IP Library › Granted Patent US 12,491,184
Granted Patent B2
US 12,491,184 · App. 19/094,716 · Granted Dec 9, 2025

Compositions and methods of use for modified release minoxidil

Inventor: Reid Waldman (West Hartford, CT)
Assignee: VERADERMICS, INCORPORATED
A61K31/506A61K9/0053A61K9/2013A61K9/2018A61K9/2054A61K9/28A61P17/14
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Quick Facts
Patent No.
US 12,491,184
App. No.
19/094,716
Granted
Dec 9, 2025
Kind
B2
Abstract

The compositions and methods provided herein include a pharmaceutical formulation for oral administration comprising a daily dose of a modified release formulation of minoxidil or a pharmaceutically acceptable salt thereof. Also provided herein are pharmaceutical formulations for oral administration comprising a daily dose of a modified release formulation of minoxidil or a pharmaceutically acceptable salt thereof and one or more additional active agents. Also provided herein are methods of treating hair loss by administering to a subject in need thereof a daily dose of a modified release formulation of minoxidil or a pharmaceutically acceptable salt thereof. Further provided herein is a kit including a slow modified release vehicle comprising oral minoxidil or a pharmaceutically acceptable salt thereof.

Claims (22)

1 . A method of treating hair loss, comprising orally administering to a human subject who is experiencing hair loss a modified release pharmaceutical formulation comprising about 4.5 mg of minoxidil or a molar equivalent amount of the pharmaceutically acceptable salt thereof; wherein the modified release pharmaceutical formulation provides:

a C max of minoxidil that is about 0.25 ng/ml to about 20 ng/ml; and

a T max of minoxidil that is about 30 to about 360 minutes.

2 . The method of claim 1 , wherein a blood level of minoxidil is maintained in a range of about 1 ng/ml to about 20 ng/ml for at least about 8 hours.

3 . The method of claim 1 , wherein the modified release pharmaceutical formulation further comprises a release modifier.

4 . The method of claim 1 , wherein the modified release pharmaceutical formulation further comprises a filler, a glidant, a lubricant, or a combination thereof.

5 . The method of claim 1 , wherein the hair loss comprises female pattern hair loss.

6 . The method of claim 1 , wherein the hair loss comprises alopecia areata.

7 . The method of claim 1 , wherein the hair loss comprises telogen effluvium.

8 . The method of claim 1 , wherein the hair loss comprises central centrifugal cicatricial alopecia.

9 . The method of claim 1 , wherein the hair loss comprises lichen planopilaris.

10 . The method of claim 1 , wherein the hair loss comprises traction alopecia.

11 . The method of claim 1 , wherein the oral administration results in hair regrowth.

12 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a zero order release of minoxidil.

13 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a pseudo zero order release of minoxidil.

14 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a first order release of minoxidil.

15 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a pseudo first order release of minoxidil.

16 . The method of claim 1 , wherein the modified release pharmaceutical formulation exhibits a second order release of minoxidil.

17 . The method of claim 1 , wherein the modified release pharmaceutical formulation comprises an enteric coating.

18 . The method of claim 1 , wherein the modified release pharmaceutical formulation is administered at least once daily.

19 . The method of claim 1 , wherein the oral administration of the modified release pharmaceutical formulation results in no cardiac effects.

20 . The method of claim 19 , wherein the cardiac effects are selected from tachycardia, hypotension, premature ventricular contractions, and other tachyarrhythmias.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 8, 2025
From: WALDMAN, REID
To: VERADERMICS, INCORPORATED
Reel/Frame 072834/0299 →
Continuity (5)
Continuation 18437724 · Feb 9, 2024
Continuation PCTUS2023035920 · Oct 25, 2023
Provisional Application 63433203 · Dec 16, 2022
Provisional Application 63419155 · Oct 25, 2022
Related Publication 20250221994A1 · Jul 10, 2025
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