KR102956482B1 - 글루카곤 유사체의 액체 제형 - Google Patents

글루카곤 유사체의 액체 제형

Info

Publication number
KR102956482B1
KR102956482B1 KR1020227031361A KR20227031361A KR102956482B1 KR 102956482 B1 KR102956482 B1 KR 102956482B1 KR 1020227031361 A KR1020227031361 A KR 1020227031361A KR 20227031361 A KR20227031361 A KR 20227031361A KR 102956482 B1 KR102956482 B1 KR 102956482B1
Authority
KR
South Korea
Prior art keywords
formulation
present
concentration
aqueous liquid
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
Application number
KR1020227031361A
Other languages
English (en)
Korean (ko)
Other versions
KR20220154110A (ko
Inventor
예스퍼 스코드보르그 빌라드센
뵈빙 티네 엘리자베트 고트샬크
Original Assignee
질랜드 파마 에이/에스
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 질랜드 파마 에이/에스 filed Critical 질랜드 파마 에이/에스
Publication of KR20220154110A publication Critical patent/KR20220154110A/ko
Application granted granted Critical
Publication of KR102956482B1 publication Critical patent/KR102956482B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • 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)
KR1020227031361A 2020-03-16 2021-03-16 글루카곤 유사체의 액체 제형 Active KR102956482B1 (ko)

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 (2)

Publication Number Publication Date
KR20220154110A KR20220154110A (ko) 2022-11-21
KR102956482B1 true KR102956482B1 (ko) 2026-04-23

Family

ID=70008261

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020227031361A Active KR102956482B1 (ko) 2020-03-16 2021-03-16 글루카곤 유사체의 액체 제형

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 (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (7)

* 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
NZ704043A (en) * 2012-07-23 2017-07-28 Zealand Pharma As 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
GB201710822D0 (en) * 2017-07-05 2017-08-16 Zealand Pharma As Methods and medical uses relating to the treatment of hypoglycaemia

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
JP7834025B2 (ja) 2026-03-23
US20210283053A1 (en) 2021-09-16
HUE073401T2 (hu) 2026-01-28
HRP20251267T1 (hr) 2025-12-05
PE20230258A1 (es) 2023-02-07
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

Similar Documents

Publication Publication Date Title
US12083164B2 (en) Amylin analogues
JP2019187419A (ja) グルカゴン類似体
US10766939B2 (en) Amylin analogues
JP7580403B2 (ja) Ｇｌｐ１／２二重アゴニストの非経口医薬組成物
JP2019536796A (ja) ペプチド三重（ｔｒｉｇｏｎａｌ）ＧＬＰ１／グルカゴン／ＧＩＰ受容体アゴニストとしての新しい化合物
CN102933598A (zh) 新型胰高血糖素类似物
JP2024546026A (ja) Ｇｌｐ－１受容体及びｇｉｐ受容体二重アゴニストの医薬組成物及びその使用
US20250195424A1 (en) Liquid formulations of glucagon analogues
TWI880227B (zh) 澱粉素類似物之液體調配物
RU2819934C1 (ru) Жидкие составы аналогов глюкагона
EA050539B1 (ru) Жидкие составы аналогов глюкагона
HK40078233B (en) Liquid formulations of glucagon analogues
HK40078233A (en) Liquid formulations of glucagon analogues
HK40004264B (en) Amylin analogues

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

D16 Fast track examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D16-EXM-PA0302 (AS PROVIDED BY THE NATIONAL OFFICE)

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-NAP-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

PA0302 Request for accelerated examination

St.27 status event code: A-1-2-D10-D16-exm-PA0302

D21 Rejection of application intended

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D21-EXM-PE0902 (AS PROVIDED BY THE NATIONAL OFFICE)

PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-NAP-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

D22 Grant of ip right intended

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D22-EXM-PE0701 (AS PROVIDED BY THE NATIONAL OFFICE)

PE0701 Decision of registration

St.27 status event code: A-1-2-D10-D22-exm-PE0701

F11 Ip right granted following substantive examination

Free format text: ST27 STATUS EVENT CODE: A-2-4-F10-F11-EXM-PR0701 (AS PROVIDED BY THE NATIONAL OFFICE)

PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

U12 Designation fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U12-OTH-PR1002 (AS PROVIDED BY THE NATIONAL OFFICE)

Year of fee payment: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

Q13 Ip right document published

Free format text: ST27 STATUS EVENT CODE: A-4-4-Q10-Q13-NAP-PG1601 (AS PROVIDED BY THE NATIONAL OFFICE)