The U.S. Food and Drug Administration (FDA) has released its first draft guidance on conducting clinical trials with psychedelic drugs for potential medical treatment. Published on June 23, 2023, the guidance aims to provide researchers with important considerations when investigating the use of psychedelics in treating conditions like psychiatric disorders and substance use disorders.

The FDA acknowledges the growing interest in psychedelic drugs for therapeutic purposes but emphasizes the need for careful study design due to the unique challenges these compounds present. The draft guidance addresses various aspects of drug development, including trial conduct, data collection, subject safety, and application requirements.

It also highlights the potential for psychoactive effects and the importance of preventing drug misuse and abuse.

The FDA is inviting the public to submit comments on the draft guidance. To ensure that the agency takes them into consideration, comments should be submitted within a 60-day timeframe.

Public Psychedelics Companies Listed in the U.S. Include:

Atai Life Sciences N.V. (Nasdaq: ATAI), a biotech company focused on developing innovative mental health treatments by leveraging psychedelic compounds. They aim to address unmet medical needs in areas such as depression, anxiety, addiction, and other mental health disorders.

GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to developing therapies for mental health disorders. They focus on the research and development of psychedelic-based medicines to provide novel treatment options for patients.

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company that specializes in the development of psilocybin therapy for treatment-resistant depression. They aim to transform mental health care by combining therapy with psychedelic compounds to improve patient outcomes.

Mind Medicine (MindMed) Inc. (Nasdaq: MNMD), a leading biotech company focused on the research and development of psychedelic-inspired medicines. They aim to discover innovative treatments for mental health disorders, including addiction, anxiety, and attention deficit hyperactivity disorder (ADHD).

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company specializing in the development of therapies for central nervous system (CNS) disorders. They explore the potential of psychedelic compounds in addressing neuropsychiatric and other CNS-related conditions.

Cybin Inc. (NYSE American: CYBN), a life sciences company dedicated to advancing psychedelic therapeutics for mental health disorders. They focus on developing proprietary drug candidates to target conditions such as depression, addiction, and post-traumatic stress disorder (PTSD).

Bright Minds Biosciences Inc. (Nasdaq: DRUG), a biotechnology company focused on discovering and developing novel therapeutics for neurological and psychiatric disorders. They leverage psychedelic compounds and proprietary drug discovery platforms to advance innovative treatment options.

Enveric Biosciences, Inc. (Nasdaq: ENVB), a biotech company developing novel therapeutics for anxiety, depression, and addiction disorders. Their lead program, the EVM201 Series, focuses on synthetic psilocybin analogues, with EB-373 targeting anxiety disorders. Leveraging their proprietary platform, The Psybrary, Enveric aims to advance small-molecule treatments for mental health indications.

Silo Pharma, Inc. (Nasdaq: SILO), a development-stage biopharmaceutical company focused on the research and development of targeted therapeutics for cancer and other diseases. They explore the potential of psychedelic compounds and nanotechnology to enhance drug delivery and treatment efficacy.

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