# US 11,026,991 B2 · Compositions and methods of use thereof to promote muscle growth and function > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,991 B2 - Document ID: US11026991B2 - Status: Granted - Kind: B2 - Application number: 16/388,490 - Filed: 2019-04-18 - Published: 2019-10-24 - Granted: 2021-06-08 - Earliest claimed: 2018-04-18 - Assignees: Ingenious Ingredients, LP - Applicants: Worlds Greatest Ingredients, LP - Inventors: Martin Purpura; Ralf Jaeger; Shawn Wells; Kylin Lao; Anton Fliri - Web page: https://patentgrep.com/patent/US11026991B2 ## CPC - A61K 38/05: Dipeptides - A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205) - A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) - A61K 38/06: Tripeptides - A61P 21/00: Drugs for disorders of the muscular or neuromuscular system - A61P 21/06: Anabolic agents (androgens A61P5/26) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The disclosed compositions and methods relate to the increasing muscle mass, preventing muscle atrophy, promoting muscle growth, as well as treatment of various other conditions and diseases. In certain aspects, the disclosed compositions are comprised dileucine and leucine and pharmaceutically acceptable salts thereof. In certain aspects, disclosed compositions are administered to subjects in need thereof to increase muscle mass, prevent muscle atrophy, and/or promote muscle growth. ## Claims ### Claim 1 A composition for increasing muscle protein synthesis comprising: a. dileucine, and b. leucine wherein the dileucine is present in an amount of at least about 50% (w/w) of the combined weight of dileucine and leucine. ### Claim 2 (depends on 1) The composition of claim 1, wherein the dileucine is present in amount of about 90% (w/w). ### Claim 3 (depends on 2) The composition of claim 2, wherein the dileucine is present in amount of about 80% (w/w). ### Claim 4 (depends on 3) The composition of claim 3, wherein the dileucine is present in amount of about 70% (w/w). ### Claim 5 (depends on 4) The composition of claim 4, wherein the dileucine is present in amount of about 60% (w/w). ### Claim 6 (depends on 5) The composition of claim 5, wherein the composition further comprises a pharmaceutical carrier. ### Claim 7 A method for treating muscle atrophy in a subject or preventing muscle atrophy in a subject at risk for muscle atrophy, the method comprising administering to the subject an effective amount of a composition comprising leucine and dileucine wherein the dileucine is present in an amount of at least about 50% (w/w) of the combined weight of dileucine and leucine. ### Claim 8 (depends on 7) The method of claim 7, wherein the dileucine is present in amount of about 90% (w/w). ### Claim 9 (depends on 8) The method of claim 8, wherein the dileucine is present in amount of about 70% (w/w). ### Claim 10 (depends on 9) The method of claim 9, wherein the dileucine is present in amount of about 60% (w/w). ### Claim 11 (depends on 7) The method of claim 7, wherein the administration of the composition to the subject synergistically increases the plasma levels of leucine relative to administration of a composition comprising leucine without dileucine. ### Claim 12 (depends on 7) The method of claim 7, wherein the subject has sarcopenia. ### Claim 13 (depends on 12) The method of claim 12, wherein in the composition is administered in a therapeutically effective amount. ### Claim 14 A method for increasing muscle protein synthesis in a subject, the method comprising administering to the subject an effective amount of a composition comprising leucine and di-leucine, wherein the dileucine is present in an amount of at least about 50% (w/w) of the combined weight of dileucine and leucine and wherein administration of the composition of to the subject increases muscle protein synthesis in the subject. ### Claim 15 (depends on 14) The method of claim 14, wherein the composition further comprises at least one peptide chosen from: tri-leucine, and Leu-Leu-R, wherein R is an amino acid or an amino acid derivative, and pharmaceutically acceptable salts thereof. ### Claim 16 (depends on 15) The method of claim 15, wherein the dileucine is present in amount of about 90% (w/w). ### Claim 17 (depends on 16) The method of claim 16, wherein the dileucine is present in amount of about 70% (w/w). ### Claim 18 (depends on 17) The method of claim 17, wherein the amount of the composition administered is at least about 200 mg. ### Claim 19 (depends on 15) The method of claim 15, wherein the administration of the composition to the subject synergistically increases the plasma levels of leucine relative to administration of a composition comprising leucine without dileucine. ### Claim 20 (depends on 15) The method of claim 15, wherein the administration of the composition to the subject synergistically increases muscle mass and/or muscular strength relative to administration of a composition comprising leucine without dileucine.