Granted Patent
B1
US 12,419,895 · App. 19/224,580 · Granted Sep 23, 2025
Methods for treating subjects with Prader-Willi syndrome
Assignee:
ESSENTIALIS, INC.
A61K31/549A61K9/00A61K9/0004A61K9/2054A61K9/5026A61K9/5042A61K9/5047A61K31/137A61K31/155A61K31/551A61K38/27A61K45/06C07D285/18C07D285/22A61K2300/00
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Abstract
Provided are immediate or prolonged administration of certain potassium ATP (KATP) channel openers, optionally in combination with growth hormone, to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving KATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of KATP channel openers that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are methods of co-administering KATP channel openers with other drugs (e.g., in combination with growth hormone) to treat diseases of humans and animals (e.g., Prader-Willi Syndrome (PWS), Smith-Magenis syndrome (SMS), and the like.
Claims (26)
1. A method of treating hyperphagia in a subject having Prader-Willi Syndrome (PWS), the method comprising administering to said subject once per day a pharmaceutical formulation comprising an effective amount of diazoxide choline, wherein administration reduces hyperphagia and one or more food related behaviors in the subject.
2. The method of claim 1 , wherein the diazoxide choline is administered for at least 10 weeks.
3. The method of claim 1 , wherein the diazoxide choline is administered for one or more years.
4. The method of claim 1 , wherein the once-daily administration of diazoxide choline is in an amount from 25 mg to 100 mg.
5. The method of claim 1 , wherein the once-daily administration of diazoxide choline is in an amount from 50 mg to 180 mg.
6. The method of claim 1 , wherein the once-daily administration of diazoxide choline is in an amount from 50 mg to 275 mg.
7. The method of claim 1 , wherein the once-daily administration of diazoxide choline is in an amount from 300 mg to 500 mg.
8. The method of claim 1 , wherein the once-daily administration of diazoxide choline is in an amount from 500 mg to 2000 mg.
9. The method of claim 1 , wherein the once-daily administration of diazoxide choline is in an amount from 25 mg to 500 mg.
10. The method of claim 3 , wherein the once-daily administration of diazoxide choline is in an amount from 25 mg to 100 mg.
11. The method of claim 3 , wherein the once-daily administration of diazoxide choline is in an amount from 50 mg to 180 mg.
12. The method of claim 3 , wherein the once-daily administration of diazoxide choline is in an amount from 50 mg to 275 mg.
13. The method of claim 3 , wherein the once-daily administration of diazoxide choline is in an amount from 300 mg to 500 mg.
14. The method of claim 3 , wherein the once-daily administration of diazoxide choline is in an amount from 500 mg to 2000 mg.
15. The method of claim 3 , wherein the once-daily administration of diazoxide choline is in an amount from 25 mg to 500 mg.
16. The method of claim 1 , wherein the administration of diazoxide choline is initiated at a starting dose of diazoxide choline and then titrated every two weeks to reach a maintenance dose of diazoxide choline.
17. The method of claim 16 , wherein the starting dose of diazoxide choline is between 25-100 mg of diazoxide choline.
18. The method of claim 16 , wherein the starting dose of diazoxide choline is between 50-180 mg of diazoxide choline.
19. The method of claim 17 , wherein the maintenance dose of diazoxide choline is between 100-200 mg of diazoxide choline.
20. The method of claim 18 , wherein the maintenance dose of diazoxide choline is between 200-300 mg of diazoxide choline.
21. The method of claim 18 , wherein the maintenance dose of diazoxide choline is between 300-500 mg of diazoxide choline.
22. The method of claim 18 , wherein the maintenance dose of diazoxide choline is between 500-2000 mg of diazoxide choline.
23. The method of claim 18 , wherein the maintenance dose of diazoxide choline is between 100-500 mg of diazoxide choline.
24. The method of claim 17 , wherein the maintenance dose of diazoxide choline is between 25-250 mg of diazoxide choline.
25. The method of claim 17 , wherein the maintenance dose of diazoxide choline is between 200-300 mg of diazoxide choline.
26. The method of claim 1 , wherein the pharmaceutical formulation is administered orally.
Assignments (3)
SECURITY INTEREST
Recorded Jun 26, 2026
From: SOLENO THERAPEUTICS, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 075106/0487 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Dec 3, 2025
From: ESSENTIALIS, INC.
To: SOLENO THERAPEUTICS, INC.
Reel/Frame 073832/0312 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 7, 2025
From: COWEN, NEIL M.
To: ESSENTIALIS, INC.
Reel/Frame 071622/0561 →
Continuity (12)
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62221359
· Sep 21, 2015
Provisional Application
62170035
· Jun 2, 2015
Provisional Application
62138245
· Mar 25, 2015
Provisional Application
62080150
· Nov 14, 2014
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