IP Library › Granted Patent US 12,433,904
Granted Patent B2
US 12,433,904 · App. 17/604,619 · Granted Oct 7, 2025

Methods for treating anxiety disorders, headache disorders, and eating disorders with psilocybin

Inventors: Derek John Londesbrough (Hartlepool, GB); Christopher Brown (Gateshead, GB); Julian Scott Northen (South Shields, GB); Gillian Moore (Sedgefield, GB); Hemant Kashinath Patil (Surrey, GB); David E. Nichols (Chapel Hill, NC); Hans Ake Eriksson (Altrincham, GB); George Goldsmith (Altrincham, GB); Ekaterina Malievskaia (Altrincham, GB); Manon Cecile Elisabeth Veraart (Altrincham, GB); Lars Christian Wilde (Altrincham, GB)
Assignee: Compass Pathfinder Limited
A61K31/675A61K9/0053A61K9/20A61K9/48A61K31/661A61P25/00A61P25/04A61P25/08A61P25/16A61P25/20A61P25/22A61P25/24A61P25/28C07F9/5728C07B2200/13
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Quick Facts
Patent No.
US 12,433,904
App. No.
17/604,619
Granted
Oct 7, 2025
Kind
B2
Abstract

The disclosure provides methods for treating a subject in need thereof comprising administering to the subject a therapeutically-effective dose of psilocybin. The methods described herein may be used to treat a variety of diseases, disorders, and conditions. For example, the methods may be used to treat anxiety disorders, eating disorders, and headache disorders.

Claims (34)

1. A method of treating a migraine in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of psilocybin, wherein the psilocybin comprises crystalline psilocybin characterized by X-ray powder diffraction (XRPD) peaks at 11.5±0.1, 12.0±0.1, 14.5±0.1, 17.5±0.1 and 19.7±0.1°2θ, and wherein the crystalline psilocybin has a chemical purity of greater than 97% as determined by HPLC analysis.

2. The method of claim 1 , wherein the migraine is a migraine without aura, a migraine with aura, a chronic migraine, an abdominal migraine, a basilar migraine, a menstrual migraine, an ophthalmoplegic migraine, ophthalmic migraine, or a hemiplegic migraine.

3. The method of claim 1 , wherein at least one sign or symptom of a migraine is improved following administration of the crystalline psilocybin.

4. The method of claim 1 , wherein about 1 mg to about 40 mg of psilocybin is administered.

5. The method of claim 1 , wherein about 10 mg to about 30 mg of psilocybin is administered.

6. The method of claim 1 , wherein about 1 mg of psilocybin is administered.

7. The method of claim 1 , wherein about 5 mg of psilocybin is administered.

8. The method of claim 1 , wherein about 10 mg of psilocybin is administered.

9. The method of claim 1 , wherein about 25 mg of psilocybin is administered.

10. The method of claim 1 , wherein the psilocybin is orally administered.

11. The method of claim 1 , wherein the psilocybin is administered in a capsule.

12. The method of claim 1 , wherein the psilocybin is administered in a tablet.

13. The method of claim 1 , wherein the crystalline psilocybin is further characterized by at least one peak selected from the group consisting of 20.4±0.1, 22.2±0.1, 24.3±0.1, and 25.7±0.1 °2θ.

14. The method of claim 1 , wherein the crystalline psilocybin has no single impurity of greater than 1% as determined by HPLC analysis.

15. The method of claim 1 , wherein the subject is less than 18 years of age.

16. The method of claim 1 , wherein the subject is at least 18 years of age.

17. A method of treating a migraine in a patient, the method comprising orally administering a therapeutically effect amount of an oral dosage form, wherein the oral dosage form comprises:

crystalline psilocybin characterized by X-ray powder diffraction (XRPD) peaks at 11.5±0.1, 12.0±0.1, 14.5±0.1, 17.5±0.1 and 19.7±0.1 °2θ, wherein the crystalline psilocybin has a chemical purity of greater than 97% as determined by HPLC analysis; and

a pharmaceutically acceptable excipient.

18. The method of claim 17 , wherein the migraine is a migraine without aura, a migraine with aura, a chronic migraine, an abdominal migraine, a basilar migraine, a menstrual migraine, an ophthalmoplegic migraine, ophthalmic migraine, or a hemiplegic migraine.

19. The method of claim 17 , wherein at least one sign or symptom of the migraine is improved following administration of the crystalline psilocybin.

20. The method of claim 17 , wherein about 1 mg to about 40 mg of crystalline psilocybin is administered.

21. The method of claim 17 , wherein about 10 mg to about 30 mg of crystalline psilocybin is administered.

22. The method of claim 17 , wherein about 1 mg of crystalline psilocybin is administered.

23. The method of claim 17 , wherein about 5 mg of crystalline psilocybin is administered.

24. The method of claim 17 , wherein about 10 mg of crystalline psilocybin is administered.

25. The method of claim 17 , wherein about 25 mg of crystalline psilocybin is administered.

26. The method of claim 17 , wherein the oral dosage form is a capsule.

27. The method of claim 17 , wherein the oral dosage form is a tablet.

28. The method of claim 17 , wherein the crystalline psilocybin is further characterized by at least one peak selected from the group consisting of 20.4±0.1, 22.2±0.1, 24.3±0.1, and 25.7±0.1 °2θ.

29. The method of claim 17 , wherein the crystalline psilocybin has no single impurity of greater than 1% as determined by HPLC analysis.

30. The method of claim 17 , wherein the patient is less than 18 years of age.

31. The method of claim 17 , wherein the patient is at least 18 years of age.

32. The method of claim 17 , wherein the patient is 18 to 40 years of age.

Assignments (2)
PATENT SECURITY AGREEMENT Recorded Jun 30, 2023
From: COMPASS PATHWAYS PLC; COMPASS PATHFINDER HOLDINGS LIMITED; COMPASS PATHFINDER LIMITED; COMPASS PATHWAYS, INC.
To: HERCULES CAPITAL, INC.
Reel/Frame 064184/0068 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 26, 2021
From: LONDESBROUGH, DEREK JOHN; BROWN, CHRISTOPHER; NORTHEN, JULIAN SCOTT; MOORE, GILLIAN; PATIL, HEMANT KASHINATH; NICHOLS, DAVID E.; CROAL, MEGAN; ERIKSSON, HANS AKE; GOLDSMITH, GEORGE; HICKEY, MOLLY TABITHA; HURLEY, SHAUN; MALIEVSKAIA, EKATERINA; MARWOOD, LINDSEY; MCCULLOCH, DRUMMOND E-WEN JOE; MEDHURST, LAURIE EMMA; POULSEN, NATHAN; SELIMBEYOGLU, ASLIHAN; SOULA, ANAIS; TAN SHUXIANG, AMANDA; VERAART, MANON CECILE ELISABETH; WHELAN, TOBIAS PATRICK; WILDE, LARS CHRISTIAN; WRIGHT, STEPHEN
To: COMPASS PATHFINDER LIMITED
Reel/Frame 057922/0639 →
Continuity (21)
Provisional Application 62946159 · Dec 10, 2019
Provisional Application 62893611 · Aug 29, 2019
Provisional Application 62893110 · Aug 28, 2019
Provisional Application 62835476 · Apr 17, 2019
Provisional Application 62835450 · Apr 17, 2019
Provisional Application 62835477 · Apr 17, 2019
Provisional Application 62835474 · Apr 17, 2019
Provisional Application 62835478 · Apr 17, 2019
Provisional Application 62835465 · Apr 17, 2019
Provisional Application 62835449 · Apr 17, 2019
Provisional Application 62835482 · Apr 17, 2019
Provisional Application 62835481 · Apr 17, 2019
Provisional Application 62835460 · Apr 17, 2019
Provisional Application 62835479 · Apr 17, 2019
Provisional Application 62835480 · Apr 17, 2019
Provisional Application 62835458 · Apr 17, 2019
Provisional Application 62835484 · Apr 17, 2019
Provisional Application 62835472 · Apr 17, 2019
Provisional Application 62835464 · Apr 17, 2019
Provisional Application 62835485 · Apr 17, 2019
Related Publication 20230000883A1 · Jan 5, 2023
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