The Race to Bring Psychedelics to Psychiatry

Mali Arwyn
3 hours ago
2 min read

Steve Jobs was open about how using LSD shaped his worldview and enhanced his creativity. Spiritual leader Ram Das, who has millions of followers postmortem, attributed his spiritual awakening to psychedelics. Now pharmaceutical companies around the world are racing to bring these types of drugs to your medicine cabinet.

In 2023, the FDA legitimized the potential therapeutic use of psychedelics by issuing “first draft guidance” for clinical trials. (1) And in 2024, the FDA designated several psychedelic-based drugs as “Breakthrough Therapy”—meaning they show promise and are eligible for expedited review. (2)

Psychedelics are believed to have fast and lasting therapeutic effects due to their ability to enhance the brain’s ability to change and adapt. (3) Patients with anxiety, depression, PTSD and addiction may benefit from new treatments currently undergoing clinical trials.

British biotech company, Compass Pathways, developed a synthetic form of psilocybin—the psychoactive substance found in “magic mushrooms.” The compound, COMP360, is currently undergoing phase 3 trials for treatment-resistant depression. (4) Phase 2 trial results were reported in the New England Journal of Medicine. (5) In Canada, Cybin has a similar drug in phase 3 trials for major depressive disorder. (6)

MindMed, based in New York, developed a “pharmaceutically optimized” form of LSD to treat generalized anxiety disorder. (7) They too are engaged in phase 3 trials. The phase 2 results were published in the Journal of the American Medical Association (JAMA). (8)

Lykos Therapeutic’s pharmaceutical-grade MDMA, meant for use in conjunction with psychotherapy, was the front runner for approval until their most recent FDA application was denied. Unfortunately, they will have to go back and repeat previous testing under stricter guidelines. (9) Meanwhile, Beckley Psytech developed a fast-acting, short-duration nasal spray that contains a psychedelic tryptamine. It’s being studied for treatment-resistant depression (TRD) and alcohol use disorder (AUD). (10)

A slew of “psychedelic-inspired” drugs are also in the pipeline. Delix Therapeutics is developing neuroplasticity-promoting compounds which they claim will somehow offer the benefits of hallucinogens without actually having to hallucinate. (11) In a similar vein, Diamond Therapeutics claims to be developing “psilocybin-based drugs” with no “perceptual side effects.” (12)

While it will likely be a few years before any of these compounds are approved for prescription use, FDA commissioner, Marty Makary, told NewsNation that determining the efficacy and safety of psychedelic drugs is a “top priority.” (13)

In the mean time, you can find more information on these developments at NASDAQ.com as investors debate which companies will see profit first. (14)

References

1 https://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs

2 https://www.pharmacytimes.com/view/lsd-d-tartrate-receives-breakthrough-therapy-designation-from-fda-for-generalized-anxiety-disorder

3 https://arxiv.org/abs/2411.19840

4 https://ir.compasspathways.com/News--Events-/news/news-details/2025/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-First-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/

5 https://www.nejm.org/doi/full/10.1056/NEJMoa2206443

6 https://ir.cybin.com/investors/news/news-details/2024/Cybin-Receives-FDA-Breakthrough-Therapy-Designation-for-its-Novel-Psychedelic-Molecule-CYB003-and-Announces-Positive-Four-Month-Durability-Data-in-Major-Depressive-Disorder/

7 https://ir.mindmed.co/news-events/press-releases/detail/171/mindmed-announces-first-patient-dosed-in-panorama-the-second-pivotal-phase-3-study-of-mm120-in-generalized-anxiety-disorder#:~:text=MM120%20was%20generally%20well%2Dtolerated,and%20Healthcare%20products%20Regulatory%20Agency

8 https://jamanetwork.com/journals/jama/article-abstract/2838505

9 https://www.biopharmadive.com/news/fda-psychedelics-pipeline-cybin-mindmed-compass-incannex/725470/#:~:text=from%20your%20inbox.-,After%20an%20FDA%20rejection%2C%20here's%20what's%20next%20in%20the%20psychedelics,Amy%20Baxter%20Staff%20Reporter

10 https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-and-beckley-psytech-announce-us-fda#:~:text=BPL%2D003%20is%20Beckley%20Psytech's,claims%20pending%20in%20various%20jurisdictions