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Last Updated: January 20, 2025

Investigational Drug Information for Bufotenin


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What is the development status for investigational drug Bufotenin?

Bufotenin is an investigational drug.

There have been 5 clinical trials for Bufotenin. The most recent clinical trial was a Phase 1 trial, which was initiated on March 7th 2023.

The most common disease conditions in clinical trials are Depressive Disorder, Depression, and Disease. The leading clinical trial sponsors are GH Research Ireland Limited and [disabled in preview].

There are ninety-four US patents protecting this investigational drug and four hundred and ninety-six international patents.

Recent Clinical Trials for Bufotenin
TitleSponsorPhase
Phase 2 Clinical Trial of GH001 in Bipolar II DisorderGH Research Ireland LimitedPhase 2
A Trial of GH001 in Patients With Treatment-resistant DepressionGH Research Ireland LimitedPhase 2
Phase 2 Clinical Trial of GH001 in Postpartum DepressionGH Research Ireland LimitedPhase 2

See all Bufotenin clinical trials

Clinical Trial Summary for Bufotenin

Top disease conditions for Bufotenin
trials000111112222Depressive DisorderDepressionDisease[disabled in preview]
Top clinical trial sponsors for Bufotenin
trials011223344556GH Research Ireland Limited[disabled in preview]

See all Bufotenin clinical trials

US Patents for Bufotenin

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
Bufotenin ⤷  Subscribe Pharmaceutical compositions resistant to abuse EGALET LTD. (London, GB) ⤷  Subscribe
Bufotenin ⤷  Subscribe Abuse-deterrent controlled release formulations Patheon Softgels Inc. (High Point, NC) ⤷  Subscribe
Bufotenin ⤷  Subscribe Opioid and attention deficit hyperactivity disorder medications possessing abuse deterrent and anti-dose dumping safety features Pisgah Laboratories, Inc. (Pisgah Forest, NC) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 3 of 3 entries

International Patents for Bufotenin

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
Bufotenin Australia AU2010211376 2029-02-06 ⤷  Subscribe
Bufotenin Australia AU2013257533 2029-02-06 ⤷  Subscribe
Bufotenin Canada CA2751627 2029-02-06 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 3 of 3 entries

Bufotenin: A Promising Psychedelic Drug Candidate

Introduction

Bufotenin, a psychedelic compound found in various natural sources, including the glands of the Colorado River toad and certain plant species, is gaining significant attention in the pharmaceutical industry for its potential therapeutic benefits. Here, we will delve into the current development updates and market projections for this drug candidate.

Chemical and Biological Background

Bufotenin is structurally related to other psychedelics like DMT and 5-MeO-DMT. It is produced through the N-methylation of serotonin, a process that can be catalyzed by specific enzymes such as the N-methyltransferase found in the cane toad[1].

Current Development Status

GH Research PLC

GH Research PLC is at the forefront of developing bufotenin and its analogs, particularly 5-MeO-DMT (mebufotenin), for various psychiatric and neurological disorders. Their product candidate, GH001, is being developed for the treatment of Treatment-Resistant Depression (TRD) and other indications such as postpartum depression and bipolar II disorder.

  • Phase 2b Clinical Trials: GH001 is currently in Phase 2b clinical trials for TRD, with an expected completion in Q3 2024. These trials involve inhaled administration using a proprietary device to achieve optimal pharmacokinetics and peak experience (PE)[2].
  • Other Routes of Administration: GH Research is also exploring intravenous and nasal administration routes for mebufotenin, with Phase 1 trials completed for intravenous administration and preclinical development ongoing for nasal administration[2].

Beckley Psytech

Beckley Psytech, in collaboration with atai Life Sciences, is developing BPL-003, a novel intranasal formulation of 5-MeO-DMT.

  • Phase 1 Clinical Trials: BPL-003 has demonstrated good safety and tolerability profiles in Phase 1 clinical trials. The medium and high doses reliably induced profound psychedelic experiences with rapid onset and short duration (60-90 minutes)[4].
  • Phase 2a and 2b Clinical Studies: Beckley Psytech is conducting Phase 2a and 2b clinical studies for BPL-003 in patients with TRD and Alcohol Use Disorder (AUD), with data anticipated in the first half and mid-2024, respectively[4].

Therapeutic Potential

Treatment-Resistant Depression

Both GH Research and Beckley Psytech are focusing on the therapeutic potential of bufotenin and its analogs in treating TRD. The rapid onset and short duration of psychedelic effects make these compounds promising for acute treatment of depressive episodes[2][4].

Other Indications

In addition to TRD, these drug candidates are being explored for other psychiatric and neurological disorders, including postpartum depression, bipolar II disorder, and alcohol use disorder. The versatility of these compounds in addressing various mental health conditions underscores their significant therapeutic potential[2][4].

Market Projections

Regulatory Landscape

The regulatory landscape for psychedelic drugs is evolving, with several states and countries reconsidering their prohibition policies. However, the path to regulatory approval remains complex and uncertain. No psychedelic therapies, including those based on bufotenin, have been approved for commercialization in the United States or the European Union yet[3].

Market Size and Growth

The market for psychedelics is significantly smaller than that for cannabis but is growing rapidly. According to RAND Corporation, the total number of use days for psychedelics is much lower than for cannabis, but the market is driven largely by infrequent users, which could indicate a niche but dedicated consumer base[5].

Competitive Landscape

The competitive landscape for psychedelic drug development is becoming increasingly crowded, with multiple companies and research institutions investing in various psychedelic compounds. However, the focus on bufotenin and its analogs by companies like GH Research and Beckley Psytech positions these entities at the forefront of this emerging market[2][4].

Challenges and Risks

Clinical Trial Outcomes

The success of bufotenin-based therapies is heavily dependent on the outcomes of ongoing and future clinical trials. Adverse public perception and undesirable clinical trial outcomes could significantly impact the regulatory approval process and future development[3].

Manufacturing and Scalability

The scalability and commercial viability of manufacturing methods for bufotenin and its analogs are critical factors. The current bioproduction platforms face challenges in achieving the throughput and scale of synthetic chemistry, which could affect the availability of these drugs for widespread use[1].

Safety and Tolerability

While initial trials have shown good safety and tolerability profiles, the long-term safety and potential side effects of these compounds remain to be fully understood. This is a crucial area of ongoing research and monitoring[2][4].

Key Takeaways

  • Therapeutic Potential: Bufotenin and its analogs show promising therapeutic potential for treating various psychiatric and neurological disorders, particularly TRD.
  • Current Development: GH Research and Beckley Psytech are leading the development of these compounds, with several clinical trials ongoing.
  • Regulatory Landscape: The path to regulatory approval is complex and uncertain, but there is a growing trend towards reconsidering prohibition policies.
  • Market Projections: The market for psychedelics is growing, though it remains smaller than the cannabis market.
  • Challenges: Clinical trial outcomes, manufacturing scalability, and long-term safety are key challenges that need to be addressed.

FAQs

Q: What is bufotenin and how is it produced? A: Bufotenin is a psychedelic compound produced through the N-methylation of serotonin, a process that can be catalyzed by specific enzymes found in certain organisms like the cane toad[1].

Q: Which companies are leading the development of bufotenin-based therapies? A: GH Research PLC and Beckley Psytech are at the forefront of developing bufotenin and its analogs for various psychiatric and neurological disorders[2][4].

Q: What are the current clinical trial stages for bufotenin-based therapies? A: GH001 by GH Research is in Phase 2b clinical trials for TRD, while BPL-003 by Beckley Psytech is in Phase 2a and 2b clinical studies for TRD and AUD[2][4].

Q: What are the potential therapeutic indications for bufotenin? A: Bufotenin and its analogs are being explored for treating TRD, postpartum depression, bipolar II disorder, and alcohol use disorder[2][4].

Q: What are the main challenges in the development and market approval of bufotenin-based therapies? A: The main challenges include clinical trial outcomes, regulatory approval uncertainties, manufacturing scalability, and long-term safety concerns[1][3][4].

Sources

  1. Journal of Biological Chemistry: "A cane toad (Rhinella marina) N-methyltransferase converts primary..."
  2. GH Research PLC: "Corporate Presentation - Investor Relations"
  3. GH Research PLC: "SEC Filing - Investor Relations"
  4. Synapse by Patsnap: "Atai Strategic Investment in Beckley Psytech to Jointly Develop..."
  5. RAND Corporation: "Considering Alternatives to Psychedelic Drug Prohibition"

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