Reporting by Josh Hardman and Noah Smith.
Nonprofit psychedelic research organization Usona Institute finalized the submission of a new drug application (NDA) to the United States Food and Drug Administration (FDA) for its candidate psilocybin for major depressive disorder (MDD), Alpha psychedelic understand.
This means this is the second psychedelic NDA currently under review by the agency, after we reported that Resilient Pharmaceuticals (formerly Lykos Therapeutic) refiled her request for MDMA for PTSD over the summer. This also means that the FDA could make a decision on a psychedelic application in late 2026, if the most optimistic timelines hold, or very early in the new year, given that Usona, like Compass Waysbenefits from a National Commissioner’s Priority Check (CNPV) which aims to render a decision to a developer within two months.
Here, we review the context surrounding Usona’s program and application, and what it could mean for its main competitor, Compass, a for-profit psilocybin drug developer that plans to soon submit its own NDA for treatment-resistant depression (TRD).
Where is the race?
We have believed for many months that the race for approval of a psilocybin product between Usona and Compass is neck and neck: too close to be decided.
Both programs benefit from ongoing FDA and CNPV review, as well as breakthrough therapy designation. Compass revealed that FDA site inspections began in September, and that several Usona sites and its headquarters in Wisconsin were also subject to inspections by the agency, according to our information.
According to sources close to Usona, who spoke with Alpha psychedelic Speaking on condition of anonymity, the nonprofit is currently working with the agency to answer questions and design things like the Risk Evaluation and Mitigation Strategy (REMS) program that will govern the use of its psilocybin product.
Compass, meanwhile, announced plans to file its NDA this quarter, although there have been no further updates as of this writing. Its quarterly update is scheduled for this week, November 3.
Now it appears Usona may have a slight advantage. Still, there are plenty of things between any approval and launch that Compass can maintain the edge on, as we’ll discuss later.
Usona declined to comment when contacted by Alpha psychedelic. The nonprofit is, in some ways, similar to Resilient, in that it has remained silent on its regulatory steps of late, which have been widely reported in these pages.
Although Usona is careful not to telegraph her own progress, she is happy to act as a unifier for others to do just that. Last Wednesday, the nonprofit brought together various stakeholders in the psychedelics field to its campus in Fitchburg, Wisconsin, for its “Models of Care Summit.” Participants included other psychedelic drug developers such as Compass, AbbVie and Otsuka, as well as…
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