IP Library Granted Patent US 12,472,163
Granted Patent B2
US 12,472,163 · App. 19/173,537 · Granted Nov 18, 2025

Compositions of matter and pharmaceutical compositions

Inventors: Christopher G. Witowski (Tampa, FL); Jacqueline L. Salm (Tampa, FL)
Assignee: Atai Therapeutics, Inc.
A61K31/4045A61K9/0043A61K9/06A61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/2054A61K9/7061A61K9/7069A61K31/405A61K31/48A61K31/55A61K31/675C07D209/16
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Quick Facts
Patent No.
US 12,472,163
App. No.
19/173,537
Granted
Nov 18, 2025
Kind
B2
Abstract

Pharmaceutical formulations of novel indole compounds and psilocybin analogs are manufactured, provided in novel oral, transdermal, and nasal pharmaceutical compositions for use to treat neurological, mood or abuse diseases and disorders.

Claims (25)

1 . A pharmaceutical product for delivery across a mucosal membrane, wherein said product comprises:

a therapeutically effective amount of 4-acetoxy-N,N-dimethyltryptamine (4-AcO-DMT), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), 5-hydroxy-N,N-dimethyltryptamine (5-OH-DMT), or N,N-dimethyltryptamine-N-oxide (DMT-NO), or a pharmaceutically acceptable salt thereof,

and a pharmaceutically acceptable carrier,

wherein mucosal administration of the pharmaceutical product provides absorption of the 4-AcO-DMT, 5-MeO-DMT, 5-OH-DMT, or DMT-NO into the blood after administration.

2 . The pharmaceutical product of claim 1 , wherein the pharmaceutically acceptable carrier is an adhesive polymer.

3 . The pharmaceutical product of claim 1 , wherein the mucosal membrane is sublingual, buccal, or nasal.

4 . The pharmaceutical product of claim 1 , wherein the product is in the form of a strip, a solution, a suspension, a gel, a liquid, an emulsion, liposomes, microparticles, a film, a powder, or a patch.

5 . The pharmaceutical product of claim 4 , wherein the product is a strip.

6 . The pharmaceutical product of claim 4 , wherein the product is a solution.

7 . The pharmaceutical product of claim 4 , wherein the product is a suspension.

8 . The pharmaceutical product of claim 4 , wherein the product is a gel.

9 . The pharmaceutical product of claim 4 , wherein the product is a liquid.

10 . The pharmaceutical product of claim 4 , further comprising a monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA), or an atypical antidepressant.

11 . The pharmaceutical product of claim 6 , wherein the product comprises a therapeutically effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

12 . The pharmaceutical product of claim 6 , wherein the product comprises about 5 mg to about 25 mg of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

13 . The pharmaceutical product of claim 6 , wherein the product comprises about 6 mg of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

14 . The pharmaceutical product of claim 6 , wherein the product comprises about 8 mg of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

15 . The pharmaceutical product of claim 6 , wherein the product comprises about 12 mg of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

16 . The pharmaceutical product of claim 6 , wherein the product comprises about 18 mg of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

17 . The pharmaceutical product of claim 11 , wherein the product comprises ethanol.

18 . The pharmaceutical product of claim 12 , wherein the product comprises ethanol.

19 . The pharmaceutical product of claim 13 , wherein the product comprises ethanol.

20 . The pharmaceutical product of claim 14 , wherein the product comprises ethanol.

21 . The pharmaceutical product of claim 15 , wherein the product comprises ethanol.

22 . The pharmaceutical product of claim 16 , wherein the product comprises ethanol.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 8, 2025
From: WITOWSKI, CHRISTOPHER G.; SALM, JACQUELINE L.
To: TERP LIFE, LLC
Reel/Frame 072187/0753 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 8, 2025
From: PSILERA INC.
To: ATAI LIFE SCIENCES N.V.
Reel/Frame 072187/0792 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 8, 2025
From: ATAI LIFE SCIENCES N.V.
To: ATAI THERAPEUTICS, INC.
Reel/Frame 072187/0819 →
CHANGE OF NAME Recorded Sep 8, 2025
From: TERP LIFE, LLC
To: PSILERA INC.
Reel/Frame 072836/0576 →
Continuity (7)
Continuation 18744484 · Jun 14, 2024
Continuation 18229286 · Aug 2, 2023
Continuation 17314107 · May 7, 2021
Provisional Application 63134805 · Jan 7, 2021
Provisional Application 63106516 · Oct 28, 2020
Provisional Application 63021866 · May 8, 2020
Related Publication 20250235428A1 · Jul 24, 2025
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