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.

Company

Indication

Phase I

Phase II

Phase III

MAPS Logo

Post-traumatic stress disorder (PTSD)

MDMA
III
Compass Pathways logo colour

Treatment-resistant depression (TRD)

COMP360
II
Usona Institute logo

Major depressive disorder (MDD)

Psilocybin
II
MAPS Logo

Eating disorders (anorexia nervosa and binge-eating disorder)

MDMA
II
MAPS Logo

Anxiety associated with a life-threatening illness

MDMA
II
MAPS Logo

Social anxiety in autistic adults

MDMA
II
MindMed Logo

Anxiety

LSD
II
MindMed Logo

Cluster headaches

LSD
II
Seelos Therapeutics

Acute suicidal ideation and behaviour (ASIB) in major depressive disorder

SLS-002
II
Awakn Life Sciences

Alcohol use disorder

MDMA
II
B.More

Alcohol use disorder

Psilocybin
II
Braxia Scientific Logo

Treatment-resistant depression

Psilocybin
II
Tryp Therapeutics Logo 1

Overeating disorders

TRP-8802
II
Compass Pathways logo colour

Post-traumatic stress disorder (PTSD)

COMP360
II
Cybin

Major depressive disorder

CYB001
II
DemeRx Logo

Opioid use disorder

DMX-NB1
II
Eleusis Logo

Major depressive disorder (adjunctive treatment)

ELE-Ket+
II
Incannex

Generalized anxiety disorder

Psilocybin
II
MAPS Logo

CBCT for PTSD

MDMA
II
MindMed Logo

Attention deficit hyperactivity disorder (ADHD)

LSD
II
MindMed Logo

Undisclosed severe pain indication

LSD
II
Mydecine Innovations logo

Post-traumatic stress disorder (PTSD)

Psilocybin
II
Perception Neuroscience

Treatment-resistant depression (TRD)

PCN-101
II
Pharmather

Levodopa-induced dyskinesia in patients with Parkinson's disease

Ketamine
II
GH Research

Treatment-resistant depression (TRD)

GH001
I / II
Small Pharma Logo

Major depressive disorder (MDD)

SPL026
I / II
DemeRx Logo

Opioid use disorder

DMX-1002
I / II
Beckley Psytech Logo

Undisclosed

5-MeO-DMT
I
Eleusis Logo

Alzheimer's Disease

ELE-LSD
I
MindMed Logo

Opioid use disorder

18-MC
I
MindMed Logo

Undisclosed

DMT
I
MindMed Logo

Undisclosed

MDMA+LSD
I
MindMed Logo

Undisclosed

Mescaline
I
MindMed Logo
Ketanserin
I
Algernon Pharmaceuticals

Ischemic stroke and post-stroke rehabilitation

AP-188
I
Beckley Psytech Logo

Short-lasting unilaterial neuralgiform headache attacks (SUNHA)

Psilocybin
I
Ceruvia Lifesciences

Cluster headache

NYPRG-101
I
Ceruvia Lifesciences

Migraine

NYPRG-101
I
Ceruvia Lifesciences

Migraine

SYNP-101
I
Ceruvia Lifesciences

Cluster headache

SYNP-101
I
Ceruvia Lifesciences

Obsessive compulsive disorder

SYNP-101
I
Diamond Therapeutics

Anxiety

Psilocybin
I
Entheon Biomedical Logo

(Unspecified) Substance use disorder

DMT
I
Filament Health invite

Undisclosed

PEX010
II
Filament Health invite

Undisclosed

PEX020...
I
Filament Health invite

Undisclosed

PEX030...
I
Journey Colab

Alcohol use disorder

JOUR-001
I
MindMed Logo

Social anxiety associated with Autism Spectrum Disorder

R-MDMA
I
Numinus logo

Undisclosed

PSYBINA
I
Sacred Medicines

Undisclosed

Ayahuasca
I

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.

Preclinical

CaamTech Logo Colour
Various
Preclinical
Cybin
CYB003/4
Preclinical
Eleusis Logo
ELE-Psilo+
Preclinical
Tryp Therapeutics Logo 1
TRP-8802
Preclinical
Gilgamesh Pharmaceuticals logo
Various
Preclinical
Viridia Life Sciences
DMT
Preclinical
GH Research
GH002
Preclinical
Bexson Biomedical
BB-106
Preclinical
Small Pharma Logo
Unkown
Preclinical
Field Trip logo
FT-104
Preclinical
Psilera Bioscience
Various
Preclinical
Delix Therapeutics
Various
Preclinical
Lophora
Psilocybin
Preclinical
Lobe Sciences Logo
Psilocybin + NAC
Preclinical
Neonmind logo
Psilocybin
Preclinical
Bright Minds Biosciences
Various
Preclinical
Alvarius Placeholder
5-MeO-DMT
Preclinical
Usona Institute logo
5-MeO-DMT
Preclinical
Wesana Health
Psilocybin
Preclinical
BetterLife Pharma
TD-0148A
Preclinical
Mydecine Innovations logo
Various
Preclinical
Revixia Life Sciences
RLS-01
Preclinical
Ceruvia Lifesciences
NYPRG-101
Preclinical
Mindstate Design Labs
MSD-101
Preclinical
Nova Mentis logo
Psilocybin
Preclinical

Discovery

Eleusis Logo
Discovery
EmpathBio Logo
Discovery
Tactogen
Discovery
CaamTech Logo Colour
Discovery
Cybin
Discovery
Mindset Pharma Logo
Discovery
PsyBio Logo
Discovery
Mindstate Design Labs
Discovery

Suggestions & Comments

Psilocybin 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. 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, you are welcome to contact us at industry@psilocybinalpha.com