major Depressive Disorder (MDD) | CYB003 (Deuterated Psilocybin Analog) | Phase 2

biomind labs

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

biomind labs

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

GilgameshLogo

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

GilgameshLogo

Major Depressive Disorder (MDD) | GM-2505 (5HT2A Agonist) | Phase 2

Reunion Logo

Post-Partum Depression (PPD) | RE104 (4-HO-DiPT; Isoprocin Glutarate) | Phase 2

Transcend Therapeutics Logo

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

Tactogen

Post-Traumatic Stress Disorder (PTSD) | MDMA + Citalopram | Phase 2

62dfc9bcaf097fb141479cf0

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

Diamond Therapeutics

Generalized Anxiety Disorder (GAD) | Low Dose Psilocybin | Phase 2

Reset Pharma

Demoralization in Patients With Cancer | RSTP-1000 (Psilocybin) | Phase 2

Phase 1

DemeRx Logo

Opiate Withdrawal Syndrome | DMX-1002 (Ibogaine) | Phase 1/2

Cybin

Major Depressive Disorder (MDD) | CYB003 (Deuterated Psilocybin Analog) | Phase 1/2

Delix Logo (Colour)

Depressive Disorders | AAZ-A-154 | Phase 1

Beckley Psytech Logo

Major Depressive Disorder (MDD) | ELE-101 (Psilocin) | Phase 1/2

Algernon Pharmaceuticals

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

biomind labs

Healthy Volunteers | BMND01 (DMT) | Phase 1

MindMed Logo

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

Ceruvia Lifesciences

Cluster Headaches | NYPRG-101 (BOL-148) | Phase 1

GH Research

Healthy Volunteers | GH002 (5-MeO-DMT) | Phase 1

EmpathBio Logo

Post-traumatic stress disorder (PTSD) | EMP-01 (MDMA Derivative) | Phase 1

Viridia Life Sciences

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

Bright Minds Biosciences

Healthy Volunteers | BMB-101 (5-HT2C Agonist) | Phase 1

Ceruvia Lifesciences

Migraines | NYPRG-101 (BOL-148) | Phase 1

Lobe Sciences Logo

Chronic Cluster Headache | L-130 (Psilocin) | Phase 1

Ceruvia Lifesciences

Headache Disorder | SYNP-101 (Psilocybin) | Phase 1

Ceruvia Lifesciences

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

Transcend Therapeutics Logo

Major Depressive Disorder (MDD) | TSND-201 (Methylone) | Phase 1

Reconnect Logo

Affective Disorders | RE01 (Pharmahuasca) | Phase 1

Reconnect Logo

Chronic Pain | RE02 (5-MeO-DMT) | Phase 1

Psychae Logo

Healthy Volunteers | DMT | Phase 1

Usona Institute logo

Undisclosed | 5-MeO-DMT | Phase 1

Alvarius Logo (1)

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

Journey Colab

Substance Use Disorders | JOUR-5700 (Mescaline) | Phase 1

Clexio Biosciences

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

Clearmind Medicine

Alcohol Use Disorder (AUD) | CMND-100 (MEAI) | 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.

Note that the amount of publicly-available information for each program differs.

Preclinical

Delix Logo (Colour)
Cybin
Ceruvia Lifesciences
Bexson Biomedical
GilgameshLogo
Terran Biosciences Logo
Freedom Biosciences
62dfc9bcaf097fb141479cf0
Arcadia Medicine Logo
Lophora
Psilera
Transcend Therapeutics Logo
Bright Minds Biosciences
CaamTech Logo Colour
GH Research
ASRI
Neonmind logo
Journey Colab
Tactogen
Better Life
Lobe Sciences Logo
Sensorium Therapeutics Logo
Clearmind Medicine
Tryp Therapeutics
Enveric Biosciences
Empyrean Logo
Mindstate Design
Psy Therapeutics
2A Bio
Intracellular
PSYLO Logo
ATAI Life Sciences Logo

Discovery

ATAI Life Sciences Logo
CaamTech Logo Colour
Psy Therapeutics
Compass Pathways logo colour
Empyrean Logo
PSYLO Logo
Mindstate Design
Beckley Psytech Logo
Onsero Logo

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 this Psychedelics Drugs Development Tracker, or discuss obtaining a more detailed version of this dataset, you are welcome to contact us at industry@psychedelicalpha.com.