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.
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
Post-traumatic stress disorder (PTSD)
Treatment-resistant depression (TRD)
Major depressive disorder (MDD)
Eating disorders (anorexia nervosa and binge-eating disorder)
Anxiety associated with a life-threatening illness
Social anxiety in autistic adults
Anxiety
Cluster headaches
Acute suicidal ideation and behaviour (ASIB) in major depressive disorder
Alcohol use disorder
Major depressive disorder
Opioid use disorder
Major depressive disorder (adjunctive treatment)
CBCT for PTSD
Attention deficit hyperactivity disorder (ADHD)
Post-traumatic stress disorder (PTSD)
Treatment-resistant depression (TRD)
Major depressive disorder (MDD)
Opioid use disorder
Alzheimer's Disease
Opioid use disorder
Undisclosed
Undisclosed
Treatment-resistant depression (TRD)
Ischemic stroke and post-stroke rehabilitation
Undisclosed
Short-lasting unilaterial neuralgiform headache attacks (SUNHA)
Anxiety
(Unspecified) Substance use disorder
Alcohol use disorder
Undisclosed
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
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