For the roughly 2 to 3 million Americans living with treatment-resistant depression, the question is not whether a psilocybin-based therapy will eventually reach the market — the clinical data already strongly suggest it will — but when, specifically, it might become available to them.
Compass Pathways' synthetic psilocybin treatment, COMP360, remains the most clinically advanced psychedelic therapy currently in the FDA's pipeline. With a New Drug Application submission targeted for the fourth quarter of 2026 and a National Priority Voucher granting a compressed one-to-two-month review window, a realistic timeline for final FDA approval points to early 2027 — though initial access would almost certainly be limited to specialized treatment centers rather than a typical pharmacy prescription.
