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Last Updated: January 20, 2025

Investigational Drug Information for Psilocybin


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What is the development status for investigational drug Psilocybin?

Psilocybin is an investigational drug.

There have been 143 clinical trials for Psilocybin. The most recent clinical trial was a Phase 2 trial, which was initiated on November 1st 2022.

The most common disease conditions in clinical trials are Depression, Depressive Disorder, and Disease. The leading clinical trial sponsors are Johns Hopkins University, COMPASS Pathways, and Heffter Research Institute.

There are seven hundred and twenty-six US patents protecting this investigational drug and zero international patents.

Recent Clinical Trials for Psilocybin
TitleSponsorPhase
Inpatient Buprenorphine Induction With Psilocybin for Opioid Use DisorderJohns Hopkins UniversityPhase 2
Safety Profile of Psilocybin for Cocaine Use DisorderUniversity of California, Los AngelesEarly Phase 1
A Randomized Neuroimaging Trial of Psilocybin in DepressionSunnybrook Health Sciences CentrePhase 2

See all Psilocybin clinical trials

Clinical Trial Summary for Psilocybin

Top disease conditions for Psilocybin
trials05101520253035DepressionDepressive DisorderDisease[disabled in preview]
Top clinical trial sponsors for Psilocybin
trials0246810121416182022Johns Hopkins UniversityCOMPASS PathwaysHeffter Research Institute[disabled in preview]

See all Psilocybin clinical trials

US Patents for Psilocybin

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
Psilocybin ⤷  Subscribe Devices and methods for continuous analyte monitoring DexCom, Inc. (San Diego, CA) ⤷  Subscribe
Psilocybin ⤷  Subscribe Devices and methods for continuous analyte monitoring DexCom, Inc. (San Diego, CA) ⤷  Subscribe
Psilocybin ⤷  Subscribe Indicator and analytics for sensor insertion in a continuous analyte monitoring system and related methods DexCom, Inc. (San Diego, CA) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 3 of 3 entries

International Patents for Psilocybin

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
Psilocybin Denmark DK3069279 2033-11-14 ⤷  Subscribe
Psilocybin European Patent Office EP3069279 2033-11-14 ⤷  Subscribe
Psilocybin European Patent Office EP3796332 2033-11-14 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 3 of 3 entries

The Future of Psilocybin: Development Updates and Market Projections

Introduction to Psilocybin

Psilocybin, the active ingredient in "magic mushrooms," has been gaining significant attention in recent years for its potential therapeutic benefits in treating various mental health disorders. This article will delve into the current development updates and market projections for psilocybin-based therapies.

Current Development Status

Cybin's CYB003: A Leading Psilocybin-Based Therapy

Cybin Inc., a clinical-stage biopharmaceutical company, is at the forefront of psilocybin research with its lead drug candidate, CYB003. CYB003 is a proprietary formulation of psilocybin, currently in Phase 2 clinical trials for the treatment of major depressive disorder (MDD) and alcohol use disorder (AUD)[1][4].

  • Clinical Milestones: Cybin expects to report 12-month Phase 2 efficacy data for CYB003 in early Q4 2024, providing crucial insights into its long-lasting therapeutic potential. The initiation of the pivotal Phase 3 study for MDD is also imminent[4].

  • Regulatory Support: CYB003 has received FDA Breakthrough Therapy Designation, which validates its potential for significant clinical improvements over existing treatments and expedites its development pathway towards commercialization[1][4].

Other Psilocybin-Based Therapies

In addition to Cybin's CYB003, other companies and research institutions are actively exploring the therapeutic potential of psilocybin. These efforts include various formulations and delivery methods, such as processed psychedelic mushrooms like gums and gellies, which offer easier consumption and more consistent dosing[2].

Market Projections

Growing Market Size

The market for psilocybin and other psychedelic drugs is projected to experience significant growth over the next few years.

  • U.S. Psychedelic Mushroom Market: The U.S. psychedelic mushroom market was estimated at USD 2.25 billion in 2024 and is expected to grow at a CAGR of 11.5% from 2025 to 2030, reaching USD 4.32 billion by 2030[2].

  • Global Psychedelic Drugs Market: The global psychedelic drugs market, which includes psilocybin, was valued at USD 2.71 billion in 2023 and is projected to reach USD 7.35 billion by 2031, with a CAGR of 13.3%[3].

Key Drivers of Market Growth

Several factors are driving the growth of the psilocybin market:

  • Increasing Legalization and Decriminalization: The growing movement to decriminalize and legalize psychedelic substances in the United States and Canada is creating a more favorable regulatory environment for the development and commercialization of psilocybin-based therapies[1][2][3].

  • Therapeutic Potential: The efficacy of psilocybin in treating mental health conditions such as depression, anxiety, PTSD, and addiction is supported by a growing body of research. This therapeutic potential is increasing demand and interest in these substances[2][3].

  • Collaborations and Research Funding: Collaborations between academia and industry, along with increasing research funding, are accelerating the development of psychedelic-based therapies. These collaborations and funding are crucial for identifying novel drug candidates and enhancing existing treatments[3].

Regulatory Landscape

Evolving Regulatory Environment

The regulatory landscape for psychedelic-based therapies is evolving positively.

  • FDA Guidance and Designations: The FDA's guidance for the development of psychedelic-based therapies and the Breakthrough Therapy Designation for CYB003 are significant steps forward. These developments provide clear guidelines and expedite the approval process for these therapies[1].

  • State and Local Legalizations: Cities and states in the U.S., such as Denver, Oakland, and Oregon, have decriminalized or legalized psilocybin for therapeutic use, paving the way for further legalization and increased market opportunities[1][2].

Challenges and Restraints

Cultural and Public Safety Issues

Despite the positive outlook, there are challenges to consider:

  • Cultural Obstacles: In areas with conservative values or where psychedelic use contradicts cultural norms, acceptance may be limited. This can affect demand and regulatory approval processes[3].

  • Misuse and Public Safety: Concerns about the misuse of psychedelic substances and public safety issues need to be addressed through education and responsible regulation[3].

Market Segmentation

Product Types and Applications

The market for psilocybin is segmented based on product types, forms, and applications.

  • Product Types: The Psilocybe segment, which includes various species like Psilocybe cubensis and Psilocybe semilanceata, dominates the market. Other segments include Gymnopilus and Panaeolus[2].

  • Forms: Processed forms like gums and gellies are gaining popularity due to their ease of consumption and consistent dosing. Other forms include fresh/whole and dried mushrooms[2].

  • Applications: The primary applications are for depression relief, anxiety relief, de-addiction, and recreational use. The therapeutic applications are expected to drive significant growth as more research validates the efficacy of psilocybin[2].

Expert Insights and Statistics

Therapeutic Efficacy

"Psilocybin has shown remarkable promise in treating conditions such as depression, anxiety, and PTSD. The growing body of research supporting its efficacy is a key driver of market growth," says Dr. Atul R. Mahableshwarkar, a program lead for Cybin's CYB003[4].

  • Market Size: The U.S. psychedelic mushroom market is expected to reach USD 4.32 billion by 2030, with a CAGR of 11.5% from 2025 to 2030[2].

  • Growth Rate: The global psychedelic drugs market is projected to grow at a CAGR of 13.3% from 2024 to 2031[3].

Key Takeaways

  • Positive Regulatory Environment: Increasing legalization and decriminalization, along with favorable regulatory developments, are driving the growth of psilocybin-based therapies.
  • Therapeutic Potential: Psilocybin has shown significant promise in treating mental health disorders, supported by a growing body of research.
  • Market Growth: The market for psilocybin is expected to grow substantially, with the U.S. market reaching USD 4.32 billion by 2030 and the global market reaching USD 7.35 billion by 2031.
  • Challenges: Cultural obstacles and public safety concerns need to be addressed to ensure sustainable market growth.

FAQs

What is the current status of Cybin's CYB003?

Cybin's CYB003 is currently in Phase 2 clinical trials for the treatment of major depressive disorder (MDD) and alcohol use disorder (AUD). The company expects to report 12-month Phase 2 efficacy data in early Q4 2024 and is preparing to initiate the pivotal Phase 3 study for MDD[4].

How is the regulatory environment impacting psilocybin development?

The regulatory environment is becoming increasingly favorable, with the FDA providing guidance and granting Breakthrough Therapy Designation to CYB003. State and local legalizations are also contributing to a more supportive regulatory landscape[1][2].

What are the primary applications of psilocybin?

The primary applications of psilocybin include depression relief, anxiety relief, de-addiction, and recreational use. Therapeutic applications are driving significant market growth as research validates the efficacy of psilocybin[2].

What are the key drivers of the psilocybin market growth?

Key drivers include increasing legalization and decriminalization, the therapeutic potential of psilocybin, collaborations between academia and industry, and increasing research funding[1][2][3].

What are the potential challenges for the psilocybin market?

Potential challenges include cultural obstacles, public safety concerns, and the risk of misuse. Addressing these issues through education and responsible regulation is crucial for sustainable market growth[3].

Sources

  1. Future Outlook: Cybin Stock Forecast Through 2025 - Digital Dev.
  2. U.S. Psychedelic Mushroom Market Size, Share Report, 2030 - Grand View Research.
  3. Psychedelic Drugs Market Size, Outlook & Industry Growth By 2031 - Data Bridge Market Research.
  4. Cybin Provides Corporate Update on Upcoming Clinical Milestones - BioSpace.
  5. Magic Mushroom Market Size Report, 2022-2027 - IndustryARC.

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