USGrantedDelivery formulation

Preparation of psilocybin, different polymorphic forms, intermediates, formulations and their use

US-10519175-B2

Bibliographic data

Patent number
US-10519175-B2
Jurisdiction
US
Status
Granted
Type
Delivery formulation
Priority date
9 October 2017
Grant date
31 December 2019

Abstract

Crystalline psilocybin (notably Polymorph A / Hydrate A), processes for its preparation, intermediates, and pharmaceutical formulations, together with their use in the treatment of psychiatric and behavioural disorders.

Assignees

COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a UK-headquartered clinical-stage biopharmaceutical company and the most advanced developer of a classic psychedelic medicine. Its lead asset, COMP360 — a synthetic, proprietary formulation of psilocybin — is being developed for treatment-resistant depression (TRD) delivered alongside a psychological-support model. COMP360 is the first psilocybin programme to complete two positive pivotal Phase 3 trials: COMP005 met its primary endpoint in June 2025 and the confirmatory COMP006 (two fixed doses given three weeks apart) did so in February 2026, with 26-week data reported in July 2026 confirming a rapid and durable antidepressant profile. In April 2026 the FDA granted a rolling NDA submission request and selected COMP360 for the Commissioner's National Priority Voucher programme, which carries a shortened review window. COMPASS has since begun that rolling submission and guides to a potential US launch in the first half of 2027, subject to approval, positioning it as the frontrunner for the first FDA-approved classic psychedelic therapy.
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Prior art & evidence

Prior art and related research that speaks to this patent, curated from the Blossom database.

Prior art

Journal article2019
Usona Institute open-science psilocybin synthesis and crystalline characterisation

Usona Institute published a scalable multigram synthesis of psilocybin, and characterised its crystalline forms, without patenting the work.

Analysis

Few psychedelic patents have drawn as much scrutiny as this one. COMPASS Pathways claims a specific crystalline form of psilocybin, Polymorph A, rather than the molecule itself, which has been known since Albert Hofmann first synthesised it in 1958.

Critics, including Freedom to Operate and Porta Sophia, have argued that crystalline psilocybin was already described in the prior art, and have filed challenges on that basis. The question the patent raises is a recurring one in this field: where does genuine pharmaceutical innovation end, and where does the enclosure of long-known chemistry begin?