JP2020500164A - テルリプレシン組成物およびその使用方法 - Google Patents

テルリプレシン組成物およびその使用方法 Download PDF

Info

Publication number
JP2020500164A
JP2020500164A JP2019521093A JP2019521093A JP2020500164A JP 2020500164 A JP2020500164 A JP 2020500164A JP 2019521093 A JP2019521093 A JP 2019521093A JP 2019521093 A JP2019521093 A JP 2019521093A JP 2020500164 A JP2020500164 A JP 2020500164A
Authority
JP
Japan
Prior art keywords
terlipressin
administered
capsule
dosage form
subject
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.)
Withdrawn
Application number
JP2019521093A
Other languages
English (en)
Japanese (ja)
Other versions
JP2020500164A5 (cg-RX-API-DMAC10.html
Inventor
ゲイリー パトゥー,
ゲイリー パトゥー,
Original Assignee
キアズマ インコーポレイテッド
キアズマ インコーポレイテッド
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 キアズマ インコーポレイテッド, キアズマ インコーポレイテッド filed Critical キアズマ インコーポレイテッド
Publication of JP2020500164A publication Critical patent/JP2020500164A/ja
Publication of JP2020500164A5 publication Critical patent/JP2020500164A5/ja
Priority to JP2023108121A priority Critical patent/JP2023120445A/ja
Priority to JP2024194379A priority patent/JP2025020319A/ja
Withdrawn legal-status Critical Current

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
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/095—Oxytocins; Vasopressins; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4425—Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/451—Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1816—Erythropoietin [EPO]
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/02—Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
JP2019521093A 2016-10-21 2017-10-20 テルリプレシン組成物およびその使用方法 Withdrawn JP2020500164A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2023108121A JP2023120445A (ja) 2016-10-21 2023-06-30 テルリプレシン組成物およびその使用方法
JP2024194379A JP2025020319A (ja) 2016-10-21 2024-11-06 テルリプレシン組成物およびその使用方法

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662410971P 2016-10-21 2016-10-21
US62/410,971 2016-10-21
US201762472291P 2017-03-16 2017-03-16
US62/472,291 2017-03-16
PCT/US2017/057601 WO2018075897A1 (en) 2016-10-21 2017-10-20 Terlipressin compositions and their methods of use

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023108121A Division JP2023120445A (ja) 2016-10-21 2023-06-30 テルリプレシン組成物およびその使用方法

Publications (2)

Publication Number Publication Date
JP2020500164A true JP2020500164A (ja) 2020-01-09
JP2020500164A5 JP2020500164A5 (cg-RX-API-DMAC10.html) 2020-11-26

Family

ID=62019439

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2019521093A Withdrawn JP2020500164A (ja) 2016-10-21 2017-10-20 テルリプレシン組成物およびその使用方法
JP2023108121A Withdrawn JP2023120445A (ja) 2016-10-21 2023-06-30 テルリプレシン組成物およびその使用方法
JP2024194379A Pending JP2025020319A (ja) 2016-10-21 2024-11-06 テルリプレシン組成物およびその使用方法

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2023108121A Withdrawn JP2023120445A (ja) 2016-10-21 2023-06-30 テルリプレシン組成物およびその使用方法
JP2024194379A Pending JP2025020319A (ja) 2016-10-21 2024-11-06 テルリプレシン組成物およびその使用方法

Country Status (10)

Country Link
US (3) US10993984B2 (cg-RX-API-DMAC10.html)
EP (2) EP4516803A3 (cg-RX-API-DMAC10.html)
JP (3) JP2020500164A (cg-RX-API-DMAC10.html)
AU (2) AU2017345720B2 (cg-RX-API-DMAC10.html)
CA (1) CA3037581A1 (cg-RX-API-DMAC10.html)
ES (1) ES3023754T3 (cg-RX-API-DMAC10.html)
IL (2) IL265761B2 (cg-RX-API-DMAC10.html)
MA (1) MA46586A (cg-RX-API-DMAC10.html)
WO (1) WO2018075897A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA201901912B (cg-RX-API-DMAC10.html)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2678833C2 (ru) 2008-09-17 2019-02-04 Киазма Инк. Фармацевтические композиции и соответствующие способы доставки
SI3253401T1 (sl) 2015-02-03 2025-07-31 Amryt Endo, Inc. Zdravljenje akromegalije z oralnim oktreotidom
CN109223720B (zh) * 2018-09-12 2020-11-27 南京康舟医药科技有限公司 注射用醋酸特利加压素冻干粉针剂的制备方法
US20230399360A1 (en) * 2019-12-20 2023-12-14 Northwestern University Terlipressin-octadecanedioic acid conjugate for vasoconstrictive therapy
US11141457B1 (en) 2020-12-28 2021-10-12 Amryt Endo, Inc. Oral octreotide therapy and contraceptive methods
CN114306250B (zh) * 2021-11-26 2023-07-14 苏州天马医药集团天吉生物制药有限公司 一种醋酸特利加压素制剂及其制备方法
CA3238277A1 (en) * 2022-01-13 2023-07-20 David Caron Oral dosage forms
US20240156895A1 (en) * 2022-10-28 2024-05-16 Mallinckrodt Pharmaceuticals Ireland Limited Compositions for improving kidney function in patients with hepatorenal syndrome

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040102362A1 (en) * 2000-09-15 2004-05-27 Didier Lebrec Protocol for paracentesis
US20110311621A1 (en) * 2010-03-16 2011-12-22 Paul Salama Pharmaceutical compositions and methods of delvery
JP2012502973A (ja) * 2008-09-17 2012-02-02 キアズマ インコーポレイテッド 医薬組成物および関連する送達方法
WO2014165607A2 (en) * 2013-04-02 2014-10-09 Stealth Peptides International, Inc. Aromatic-cationic peptide formulations, compositions and methods of use
WO2016065117A1 (en) * 2014-10-24 2016-04-28 Ikaria Therapeutics Llc Method of treating patients with hepatorenal syndrome type 1

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH455823A (de) 1964-08-01 1968-05-15 Ceskoslovenska Akademie Ved Verfahren zur Herstellung von Peptiden
JO2937B1 (en) 2004-08-11 2016-03-15 فيرينغ.بي.في Tight muscles of the peptide vascular tensioner receptor
US8883965B2 (en) 2006-02-10 2014-11-11 Ferring B.V. Compounds
GB2438834A (en) 2006-06-08 2007-12-12 Optinose As Intranasal protein administration
US7960336B2 (en) * 2007-08-03 2011-06-14 Pharmain Corporation Composition for long-acting peptide analogs
AU2015201581B2 (en) * 2008-09-17 2017-03-09 Amryt Endo, Inc. Pharmaceutical Compositions and Related Methods of Delivery
JO3371B1 (ar) 2013-07-26 2019-03-13 Ferring Bv ناهضات مستقبل فاسوبريسين 2
AU2016240068B9 (en) 2015-03-30 2020-07-30 Sunnybrook Research Institute Method for treating cancer
JP2017014206A (ja) 2015-06-30 2017-01-19 ナノアンティバイオティクス,インコーポレイテッド 腹水の治療

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040102362A1 (en) * 2000-09-15 2004-05-27 Didier Lebrec Protocol for paracentesis
JP2012502973A (ja) * 2008-09-17 2012-02-02 キアズマ インコーポレイテッド 医薬組成物および関連する送達方法
US20110311621A1 (en) * 2010-03-16 2011-12-22 Paul Salama Pharmaceutical compositions and methods of delvery
WO2014165607A2 (en) * 2013-04-02 2014-10-09 Stealth Peptides International, Inc. Aromatic-cationic peptide formulations, compositions and methods of use
WO2016065117A1 (en) * 2014-10-24 2016-04-28 Ikaria Therapeutics Llc Method of treating patients with hepatorenal syndrome type 1

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
AM. J. GASTROENTEROL. (JUL 2016) VOL.111, ISSUE 7, P.1041-1042, JPN6022030412, ISSN: 0005002590 *
J. CLIN. HEPATOL. (2015) VOL.31, NO.8, P.1287-1290, JPN6022030413, ISSN: 0005002591 *

Also Published As

Publication number Publication date
AU2017345720B2 (en) 2023-07-27
IL265761B1 (en) 2024-07-01
JP2023120445A (ja) 2023-08-29
US10993984B2 (en) 2021-05-04
EP4516803A3 (en) 2025-06-25
AU2023255036B2 (en) 2026-06-18
EP3528828B1 (en) 2025-01-29
US20250000933A1 (en) 2025-01-02
JP2025020319A (ja) 2025-02-12
AU2023255036A1 (en) 2023-11-16
AU2017345720A1 (en) 2019-04-11
NZ751717A (en) 2025-05-02
IL265761A (en) 2019-06-30
US20190240284A1 (en) 2019-08-08
ES3023754T3 (en) 2025-06-03
IL313083A (en) 2024-07-01
EP4516803A2 (en) 2025-03-05
IL265761B2 (en) 2024-11-01
MA46586A (fr) 2019-08-28
WO2018075897A1 (en) 2018-04-26
CA3037581A1 (en) 2018-04-26
EP3528828A1 (en) 2019-08-28
US20220313773A1 (en) 2022-10-06
ZA201901912B (en) 2023-10-25
EP3528828A4 (en) 2020-07-01

Similar Documents

Publication Publication Date Title
JP2025020319A (ja) テルリプレシン組成物およびその使用方法
JP4659358B2 (ja) 経口インスリン療法
JP7443443B2 (ja) 関節を治療するための組成物及びキット
AU2016326749B2 (en) Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
CN110709061A (zh) 抗沉淀的小分子药物制剂
KR20190086446A (ko) 치료제의 장 전달을 위한 제제
JP2023533129A (ja) 非プロトン性極性溶媒中の安定な持続放出治療組成物およびその製造方法
KR20250111106A (ko) 비양성자성 극성 용매에서 안정한 레보티록신 조성물
US12005049B2 (en) Methods of preventing cancer metastasis
JP2010528112A (ja) 糖尿病を治療する方法
US20240148678A1 (en) Sustained release injectable therapeutic formulations using aprotic polar solvents
HK40120596A (en) Terlipressin compositions and their methods of use
HK40014065A (en) Terlipressin composition for use in treating ascites
HK40014065B (en) Terlipressin composition for use in treating ascites
HK40123830A (en) Sustained release injectable formulations using aprotic polar solvents
HK40081665A (en) Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
WO2023245470A1 (zh) Mdp类似物在制备用于治疗炎症性肠病的药物中的用途

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20201019

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20201019

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20210917

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20211117

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220316

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20220722

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20221011

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230123

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20230301

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230630

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20230710

A761 Written withdrawal of application

Free format text: JAPANESE INTERMEDIATE CODE: A761

Effective date: 20230712