IL281362B1 - Glucagon-like peptide 2 (GLP-2) analog formulations and methods and uses thereof - Google Patents

Glucagon-like peptide 2 (GLP-2) analog formulations and methods and uses thereof

Info

Publication number
IL281362B1
IL281362B1 IL281362A IL28136221A IL281362B1 IL 281362 B1 IL281362 B1 IL 281362B1 IL 281362 A IL281362 A IL 281362A IL 28136221 A IL28136221 A IL 28136221A IL 281362 B1 IL281362 B1 IL 281362B1
Authority
IL
Israel
Prior art keywords
glp
glucagon
analogues
peptide
formulations
Prior art date
Application number
IL281362A
Other languages
English (en)
Hebrew (he)
Other versions
IL281362A (en
Original Assignee
Zealand Pharma As
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
Application filed by Zealand Pharma As filed Critical Zealand Pharma As
Publication of IL281362A publication Critical patent/IL281362A/en
Publication of IL281362B1 publication Critical patent/IL281362B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • 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
    • A61K9/08—Solutions
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
IL281362A 2018-09-28 2021-03-09 Glucagon-like peptide 2 (GLP-2) analog formulations and methods and uses thereof IL281362B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18197755.4A EP3628683A1 (en) 2018-09-28 2018-09-28 Formulations of glucagon-like-peptide-2 (glp-2) analogues
PCT/EP2019/076305 WO2020065064A1 (en) 2018-09-28 2019-09-27 Formulations of glucagon-like-peptide-2 (glp-2) analogues

Publications (2)

Publication Number Publication Date
IL281362A IL281362A (en) 2021-04-29
IL281362B1 true IL281362B1 (en) 2026-03-01

Family

ID=63794308

Family Applications (1)

Application Number Title Priority Date Filing Date
IL281362A IL281362B1 (en) 2018-09-28 2021-03-09 Glucagon-like peptide 2 (GLP-2) analog formulations and methods and uses thereof

Country Status (14)

Country Link
US (2) US20220265551A1 (https=)
EP (2) EP3628683A1 (https=)
JP (2) JP7566730B2 (https=)
KR (2) KR20260008798A (https=)
CN (3) CN112771073B (https=)
AU (1) AU2019348538B2 (https=)
BR (1) BR112021005858A2 (https=)
CA (1) CA3114330A1 (https=)
CL (1) CL2021000678A1 (https=)
IL (1) IL281362B1 (https=)
MX (2) MX2021003271A (https=)
NZ (1) NZ775113A (https=)
SG (1) SG11202102383VA (https=)
WO (1) WO2020065064A1 (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL299864B2 (en) 2017-06-16 2024-06-01 Zealand Pharma As Dosage regimes for the administration of glucagon-like-peptide-2 (glp-2) analogues
MX2022014671A (es) * 2020-05-22 2023-02-13 Hanmi Pharm Ind Co Ltd Formulacion liquida de conjugado de glp-2 de accion prolongada.
MX2023006901A (es) * 2020-12-16 2023-06-26 Zealand Pharma As Uso de analogos de glp-2 en pacientes con insuficiencia renal.
RS67423B1 (sr) * 2021-09-10 2025-12-31 Zealand Pharma As Postupak za formulisanje sastava koji sadrže analoge glukagonu sličnog peptida-2 (glp-2)
IL313732A (en) 2021-12-23 2024-08-01 Zealand Pharma As Processes for synthesizing glucagon-like-peptide 2 (glp-2) analogues
KR20250075601A (ko) 2022-09-30 2025-05-28 질랜드 파마 에이/에스 글루카곤-유사-펩타이드-2(glp-2) 유사체 및 단장 증후군(sbs) 치료를 위한 이의 의학적 용도
US20240415933A1 (en) * 2022-10-03 2024-12-19 Orbicular Pharmaceutical Technologies Private Limited Stable injectable compositions of glp-2 peptide
IL322328A (en) 2023-01-27 2025-09-01 Zealand Pharma As Glucagon-like peptide-2 (GLP-2) analogs and their medical uses for the treatment of short bowel syndrome (SBS)
TW202535919A (zh) 2023-12-28 2025-09-16 丹麥商西蘭製藥公司 類升糖素肽2(glp-2)類似物之調配物及其用途

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049314A2 (en) * 1999-12-30 2001-07-12 Nps Allelix Corp. Glp-2 formulations
WO2006117565A2 (en) * 2005-05-04 2006-11-09 Zealand Pharma A/S Glucagon-like-peptide-2 (glp-2) analogues
WO2008056155A1 (en) * 2006-11-08 2008-05-15 Zealand Pharma A/S Selective glucagon-like-peptide-2 (glp-2) analogues
WO2016065181A1 (en) * 2014-10-23 2016-04-28 Amgen Inc. Reducing viscosity of pharmaceutical formulations
WO2018094404A1 (en) * 2016-11-21 2018-05-24 Eiger Biopharmaceuticals, Inc. Buffered formulations of exendin (9-39)

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HU225496B1 (en) * 1993-04-07 2007-01-29 Scios Inc Pharmaceutical compositions of prolonged delivery, containing peptides
US5789379A (en) 1995-04-14 1998-08-04 Allelix Biopharmaceutical Inc. Glucagon-like peptide-2 analogs
US6184201B1 (en) 1995-04-14 2001-02-06 Nps Allelix Corp. Intestinotrophic glucagon-like peptide-2 analogs
EP1231219B1 (en) 1996-04-12 2010-08-25 1149336 Ontario Inc. GLucagon-like peptide-2 analogs
EP1076066A1 (en) 1999-07-12 2001-02-14 Zealand Pharmaceuticals A/S Peptides for lowering blood glucose levels
AU2020501A (en) 1999-12-08 2001-06-18 1149336 Ontario Inc. Chemotherapy treatment
DK1360202T3 (da) 2001-02-16 2008-09-22 Conjuchem Biotechnologies Inc Langvarigt glucagon-lignende peptid 2 (GLP-2) til behandling af gastrointestinale sygdomme og lidelser
ES2336826T3 (es) * 2005-05-03 2010-04-16 Novetide, Ltd. Procedimientos para la produccion de un peptido que presenta una amida c-terminal.
CN101341254A (zh) * 2005-12-24 2009-01-07 蒂加斯克乳制品研究中心 反-10，顺-12十八碳二烯酸的生产方法
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CN101668535B (zh) * 2006-12-29 2017-07-28 益普生制药股份有限公司 Glp‑1药物组合物
KR20130115086A (ko) * 2010-05-17 2013-10-21 세빅스 인코포레이티드 페길화된 c-펩티드
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HRP20161703T1 (hr) * 2012-11-20 2017-03-10 Fresenius Kabi Usa, Llc Formulacije kaspofungin acetata

Patent Citations (11)

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Publication number Priority date Publication date Assignee Title
WO2001049314A2 (en) * 1999-12-30 2001-07-12 Nps Allelix Corp. Glp-2 formulations
WO2006117565A2 (en) * 2005-05-04 2006-11-09 Zealand Pharma A/S Glucagon-like-peptide-2 (glp-2) analogues
US7563770B2 (en) * 2005-05-04 2009-07-21 Zealand Pharma A/S Glucagon-like-peptide-2 (GLP-2) analogues
US7745403B2 (en) * 2005-05-04 2010-06-29 Zealand Pharma A/S Methods of treating chemotherapy-induced diarrhea/mucositis using glucagon-like-peptide-2(GLP-2)analogues
US8163696B2 (en) * 2005-05-04 2012-04-24 Zealand Pharma A/S Treatment of inflammatory bowel disease using glucagon-like-peptide-2 (GLP-2) analogues
US8263552B2 (en) * 2005-05-04 2012-09-11 Zealand Pharma A/S Glucagon-like-peptide-2 (GLP-2) analogues
US9125882B2 (en) * 2005-05-04 2015-09-08 Zealand Pharma A/S Glucagon-like-peptide-2 (GLP-2) analogues
US9580487B2 (en) * 2005-05-04 2017-02-28 Zealand Pharma A/S Method of treating stomach or bowel-related disorders by administering glucagon-like-peptide-2 (GLP-2) analogues
WO2008056155A1 (en) * 2006-11-08 2008-05-15 Zealand Pharma A/S Selective glucagon-like-peptide-2 (glp-2) analogues
WO2016065181A1 (en) * 2014-10-23 2016-04-28 Amgen Inc. Reducing viscosity of pharmaceutical formulations
WO2018094404A1 (en) * 2016-11-21 2018-05-24 Eiger Biopharmaceuticals, Inc. Buffered formulations of exendin (9-39)

Also Published As

Publication number Publication date
NZ775113A (en) 2026-01-30
CA3114330A1 (en) 2020-04-02
JP7738136B2 (ja) 2025-09-11
JP2022502432A (ja) 2022-01-11
CN118267455A (zh) 2024-07-02
CN120204366A (zh) 2025-06-27
KR20210069056A (ko) 2021-06-10
WO2020065064A1 (en) 2020-04-02
CN112771073B (zh) 2025-07-01
MX2021003271A (es) 2021-05-12
MX2026000859A (es) 2026-03-02
CN112771073A (zh) 2021-05-07
JP7566730B2 (ja) 2024-10-15
EP3856766A1 (en) 2021-08-04
JP2024156754A (ja) 2024-11-06
AU2019348538A1 (en) 2021-05-20
BR112021005858A2 (pt) 2021-07-27
SG11202102383VA (en) 2021-04-29
US20240065978A1 (en) 2024-02-29
EP3628683A1 (en) 2020-04-01
IL281362A (en) 2021-04-29
US20220265551A1 (en) 2022-08-25
KR20260008798A (ko) 2026-01-16
AU2019348538B2 (en) 2025-04-03
CL2021000678A1 (es) 2021-08-06

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