Psychedelics Drug Development Tracker

Developed by Michael Haichin, PharmD

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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.

Phase 3

MAPS PBC

MAPS has completed conducting two Phase 3 trials investigating MDMA-assisted psychotherapy as a potential treatment of post-traumatic stress disorder after receiving Breakthrough Therapy Status from the FDA. The first Phase III study (MAPP1) is published here and a second Phase III study (MAPP2) was announced as completed in December 2022 (NCT04077437). 

MAPS is targeting an NDA submission to the FDA in 2023. Phase 3 participants who were assigned to the placebo group are eligible to enrol in an open label trial to receive MDMA (NCT04714359).

Phase 3 participants who received MDMA treatment are eligible to enrol in a long-term follow-up study. More details about the ongoing trial can be found in the clinical trial registration link below.

MAPS was also granted an Innovation Passport Designation for MDMA-assisted psychotherapy from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). More details about MAPS's MDMA product, including previous trial results, can be found in their published Investigator's Brochure.

ClinicalTrials.gov Identifier: NCT05066282

MAPS PBC

Post-traumatic stress disorder (PTSD) | MDMA | Phase 3

COMPASS Pathways

COMP360 is a psilocybin formulation currently being evaluated for potential use in treatment-resistant depression, after receiving Breakthrough Therapy Status from the FDA. Compass' Phase 3 program is composed of three clinical trials, two pivotal trials (known as COMP 005 and COMP 006) and one long-term follow-up, and is expected to commence by the end of 2022. More details about COMP005 can be found in the clinical trial registration link below. To learn more about the design of the Phase 3 studies, see Psychedelic Alpha Bulletin #120.

ClinicalTrials.gov Identifier COMP005: NCT05624268

ClinicalTrials.gov Identifier COMP006: NCT05711940

Compass Pathways logo colour

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

Awakn Life Sciences

Awakn is set to evaluate ketamine-assisted psychotherapy in a Phase 3 trial for the treatment of alcohol use disorder. Results from the Phase 2 trial can be found here.

Awakn Life Sciences

Alcohol use disorder (AUD) | Ketamine | Phase 3

Phase 2

GH Research

GH001 is an inhaled formulation of 5-MeO-DMT, a short-acting psychedelic. GH001 is set to be evaluated in a Phase 2b trial for potential use in treatment-resistant depression. More details about the Phase 2b study can be found in the clinical trial registration link below. A combined Phase I/II study investigating GH001 for potential use in treatment-resistant depression was completed in 2021. The results of a Phase I study of GH001 were published here.

EudraCT Number: 2022-000574-26

GH Research

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

MindMed

MM-120 is a formulation of LSD being evaluated in a Phase 2b study as a potential treatment for generalized anxiety disorder. As part of a deal with University Hospital Basel's Liechti Lab, MindMed acquired the rights to a completed Phase 2 trial, which was published here. 

More details about the ongoing study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05407064

MindMed Logo

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

B.More

SYNP-101 is a synthetic form of psilocybin being developed by B.More. SYNP-101 is set to be evaluated in a Phase 2b trial as a potential treatment for alcohol use disorder. The results of an associated pilot trial can be found here. 

B More Logo

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

Apex Labs

APEX-52 is a low dose psilocybin formulation being evaluated in a Phase 2b study as a potential take home treatment for depression in veterans with PTSD.

Apex Labs Logo

Post-traumatic stress disorder (PTSD) | APEX-25 (Psilocybin) | Phase 2b

Perception Neuroscience (an atai Life Sciences platform company)

PCN-101 is arketamine (or R-ketamine), an isomer of ketamine. PCN-101 was evaluated in a Phase II trial for potential use in treatment-resistant depression. More details about the study can be found in the clinical trial registration below. Perception Neuroscience is one of atai Life Sciences' drug development programs.

ClinicalTrials.gov Identifier: NCT05414422

Perception Neuroscience

Treatment-resistant depression (TRD) | PCN-101 (R-ketamine) | Phase 2 (Complete)

GH Research

GH001 is an inhaled formulation of 5-MeO-DMT, a short-acting psychedelic. GH001 is being evaluated in a Phase 2 trial in patients with bipolar II disorder and a current major depressive episode. More details about the Phase 2 study can be found in the clinical trial registration link below.

EudraCT Number: 2021-006861-39

GH Research

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

GH Research

GH001 is an inhaled formulation of 5-MeO-DMT, a short-acting psychedelic. GH001 is being evaluated in a Phase 2 trial in patients with postpartum depression. More details about the Phase 2 study can be found in the clinical trial registration link below.

EudraCT Number: 2021-006879-42

GH Research

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

Nova Mentis

NM-1001 is a low dose psilocybin formulation set to be evaluated in a Phase 2a trial as a potential treatment for Fragile X Syndrome. Nova Mentis was granted orphan drug designation from the FDA and European Medicines Agency for the development of NM-1001. Results from preclinical studies on NM-1001 can be found here.

Nova Mentis logo

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

Beckley Psytech

BPL-003 is an intranasal formulation of synthetic 5-MeO-DMT and is currently being evaluated in a Phase 2 study for treatment-resistant depression. More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05660642

Beckley Psytech Logo

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

MindMed

MM-110, also known as 18-MC or zolunicant, is a non-hallucinogenic ibogaine derivative. MM-110 intended for use in opioid withdrawal and as a potential treatment of opioid use disorder and is set to be evaluated in a Phase 2a trial. Details about a completed Phase 1 study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT04292197

MindMed Logo

Opioid Withdrawal | MM-110 (18-MC) | Phase 2a

MAPS PBC

MAPS is evaluating MDMA-assisted group therapy in a Phase 2 trial as a potential treatment for PTSD. More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05173831

MAPS PBC

Post-traumatic stress disorder (PTSD) | MDMA | Phase 2

MAPS PBC

MAPS is evaluating MDMA-assisted psychotherapy in a Phase 2 study as a potential treatment for eating disorders (anorexia nervosa and binge eating disorder). More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT04454684

MAPS PBC

Anorexia nervosa & Binge eating disorder | MDMA | Phase 2

Usona Institute

The Usona Institute is currently evaluating psilocybin-assisted therapy in a Phase 2 trial as a potential treatment for major depressive disorder, after receiving Breakthrough Therapy Status from the FDA. More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT03866174

Usona Institute logo

Major Depressive Disorder (MDD) | Psilocybin | Phase 2

TRYP Therapeutics

TRP-8802 is an orally-delivered synthetic psilocybin formulation set to be evaluated in a Phase 2 trial as a potential treatment for fibromyalgia. More details about the trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05128162

Tryp Therapeutics

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

COMPASS Pathways

COMP360 is a psilocybin formulation currently being evaluated in a Phase 2 trial for potential use in anorexia nervosa. More information about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05481736

Compass Pathways logo colour

Anorexia Nervosa | COMP360 (Psilocybin) | Phase 2

COMPASS Pathways

COMP360 is a psilocybin formulation currently being evaluated in a Phase II trial for potential use in post-traumatic stress disorder (PTSD). More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05312151

Compass Pathways logo colour

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

Braxia Scientific

Braxia is evaluating psilocybin-assisted therapy in a Phase II trial for potential use in treatment-resistant depression. More details about the trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05029466

Braxia Scientific

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

Janssen Research & Development

SPRAVATO is an intranasal esketamine formulation being evaluated in a Phase 2 study as a potential treatment for symptoms of major depressive disorder including suicidal ideation, in participants 12 to less than 18 years of age. SPRAVATO has already received FDA approval for use in adults with treatment-resistant depression or acute suicidal ideation and behaviour in major depressive disorder. Please see the SPRAVATO label for more information. 

More details about the ongoing trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT03185819

Janssen logo

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

Seelos Therapeutics

SLS-002 is an intranasal racemic ketamine product currently being evaluated in a Phase 2 trial as a potential treatment for acute suicidal ideation and behaviour (ASIB) in major depressive disorder. More details about the ongoing trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT04669665

Seelos Therapeutics

Acute Suicidal Ideation and Behaviour (ASIB) | SLS-002 (Ketamine) | Phase 2

MindMed

As part of a deal with University Hospital Basel's Liechti Lab, MindMed has acquired the rights to an ongoing Phase II evaluating LSD as a potential treatment for cluster headaches. More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT03781128

MindMed Logo

Cluster Headaches | LSD | Phase 2

Incannex Healthcare

In partnership with Monash University, Incannex is evaluating psilocybin-assisted therapy in a Phase II trial as a potential treatment for generalized anxiety disorder. More details about the study can be found in the clinical trial registration link below.

ANZCTR Trial ID: ACTRN12621001358831

Incannex

Generalized Anxiety Disorder (GAD) | Psilocybin | Phase 2

Clexio Biosciences

CLE-100 is a formulation of oral esketamine currently being evaluated in a Phase 2 study as a potential treatment for major depressive disorder. More details about the trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT04103892

Clexio Biosciences

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

Clairvoyant Therapeutics

Clairvoyant is evaluating psilocybin-assisted therapy in a Phase 2 trial as a potential treatment for alcohol use disorder. More details about the study can be found in the clinical trial registration link below.

EudraCT Number: 2021-006200-33

ClairvoyantLogo2

Alcohol Use Disorder (AUD) | Psilocybin | Phase 2

Ceruvia Lifesciences

SYNP-101 is a synthetic form of psilocybin being developed as a potential treatment for obsessive compulsive disorder. SYNP-101 is currently being evaluated in a Phase 2 trial. More details about an associated trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT03356483

Ceruvia Lifesciences

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

Psyence Group

Psyence is set to evaluate psilocybin-assisted therapy in a Phase 2 study for the treatment of adjustment disorder due to an incurable cancer diagnosis in a palliative care context.

Psyence

Adjustment Disorder | Psilocybin | Phase 2

Beckley Psytech

BPL-003 is an intranasal formulation of synthetic 5-MeO-DMT and is currently being evaluated in a Phase 2 study for alcohol use disorder. More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05674929

Beckley Psytech Logo

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

Small Pharma

Top-line results from Small Pharma's Phase IIa trial of DMT for MDD are now available.

SmallPharmaLogo

Major Depressive Disorder (MDD) | SPL026 (DMT) | Phase 2a (Completed)

MindMed

MM-120 is a formulation of LSD being evaluated in a Phase 2 trial as a potential treatment for attention deficit hyperactivity disorder (ADHD) in adults. More details about the trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05200936

MindMed Logo

Attention Deficit Disorder (ADHD) | MM120 (LSD) | Phase 2a

Phase 1

Cybin

CYB003 is an orally dissolving tablet formulation of an unknown deuterated psilocybin analog currently being evaluated in a Phase 1/2 trial for major depressive disorder. More details about the study can be found in the clinical trial registration below.

ClinicalTrials.gov Identifier: NCT05385783

Cybin

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

DemeRx IB (an atai Life Sciences platform company)

DMX-1002 is an ibogaine formulation set to be evaluated in a combined Phase I/II study as a potential treatment for opioid use disorder (specifically for medically-assisted detoxification). DemeRx is one of atai Life Sciences' drug development programs. More details about the Phase I/II study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05029401

DemeRx Logo

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

Beckley Psytech

ELE-001 is an intravenous (IV) formulation of psilocin, the active metabolite of psilocybin, being developed as a possible treatment for depression. ELE-001 was acquired by Beckley Psytech from Eleusis Therapeutics in October 2022, who had begun a Phase 1/2 trial. More details about the trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05434156

Beckley Psytech Logo

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

Algernon Pharmaceuticals

AP-188 is a sub-hallucinogenic, IV DMT formulation being developed as a possible treatment of ischemic stroke and for post-stroke rehabilitation. AP-188 is currently being evaluated in a Phase 1 trial.

ClinicalTrials.gov Identifier: NCT05559931

Algernon Pharmaceuticals

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

Biomind Labs

BMND01 is a liquid inhaled formulation of DMT that was evaluated in a Phase 1 study. More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05573568

biomind labs

Healthy Volunteers | BMND01 (DMT) | Phase 1

Optimi Health

MELOCIN is a naturally derived Psilocybe extract set to be evaluated in a Phase I trial. More details about the trial can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05252598

Optimi Health

Healthy Volunteers | Psilocybin | Phase 1

MindMed

MM-402 is R(-)-MDMA, an isomer of MDMA, as a potential treatment for social anxiety associated with Autism Spectrum Disorder. R-MDMA is being evaluated in a Phase I trial comparing it S-MDMA and racemic MDMA (R/S MDMA). More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05277636

MindMed Logo

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

MindMed

MindMed is evaluating mescaline in a Phase I trial, though the intended indication(s) remains unclear. More details about the trial can be found in the clinical trial link below.

ClinicalTrials.gov Identifier: NCT04849013

MindMed Logo

Healthy Volunteers | Mescaline | Phase 1

Reunion Neuroscience

RE104 is isoprocin glutarate, a prodrug of 4-HO-DiPT. RE104 is currently being evaluated in a Phase 1 trial and is intended for use in postpartum depression. More details about the study can be found in the clinical trial registration link below.

ANZCTR Trial ID: ACTRN12622000713796

Reunion Logo

Healthy Volunteers | RE104 (4-HO-DiPT; Isoprocin Glutarate) | Phase 1

Ceruvia Lifesciences

NYPRG-101 is a non-hallucinogenic LSD analog, more commonly known as 2-Bromo-LSD or BOL-148. NYPRG-101 is currently in Phase I and is being evaluated as a potential treatment of cluster headaches.

Ceruvia Lifesciences

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

GH Research

GH002 is an injectable formulation of 5-MeO-DMT, a short-acting psychedelic. GH002 is set to be evaluated in a Phase 1 study.

GH Research

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

Mindset Pharma

MSP-1014 is a deuterated prodrug of psilocybin set to be evaluated in a Phase 1 study. MSP-1014 is intended as a potential treatment of major depressive disorder.

MindSetLogo

Major Depressive Disorder (MDD) | MSP-1014 (Deuterated Psilocybin Prodrug) | Phase 1

EmpathBio

EmpathBio is developing EMP-01, an MDMA-derivative for use in entactogen-assisted psychotherapy to treat post-traumatic stress disorder. EMP-01 is currently being evaluated in a Phase 1 trial. More details about the study can be found in the clinical trial registration link below. EmpathBio is one of atai Life Sciences' drug development programs.

ANZCTR Trial ID: ACTRN12622001335785

EmpathBio Logo

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

Small Pharma

SPL026 is a formulation of DMT being developed as a potential treatment for major depressive disorder. SPL026 is currently being evaluated in a Phase 1 study to compare the effects when administered intravenously (IV) or intramuscularly (IM). Small Pharma was granted an Innovation Passport Designation for SPL026 from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05644093

SmallPharmaLogo

Major Depressive Disorder (MDD) | SPL029 (DMT) | Phase 1

Small Pharma

SPL028 is a formulation of an unknown deuterated DMT molecule. SPL028 is currently being evaluated in a Phase 1 trial to compare the effects when administered intravenously (IV) or intramuscularly (IM).

SmallPharmaLogo

Healthy Volunteers | SPL028 (Deuterated DMT) | Phase 1

Virida Life Sciences

VLS-01 is a formulation of DMT intended for potential use in treatment-resistant depression. VLS-01 is currently being evaluated in a Phase 1 trial to compare the effects when administered intravenously (IV) or buccally.

ANZCTR Trial ID: ACTRN12622000851763

Viridia Life Sciences

Treatment-resistant depression (TRD) | VLS-01 (DMT) | Phase 1

Bright Minds Biosciences

BMB-101 is an unknown 5-HT2C agonist being evaluated in a Phase 1 trial for potential use in Dravet Syndrome, opioid use disorder, and binge eating disorder. More details about the study can be found in the clinical trial registration link below.

ClinicalTrials.gov Identifier: NCT05397041

Bright Minds Biosciences

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

Diamond Therapeutics

Diamond Therapeutics' lead programme is the development of low-dose psilocybin for the potential treatment of undisclosed anxiety disorders. Diamond completed a Phase 1 trial in late 2022. Previously reported preclinical trial results can be found here.

Diamond Therapeutics

Anxiety Disorders | Psilocybin | Phase 1

Ceruvia Lifesciences

NYPRG-101 is a non-hallucinogenic LSD analog, more commonly known as 2-Bromo-LSD or BOL-148. NYPRG-101 is currently in Phase I and is being evaluated as a potential treatment of migraines.

Ceruvia Lifesciences

Migraines | NYPRG-101 (BOL-148) | 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 Therapeutics

Delix Therapeutics is developing a number of non-hallucinogenic psychedelic compounds, referred to as psychoplastogens, and is currently in the preclinical stage of development. Details about one of Delix Therapeutics' lead compounds "DLX-7" or Tabernanthalog (TBG), an ibogaine analog, were published here and here. Details about another compound, "DLX-1", also known as AAZ-A-154, were published here.

Delix Logo (Colour)

Cybin

CYB003 is an orally dissolving tablet formulation of an unknown deuterated psilocybin analog currently in the preclinical stage of development, intended as a treatment for alcohol use disorder.

CYB004 is an inhaled formulation of an unknown deuterated DMT molecule. CYB004 is currently in the preclinical stage being evaluated as a treatment for generalized anxiety disorder with or without major depressive disorder.

CYB005 is an unknown phenethylamine 5-HT2A agonist derivative currently in the preclinical stage of development for an unknown indication.

Cybin

Ceruvia Lifesciences

NYPRG-101 is a non-hallucinogenic LSD analog, more commonly known as 2-Bromo-LSD or BOL-148. NYPRG-101 is currently in the preclinical stage and is being evaluated as a potential treatment of both opioid and alcohol use disorder.

Ceruvia Lifesciences

Bexson Biomedical

BB-106 is a ketamine formulation delivered subcutaneously via a wearable medical pump. BB-106 is currently in the preclinical stage and is being evaluated as a potential treatment of depression, as well as a variety of pain-related indications including post-operative pain, cancer pain, and Complex Regional Pain Syndrome.

Bexson Biomedical

Gilgamesh Pharmaceuticals

Gilgamesh Pharmaceuticals is a preclinical biotechnology company developing several psychedelic-related medicines including:

• GM-1020, a less-dissociative, oral arylcyclohexamine NMDA antagonist molecule, as a potential treatment for depression;

• GM-2505, a 5-HT2A agonist and 5-HT releaser intended as a potential treatment for depression;

• GM-300X, an ibogaine analogue intended as a potential treatment of opioid use disorder;

• GM-200X, a non-hallucinogenic 5-HT2A agonist intended as a potential treatment for attention deficit hyperactivity disorder (ADHD).

GM-1020 and GM2505 are anticipated to proceed to Phase I trials in 2023.

GilgameshLogo

Terran Biosciences

Terran Biosciences is developing a number of unknown compounds to treat neurological and psychiatric indications, having acquired or licensed assets from Concert Pharmaceuticals, Blumentech, Sanofi, and University of Maryland, Baltimore.

Terran Biosciences Logo

Freedom Biosciences

Freedom Biosciences is in the preclinical stages of developing a combination therapy consisting of ketamine and an mTORC1 inhibitor (presumed to be rapamycin) for the treatment of major depressive disorder.

Freedom Biosciences

Mindset Pharma

Mindset Pharma is currently in the preclinical stages of development for a number of compounds including MSP-2020 and MSP-2003, two unknown 5-HT2A agonists. Mindset Pharma is collaborating with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies.

MindSetLogo

Arcadia Medicine

AM-1002 is an unknown phenethylamine empathogen in the preclinical stage of development, intended for use in PTSD.

AM-1004 is a combination (psychoactive-empathogen) product in the preclinical stage of development, intended for use in major depressive disorder.

Arcadia Medicine Logo

Lophora

LPH-5 is an unknown 5-HT2A agonist currently in the preclinical stage and is being investigated for potential use in treatment-resistant depression. Lophora anticipates initiating a Phase I study of LPH-5 in 2023.

Lophora

Psilera

Psilera is currently in the preclinical stages of development for a number of compounds including:

• A transdermal formulation of DMT;

• An intranasal formulation of DMT;

• A transdermal formulation of psilacetin, a prodrug of psilocin;

• Two DMT analogues, PSIL-001 and PSIL-002.

Psilera Bioscience

Transcend Therapeutics

Methylone.

Transcend Therapeutics Logo

Bright Minds Biosciences

Bright Minds has a number of 5-HT2A and combined 5-HT2A + 5-HT2C agonist molecules in the preclinical stage of development. The 5-HT2A compounds are being evaluated for use in depression and post-traumatic stress disorder. The combined 5-HT2A + 5-HT2C compounds are being evaluated for use in several chronic pain disorders, including cluster headaches and chemotherapy-induced peripheral neuropathy.

Bright Minds Biosciences

CaaMTech

CaaMTech has a collaborative preclinical drug development program with the Designer Drug Research Unit at the National Institute on Drug Abuse Intramural Research Program to help determine which of their compounds are the most promising to proceed to human trials. These include, but are not limited to:

  • Psilacetin (4-AcO-DMT), a prodrug of psilocin, the active metabolite of psilocybin;
  • 4-AcO-MET, 4-AcO-MALT, and 4-AcO-DALT, three psilacetin derivatives (source);
  • Deprocin (4-HO-DPT), a structural analogue of psilocin;
  • DMPT and DMALT (Source);
  • EPT and MALT, structural analogues of DMT (Source);
  • 5-MeO-DALT;
  • 5-MeO-DPT
  • Norpsilocin, another tryptamine found in psilocybin mushrooms (Source);
  • Miprocin (4-OH-MiPT);
  • 4-HO-TMT ("Amphoria"), the suspected active metabolite of aeruginascin, another tryptamine found in psilocybin mushrooms and 4-AcO-TMT ("Prophoria"), a prodrug of 4-HO-TMT (Source);
  • Bufotenidium (5-HTQ), also known as bufotenidine;
  • 2-5-Dimethylbufotenine (5-MeO-2-ME-DMT), a bufotenin derivative, and 2,5-dimethylbufotenidine (5-MeO-2-ME-TMT), a bufotenidine derivative (Source)
CaamTech Logo Colour

GH Research

GH003 is an intranasal formulation of 5-MeO-DMT, a short-acting psychedelic. GH003 is currently in the preclinical stage for an unknown indication.

GH Research

Small Pharma

SPL029 is an unknown oral tryptamine 5-HT2A agonist molecule currently in the preclinical stage for an unknown indication.

SmallPharmaLogo

Neonmind Biosciences

NEO-001 is a synthetic form of psilocybin in the preclinical stages of development as a potential treatment for weight loss. NeonMind is currently conducting a preclinical trial with psilocybin as a potential treatment for obesity.

Neonmind logo

Journey Colab

JOUR-5700 is a synthetic form of mescaline in the preclinical stages of development for the potential treatment of alcohol use disorder.

Journey Colab

Tactogen

Tactogen has a number of unknown entactogen molecules in the preclinical stage of development.

Tactogen

BetterLife Pharma

BETR-001 is a non-hallucinogenic LSD derivative molecule, more commonly known as 2-Bromo-LSD or BOL-148. BETR-001 is currently in the preclinical stage and is being investigated for potential use in treatment-resistant depression, as well as migraines.

BetterLife Pharma

Lobe Sciences

L-131.

Lobe Sciences Logo

Sensorium Therapeutics

SENS-01 is an unknown molecule currently in the preclinical stage of development, intended for use in anxiety and depression.

Sensorium Therapeutics Logo

Clearmind Medicine

CMND-100 is a synthetic form of MEAI

Clearmind Medicine

Tryp Therapeutics

TRP-8802 is an orally-delivered synthetic psilocybin formulation currently in the preclinical stage of being evaluated as a potential treatment for phantom limb pain.

TRP-8803 is an IV formulation of psilocin, the active metabolite of psilocybin. TRP-8803 is in the preclinical stage of development for indications including binge eating disorder, fibromyalgia, and phantom limb pain.

Tryp Therapeutics

Lusaris Therapeutics

LSR-1019 is a sublingual formulation of 5-MeO-DMT currently in the preclinical stage, intended for use in treatment-resistant depression.

Lusaris Therapeutics Logo

Empyrean Neuroscience

PsiD+.

Empyrean Logo

Mindstate Design Labs

MSD-100.

Mindstate Design

Discovery

PsyBio Therapeutics

PsyBio is developing a portfolio of tryptamine-derived candidates including psilocybin and norbaeocystin for a variety of undisclosed psychiatric conditions.

PsyBio Logo

CaaMTech

CaaMTech is a drug discovery company that aims to synthesize and characterize old and novel tryptamine compounds as well as optimize their various formulations. Their portfolio (see above for a partial list of published compounds) then undergoes preclinical assessment as part of a collaborative preclinical drug development program with the Designer Drug Research Unit at the National Institute on Drug Abuse Intramural Research Program.

CaamTech Logo Colour

Psy Therapeutics

PSY-01, PSY-02, PSY-05, PSY-06.

Psy Therapeutics

COMPASS Pathways

Discovery Center.

Compass Pathways logo colour

Empyrean Neuroscience

DMT and psilocybin (PsiM+, PsiK+, PsiH+, PsiX) discovery programs.

Empyrean Logo

Mindset Pharma

Mindset Pharma is currently in the discovery stages of development for a number of novel psychedelic compounds, including Family 3 ("Low-potency, long-duration for micro-dosing") and Family 4 (DMT/ 5-MeO-DMT-inspired compounds). Mindset Pharma is collaborating with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies.

MindSetLogo

Psylo

Psylo is currently in the discovery stages of development for a number of compounds including:

• A shorter acting psychedelic (Family 1)

• A sub-perceptual long acting psychedelic (Family 2)

• A non-hallucinogenic psychoplastogen (Family 3)

PSYLO Logo

Mindstate Design Labs

MSD-101, MSD-102, MSD-103, MSD-104, MSD-105 Discovery Programs.

Mindstate Design

Lusaris Therapeutics

Lusaris is developing a portfolio of new compounds, including LSR-2000 and LSR-3000, intended for various neuropsychiatric and neurological disorders.

Lusaris Therapeutics Logo

Beckley Psytech

NCE discovery program.

Beckley Psytech Logo

Onsero Therapeutics

Onsero is developing a portfolio of unknown 5-HT2A agonists for undisclosed neuropsychiatric indications.

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.