KR20250023993A - L-오르니틴 페닐아세테이트의 제제 - Google Patents

L-오르니틴 페닐아세테이트의 제제 Download PDF

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Publication number
KR20250023993A
KR20250023993A KR1020247042587A KR20247042587A KR20250023993A KR 20250023993 A KR20250023993 A KR 20250023993A KR 1020247042587 A KR1020247042587 A KR 1020247042587A KR 20247042587 A KR20247042587 A KR 20247042587A KR 20250023993 A KR20250023993 A KR 20250023993A
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KR
South Korea
Prior art keywords
phenylacetylglutamine
plasma
phenylacetate
auc
oral pharmaceutical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
KR1020247042587A
Other languages
English (en)
Korean (ko)
Inventor
로렌 왕
린다 에스 그레이스
스탠리 버코프저
Original Assignee
오세라 테라퓨틱스, 아이엔씨.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/133,087 external-priority patent/US20160338982A1/en
Application filed by 오세라 테라퓨틱스, 아이엔씨. filed Critical 오세라 테라퓨틱스, 아이엔씨.
Publication of KR20250023993A publication Critical patent/KR20250023993A/ko
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group 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
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Obesity (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
KR1020247042587A 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제 Pending KR20250023993A (ko)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US201562255300P 2015-11-13 2015-11-13
US62/255,300 2015-11-13
US201662276754P 2016-01-08 2016-01-08
US62/276,754 2016-01-08
US15/133,087 US20160338982A1 (en) 2015-04-20 2016-04-19 Formulations of l-ornithine phenylacetate
US15/133,087 2016-04-19
KR1020187016373A KR20180086431A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제
PCT/US2016/061678 WO2017083758A1 (en) 2015-11-13 2016-11-11 Formulation of l-ornithine phenylacetate

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020187016373A Division KR20180086431A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제

Publications (1)

Publication Number Publication Date
KR20250023993A true KR20250023993A (ko) 2025-02-18

Family

ID=58695607

Family Applications (2)

Application Number Title Priority Date Filing Date
KR1020247042587A Pending KR20250023993A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제
KR1020187016373A Ceased KR20180086431A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제

Family Applications After (1)

Application Number Title Priority Date Filing Date
KR1020187016373A Ceased KR20180086431A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제

Country Status (12)

Country Link
EP (1) EP3373923A4 (cg-RX-API-DMAC7.html)
JP (2) JP7294807B2 (cg-RX-API-DMAC7.html)
KR (2) KR20250023993A (cg-RX-API-DMAC7.html)
CN (2) CN108366983A (cg-RX-API-DMAC7.html)
AU (2) AU2016353350B2 (cg-RX-API-DMAC7.html)
BR (1) BR112018009349A8 (cg-RX-API-DMAC7.html)
CA (1) CA3004331A1 (cg-RX-API-DMAC7.html)
IL (1) IL258630B2 (cg-RX-API-DMAC7.html)
MX (2) MX389926B (cg-RX-API-DMAC7.html)
RU (1) RU2018113801A (cg-RX-API-DMAC7.html)
SG (1) SG11201802987UA (cg-RX-API-DMAC7.html)
WO (1) WO2017083758A1 (cg-RX-API-DMAC7.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20190146A1 (ar) 2016-12-19 2019-06-18 Axcella Health Inc تركيبات حمض أميني وطرق لمعالجة أمراض الكبد
WO2019036471A1 (en) 2017-08-14 2019-02-21 Axcella Health Inc. AMINO ACIDS BRANCHED FOR THE TREATMENT OF LIVER DISEASE
EP3810123A1 (en) 2018-06-20 2021-04-28 Axcella Health Inc. Compositions and methods for the treatment of fat infiltration in muscle
US12697317B2 (en) 2019-10-16 2026-08-04 Amalive Limited Dosages and uses of ornithine phenylacetate for treating hyperammonemia
WO2024261477A1 (en) 2023-06-20 2024-12-26 Yaqrit Limited Combination of tlr4 antagonist, ornithine and phenylacetate or phenylbutyrate

Family Cites Families (15)

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Publication number Priority date Publication date Assignee Title
US4783443A (en) 1986-03-03 1988-11-08 The University Of Chicago Amino acyl cephalosporin derivatives
PT2319581E (pt) * 2004-11-26 2015-06-30 Ucl Business Plc Composições compreendendo ornitina e fenilacetato ou fenilbutirato para tratamento de encefalopatia hepática
GB0426141D0 (en) * 2004-11-26 2004-12-29 Ucl Biomedica Plc Treatment
DE102007009243A1 (de) * 2007-02-22 2008-09-18 Evonik Röhm Gmbh Pellets mit einer Wirkstoff-Matrix und einem Polymerüberzug, sowie ein Verfahren zur Herstellung der Pellets
AU2015221466B2 (en) * 2009-04-03 2017-02-02 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
CN106810464B (zh) * 2009-04-03 2019-01-22 欧塞拉治疗有限公司 L-鸟氨酸苯乙酸盐及其制备方法
ES2517340T3 (es) * 2009-06-08 2014-11-03 Ucl Business Plc Tratamiento de la hipertensión portal usando L-ornitina y fenilacetato
AU2014250643B2 (en) 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
EP2625162B1 (en) * 2010-10-06 2019-03-13 Ocera Therapeutics, Inc. Methods of making l-ornithine phenyl acetate
CN102993037B (zh) * 2012-11-20 2015-03-04 南京工业大学 一种l-鸟氨酸苯乙酸盐的制备方法
CN103705490B (zh) * 2013-10-31 2016-08-17 蚌埠丰原医药科技发展有限公司 一种门冬氨酸鸟氨酸的缓释制剂及其制备工艺
KR20230018526A (ko) * 2014-11-24 2023-02-07 유씨엘 비즈니스 리미티드 암모니아-저감 치료를 이용한 간성상세포 활성화와 연관된 질병의 치료
HK1251149A1 (zh) * 2015-04-20 2019-01-25 Ocera Therapeutics, Inc. L-鸟氨酸苯乙酸盐制剂
JP6990170B2 (ja) * 2015-08-18 2022-01-12 オセラ セラピューティクス, インコーポレイテッド L-オルニチンをフェニルアセテートおよびフェニルブチレートのうちの少なくとも1つと組み合わせて用いる筋肉喪失の治療および予防
JP6989495B2 (ja) * 2015-09-25 2022-01-05 オセラ セラピューティクス, インコーポレイテッド L−オルニチンをフェニルアセテートおよびフェニルブチレートのうちの少なくとも1つと組み合わせて用いる神経細胞喪失の治療および予防

Also Published As

Publication number Publication date
CN108366983A (zh) 2018-08-03
BR112018009349A2 (pt) 2018-11-13
IL258630A (en) 2018-06-28
KR20180086431A (ko) 2018-07-31
JP2022058446A (ja) 2022-04-12
CN113768863A (zh) 2021-12-10
MX389926B (es) 2025-03-20
BR112018009349A8 (pt) 2019-02-26
IL258630B2 (en) 2023-08-01
WO2017083758A1 (en) 2017-05-18
MX2018005088A (es) 2019-05-16
MX2022001517A (es) 2022-11-16
JP7294807B2 (ja) 2023-06-20
IL258630B1 (en) 2023-04-01
JP2018533601A (ja) 2018-11-15
AU2016353350A1 (en) 2018-05-10
CA3004331A1 (en) 2017-05-18
AU2021290236A1 (en) 2022-02-10
EP3373923A4 (en) 2019-07-03
RU2018113801A (ru) 2019-12-16
AU2016353350B2 (en) 2021-09-23
SG11201802987UA (en) 2018-05-30
EP3373923A1 (en) 2018-09-19

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Comment text: Divisional Application for International Patent

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Patent event date: 20241223

Application number text: 1020187016373

Filing date: 20180608

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Patent event code: PA02012R01D

Patent event date: 20250121

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