2022 Predictions: How Did We Do?
Before we share some key trends to watch in 2023, let’s take a brief moment to revisit (and, evaluate) our 2022 predictions.
Psychedelics R&D Moves Beyond Mental Health
We predicted that, while mental health conditions like PTSD and depression represent the beachhead for psychedelic clinical research and drug development, a broader set of indications would begin to emerge as the subjects of psychedelic research.
In 2022, that trend began to take shape, for example in the study of headache disorders and inflammatory diseases.
See our Beyond Psychiatry section in Research Themes.
The ‘Psychedelic Patent Wars’ Rage On
Patents and IP-related matters remained a hot topic in the psychedelics space throughout 2022, with our understanding of key tensions and actors benefiting from greater nuance.
While patent filings continue apace, litigation remains virtually non-existent as of yet. In August, Terran Biosciences filed what is understood to be the first psychedelics-related trade secret lawsuit against COMPASS Pathways. Elsewhere, Carey Turnbull’s psychedelic patent watchdog non-profit Freedom to Operate brought two post-grant reviews against COMPASS Pathways’ Polymorph A patents, which it survived with the Patent Trial and Appeal Board siding with the British company. Separately, lawyer Matt Zorn asked Turnbull if he would sign a defensive patent pledge pertaining to the Schindler Applications, which sought to cover a psychedelic treatment for headache disorders.
In 2022, Journey Colab became the first psychedelics drug developer or manufacturer to publish a Patent Pledge, despite discussion from other parties on the matter.
Is Consolidation on the Cards?
We expected to see some level of consolidation in 2022, and that rang true to some extent: see our M&A, Licensing and Partnerships section.
In our 2021 review, MINDCURE CEO Kelsey Ramsden told us that half of the psychedelics companies with a sub-$300m market cap would “die” in the coming year. That certainly came true, with her own company ceasing operations just months thereafter.
A Closer Eye on Insurance Coverage
We also expected to see more attention paid on the cost-effectiveness of psychedelic-assisted therapies and the appetites of payors to cover the novel treatment modality. On this topic, we wrote:
“As MAPS’ MDMA-AT for PTSD nears potential approvals, and COMPASS Pathways enters Phase 3 trials, we will see a greater focus on the cost-effectiveness of psychedelic-assisted therapies and the willingness of insurance companies to cover these novel treatments in 2022.”
“Insurance coverage will be key to ensuring a scalable and accessible roll-out of psychedelic-assisted therapies. We will be keeping a close eye on this trend, and groups like GIPSE and companies like Enthea, in 2022.”
Fortunately, our prediction rang true and this important topic is receiving a great deal of attention.
Early in the year, members of the Global Initiative for Psychedelic Science Economics (GIPSE) published their updated cost-effectiveness analysis of MDMA-AT for PTD, based on MAPS’ available Phase 3 data. As we covered at the time, the analysis estimated that, compared to standard of care, MDMA-AT generates net health care savings of $132.9m over a 30 year period, per 1,000 patients.
This analysis was based on costs reported in, and modelled based on, MAPS’ Phase 3 trial protocol. These costs will likely increase significantly come any approval and commercialisation, as will the types of PTSD patients who receive the treatment.
Psychedelic-assisted therapy benefit plan administrator Enthea, meanwhile, raised a $2m seed round towards the close of the year.
See our From Approvals to Access section of the 2022 Review for more on these matters.
All Eyes on Oregon
We predicted that the rule-making process surrounding Oregon’s Psilocybin Services program would capture a significant portion of attention within the space, and that certainly (and, unsurprisingly) rang true. As discussed below (in our 2023 trends to watch), this attention should only increase as we prepare to observe how the first psilocybin service providers fare.
(Psychedelic) Drug Policy Reform Efforts Continue
This was another easy prediction which certainly rang true: See our Psychedelic Policy & Law in 2022 section.
Psychedelics companies and researchers continue to explore digital therapeutics and innovative tech across the drug development pipeline and patient journey
This was a mixed bag. While drug developers like COMPASS and atai are leveraging technology across a variety of applications (from streamlining operations through to predicting patient response and relapse), as the cash crunch has bedded in we’re seeing some of these divisions (and, standalone companies) slimmed down or shelved.
Might we see conventional drug developers expand their pipelines to include psychedelics?
We didn’t see this happen in any meaningful way, aside from Otsuka to some extent via its collaboration with Mindset Pharma.
We’ll see plenty of failures in 2022, with a number of preclinical and clinical studies wrapping
There were a number of drug development programs quietly wrapped in 2022, as well as some more explicit pipeline pruning.
The debate around the rigour of trials will continue
It did indeed. See our Spotlight on Psychedelic Research Methods for more.
Trends to Watch: Psychedelics in 2023
As we look ahead to 2023, here are some of the themes we’re keeping an eye on.
Late-stage clinical trial results
- We should expect to see topline results from MAPS’ second Phase 3 trial of MDMA-assisted therapy for PTSD in the first half of 2023, with a potential New Drug Application (NDA) submitted in Q3.
- We’re also expecting results from Usona Institute’s Phase 2 study of psilocybin for major depressive disorder (MDD) in early 2023.
Clarity over the future of at-home ketamine providers
- As we noted in our review of psychedelic law and policy in 2022, at-home ketamine services have come under increasing scrutiny of late.
- Further, a COVID-era waiver to the Ryan Haight Act allowing remote prescribing of scheduled substances is set to sunset in 2023 as the Public Health Emergency comes to a close.
- We expect to gain clarity over the viability of the entirely remote ketamine telemedicine model (i.e., no initial in-person assessment prior to prescribing) in Q1 2023.
Psychedelic policy reform continues
- This will likely be the most prominent theme in 2023, with initiatives at the federal, state and local level in the U.S. and a growing number of efforts around the world.
- In the U.S., we should expect to learn more about the Federal Task Force and psychedelic caucus, PACT, at the federal level. We will also learn how the flurry of psychedelic policy reform bills filed in a number of states, and local decriminalisation efforts, will fare.
- In Australia, we will follow the limited rescheduling of MDMA and psilocybin (see our coverage) with great interest as we learn just how meaningful of an access pathway this move proves to be.
- At the EU level, we’re following discussions among various supranational bodies regarding psychedelic research and PATs.
- In Canada, we’re likely to see further efforts to expand existing, limited access pathways like the Special Access Program as well as decriminalisation initiatives like that seen in B.C.
- Psychedelic policy reform efforts will spring up in other lesser-discussed areas, too (see a dispatch from Czechia, for example).
An opportunity to evaluate legal psilocybin programs
- Oregon Psilocybin Services will review and award licences this year, meaning we will get a first look at how these psilocybin service centres fare. The program will get off to a relatively slow start, which might be complicated by efforts to introduce further red tape.
- Colorado’s Natural Medicine Advisory Board will likely be paying close attention to Oregon’s psilocybin services as they work out the nuts and bolts of the state’s own program. They’ll have the whole calendar year to establish rules, and licensing applications are expected to open at the very end of September, 2024.
- Given that some see these state psilocybin services models as natural experiments of sorts, discussions over the balance between data privacy on the one hand and the generation of valuable (real-world) safety and efficacy data on the other will continue to be salient.
Commercialisation-related discussions become dominant
- As MDMA-assisted therapy, and other psychedelic-assisted therapy (PAT) protocols in late-stage trials, prepare to move from carefully-controlled trials into the ‘real world’, discussions around commercialisation will become dominant.
- We explore a number of these considerations in two of our Year in Review sections: Late-Stage Psychedelic Trials and From Approvals to Access.
- This will include an increasing focus on topics like cost-effectiveness and the courting of payors, as well as the identification and/or establishment of necessary elements of PAT infrastructure.
- This focus on infrastructure, which has been emerging over the past two years, will only heighten in 2023 as we approach the convergence of the period where it’s ‘too early’ to begin building the ‘rails’ for PATs in the medical model and the period where it’s ‘too late’: i.e., a situation where the post-approval roll-out of MDMA-AT, for example, is severely stymied by a lack of infrastructure (such as appropriate clinic space, trained therapists, etc.).
- Relatedly, the matter of incentives will likely draw focus as greater attention is paid to the projected pool of PAT providers.
Non-hallucinogenic psychedelics tested in humans
- We should expect to learn more about so-called non-hallucinogenic psychedelics, or psychoplastogens, as they enter the first in-human trials. Aside from learning about their safety in Phase 1 trials, researchers will also learn whether they’re actually non-hallucinogenic in humans.
- We will also learn more from researchers who are employing novel trial designs in an attempt to arrive at the answer of whether subjective effects are necessary to the apparent therapeutic effects of psychedelics faster than the time it would take novel psychoplastogens to progress to (and through) mid-stage clinical trials. These include studies by Boris Heifets’ lab at Stanford and University of Wisconsin’s study that sees psilocybin co-administered with midazolam.
- See our Skipping the Trip section of our Research Themes review for more.
More psychedelics companies will go bust
- Given macro and sector-specific financial pressures, we expect at least a dozen psychedelic companies will cease operations in the first half of 2023 alone, with many more over the course of the year.
- As companies seek to cut costs we will see employee lay-offs and a reduced focus on staffing non-clinical divisions, such as digital therapeutics and tech teams, at drug developers.
- With valuations taking a significant hit and fundraising prospects looking less than rosy for many companies, those with relatively large amounts of cash-on-hand will continue shopping around for pipeline assets to acquire or licence. Much of this will be window shopping as relatively well-capitalised companies seek to fund their own pipeline assets, but there will be a limited amount of M&A.
- See Psychedelic Funding in 2022, Psychedelics in the Public Markets, and other sections from our Year in Review for more.
More people will get involved in the so-called ‘psychedelic renaissance’
- Despite the fact that psychedelics companies are facing a challenging financial environment, the pace of research, policy reform and public interest in psychedelics more broadly continues apace.
- As such, we expect to see more psychedelics-related courses and other educational opportunities. Collaboration among these initiatives will hopefully increase, fostered by the likes of the Psychedelic Educators Network (and the Psychedelic Research Center Consortium, on the research side).
- While many companies will look to streamline their operations, we will likely continue to see many job opportunities available in the psychedelic space, including new types of jobs. For more on this topic, see our Psychedelic Careers panel with early-career people from across the psychedelics space, and consider creating a profile on our Psychedelic Job Board.
- We will also see psychedelics-related professional associations (e.g., the Psychedelic Pharmacists Association and American Psychedelic Practitioners Association) continue to grow, as well as affinity groups (e.g., the Asian Psychedelic Collective).
Bonus: Expected Psychedelic Clinical Trial Completions and Readouts in 2023
Below is a table of key psychedelic clinical trials expected to complete in 2023. Note that the table is non-exhaustive and was generated using publicly-available information. Trial completion and readout timelines frequently change.
Dates in parentheses indicate projected readouts according to company announcements. IIT refers to Investigator-Initiated Trials.
|Quarter Completing||Trial Title||Sponsor||Type||Phase|
|Q1 2023||LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects||University Hospital, Basel||IIT||Phase 1|
|Q1 2023||IM and IV SPL026 Drug Product in Healthy Participants||Small Pharma||Commercially Sponsored||Phase 1|
|Q1 2023||Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder||Keith Heinzerling||IIT||Phase 2|
|Q1 2023||A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer||University of Utah||IIT||Phase 1|
|Q1 2023||The Efficacy and Tolerability of Psilocybin in Participants With Treatment-Resistant Depression: a Phase 2, Randomized Feasibility Study||Brain and Cognition Discovery Foundation||Commercially Affiliated||Phase 2|
|Q1 2023 (H1 2023 Readout)||A study to assess Two formulations of VLS-01 (DMT) in healthy participants||Virida Life Sciences (atai Life Sciences)||Commercially Sponsored||Phase 1|
|Q1 2023||An Open-Label Feasibility Study to Assess the Safety and Effect of Manualised MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder among Four Australians||Edith Cowan University||IIT||Phase 1/2|
|Q1 2023||Role of the Serotonin 5-HT2A Receptor in Mescaline-induced Altered States of Consciousness (MDR)||University Hospital, Basel||IIT||Phase 1|
|Q1 2023 (H2 2023 Readout)||Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of EMP-01 (MDMA Derivative) in Healthy Adult Volunteers||EmpathBio (atai Life Sciences)||Commercially Sponsored||Phase 1|
|Q1 2023 (H1 2023 Readout)||A Study of Psilocybin for Major Depressive Disorder (MDD)||Usona Institute||Commercially Sponsored||Phase 2|
|Q1 2023 (Q1 2023 Readout)||A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of RE104 In Healthy Volunteers||Reunion Neuroscience||Commercially Sponsored||Phase 1|
|Q2 2023||The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.||Sheppard Pratt Health System||Commercially Affiliated||Phase 2|
|Q2 2023||Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder||Yale University||Commercially Affiliated||Phase 1|
|Q2 2023||A Single Ketamine Infusion Combined With Music for Suicidal Ideation During a Depressive Episode: A Randomized Open Label Clinical Trial||The University of Texas Health Science Center at Tyler||IIT||Phase 2|
|Q2 2023||SPL026 With or Without SSRIs in Participants With MDD||Small Pharma||Commercially Sponsored||Phase 1|
|Q2 2023||Effects of Psilocybin in Anorexia Nervosa||Johns Hopkins University||IIT||Phase 1|
|Q2 2023||Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study||Anders Fink-Jensen, MD, DMSci||IIT||Phase 2|
|Q2 2023||An Open-Label Expanded Access Protocol for Esketamine Treatment of Subjects With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives||Janssen-Cilag, S.A.||IIT||Phase 3|
|Q2 2023||A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide||Janssen Research & Development, LLC||Commercially Sponsored||Phase 2|
|Q2 2023||Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion||Johns Hopkins University||IIT||Phase 1|
|Q2 2023||A Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Psychotherapy for the Treatment of Participants With Posttraumatic Stress Disorder||MAPS||Commercially Sponsored||Phase 3|
|Q2 2023||A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers||Bright Minds Biosciences||Commercially Sponsored||Phase 1|
|Q2 2023||Psilocybin for Treatment of Obsessive Compulsive Disorder||University of Arizona||IIT||Phase 1|
|Q2 2023||Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness||St. Vincent's Hospital Melbourne||Commercially Affiliated||Phase 2|
|Q2 2023||A pilot study testing the feasibility of a single microdose of ayahuasca alkaloids on neurotransmitters, inflammation marker levels, safety, and mood in healthy adult volunteers||Biochem Industries||Commercially Sponsored||N/A|
|Q2 2023||A Treatment Development Study of MDMA-Assisted Psychotherapy for PTSD||Remedy||Commercially Sponsored||Phase 2|
|Q2 2023||Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification||International Center for Ethnobotanical Education, Research, and Service||Commercially Affiliated||Phase 2|
|Q2 2023||A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin||University of Wisconsin, Madison||Commercially Affiliated||Phase 1|
|Q2 2023||A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide||Seelos Therapeutics, Inc.||Commercially Sponsored||Phase 2|
|Q2 2023||Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders||Yale University||Commercially Affiliated||Phase 1|
|Q2 2023||Thorough QT/QTc (TQT) Clinical Trial to Evaluate the Effect of Psilocybin on Cardiac Repolarization in Healthy Volunteers||Usona Institute||Commercially Sponsored||Phase 1|
|Q2 2023||Recall of Experience and Conscious Awareness in Psilocybin Treatment of Depression (The RECAP Study): Pilot Phase in Healthy Adult Volunteers||University of Wisconsin, Madison||IIT||Phase 1|
|Q2 2023||Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study||Joshua Woolley, MD/PhD||IIT||Phase 2|
|Q2 2023 (H1 2023 Readout)||A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of Ascending Single and Fixed Repeat Intravenous Doses of DMT in Healthy Subjects||Algernon Pharmaceuticals||Commercially Sponsored||Phase 1|
|Q2 2023||Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users||Medical University of South Carolina||IIT||Phase 2|
|Q3 2023||Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function (MASM)||University of California, San Diego||IIT||Phase 1|
|Q3 2023||Behavioral and Neural Mechanisms Supporting Psilocybin-assisted Therapy for Phantom Limb Pain||University of California, San Diego||IIT||Phase 1|
|Q3 2023||Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II||Yale University||IIT||Phase 1|
|Q3 2023||ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression||Beckley Psytech||Commercially Sponsored||Phase 1/2|
|Q3 2023||Psilocybin-facilitated Treatment for Cocaine Use: A Pilot Study||University of Alabama at Birmingham||IIT||Phase 2|
|Q3 2023||An Observational Pre-post Study Evaluating the Safety of Tabernanthe Iboga Exposure||Stanford University||IIT||N/A|
|Q3 2023||Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health||University of Alabama at Birmingham||Commercially Affiliated||N/A|
|Q3 2023 (H2 2023 Readout)||The Safety and Tolerability of COMP360 in Participants With Post-Traumatic Stress Disorder||COMPASS Pathways||Commercially Sponsored||Phase 2|
|Q3 2023||Microdosing Psychedelics to Improve Mood||Rotem Petranker||IIT||Phase 2|
|Q3 2023||Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample||University of Wisconsin, Madison||Commercially Affiliated||Phase 1|
|Q3 2023||The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC)||Emory University||IIT||Phase 1|
|Q3 2023||Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder||Halucenex Life Sciences Inc.||Commercially Sponsored||Phase 2|
|Q3 2023||Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study||University Hospital, Basel||IIT||Phase 1|
|Q4 2023 (Q1 2023 Interim Readout)||A Study of a Psilocybin Analog (CYB003) in Health Participants With and Without Major Depressive Disorder||Cybin||Commercially Sponsored||Phase 1/2|
|Q4 2023||Safety and efficacy of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder [Psi-GAD-1]: a randomised triple-blind active-placebo-controlled trial||Monash University||Commercially Affiliated||Phase 2|
|Q4 2023||An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder||Beckley Psytech||Commercially Sponsored||Phase 2|
|Q4 2023 (H2 2023 Readout)||An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 (5-MeO-DMT) in Patients With Treatment Resistant Depression||Beckley Psytech||Commercially Sponsored||Phase 2a|
|Q4 2023||Psilocybin Treatment in Obsessive-Compulsive Disorder: a Preliminary Efficacy Study and Exploratory Investigation of Neural Correlates.||Yale University||IIT||Phase 1|
|Q4 2023||The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder||Maryland Oncology Hematology, PA||Commercially Affiliated||Phase 2|
|Q4 2023 (H1 2023 Phase 1 Readout)||Ibogaine to Determine Maximum Tolerated Dose (MTD) or Treat-to-Target Dose (TTD) for the Evaluation of Efficacy and Safety||DemeRx IB, Inc. (atai Life Sciences)||Commercially Sponsored||Phase 1/2|
|Q4 2023||An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)||Sheppard Pratt Health System||Commercially Affiliated||Phase 2|