Companies specializing in psychedelic drugs are pushing for a transformation in mental health care
In the ever-evolving landscape of mental health treatment, the psychedelic drug industry is making significant strides, offering promising alternatives for patients who have been left behind by existing approaches. This rapid progress is marked by pivotal clinical trial successes, stronger regulatory support, innovative drug development, and integrative therapeutic approaches.
One of the key players in this emerging industry is GH Research, an Irish company that is researching the antidepressant potential of mebufotenin. Their lead product candidate, GH001, has already completed phase 1 and 2 trials in patients with treatment-resistant depression, demonstrating positive results.
Similarly, Enveric Biosciences, based in the United States, is focused on developing neuroplastogenic therapeutics for depression, anxiety, and addiction disorders. Their lead candidate, EB-003, is an intranasal formulation of mebufotenin benzoate, currently in preclinical development for neuropsychiatric disorders. EB-003 demonstrated positive effects in a preclinical model for post-traumatic stress disorder, indicating its potential for treating a range of mental health conditions.
Enveric Biosciences also has a second candidate, EB-002, which is a next-generation synthetic prodrug of psilocin, targeting psychiatric disorders. Another company, MindBio Therapeutics from Australia, is pioneering psychedelic microdosing for conditions such as depression and anxiety. Their lead candidate, MB22001, is a proprietary and self-titratable form of LSD, currently being trialed in patients at home for depression.
Atai Life Sciences, set up in 2018 in response to a lack of innovation in the mental health treatment landscape, operates with many smaller companies under its umbrella and has stakes in other players in the psychedelic drug industry. Their most advanced program is a candidate called BPL-003, an intranasal formulation of mebufotenin benzoate.
Compass Pathways is another significant player, developing a synthetic form of psilocybin for the treatment of depression. In February 2025, the primary endpoint was met in a phase 2b trial of GH001 in treatment-resistant depression, marking a significant milestone in the industry.
The first psychedelic drug to be approved in the U.S. for treating a mental health indication was a nasal spray form of ketamine in 2019. Now, the FDA is actively pursuing expedited review pathways for psychedelic therapies, aiming to reduce regulatory hurdles and accelerate approvals. Texas notably allocated $50–100 million to support FDA-approved ibogaine trials targeting opioid use disorder, PTSD, and other conditions, indicating growing governmental backing.
Beyond classical psychedelics, non-hallucinogenic neuroplastogens are emerging as a new class of therapeutics offering advantages such as simpler delivery and fewer societal acceptance issues, potentially improving clinical and commercial scalability. There is also growing research into combination therapies, integrating psychedelics with neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS), which may produce synergistic effects by enhancing neuroplasticity.
Finally, psychedelics continue to show promise for addressing existential distress in terminal illness, improving anxiety and depression related to end-of-life concerns by enhancing spiritual well-being and acceptance.
In conclusion, the psychedelic drug industry in 2025 is rapidly advancing with pivotal clinical trial successes, stronger regulatory support, innovative drug development, and integrative therapeutic approaches for challenging mental health disorders such as treatment-resistant depression, PTSD, and substance use disorders.
[1] Psychedelic Drug Industry Advances [2] Clinical Trials Show Promise for Psychedelics [3] Psychedelics for Mental Health: A New Era [4] Neuroplastogens: A New Class of Psychedelic Therapeutics [5] Investor Enthusiasm for Psychedelic Drugs
- Clinical trials for GH Research's antidepressant candidate, GH001, have demonstrated positive results in patients with treatment-resistant depression, marking a significant stride in the psychedelic drug industry.
- Enveric Biosciences' drug development focuses on neuroplastogenic therapeutics for depression, anxiety, and addiction disorders, with EB-003 showing promise in preclinical trials for neuropsychiatric disorders.
- As the FDA pursues expedited review pathways for psychedelic therapies and investors show enthusiasm, there is a growing focus on the development of non-hallucinogenic neuroplastogens as a new class of therapeutics in the mental health-and-wellness sector.
