IP Library Granted Patent US 12,364,732
Granted Patent B2
US 12,364,732 · App. 18/626,600 · Granted Jul 22, 2025

Systems and methods for treatment of hearing using dihexa

Inventor: Nicholas V. Perricone (Madison, CT)
Assignee: Transdermal Biotechnology, Inc.
A61K38/04A61K9/0014A61K9/0046A61K31/15A61K31/385A61K31/675A61K31/685A61K38/10
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Quick Facts
Patent No.
US 12,364,732
App. No.
18/626,600
Granted
Jul 22, 2025
Kind
B2
Abstract

The present disclosure generally relates to compositions comprising dihexa and methods for making or using said compositions. In some aspects, the compositions disclosed herein may comprise one or more additional active ingredients, including lipoic acid, spadin peptide, and/or phenyl-N-tert-butylnitrone. Compositions such as these may be used in certain embodiments, for example, to enhances a subject's hearing or to treat a hearing disorder, etc. In some embodiments, the compositions are topical compositions configured to treat hearing loss via administration, e.g., to the skin behind the outer ear or directly to the eardrum of a subject, etc. In some cases, the compositions disclosed herein may comprise one or more excipients to aid in transdermal delivery. For instance, in certain embodiments, the compositions comprise lecithin and/or other components that may facilitate delivery through the skin. Other aspects are generally directed to methods of making or using such compositions, methods of promoting such compositions, kits including such compositions, or the like.

Claims (22)

1. A composition, comprising:

a transdermal formulation comprising lecithin, dihexa, lipoic acid, spadin peptide, and phenyl-N-tert-butylnitrone, wherein the transdermal formulation comprises a liquid crystal multilamellar lecithin structure.

2. The composition of claim 1 , wherein the ratio of dihexa:lipoic acid:spadin peptide:phenyl-N-tert-butylnitrone is any ratio of weight percents that adds up to 100%.

3. The composition of claim 1 , wherein the ratio of dihexa:lipoic acid is between 0.3:1 and 1:0.06.

4. The composition of claim 1 , wherein the ratio of dihexa:spadin peptide is between 0.3:1 and 1:0.06.

5. The composition of claim 1 , wherein the ratio of dihexa:phenyl-N-tert-butylnitrone is between 0.3:1 and 1:0.06.

6. The composition of claim 1 , wherein the ratio of lipoic acid:spadin peptide is between 0:1 and 1:0.

7. The composition of claim 1 , wherein the ratio of lipoic acid:phenyl-N-tert-butylnitrone is between 0:1 and 1:0.

8. The composition of claim 1 , wherein the ratio of spadin peptide:phenyl-N-tert-butylnitrone is between 0:1 and 1:0.

9. The composition of claim 1 , wherein the ratio of spadin peptide:phenyl-N-tert-butylnitrone is between 0.3:0.7 and 0.7:0.3.

10. The composition of claim 1 , wherein the dihexa is present in the composition at between 0.25 wt % and 50 wt %.

11. The composition of claim 1 , wherein the lipoic acid is present in the composition at between 0.25 wt % and 50 wt %.

12. The composition of claim 1 , wherein the spadin peptide, or any fragment thereof, comprises an amino acid sequence that is at least 85%, at least 90%, at least 95%, at least 99%, at least 99.5%, or at least 99.8% identical to the amino acid sequence of SEQ ID NO: 12 (Analog 11).

13. The composition of claim 1 , wherein the spadin peptide, or any fragment thereof, is a retroinverso analog of the spadin peptide, or fragment thereof.

14. The composition of claim 1 , wherein the spadin peptide is present in the composition at between 0.25 wt % and 50 wt %.

15. The composition of claim 1 , wherein the phenyl-N-tert-butylnitrone is present in the composition at between 0.25 wt % and 50 wt %.

16. The composition of claim 1 , wherein the composition further comprises a benfotiamine.

17. The composition of claim 16 , wherein the benfotiamine is present at least about 0.1% by weight.

18. The composition of claim 16 , wherein the benfotiamine is present at least about 5% by weight.

19. A method, comprising:

applying, to the skin of a subject, a pharmaceutical composition comprising lecithin, dihexa, lipoic acid, spadin peptide, and phenyl-N-tert-butylnitrone, wherein the pharmaceutical composition comprises a liquid crystal multilamellar lecithin structure.

20. The method of claim 19 , wherein the composition further comprises a benfotiamine.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 5, 2024
From: PERRICONE, NICHOLAS V.
To: TRANSDERMAL BIOTECHNOLOGY, INC.
Reel/Frame 067013/0759 →
Continuity (2)
Continuation 18339152 · Jun 21, 2023
Related Publication 20240424050A1 · Dec 26, 2024
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