JP7752619B2 - Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法 - Google Patents

Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法

Info

Publication number
JP7752619B2
JP7752619B2 JP2022548518A JP2022548518A JP7752619B2 JP 7752619 B2 JP7752619 B2 JP 7752619B2 JP 2022548518 A JP2022548518 A JP 2022548518A JP 2022548518 A JP2022548518 A JP 2022548518A JP 7752619 B2 JP7752619 B2 JP 7752619B2
Authority
JP
Japan
Prior art keywords
dose
administration
liquid pharmaceutical
pharmaceutical dosage
seq
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
JP2022548518A
Other languages
English (en)
Japanese (ja)
Other versions
JP2023514992A5 (https=
JP2023514992A (ja
Inventor
ネスター，ジョン
クリシュナン，ヴィジャヤンティ
Original Assignee
スピットファイア ファーマ エルエルシー
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 スピットファイア ファーマ エルエルシー filed Critical スピットファイア ファーマ エルエルシー
Publication of JP2023514992A publication Critical patent/JP2023514992A/ja
Publication of JP2023514992A5 publication Critical patent/JP2023514992A5/ja
Priority to JP2025162266A priority Critical patent/JP2026021305A/ja
Application granted granted Critical
Publication of JP7752619B2 publication Critical patent/JP7752619B2/ja
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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61K47/06—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
    • A61K47/16—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
    • A61K47/26—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
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Obesity (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Child & Adolescent Psychology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Emergency Medicine (AREA)
  • Toxicology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2022548518A 2020-02-21 2021-02-21 Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法 Active JP7752619B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025162266A JP2026021305A (ja) 2020-02-21 2025-09-29 Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US202062980093P 2020-02-21 2020-02-21
US62/980,093 2020-02-21
US202063122108P 2020-12-07 2020-12-07
US63/122,108 2020-12-07
US202163133540P 2021-01-04 2021-01-04
US63/133,540 2021-01-04
PCT/US2021/018947 WO2021168386A1 (en) 2020-02-21 2021-02-21 Glp-1r and gcgr agonists, formulations, and methods of use

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025162266A Division JP2026021305A (ja) 2020-02-21 2025-09-29 Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法

Publications (3)

Publication Number Publication Date
JP2023514992A JP2023514992A (ja) 2023-04-12
JP2023514992A5 JP2023514992A5 (https=) 2024-03-01
JP7752619B2 true JP7752619B2 (ja) 2025-10-10

Family

ID=77391258

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2022548518A Active JP7752619B2 (ja) 2020-02-21 2021-02-21 Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法
JP2025162266A Pending JP2026021305A (ja) 2020-02-21 2025-09-29 Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025162266A Pending JP2026021305A (ja) 2020-02-21 2025-09-29 Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法

Country Status (11)

Country Link
US (2) US20210290732A1 (https=)
EP (1) EP4106796A4 (https=)
JP (2) JP7752619B2 (https=)
KR (1) KR20220143923A (https=)
CN (1) CN115427065A (https=)
AU (1) AU2021224246A1 (https=)
BR (1) BR112022016470A2 (https=)
CA (1) CA3168001A1 (https=)
IL (1) IL295744A (https=)
MX (1) MX2022010320A (https=)
WO (1) WO2021168386A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108892709A (zh) * 2011-05-18 2018-11-27 欧莫德里斯制药公司 改良的肽药物
MX360816B (es) * 2012-11-20 2018-11-15 Mederis Diabetes Llc Productos farmacéuticos peptídicos mejorados para la resistencia a la insulina.
US20230317230A1 (en) * 2019-05-02 2023-10-05 Closed Loop Medicine Ltd. Method for treating obesity
CN117202924A (zh) * 2020-12-07 2023-12-08 斯皮特弗尔制药有限责任公司 使用glp-1r和gcgr平衡激动剂降低血糖和/或体重的治疗方案和方法
CN118234742A (zh) * 2021-12-01 2024-06-21 江苏恒瑞医药股份有限公司 Glp-1和gip受体双重激动剂的药物组合物及其用途
JP2025537192A (ja) * 2022-11-05 2025-11-14 スピットファイア ファーマ エルエルシー Ｇｌｐ－１ｒおよびｇｃｇｒアゴニストを使用した心血管リスク因子の処置のための治療レジメンおよび方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008513384A (ja) 2004-09-17 2008-05-01 ノボ ノルディスク アクティーゼルスカブ インスリンおよびインスリン分泌性ペプチドを含有する医薬組成物
JP2008519809A (ja) 2004-11-12 2008-06-12 ノボ ノルディスク アクティーゼルスカブ 安定なペプチド製剤
JP2017519009A (ja) 2014-06-13 2017-07-13 サンタ マリア バイオセラピューティクス インコーポレイテッド 製剤化された受容体ポリペプチドおよび関連する方法
JP2017519739A (ja) 2014-05-28 2017-07-20 メデリス ダイアビーティーズ，エルエルシー インスリン抵抗性のための改善されたペプチド医薬品
JP2018503595A (ja) 2014-09-24 2018-02-08 エルロン・セラピューティクス・インコーポレイテッドＡｉｌｅｒｏｎ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． ペプチド模倣大環状分子およびその製剤
JP2019510078A (ja) 2016-02-23 2019-04-11 セセン バイオ， インコーポレイテッド Ｉｌ−６アンタゴニスト製剤およびその使用
WO2019136158A1 (en) 2018-01-03 2019-07-11 Spitfire Pharma, Inc. Improved peptide pharmaceuticals for treatment of nash and other disorders

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108892709A (zh) * 2011-05-18 2018-11-27 欧莫德里斯制药公司 改良的肽药物
MX360816B (es) * 2012-11-20 2018-11-15 Mederis Diabetes Llc Productos farmacéuticos peptídicos mejorados para la resistencia a la insulina.
ES2906975T3 (es) * 2012-11-20 2022-04-21 Eumederis Pharmaceuticals Inc Productos farmacéuticos de péptidos mejorados
EP2986313B1 (en) * 2013-04-18 2019-06-12 Novo Nordisk A/S Stable, protracted glp-1/glucagon receptor co-agonists for medical use
JP2017517549A (ja) * 2014-06-13 2017-06-29 サノフイ 活性薬剤成分のナノカプセル製剤
EP4523705A3 (en) * 2015-06-30 2025-06-11 Hanmi Pharm. Co., Ltd. Glucagon derivative and a composition comprising a long acting conjugate of the same

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008513384A (ja) 2004-09-17 2008-05-01 ノボ ノルディスク アクティーゼルスカブ インスリンおよびインスリン分泌性ペプチドを含有する医薬組成物
JP2008519809A (ja) 2004-11-12 2008-06-12 ノボ ノルディスク アクティーゼルスカブ 安定なペプチド製剤
JP2017519739A (ja) 2014-05-28 2017-07-20 メデリス ダイアビーティーズ，エルエルシー インスリン抵抗性のための改善されたペプチド医薬品
JP2017519009A (ja) 2014-06-13 2017-07-13 サンタ マリア バイオセラピューティクス インコーポレイテッド 製剤化された受容体ポリペプチドおよび関連する方法
JP2018503595A (ja) 2014-09-24 2018-02-08 エルロン・セラピューティクス・インコーポレイテッドＡｉｌｅｒｏｎ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． ペプチド模倣大環状分子およびその製剤
JP2019510078A (ja) 2016-02-23 2019-04-11 セセン バイオ， インコーポレイテッド Ｉｌ−６アンタゴニスト製剤およびその使用
WO2019136158A1 (en) 2018-01-03 2019-07-11 Spitfire Pharma, Inc. Improved peptide pharmaceuticals for treatment of nash and other disorders

Also Published As

Publication number Publication date
AU2021224246A1 (en) 2022-09-15
US20210290732A1 (en) 2021-09-23
JP2026021305A (ja) 2026-02-10
CN115427065A (zh) 2022-12-02
EP4106796A4 (en) 2024-04-17
US20250262280A1 (en) 2025-08-21
EP4106796A1 (en) 2022-12-28
IL295744A (en) 2022-10-01
BR112022016470A2 (pt) 2022-11-22
JP2023514992A (ja) 2023-04-12
CA3168001A1 (en) 2021-08-26
KR20220143923A (ko) 2022-10-25
MX2022010320A (es) 2023-01-30
WO2021168386A1 (en) 2021-08-26

Similar Documents

Publication Publication Date Title
JP7670749B2 (ja) Ｎａｓｈおよびその他障害の処置用の改善されたペプチド薬剤
JP7752619B2 (ja) Ｇｌｐ－１ｒおよびｇｃｇｒアゴニスト、製剤、ならびに使用方法
US20250134963A1 (en) Therapeutic Regimens and Methods for Lowering Blood Glucose and/or Body Weight using GLP-1R and GCGR Balanced Agonists
US20240148879A1 (en) Glp-1r, gip-r and/or gcgr agonists, formulations, and methods of use
US20240269238A1 (en) Therapeutic Regimens and Methods for Reducing Body Weight in a Subject with Fatty Liver Disease using a GLP-1R and GCGR Agonist
US12171806B2 (en) Therapeutic regimens and methods for lowering blood glucose and/or body weight using GLP-1R and GCGR balanced agonists
KR20250089562A (ko) Glp-1r 및 gcgr 효능제를 사용하여 심혈관 위험 인자를 치료하기 위한 치료 요법 및 방법
HK40101792A (zh) 使用glp-1r和gcgr平衡激动剂降低血糖和/或体重的治疗方案和方法

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20221129

RD12 Notification of acceptance of power of sub attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7432

Effective date: 20221219

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20221219

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240221

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20240221

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20250303

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250603

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20250903

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20250930

R150 Certificate of patent or registration of utility model

Ref document number: 7752619

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150