Granted Patent
B2
US 12,685,721 · App. 17/801,389 · Granted Jul 21, 2026
Aerosol comprising 5-methoxy-N,N-dimethyltryptamine
Assignee:
GH Research Ireland Limited
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Abstract
Aerosols of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof are provided which are useful for administration to a patient through an inhalation route. The aerosols have aerosol particle mass densities in the range of about 0.5 mg/I to about 12.5 mg/I.
Claims (19)
1 . A method of treating major depressive disorder in a patient comprising administering a pharmaceutical aerosol to the patient, the pharmaceutical aerosol comprising:
(a) air; and
(b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) freebase and/or a pharmaceutically acceptable salt thereof; wherein
the pharmaceutical aerosol has an aerosol particle mass density of 1 mg/l to 10 mg/l,
the pharmaceutical aerosol has a mass median aerodynamic diameter (MMAD) of 0.1 μm to 3 μm, and
the pharmaceutical aerosol has a volume of about 1.5 to about 3 liters.
2 . The pharmaceutical aerosol method according to claim 1 , wherein the aerosol particle mass density is from 1.3 mg/l to 10 mg/l.
3 . The method according to claim 1 , wherein a fine particle fraction (FPF), determined as a weight percentage of aerosol particles with an aerodynamic diameter of less than or equal to 5 μm relative to a total mass of the aerosol particles, is at least 90 wt %.
4 . The method according to claim 1 , wherein less than 1 wt % impurities are present in the pharmaceutical aerosol.
5 . The pharmaceutical aerosol method according to claim 1 , wherein less than 0.5 wt % 5-MeO-DMT degradation products resulting from a chemical modification of 5-MeO-DMT as a result of a chemical reaction during aerosol formation are present in the pharmaceutical aerosol.
6 . The method according to claim 1 , wherein the pharmaceutical aerosol consists essentially of:
(a) air; and
(b) the aerosol particles of 5-MeO-DMT freebase or a pharmaceutically acceptable salt thereof.
7 . The method according to claim 1 , wherein the pharmaceutical aerosol has a volume of 2 liters to 3 liters.
8 . The method according to claim 1 , wherein the MMAD is determined with a Next Generation Impactor (NGI) in accordance with methods shown in United States Pharmacopeia (USP) <601>.
9 . The method according to claim 8 , wherein the NGI is operated at an airflow of 15 liters/minute.
10 . The method according to claim 8 , wherein the NGI is operated at an airflow of 30 liters/minute.
11 . The method according to claim 1 , wherein a pharmaceutically acceptable salt form of the 5-MeO-DMT is present in the aerosol.
12 . The method according to claim 1 , wherein a freebase form of the 5-MeO-DMT is present in the aerosol.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 4, 2026
From: TERWEY, THEIS
To: GH RESEARCH IRELAND LIMITED
Reel/Frame 073972/0975 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Oct 3, 2022
From: TERWAY, THEIS
To: GH RESEARCH IRELAND LIMITED
Reel/Frame 061288/0776 →
Priority Claims (1)
EP 20159161
· Feb 24, 2020
· regional
Continuity (1)
Related Publication
20230075124A1
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