2026 Could Be the Year Psychedelics Finally Break Through
The psychedelic medicine field is entering its most consequential year yet. Two companies are preparing to file for FDA approval of treatments that could reshape mental health care. Compass Pathways is developing COMP360, a psilocybin therapy for treatment resistant depression. Definium is advancing MM120, an LSD based treatment targeting generalized anxiety disorder and major depressive disorder. Wall Street analysts are calling 2026 “a very big year for psychedelics.” Both therapies could reach approval as early as 2027.
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| Key Takeaway | Details |
|---|---|
| Lead Companies | Compass Pathways (COMP360) and Definium (MM120) |
| Target Conditions | Treatment resistant depression, anxiety, MDD, PTSD |
| Projected Approval Timeline | As early as 2027 |
| FDA Support | Commissioner Makary pledged rapid review of psychedelic data |
| Key Differentiator | COMP360 single session vs. Spravato’s ~10 sessions over six weeks |
| Remaining Hurdles | DEA rescheduling, state law updates, clinic scalability |
Lessons From the Lykos Setback
The FDA rejected Lykos Therapeutics’ MDMA therapy for PTSD in August 2024. The decision shook the industry. But the details told a more nuanced story. The agency focused its concerns on trial design, not on psychedelics as a drug class. That distinction matters enormously. Compass and Definium have built their late stage programs with those lessons in hand.
Compass plans several Phase III data readouts this quarter. Definium has three Phase III data drops on deck. RBC Capital Markets described these catalysts as a potential “tipping point” for the entire sector.
Washington Is Paying Attention
So will regulators cooperate? Signs point toward yes. FDA Commissioner Marty Makary pledged a rapid review of psychedelic therapy data last year. Health Secretary Robert F. Kennedy Jr. has also voiced support for expanding access to these treatments.
Analysts note the current administration’s willingness to rethink old norms could change how advisory committees evaluate psychedelic drugs. That shift could accelerate the timeline to approval.
The Gap Between Approval and Access
Even after the FDA acts, patients will not gain instant access. The DEA must reschedule psilocybin and LSD from Schedule 1. Each state then needs to update its own laws. About half have trigger laws that automatically follow federal guidance. The rest will require separate legislative action.
Delivery logistics present another real challenge. COMP360 sessions can last six hours. MM120 can take eight. Compare that to Spravato, which runs about two hours per visit. Clinics will need to rethink operations and staffing.
Despite those hurdles, analysts project both drugs could win approval by 2027. Compass also recently received FDA acceptance of an investigational drug application for COMP360 in PTSD. That indication alone could serve an estimated 13 million patients.
For those living with treatment resistant depression, anxiety or PTSD, this year’s clinical readouts may represent the beginning of a new era in mental health care.
