Developed by Michael Haichin, PharmD.
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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.
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Those unfamiliar with the drug development and approval process may wish to review our Primer before continuing…
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.
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 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 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.
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.
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.
Treatment-Resistant Depression; Acute Suicidal Ideation & Behaviour in Major Depressive Disorder | Spravato (Esketamine) | Approved
Treatment-Resistant Depression | COMP360 (Psilocybin) | Phase 3
Major Depressive Disorder | Psilocybin | Phase 3
Major Depressive Disorder | CYB003 (Deuterated Psilocybin Analog) | Phase 3
Generalized Anxiety Disorder | MM-120 (LSD D-tartrate ODT) | Phase 3
Alcohol Use Disorder | Ketamine | Phase 3
Post-Traumatic Stress Disorder | MDMA | Phase 3
Treatment-Resistant Depression; Bipolar II Disorder; Postpartum Depression | GH001 (5-MeO-DMT) | Phase 2
Treatment-Resistant Depression; Alcohol Use Disorder | BPL-003 (5-MeO-DMT) | Phase 2
Post-Traumatic Stress Disorder | TSND-201 (Methylone) | Phase 2
Major Depressive Disorder | LSD D-tartrate ODT | Phase 2
Major Depressive Disorder | MSP-1014 (Psilocybin-Like NCE) | Phase 2
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
Post-Partum Depression | RE104 (4-OH-DiPT Prodrug Subcutaneous Injection) | Phase 2
PTSD | COMP360 (Psilocybin) | Phase 2a
Depression & Anxiety With PTSD; Depression with PTSD | APEX-52 / 90 (Psilocybin) | Phase 2
Major Depressive Disorder (MDD) | GM-1020 (Oral NMDAR Antagonist) | Phase 2
Fragile X Syndrome | Psilocybin | Phase 2
Alcohol Use Disorder | SYNP-101 (Psilocybin) | Phase 2
Fibromyalgia; Binge Eating Disorder; IBS | TRP-8802 (Psilocybin) | Phase 2
Major Depressive Disorder | ELE-101 (IV Psilocin) | Phase 2
Methamphetamine Use Disorder; Opioid Use Disorder | PEX010 (Psilocybin) | Phase 2
Generalized Anxiety Disorder | Psi-GAD (Psilocybin) | Phase 2
Adjustment Disorder | Psilocybin | Phase 2
Generalized Anxiety Disorder | Psilocybin | Phase 2
Demoralization Syndrome | RSTP-1000 (Psilocybin) | Phase 2
Post-Traumatic Stress Disorder | MDMA + Citalopram | Phase 2
Social Anxiety in Autism Spectrum Disorder | ALA-002 (Non-Racemic MDMA) | Phase 2
Major Depressive Disorder; Existential Distress in Cancer Patients | MB22001 (LSD) | Phase 2
Treatment-Resistant Depression (TRD) | BMND01 (DMT) | Phase 2
PTSD; Acute Suicidal Ideation & Behaviour in MDD | SLS-002 (Intranasal Ketamine) | Phase 2
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
Opioid Use Disorder | IBX-210 (IV Ibogaine) | Phase 1/2
Alcohol Use Disorder | DMX-1001 (Noribogaine) | Phase 1
Substance Use Disorders | 5-MeO-DMT | Phase 1
Undisclosed | 5-MeO-DMT | Phase 1
Social Anxiety Disorder | EMP-01 (R-MDMA) | Phase 1
Metabolic Disease | REL-P11 (Psilocybin) | Phase 1
Treatment-Resistant Depression | VLS-01 (Buccal Film DMT) | Phase 1
Psychiatric/Neurological Disorders | GH002 (IV 5-MeO-DMT) | Phase 1
Opioid Use Disorder; Obsessive Compulsive Disorder; Premenstrual Dysphoric Disorder; Neuropsychiatric Disorders | MLS101 (Psilocybin) | Phase 1
Headache Disorder; Obsessive Compulsive Disorder | SYNP-101 (Psilocybin) | Phase 1
Major Depressive Disorder; CNS Disorders | TSND-201 (Methylone) | Phase 1
Autism Spectrum Disorder | MM-402 (R(-)-MDMA) | Phase 1
Headache Disorders | NYPRG-101 (BOL-148) | Phase 1
Undisclosed | DMT & Beta-Carboline | Phase 1
Stroke | AP-188 (IV DMT) | Phase 1
Alcohol Use Disorder | AWKN-002 (Esketamine OTF) | Phase 1
Depression in Bipolar Disorder | CLE-100 (Esketamine) | Phase 1
Obesity | BMND06 (Mescaline-Based) | Phase 1
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
Undisclosed | MSD-001 (5-MeO-MiPT) | Phase 1
Parkinson's | BMND09 | Phase 1
Treatment-Resistant Depression | LPH-5 (Novel Phenethylamine) | Phase 1
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.
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)
Mood & Neuropsychiatric Disorders | ITI-1549 (Non-Hallucinogenic Neuroplastogen)
Neuropsychiatry | DLX-159 (Tryptamine Neuroplastogen)
Substance Use Disorders | DLX-007 (Tabernanthalog)
Inflammatory Diseases & Others | Various NCEs
Psychiatric/Neurological Disorders | GH003 (Nasal 5-MeO-DMT)
Cluster Headache | TACT908
Alcohol Use Disorder; Eating Disorders | TACT411/833
Neuropsychiatry | NCEs
Social Anxiety Disorder | SENS-01
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)
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)
Major Depressive Disorder | AM-1004 (Psychoactive & Empathogen)
Substance Use Disorders | AM-1006 (Psychoactive NCE)
PTSD | AM-1002 (Non-Racemic MDMA)
Alcohol Use Disorder | LPH-48 (Novel Phenethylamine; LPH-5 Analog)
Undisclosed | 5-HT2AR Active Compounds
Undisclosed | RE245 (Neuroplastogen)
Undisclosed | EGX-121 (Non-Tryptamine NCE)
Undisclosed | NCEs
Pain & Headache | NCEs
CNS Disorders | CYB005 (Phenethylamine Derivative)
Opioid Use Disorder | Psychoplastogens
Undisclosed | NMDA Receptor Antagonists
Acute Pain Management & Mental Health Indications | BB106 (Ketamine)
Undisclosed | Various
Undisclosed | NCEs
Substance Use Disorders | Non-Hallucinogenic Ibogaine Derivative
Major Depressive Disorder; Anxiety Disorder; Neuropathic Pain | BETR-001 (BOL-148)
Traumatic Brain Injury | Ibogaine
Glaucoma | DMT
Anxiety, Depression & Other Disorders | EB-003 (DMT Analog)
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)
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
IBS; Binge Eating Disorder; Fibromyalgia | IV Psilocin
Substance Use & Mental Health Disorders | Aminoindane NCEs
Substance Use Disorders | MDMA Zydis
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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