IP Library › Granted Patent US 12,643,917
Granted Patent B2
US 12,643,917 · App. 19/236,398 · Granted Jun 2, 2026

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

Inventors: Derek John Londesbrough (Hartlepool, GB); Christopher Brown (Gateshead, GB); Julian Scott Northen (South Shields, GB); Gillian Moore (Sedgefield, GB); David E. Nichols (Chapel Hill, NC)
Assignee: Compass Pathfinder Limited
C07F9/5728A61K9/0053A61K9/2054A61K47/36A61K47/38C07D209/16C07B2200/13
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Quick Facts
Patent No.
US 12,643,917
App. No.
19/236,398
Granted
Jun 2, 2026
Kind
B2
Abstract

This invention relates to the large-scale production of psilocybin for use in medicine. More particularly, it relates to a method of obtaining high purity crystalline psilocybin, particularly, in the form of Polymorph A. It further relates to a method for the manufacture of psilocybin and intermediates in the production thereof and formulations containing psilocybin.

Claims (23)

1 . A pharmaceutical blend comprising a crystalline hydrate of psilocybin and at least one pharmaceutically acceptable excipient, wherein the pharmaceutical blend has a blend uniformity of greater than about 95%, and wherein the crystalline hydrate of psilocybin is characterized by X-ray diffraction (XRPD) peaks at 8.9±0.1, 13.8±0.1, and 23.1±0.1° 2θ.

2 . The pharmaceutical blend of claim 1 , wherein the crystalline hydrate of psilocybin is further characterized by at least one peak selected from the group consisting of 6.5±0.1, 12.6±0.1, 16.2±0.1 19.4±0.1, 20.4±0.1, 20.8±0.1, 21.5±0.1, 22.5±0.1, and 23.5±0.1° 2θ.

3 . The pharmaceutical blend of claim 1 , wherein the crystalline hydrate of psilocybin has a chemical purity of greater than 97% as determined by HPLC analysis.

4 . The pharmaceutical blend of claim 1 , wherein the crystalline hydrate of psilocybin has a chemical purity of greater than 98% as determined by HPLC analysis.

5 . The pharmaceutical blend of claim 1 , wherein the crystalline hydrate of psilocybin has a chemical purity of greater than 99% as determined by HPLC analysis.

6 . The pharmaceutical blend of claim 1 , wherein the crystalline hydrate of psilocybin has no single impurity of greater than 1% as determined by HPLC analysis.

7 . The pharmaceutical blend of claim 1 , wherein the crystalline hydrate of psilocybin has less than 1% psilocin as determined by HPLC analysis.

8 . A plurality of tablets, each comprising crystalline hydrate of psilocybin,

wherein the plurality of tablets has a psilocybin content uniformity of greater than about 90%, and

wherein the crystalline hydrate of psilocybin is characterized by X-ray diffraction (XRPD) peaks at 8.9±0.1, 13.8±0.1, and 23.1±0.1° 2θ.

9 . The plurality of tablets of claim 8 , wherein the crystalline hydrate of psilocybin is further characterized by at least one peak selected from the group consisting of 6.5±0.1, 12.6±0.1, 16.2±0.1 19.4±0.1, 20.4±0.1, 20.8±0.1, 21.5±0.1, 22.5±0.1, and 23.5±0.1° 2θ.

10 . The plurality of tablets of claim 8 , wherein the plurality of tablets has a psilocybin content uniformity of greater than about 95%.

11 . The plurality of tablets of claim 8 , wherein the crystalline psilocybin has a chemical purity of greater than 97%.

12 . The plurality of tablets of claim 8 , wherein the crystalline psilocybin has a chemical purity of greater than 98%.

13 . The plurality of tablets of claim 8 , wherein the crystalline psilocybin has a chemical purity of greater than 99%.

14 . A pharmaceutical blend comprising crystalline hydrate of psilocybin and one or more pharmaceutically acceptable excipients,

wherein the pharmaceutical blend has an acceptance value of less than about 15, and

wherein the crystalline hydrate of psilocybin is characterized by X-ray powder diffraction (XRPD) peaks at 8.9±0.1, 13.8±0.1, and 23.1±0.1° 2θ.

15 . The pharmaceutical blend of claim 14 , wherein the pharmaceutical blend has an acceptance value of less than 10.

16 . The pharmaceutical blend of claim 14 , wherein the crystalline hydrate of psilocybin is further characterized by at least one XRPD peak at 6.5±0.1, 12.6±0.1, 16.2±0.1 19.4±0.1, 20.4±0.1, 20.8±0.1, 21.5±0.1, 22.5±0.1, and 23.5±0.1° 2θ.

17 . The pharmaceutical blend of claim 14 , wherein the crystalline hydrate of psilocybin has a chemical purity of greater than 97%.

18 . The pharmaceutical blend of claim 14 , wherein the crystalline hydrate of psilocybin has a chemical purity of greater than 98%.

19 . The pharmaceutical blend of claim 14 , wherein the crystalline hydrate of psilocybin has a chemical purity of greater than 99%.

Assignments (2)
CHANGE OF NAME Recorded Aug 14, 2025
From: COMPASS PATHWAYS LIMITED
To: COMPASS PATHFINDER LIMITED
Reel/Frame 072019/0213 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 14, 2025
From: LONDESBROUGH, DEREK JOHN; BROWN, CHRISTOPHER; NORTHEN, JULIAN SCOTT; MOORE, GILLIAN; PATIL, HEMANT KASHINATH; NICHOLS, DAVID E.
To: COMPASS PATHWAYS LIMITED
Reel/Frame 072465/0985 →
Priority Claims (3)
GB 1716505 · Oct 9, 2017 · national
GB 1810588 · Jun 28, 2018 · national
GB 1816438 · Oct 9, 2018 · national
Continuity (12)
Continuation 18989682 · Dec 20, 2024
Division 18433051 · Feb 5, 2024
Continuation 18135265 · Apr 17, 2023
Continuation 17886204 · Aug 11, 2022
Continuation 17531159 · Nov 19, 2021
Continuation 17228936 · Apr 13, 2021
Continuation 17172411 · Feb 10, 2021
Continuation 17116739 · Dec 9, 2020
Continuation 16920223 · Jul 2, 2020
Continuation 16679009 · Nov 8, 2019
Continuation 16155386 · Oct 9, 2018
Related Publication 20250304607A1 · Oct 2, 2025
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