BioSpace takes stock of the psychedelic therapeutics space, which is once again on the cusp of its first FDA approval.
Psychedelic therapeutics are at a tipping point—and they may be about to drop. After Lykos’ MDMA-assisted therapy for post-traumatic stress disorder failed to win FDA approval in 2024, the space stepped back from the limelight. But now they’re back, with Compass Pathways knocking on the regulator’s door and Definium Therapeutics and other psychedelic drugmakers hoping to file soon.
Compass is in the midst of a rolling submission to the FDA for COMP360, its psylocibin-based candidate for treatment resistant depression (TRD), and analysts anticipate a possible approval by the end of this year. Meanwhile, Definium’s LSD-based therapy has been meeting or exceeding high expectations in recent clinical readouts. In June, the drug elicited “profound” efficacy in a late-stage depression trial, then just last week delivered again with a solid late-stage win in anxiety.
Meanwhile, pharma superstar Eli Lilly provided the ultimate validation for the space this summer with the $3.8 billion acquisition of AtaiBeckley. As Health Secretary Robert F. Kennedy Jr. works to phase out selective serotonin reuptake inhibitors (SSRIs)—a current mainstay of mental health treatment—the time could be ripe for the entrance of psychedelics onto the U.S. market. The next 12 months are certain to be pivotal for the space.
COMP360 coming soon?
Jefferies analysts give COMP360 a 75–85% chance of approval this year, with the potential to launch by the first half of 2027. The firm’s July 17 prediction came after the asset proved its durability in a second Phase 3 trial earlier that month. COMP360 has succeeded in two “highly statistically significant” Phase 3 trials, Compass said in a February press release, “demonstrating a level of clinical effect that has historically been extremely difficult to achieve in TRD.”
If given the FDA’s greenlight, COMP360 will compete on the market with Johnson & Johnson’s inhaled Spravato, approved for TRD in 2019 and greenlit as the first monotherapy for the condition in January 2025. While J&J has previously told BioSpace it does not consider the inhaled esketamine treatment a traditional psychedelic, analysts agree that Spravato has paved the way for Compass’ candidate.
Definium: The backup
Coming up quickly behind Compass is Definium’s DT120, a formulation of LSD being developed for major depressive disorder (MDD) and generalized anxiety disorder (GAD). DT120 has so far aced two Phase 3 trials—in MDD in June and last Wednesday in GAD.
Still to come this year, Definium is expecting topline data from another Phase 3 study of DT120 in GAD, according to the company’s corporate presentation in June. Success in that trial would position Definium to file a new drug application for the indication in the first half of next year, Stifel analysts predicted after last week’s GAD win. Meanwhile, a second Phase 3 in MDD is expected to readout in 2027.
M&A, policy momentum
While Lilly’s AtaiBeckley buy is the splashiest Big Pharma play in psychedelics so far, it is not the first. A year ago, AbbVie spent $1.2 billion to acquire Gilgamesh Pharmaceuticals’ bretisilocin, a serotonergic psychedelic in development for MDD, and Otsuka Pharmaceutical adopted a similar “mindset” in 2023, when it acquired Mindset Pharma, which was developing psychedelic and non-psychedelic medicines.
The space has also been on the receiving end of positive tailwinds generated by the Trump administration. In April, President Donald Trump signed an executive order intended to accelerate the development of and facilitate access to psychedelic therapies for serious mental health conditions. As part of the order, the FDA was instructed to grant Commissioner’s National Priority Vouchers to three psychedelic drug developers; Compass got one of these vouchers.
Editor’s note: A version of this article was originally published as a special edition of ClinicaSpace on August 17, 2026.
