IP Library › Granted Patent US 12,447,140
Granted Patent B2
US 12,447,140 · App. 17/728,600 · Granted Oct 21, 2025

Ketone bodies and ketone body esters as blood lipid lowering agents

Inventors: Kieran Clarke (Oxford, GB); Richard Lewis Veech (Rockville, MD)
Assignees: OXFORD UNIVERSITY INNOVATION LIMITED; Government of the USA, as represented by the Secretary, Department of Health and Human Services
A61K31/22A61K9/0053A61K31/047A61K31/19A61K31/365A61K45/06A61P3/06A61P3/10
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Quick Facts
Patent No.
US 12,447,140
App. No.
17/728,600
Granted
Oct 21, 2025
Kind
B2
Abstract

The subject disclosure provides compositions for reducing serum cholesterol and/or triglyceride levels in subjects. These compositions can comprise racemic β-hydroxybutyrate or D-β-hydroxybutyrate, optionally in the acid form, physiologically compatible salts of racemic β-hydroxybutyrate or D-β-hydroxybutyrate, esters of D-β-hydroxybutyrate, oligomers of D-β-hydroxybutyrate containing from 2 to 20 or more monomeric units in either linear or cyclic form, racemic 1,3 butandiol or R-1,3 butandiol alone and can be, optionally, administered in conjunction with a low fat diet to a subject. Alternatively, compositions comprising racemic β-hydroxybutyrate or D-β-hydroxybutyrate, optionally in the acid form, physiologically compatible salts of racemic β-hydroxybutyrate or D-β-hydroxybutyrate, esters of D-β-hydroxybutyrate, oligomers of D-β-hydroxybutyrate containing from 2 to 20 or more monomeric units in either linear or cyclic form, racemic 1,3 butandiol, R-1,3 butandiol or combinations thereof can be formulated as nutritional supplements (also referred to as nutritional compositions) or incorporated into therapeutic compositions containing a) anti-hypertensive agents; b) anti-inflammatory agents; c) glucose lowering agents; or d) anti-lipemic agents) which are administered to a subject, optionally in combination with a low fat diet, in order to cause a reduction or lowering of: serum cholesterol levels; triglyceride levels; serum glucose levels, serum homocysteine levels, inflammatory proteins (e.g., C reactive protein) and/or hypertension in treated subjects. Alternatively, compositions disclosed herein can be administered alone, or in combination with other therapeutic agents to prevent or reverse vascular disease.

Claims (10)

1. A method of retarding or reversing the development of vascular disease in a subject in need thereof comprising the oral administration of a composition comprising an R-1,3-butanediol ester of monomeric D-β-hydroxybutyrate alone or in combination with an additional therapeutic agent.

2. The method according to claim 1 , wherein said composition is administered in the form of the subject's diet.

3. The method according to claim 1 , wherein said method comprises the administration of a first composition comprising an R-1,3-butanediol ester of monomeric D-β-hydroxybutyrate in combination with a second composition comprising a therapeutic agent, wherein said first and second compositions are administered separately, and each composition is in unit dosage form.

4. The method according to claim 3 , wherein said therapeutic agent is selected from glucose/blood sugar lowering agents, lipid lowering (anti-lipemic) agents, blood pressure lowering agents (anti-hypertensive agents), or agents that reduce inflammation (anti-inflammatory agents).

5. The method according to claim 1 , wherein the dietary intake of fat by said subject is reduced.

6. The method according to claim 1 , wherein an R-1,3-butanediol ester of monomeric D-β-hydroxybutyrate is administered in an amount that a) provides for blood levels of D-β-hydroxybutyrate plus acetoacetate ranging from between 0.1 to 25 mM in an individual; or b) ranges from 2-100% of the total caloric intake of an individual.

7. The method according to claim 1 , wherein the dietary intake of fat by said subject is reduced.

8. The method according to claim 1 , wherein an R-1,3-butanediol ester of monomeric D-β-hydroxybutyrate is administered in an amount that a) provides for blood levels of D-β-hydroxybutyrate plus acetoacetate ranging from between 0.1 to 25 mM in an individual; or b) ranges from 2-100% of the total caloric intake of an individual.

9. The method according to claim 1 , wherein said method comprises the administration of a first composition comprising an R-1,3-butanediol ester of monomeric D-β-hydroxybutyrate in combination with a second composition comprising a therapeutic agent, wherein said first and second compositions are administered sequentially, and each composition is in unit dosage form.

10. The method according to claim 1 , wherein said method comprises the administration of a first composition comprising an R-1,3-butanediol ester of monomeric D-β-hydroxybutyrate in combination with a second composition comprising a therapeutic agent, wherein said first and second compositions are administered together, and each composition is in unit dosage form.

Assignments (3)
CHANGE OF NAME Recorded Aug 29, 2025
From: ISIS INNOVATION LIMITED
To: OXFORD UNIVERSITY INNOVATION LIMITED
Reel/Frame 072745/0495 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 29, 2025
From: CLARKE, KIERAN
To: ISIS INNOVATION LTD.
Reel/Frame 072745/0608 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 29, 2025
From: VEECH, RICHARD LEWIS
To: GOVERNMENT OF THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 072769/0747 →
Continuity (5)
Division 16203748 · Nov 29, 2018
Continuation 14931265 · Nov 3, 2015
Continuation 12811648
Provisional Application 61018962 · Jan 4, 2008
Related Publication 20230075547A1 · Mar 9, 2023
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