Psychedelics Drug Development Tracker
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.
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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
MAPS is currently conducting Phase 3 trials investigating MDMA-assisted psychotherapy as a potential treatment of post-traumatic stress disorder after receiving Breakthrough Therapy Status from the FDA. More details about MAPS's MDMA product, including previous trial results, can be found in their published Investigator's Brochure.
Although not yet peer-reviewed or published, MAPS has announced their first Phase III study (MAPP1) was successful and anticipate potential approval as early as 2023. The clinical trial registration linked below is of an ongoing Phase III study (MAPP2).
ClinicalTrials.gov Identifier: NCT04077437

Post-traumatic stress disorder (PTSD)
III
Compass Pathways
Compass Pathways' COMP360 is a psilocybin formulation currently being evaluated in a Phase II trial for potential use in treatment-resistant depression, after receiving Breakthrough Therapy Status from the FDA. The clinical trial registration linked below is of the ongoing Phase II study. COMP360 is also being evaluated in both preclinical and clinical (investigator-initiated) studies for numerous other indications.
ClinicalTrials.gov Identifier: NCT03775200

Treatment-resistant depression (TRD)
II
Usona Institute
The Usona Institute is currently evaluating psilocybin-assisted therapy in a Phase II trial as a potential treatment for major depressive disorder, after receiving Breakthrough Therapy Status from the FDA. More details about Usona's psilocybin product, including Phase I results, can be found in their published Investigator's Brochure. The clinical trial registration linked below is of an ongoing Phase II study.
ClinicalTrials.gov Identifier: NCT03866174

Major depressive disorder (MDD)
II
MAPS
MAPS is evaluating MDMA-assisted psychotherapy as a potential treatment for eating disorders (anorexia nervosa and binge eating disorder). The clinical trial registration linked below is of an ongoing Phase II study.
ClinicalTrials.gov Identifier: NCT04454684

Eating disorders (anorexia nervosa and binge-eating disorder)
II
MAPS
MAPS is evaluating MDMA-assisted psychotherapy as a potential treatment for anxiety associated with a life-threatening illness. The clinical trial registration linked below is of a completed Phase II study and the results can be found here.
ClinicalTrials.gov Identifier: NCT02427568

Anxiety associated with a life-threatening illness
II
MAPS
MAPS is evaluating MDMA-assisted psychotherapy as a potential treatment for social anxiety in autistic adults. The clinical trial registration linked below is of a completed Phase II study and the results can be found here.
ClinicalTrials.gov Identifier: NCT02008396

Social anxiety in autistic adults
II
MindMed
MindMed is evaluating LSD-assisted therapy as a potential treatment for anxiety disorder. As part of a deal with University Hospital Basel's Liechti Lab, MindMed has acquired the rights to an ongoing Phase II trial. More details about that trial can be found in the clinical trial registration link below. A second Phase II trial is set to begin in 2021.
ClinicalTrials.gov Identifier: NCT03153579

Anxiety
II
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 trial can be found in the clinical trial registration link below.
ClinicalTrials.gov Identifier: NCT03781128

Cluster headaches
II
Seelos Therapeutics
SLS-002 is an intranasal racemic ketamine product currently being evaluated in a Phase II 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

Acute suicidal ideation and behaviour (ASIB) in major depressive disorder
II
Awakn Life Sciences
Awakn Life Sciences is set to evaluate MDMA-assisted psychotherapy in a Phase II trial as a potential treatment for Alcohol Use Disorder.

Alcohol use disorder
II
Cybin
PSY001 is a sublingual film formulation of psilocybin and is set to be evaluated in a Phase II trial in 2021 as a potential treatment for Major Depressive Disorder.

Major depressive disorder
II
Eleusis
ELE-Ket+ is a combination infusion therapy that includes ketamine. A Phase II study investigating ELE-Ket+ as a potential adjunctive treatment of major depressive disorder is set to begin in Q4 2021.

Major depressive disorder (adjunctive treatment)
II
MindMed
MindMed is developing a microdosed LSD formulation that is set to be evaluated in a Phase II trial in collaboration with Maastricht University as a potential treatment for attention deficit hyperactivity disorder (ADHD) in adults.

Attention deficit hyperactivity disorder (ADHD)
II
Mydecine
Mydecine is developing a naturally sourced psilocybin product that is set to be evaluated in a Phase II trial as a potential treatment for post-traumatic stress disorder.

Post-traumatic stress disorder (PTSD)
II
GH Research
GH001 is an inhaled formulation of 5-MeO-DMT, a short-acting psychedelic. A combined Phase I/II study investigating GH001 for potential use in treatment-resistant depression is ongoing. More details of this study can be found in the clinical trial registration link below. GH001 is also undergoing preclinical evaluation for two other unknown indications.
ClinicalTrials.gov Identifier: NCT04698603

Treatment-resistant depression (TRD)
I / II
Small Pharma
SPL026 is an intravenous (IV) DMT formulation being developed by Small Pharma and is set to be evaluated in a combined Phase I/II study as a potential treatment for major depressive disorder. More details of this study can be found in the clinical trial registration link below.
ClinicalTrials.gov Identifier: NCT04673383

Major depressive disorder (MDD)
I / II
Eleusis
ELE-LSD is a low-dose LSD product being developed as a potential treatment for Alzheimer's Disease. Previously reported Phase I trial results can be found here. A second Phase I trial is set to begin in Q4 2021.

Alzheimer's Disease
I
MindMed
18-MC is a non-hallucinogenic ibogaine derivative intended for use in opioid withdrawal and as a potential treatment of opioid use disorder. 18-MC is currently being evaluated in a Phase I trial. More details about the trial can be found in the clinical trial registration link below.
ClinicalTrials.gov Identifier: NCT04292197

Opioid use disorder
I
MindMed
As part of a deal with University Hospital Basel's Liechti Lab, MindMed is set to evaluate intravenous DMT in a Phase I trial in 2021. The intended indication(s) remains unclear. More details about the trial can be found in the clinical trial registration link below.
ClinicalTrials.gov Identifier: NCT04353024

Undisclosed
I
MindMed
MindMed is evaluating the combination of LSD and MDMA in a Phase I trial in collaboration with University Hospital Basel's Liechti Lab. The intended indication(s) remains unclear and more details about the trial can be found in the clinical trial registration link below.
ClinicalTrials.gov Identifier: NCT04516902

Undisclosed
I
Perception Neuroscience
PCN-101 is arketamine (or R-ketamine), a less dissociative isomer of ketamine, being developed for potential use in treatment-resistant depression. PCN-101 is currently being evaluated in a Phase I trial. More details about the Phase I trial can be found here.

Treatment-resistant depression (TRD)
I
Beckley Psytech
Beckley Psytech is developing a synthetic version of 5-MeO-DMT and will be evaluated in a Phase I trial in 2021.

Undisclosed
I
Beckley Psytech
Beckley Psytech is developing psilocybin as a potential treatment of short-lasting unilateral neuralgiform headache attacks (SUNHA) and will be evaluated in a Phase I trial in Q1 2021.

Short-lasting unilaterial neuralgiform headache attacks (SUNHA)
I
DemeRx
DMX-IB1 is an ibogaine formulation being evaluated as a potential treatment for Opioid Use Disorder (specifically for medically-assisted detoxification).

Opioid use disorder
I
DemeRx
DMX-NB1 is a noribogaine formulation being investigated as a potential treatment of Opioid Use Disorder. Noribogaine is a long-acting metabolite of ibogaine.

Opioid use disorder
I
Diamon Therapeutics
Diamond Therapeutics' lead programme is the development of low-dose psilocybin for the potential treatment of undisclosed anxiety disorders and is set to be evaluated in a Phase I trial in early 2021.

Anxiety
I
Entheon Biomedical
Entheon Biomedical's lead programme is the development of intravenous (IV) DMT for the potential treatment of undisclosed substance use disorders and is set to be evaluated in a Phase I trial in Q3 2021.

(Unspecified) Substance use disorder
I
Journey Colab
Journey colab's lead programme is the development of synthetic mescaline for the potential treatment of alcohol use disorder and is set to be evaluated in a Phase I trial in 2021.

Alcohol use disorder
I
Sacred Medicines
Sacred Medicines is currently developing a Phase I clinical trial to study ayahuasca tea in a group therapy setting.

Undisclosed
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
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;
- 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)

Preclinical
Field Trip
FT-104 is an unknown 5-HT2A agonist molecule currently in the preclinical stage of development. Field Trip anticipates initiating a Phase I study of FT-104 in 2021.

Preclinical
Eleusis
ELE-Psilo+ is a combination infusion therapy that includes psilocybin. A Phase I study investigating ELE-Psilo+ as a potential adjunctive treatment of major depressive disorder is set to begin in Q1 2022.

Preclinical
Tryp Therapeutics
TRP-8802 is an orally-delivered synthetic psilocybin formulation currently in the preclinical stage, being evaluated as a potential treatment of fibromyalgia. Tryp is also considering other indications for TRP-8802, such as eating disorders (more specifically hyperphagia in the orphan disease Prader-Willi Syndrome), as well as other undisclosed neuropsychiatric disorders.

Preclinical
Gilgamesh Pharmaceuticals
Gilgamesh Pharmaceuticals is a preclinical biotechnology company developing several psychedelic-related medicines including:
- 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);
- a non-dissociative, oral arylcyclohexamine NMDA antagonist molecule, as a potential treatment for treatment-resistant depression.

Preclinical
Viridia Life Sciences
Viridia Life Sciences is in the preclinical stage of development of a DMT formulation. The intended indication(s) remains unclear.

Preclinical
GH Research
GH002 is an injectable formulation of 5-MeO-DMT, a short-acting psychedelic. GH002 is currently in the preclinical stage for an unknown indication.

Preclinical
Bexson Biomedical
BB-106 is a ketamine formulation delivered subcutaneously via a wearable medical pump (EZ-be POD developed by Stevanato Group). 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.

Preclinical
Small Pharma
Small Pharma is in the preclinical stage of development of unknown deuterated tryptamine compounds.

Preclinical
BetterLife Pharma
TD-0148A is a non-hallucinogenic LSD derivative molecule, more commonly known as 2-Bromo-LSD or BOL-148. TD-1048A is currently in the preclinical stage and is being investigated for potential use in treatment-resistant depression, as well as migraines.

Preclinical
Psilera Bioscience
Psilera Bioscience's drug pipeline or target indications are unclear thus far. The company is set to begin preclinical studies on a number psychedelic analogues in 2021 and may include novel DMT formulations.

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 Tabernanthalog (TBG), an ibogaine analogue, were recently published.

Preclinical
Lophora
LPH-5 is 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 2022.

Preclinical
Lobe Sciences
Lobe Sciences is currently in the preclinical stage of evaluating the combination of psilocybin and N-acetylcysteine (NAC) as a potential treatment of mild traumatic brain injury (mTBI) and/or post-traumatic stress disorder (PTSD).

Preclinical
NeonMind
NeonMind is currently conducting a preclinical trial with psilocybin as a potential treatment for weight loss.

Preclinical
Bright Minds Biosciences
Bright Minds has a number of 5-HT2C, 5-HT2A, and combined 5-HT2A + 5-HT2C agonist molecules in the preclinical stage of development. The 5-HT2C compounds are being evaluated for use in an undisclosed seizure disorder, opioid withdrawal, binge eating disorder, and Alzheimer's disease.
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 an undisclosed chronic pain disorder. Bright Minds intends to progress three lead compounds (one from each category) to human studies in 2021.

Preclinical
Alvarius
Alvarius is in the preclinical stage of developing 5-MeO-DMT as a potential treatment for cocaine use disorder.

Preclinical
Usona Institute
The Usona Institute is in the preclinical stage of development of 5-MeO-DMT for an undisclosed indication. The synthesis and characterization of 5-MeO-DMT by Usona Institute chemists was recently published and can be found here.

Preclinical
Wesana Health
Wesana is in the preclinical stage of developing psilocybin as a potential treatment for traumatic brain injury (TBI).

Preclinical
Algernon Pharmaceuticals
AP-188 is a low dose, intravenous DMT formulation currently in the preclinical stage of development. AP-188 is being investigated as a possible treatment of ischemic stroke and for post-stroke rehabilitation.

Preclinical
Discovery
Eleusis
Eleusis is developing an unknown 5-HT2A agonist molecule, intended for use as a potential treatment of peripheral inflammatory disease. Eleusis intends to select a lead candidate in Q4 2021.

EmpathBio
EmpathBio is developing an MDMA-derivative for use in entactogen-assisted psychotherapy to treat post-traumatic stress disorder. EmpathBio is currently in the lead selection stage of discovery.

Tactogen
Tactogen has synthesized and is currently screening an initial group of ~25 entactogen molecules. Tactogen intends to select a lead compound to advance to preclinical studies by Q4 2021.

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.

Cybin
Cybin's portfolio contains unknown phenethylamine and deuterated tryptamine compounds from Adelia Therapeutics, which are currently in the discovery stages for potential use in undisclosed psychiatric conditions.

Mindset Pharma
Mindset Pharma has synthesized and is currently screening 50 5-HT2A agonist molecules. Mindset intends to select a group of lead compounds to advance to preclinical studies by Q2 2021.

EntheogeniX
EntheogeniX's drug pipeline or intended indications are unclear thus far.

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