JP7834025B2 - グルカゴン類縁体の液体製剤 - Google Patents

グルカゴン類縁体の液体製剤

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Publication number
JP7834025B2
JP7834025B2 JP2022555741A JP2022555741A JP7834025B2 JP 7834025 B2 JP7834025 B2 JP 7834025B2 JP 2022555741 A JP2022555741 A JP 2022555741A JP 2022555741 A JP2022555741 A JP 2022555741A JP 7834025 B2 JP7834025 B2 JP 7834025B2
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JP
Japan
Prior art keywords
present
concentration
aqueous liquid
hypoglycemia
stable aqueous
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.)
Active
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JP2022555741A
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English (en)
Japanese (ja)
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JP2023518052A5 (cg-RX-API-DMAC10.html
JP2023518052A (ja
Inventor
ビラドセン，イェスパー・スコボー
ゴッツシャルク・ボービング，ティナ・エリザベト
Original Assignee
ジーランド・ファルマ・アー／エス
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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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Emergency Medicine (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Child & Adolescent Psychology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2022555741A 2020-03-16 2021-03-16 グルカゴン類縁体の液体製剤 Active JP7834025B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20163408 2020-03-16
EP20163408.6 2020-03-16
PCT/EP2021/056651 WO2021185821A1 (en) 2020-03-16 2021-03-16 Liquid formulations of glucagon analogues

Publications (3)

Publication Number Publication Date
JP2023518052A JP2023518052A (ja) 2023-04-27
JP2023518052A5 JP2023518052A5 (cg-RX-API-DMAC10.html) 2024-03-26
JP7834025B2 true JP7834025B2 (ja) 2026-03-23

Family

ID=70008261

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2022555741A Active JP7834025B2 (ja) 2020-03-16 2021-03-16 グルカゴン類縁体の液体製剤

Country Status (23)

Country Link
US (2) US20210283053A1 (cg-RX-API-DMAC10.html)
EP (1) EP4121003B1 (cg-RX-API-DMAC10.html)
JP (1) JP7834025B2 (cg-RX-API-DMAC10.html)
KR (1) KR102956482B1 (cg-RX-API-DMAC10.html)
CN (1) CN115279341B (cg-RX-API-DMAC10.html)
AR (1) AR121581A1 (cg-RX-API-DMAC10.html)
AU (1) AU2021236878B2 (cg-RX-API-DMAC10.html)
BR (1) BR112022018462A2 (cg-RX-API-DMAC10.html)
CA (1) CA3171184A1 (cg-RX-API-DMAC10.html)
CL (1) CL2022002472A1 (cg-RX-API-DMAC10.html)
CO (1) CO2022014452A2 (cg-RX-API-DMAC10.html)
ES (1) ES3041327T3 (cg-RX-API-DMAC10.html)
HR (1) HRP20251267T1 (cg-RX-API-DMAC10.html)
HU (1) HUE073401T2 (cg-RX-API-DMAC10.html)
IL (1) IL295977A (cg-RX-API-DMAC10.html)
MX (1) MX2022011227A (cg-RX-API-DMAC10.html)
PE (1) PE20230258A1 (cg-RX-API-DMAC10.html)
PH (1) PH12022552457A1 (cg-RX-API-DMAC10.html)
PL (1) PL4121003T3 (cg-RX-API-DMAC10.html)
RS (1) RS67245B1 (cg-RX-API-DMAC10.html)
TW (1) TW202200190A (cg-RX-API-DMAC10.html)
UA (1) UA129439C2 (cg-RX-API-DMAC10.html)
WO (1) WO2021185821A1 (cg-RX-API-DMAC10.html)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL312600B2 (en) 2022-05-30 2025-12-01 Zealand Pharma As Liquid formulations of amylin analogs
WO2025056677A1 (en) 2023-09-15 2025-03-20 Zealand Pharma A/S Dasiglucagon for use in the treatment of congenital hyperinsulinism

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015524419A (ja) 2012-07-23 2015-08-24 ジーランド ファーマ アクティーゼルスカブ グルカゴン類似体
WO2019008033A1 (en) 2017-07-05 2019-01-10 Zealand Pharma A/S METHODS AND MEDICAL USES RELATING TO THE TREATMENT OF HYPOGLYCEMIA
WO2019110838A1 (fr) 2017-12-07 2019-06-13 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant du glucagon humain et un co-polyaminoacide

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
WO2011117417A1 (en) 2010-03-26 2011-09-29 Novo Nordisk A/S Novel glucagon analogues
US9018162B2 (en) 2013-02-06 2015-04-28 Xeris Pharmaceuticals, Inc. Methods for rapidly treating severe hypoglycemia
UA121874C2 (uk) 2015-02-17 2020-08-10 Елі Ліллі Енд Компані Порошкова назальна композиція для лікування гіпоглікемії
WO2017053822A1 (en) 2015-09-23 2017-03-30 Behavioral Recognition Systems, Inc. Detected object tracker for a video analytics system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015524419A (ja) 2012-07-23 2015-08-24 ジーランド ファーマ アクティーゼルスカブ グルカゴン類似体
WO2019008033A1 (en) 2017-07-05 2019-01-10 Zealand Pharma A/S METHODS AND MEDICAL USES RELATING TO THE TREATMENT OF HYPOGLYCEMIA
WO2019110838A1 (fr) 2017-12-07 2019-06-13 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant du glucagon humain et un co-polyaminoacide

Also Published As

Publication number Publication date
MX2022011227A (es) 2022-10-07
CN115279341A (zh) 2022-11-01
EP4121003C0 (en) 2025-08-06
AU2021236878A1 (en) 2022-09-29
US20210283053A1 (en) 2021-09-16
HUE073401T2 (hu) 2026-01-28
HRP20251267T1 (hr) 2025-12-05
PE20230258A1 (es) 2023-02-07
KR102956482B1 (ko) 2026-04-23
BR112022018462A2 (pt) 2022-11-01
EP4121003A1 (en) 2023-01-25
TW202200190A (zh) 2022-01-01
AR121581A1 (es) 2022-06-15
WO2021185821A1 (en) 2021-09-23
CL2022002472A1 (es) 2023-02-17
PL4121003T3 (pl) 2026-02-23
JP2023518052A (ja) 2023-04-27
US20250195424A1 (en) 2025-06-19
KR20220154110A (ko) 2022-11-21
CA3171184A1 (en) 2021-09-23
ES3041327T3 (en) 2025-11-11
RS67245B1 (sr) 2025-10-31
PH12022552457A1 (en) 2023-12-11
AU2021236878B2 (en) 2025-09-11
CN115279341B (zh) 2026-03-31
NZ791927A (en) 2025-09-26
EP4121003B1 (en) 2025-08-06
UA129439C2 (uk) 2025-04-23
CO2022014452A2 (es) 2022-10-21
IL295977A (en) 2022-10-01

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