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
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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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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic 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
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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  • 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)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (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 (enExample)
JP (2) JP7294807B2 (enExample)
KR (2) KR20250023993A (enExample)
CN (2) CN113768863A (enExample)
AU (2) AU2016353350B2 (enExample)
BR (1) BR112018009349A8 (enExample)
CA (1) CA3004331A1 (enExample)
IL (1) IL258630B2 (enExample)
MX (2) MX389926B (enExample)
RU (1) RU2018113801A (enExample)
SG (1) SG11201802987UA (enExample)
WO (1) WO2017083758A1 (enExample)

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
US10682325B2 (en) 2017-08-14 2020-06-16 Axcella Health Inc. Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting
JP2021527670A (ja) 2018-06-20 2021-10-14 アクセラ・ヘルス・インコーポレイテッドAxcella Health Inc. 筋肉中の脂肪浸潤の治療のための組成物及び方法
US20220362192A1 (en) * 2019-10-16 2022-11-17 Ocera Therapeutics, Inc. 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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4783443A (en) 1986-03-03 1988-11-08 The University Of Chicago Amino acyl cephalosporin derivatives
PL1824563T3 (pl) * 2004-11-26 2010-07-30 Ucl Business Plc Kompozycje zawierające ornitynę i fenylooctan lub fenylomaślan do leczenia encefalopatii wątrobowej
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
SG174982A1 (en) * 2009-04-03 2011-11-28 Ocera Therapeutics Inc L-ornithine phenyl acetate and methods of making thereof
AU2015221466B2 (en) 2009-04-03 2017-02-02 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
JP5749255B2 (ja) * 2009-06-08 2015-07-15 ユーシーエル ビジネス ピーエルシー L−オルニチンフェニル酢酸塩を用いる門脈圧亢進の治療及び肝機能の修復
AU2014250643B2 (en) 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
JP6087284B2 (ja) * 2010-10-06 2017-03-01 オセラ セラピューティクス, インコーポレイテッド L−オルニチンフェニルアセテートを製造するための方法
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
IL281349B (en) * 2014-11-24 2022-09-01 Ucl Business Ltd Treatment of diseases related to hepatic stellate cell activity using ammonia-lowering treatments
CA2983146C (en) 2015-04-20 2023-09-12 Ocera Therapeutics, Inc. Formulations of l-ornithine phenylacetate
US10835506B2 (en) * 2015-08-18 2020-11-17 Ocera Therapeutics, Inc. Treatment and prevention of muscle loss using L-ornithine in combination with at least one of phenylacetate and phenylbutyrate
HK1257679A1 (zh) * 2015-09-25 2019-10-25 Ocera Therapeutics, Inc. 使用l-鸟苷酸与苯乙酸根和苯基丁酸根中至少一种的结合治疗和预防神经元细胞损失

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

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Comment text: Divisional Application for International Patent

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Patent event date: 20241223

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Filing date: 20180608

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Patent event code: PA02012R01D

Patent event date: 20250121

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