Usona Files Psilocybin for Depression NDA as Race With Compass Tightens

Reporting by Josh Hardman and Noah Smith.

Nonprofit psychedelic research organisation Usona Institute has completed its submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) concerning its psilocybin candidate for major depressive disorder (MDD), Psychedelic Alpha understands.

It means it’s the second psychedelic NDA under review by the agency at present, after we reported that Resilient Pharmaceuticals (formerly Lykos Therapeutics) refiled its MDMA for PTSD application in the summer. It also means that FDA could hand down a decision on a psychedelic application in late 2026, if the most optimistic timelines hold, or very early in the new year, given the fact that Usona, like Compass Pathways, is in receipt of a Commissioner’s National Priority Voucher (CNPV) that aims to return a decision to a developer within two months.

Here, we review the context surrounding Usona’s program and application, and what it might mean for its chief competitor, Compass, a for-profit psilocybin drug developer that is planning to submit its own NDA, for treatment-resistant depression (TRD), imminently.

Where the Race Stands

We have guided for many months that the race to approval for a psilocybin product between Usona and Compass is neck and neck: too close to call.

Both programs benefit from FDA rolling review and CNPVs, as well as breakthrough therapy designation. Compass has disclosed that FDA site inspections began in September, and several Usona sites and its headquarters in Wisconsin have also been subject to agency inspections, we understand.

According to sources close to Usona, who spoke with Psychedelic Alpha on condition of anonymity, the nonprofit is currently working with the agency to respond to its questions and design things like the risk evaluation and mitigation strategy (REMS) program that will govern its psilocybin product’s use.

Compass, meanwhile, has guided that it intends to file its NDA this quarter, though there has been no further update at the time of writing. Its quarterly update is due this week, on November 3rd.

It now appears that Usona may have a slight edge, then. Still, there is a great deal that must happen between any approval and launch that Compass may retain the edge on, as we discuss later.

Usona declined to comment when reached by Psychedelic Alpha. The nonprofit is, in some regards, similar to Resilient, in that it has kept quiet about its regulatory milestones of late, which have been reported largely in these pages.

While Usona is careful not to telegraph its own progress, it is happy to act as a convener for others to do just that. Last Wednesday, the nonprofit gathered various stakeholders from across the psychedelics field at its campus in Fitchburg, Wisconsin, for its ‘Models of Care Summit’. Attendees included other psychedelic drug developers such as Compass, AbbVie, and Otsuka, as well as ...