Fuente: Prohibición Partners Lugar: General Report Contents
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Introduction →
Definitions And Scope →
Executive Summary →
Key Trends →

Market Value →
Legislation and Regulation →
Consumer Attitudes →
Healthcare Providers’ Attitudes →

Spotlight On Health →
Psychedelics – Timeline of Key Developments →
Countries to Watch →
Psychedelic Profiles →

Key Psychedelics Deep Dive →
Other Psychedelics of Note →
Psychedelics as Medicine: Potential Therapies →
Psychedelics and Technology →

Psychedelics Per Country →
Psychedelics and The Law →
Patents and Intellectual Property →
Therapy Practitioners →

Psychedelic Research →
Glossary →


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Key takeaways




Ketamine is currently the only psychedelic in widespread clinical use.



MDMA for PTSD is currently in phase IIIb and is expected to be approved by 2023.



Psilocybin for depression has just finished data collection on a large phase IIb trial; 26 phase IIb trials have been conducted or are currently ongoing.



Universities and hospitals commonly sponsor trials. Companies have sponsored an average of 10 trials annually over the last three years, projected to rise to 40 annually in 2024. More than 30 companies have indicated an intent to run clinical trials.



We can expect MDMA-assisted psychotherapy for PTSD to be approved by the FDA in 2023. Psilocybin for depression (both MDD and TRD) will probably be approved by 2025. Approvals for ibogaine, LSD, DMT and ketamine could follow soon afterwards.




Research momentum: why this field is accelerating



Psychedelic research is pushing ahead at a pace never seen before. In the early 2000s, only a handful of researchers were conducting animal studies with mind-altering substances. Today, more than 100 papers on psychedelics are published every month.



This growing body of work includes clinical trial outcomes (with a new clinical trial started every week), observational studies (often in traditional settings), new hypotheses, and reviews that consolidate what we currently understand about psychedelics as medicines.



Psychedelic research groups shaping the field



The steep rise in psychedelic research reflects the work of research groups that have balanced the multidimensional nature of psychedelics with the rigorous demands of scientific inquiry. It has also been enabled by foundations that funded much of the early research—particularly the Heffter Research Institute, the Beckley Foundation, and MAPS.



The current wave arguably began with the study of DMT experiences by Rick Strassman in the 1990s. At the time, his group at the University of New Mexico was (as far as we know) the only place conducting psychedelic research in humans. While the study did not investigate psychedelics as medicines per se, it demonstrated that human psychedelic research could be done.



In 2000, the Johns Hopkins research group received permission to restart psychedelic research—this time in psychedelic-naive participants. The Centre for Psychedelic and Consciousness Research at Johns Hopkins (founded September 2020) represents the next phase of intensification, expanding into psilocybin research across multiple mental health disorders.



In the UK, the Imperial College London (ICL) team pioneered psychedelic research using brain imaging techniques. After more than a decade of work, ICL launched the Centre for Psychedelic Research with the explicit goal of developing psilocybin-assisted therapy into a licensed treatment for depression.



Beyond these pioneering hubs, research is also taking place globally—from Maastricht University in the Netherlands to the University of São Paulo in Brazil—led by groups and individual researchers, each approaching psychedelics through their own lens.



In the last two years, many new centres have emerged, including:




UC Berkeley Centre for the Science of Psychedelics (launched September 2020), with aims including public education, therapist training, and research.



Mount Sinai’s Centre for Psychedelic Psychotherapy and Trauma Research (launched at the start of 2021), researching MDMA, psilocybin, and others for complex mental health issues.



Mass General’s Center for the Neuroscience of Psychedelics (launched February 2021), leveraging neuroimaging to better understand mechanisms.



UCSF’s Translational Psychedelic Research, including psilocybin research for hard-to-treat disorders such as bipolar depression.



A psychedelic section within UCSF’s Neuroscape laboratory, where Robin Carhart-Harris serves as a director.




Clinical trials with psychedelics: what the data says



Although psilocybin and MDMA tend to dominate public attention, ketamine has generated the most research. As of July 2021, 140 clinical trials have been conducted with ketamine for mental health and substance use disorders. This has supported the approval of Spravato for TRD, and the widespread use of ketamine for MDD and suicidal ideation.



Participation is rising rapidly. Between 2016 and 2018, an average of 1,100 patients per year participated in trials; between 2019 and 2021, this more than doubled to 2,450 patients per year. The average trial size is 52 participants, rising from 36 on average in phase I trials to 96 per phase III trial. Excluding ketamine trials lowers the phase I average to 30 patients per trial.



Trial locations and diversity gaps



Geographically, the United States leads in clinical trial activity, with Switzerland (notably the Liechti Laboratory) in second place. The UK ranks fourth after Canada and has been increasing trial activity. China stands out for hosting a dozen trials, reflecting ketamine research dating back to 2012—and a study on psilocybin for migraines.



However, trial populations are not yet diverse. A 2018 review found 82% of patients are white and only 2% are of Asian origin, despite Asia representing around 60% of the global population. Other ethnic groups are also underrepresented. Future work on dosing, efficacy, genetics, and health-service attitudes needs more representative populations to better generalise results.



Sponsors and future growth



Sponsors have increased sharply. Across the last three years, companies have sponsored ~10 trials per year on average, while universities have also increased output. At present, the largest sponsors include COMPASS Pathways, MindMed, Johnson & Johnson, atai and its subsidiaries.



Government sponsorship is also present, notably through US Veterans Affairs services, and is expected to rise as research becomes more mainstream. Signals from Germany and Australia suggest further government funding is coming, including German support for a MIND Foundation psilocybin trial.



Industry-sponsored psychedelic trials: companies and costs



Commercial interest has expanded quickly. More than 30 companies are either running a trial, have run a trial, or have publicly indicated intent to run a trial with a psychedelic.



Development timelines and costs vary widely. At present, only Spravato (TRD and suicidal ideation) and the MDMA-for-PTSD programme provide clear examples. For Johnson & Johnson, because Spravato was a known chemical entity with a short development cycle, its development costs are likely below their typical US$5.8 billion per newly developed drug—and presumably below the estimated US$800 million average to bring a single drug to market.



MAPS has taken a leaner approach. Its total costs remain under US$100 million, with expectations to spend an additional US$100 million in further research and around US$70 million in commercialisation expenses prior to launch. While timelines have shifted over the years, 2023 remains a reasonable estimate for MDMA-assisted therapy approval.



Notable ongoing and planned clinical trials









Phase
Sponsor
Compound
Condition
Start year



Phase IIIMAPSMDMAPTSD2020

Phase IICompassPsilocybinTRD+2019
Phase IIUsonaPsilocybinMDD2019
Phase IIMindMedLSDCluster Headaches2019
Phase IISeelos TherapeuticsKetamineSuicidal Ideation2020
Phase IISmall PharmaDMTMDD2020
Phase IIGH Research5-MeO-DMTTRD (and others)2021
Phase IIMAPSMDMAEating Disorders2021
Phase IIMindMedLSDAnxiety2021
Phase IIMydecinePsilocybinPTSD2021
Phase IIAwaknMDMAAlcoholism2022
Phase IICybinPsilocybinMDD2022
Phase IIDemeRxIbogaineOpioids2022

Phase IMindMedIbogaine (18-MC)Opioids2020
Phase IPerception NeuroscienceKetamineTRD2020
Phase IBeckley Psytech5-MeO-DMTMDD2021
Phase IEleusisLSDAlzheimers2021
Phase IAlgernonDMTStroke2021
Phase IBeckley PsytechPsilocybinHeadaches/pain2021
Phase IEntheon BiomedicalDMTSUD2021
Phase IEleusisPsilocybinMDD2022
Phase ILophoraPsilocybinMDD2022
Phase IJourney ColabMescalineAUD2022









Psychedelics as medicines: projected approval timeline



This timeline is an arguably optimistic estimate for when psychedelics (or second-generation equivalents) could be approved for medical use, based on compounds currently under development (e.g., MDMA for PTSD) and those now entering clinical trials.









Indication
2019
2023
2025
2026
2027



MDDPsilocybinDMT
TRDEsketaminePsilocybinDMTKetamine
PTSDMDMAPsilocybin
Headaches / MigrainesLSDPsilocybin
Suicidal ideationEsketamineKetamine
Eating disordersMDMA
AnxietyLSD
Substance use disordersIbogaine, MDMADMT, Mescaline
AlzheimersLSD
StrokeDMT







What it takes for psychedelics to reach market



Even with strong anecdotal evidence and encouraging early research signals, many compounds will fail somewhere along the path. Based on research from Biotechnology Innovation Organisation, QLS Advisors and Informa UK (as of this year in the report), the probability of developing a novel compound into an approved medicine is below 10%. Repurposing a drug for a new indication has somewhat better odds, at about 25%.



Will psychedelics be different? Possibly—safety profiles are better understood for several classical compounds, and evidence is mounting for effectiveness. But compelling personal transformation narratives do not always translate into successful phase III outcomes.



As approvals arrive, psychedelics will also need to prove efficacy against treatments that are already approved. That challenge could become even harder if real-world data supports the effectiveness seen in trials of classical psychedelics. Off-label use may also emerge in the future, similar to patterns already seen with ketamine.








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The post Psychedelic Research: Clinical Trials, Timelines, and Key Research Groups – PSYCH: The Psychedelics As Medicine Report 3rd Edition appeared first on Prohibition Partners.