AU2017345720B2 - Terlipressin compositions and their methods of use - Google Patents

Terlipressin compositions and their methods of use Download PDF

Info

Publication number
AU2017345720B2
AU2017345720B2 AU2017345720A AU2017345720A AU2017345720B2 AU 2017345720 B2 AU2017345720 B2 AU 2017345720B2 AU 2017345720 A AU2017345720 A AU 2017345720A AU 2017345720 A AU2017345720 A AU 2017345720A AU 2017345720 B2 AU2017345720 B2 AU 2017345720B2
Authority
AU
Australia
Prior art keywords
terlipressin
subject
administered
capsule
daily
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
AU2017345720A
Other languages
English (en)
Other versions
AU2017345720A1 (en
Inventor
Gary Patou
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amryt Endo Inc
Original Assignee
Amryt Endo Inc
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 Amryt Endo Inc filed Critical Amryt Endo Inc
Publication of AU2017345720A1 publication Critical patent/AU2017345720A1/en
Application granted granted Critical
Publication of AU2017345720B2 publication Critical patent/AU2017345720B2/en
Priority to AU2023255036A priority Critical patent/AU2023255036A1/en
Assigned to AMRYT ENDO, INC. reassignment AMRYT ENDO, INC. Request to Amend Deed and Register Assignors: CHIASMA, INC.
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
    • A61K38/04—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)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (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)
AU2017345720A 2016-10-21 2017-10-20 Terlipressin compositions and their methods of use Active AU2017345720B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2023255036A AU2023255036A1 (en) 2016-10-21 2023-10-27 Terlipressin compositions and their methods of use

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
AU2023255036A Division AU2023255036A1 (en) 2016-10-21 2023-10-27 Terlipressin compositions and their methods of use

Publications (2)

Publication Number Publication Date
AU2017345720A1 AU2017345720A1 (en) 2019-04-11
AU2017345720B2 true AU2017345720B2 (en) 2023-07-27

Family

ID=62019439

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2017345720A Active AU2017345720B2 (en) 2016-10-21 2017-10-20 Terlipressin compositions and their methods of use
AU2023255036A Pending AU2023255036A1 (en) 2016-10-21 2023-10-27 Terlipressin compositions and their methods of use

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2023255036A Pending AU2023255036A1 (en) 2016-10-21 2023-10-27 Terlipressin compositions and their methods of use

Country Status (10)

Country Link
US (3) US10993984B2 (enExample)
EP (2) EP3528828B1 (enExample)
JP (3) JP2020500164A (enExample)
AU (2) AU2017345720B2 (enExample)
CA (1) CA3037581A1 (enExample)
ES (1) ES3023754T3 (enExample)
IL (2) IL313083A (enExample)
MA (1) MA46586A (enExample)
WO (1) WO2018075897A1 (enExample)
ZA (1) ZA201901912B (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100105627A1 (en) 2008-09-17 2010-04-29 Paul Salama Pharmaceutical compositions and related methods of delivery
LT3253401T (lt) 2015-02-03 2025-07-10 Amryt Endo, Inc. Akromegalijos gydymas geriamuoju oktreotidu
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
WO2021127234A2 (en) * 2019-12-20 2021-06-24 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
US20240156895A1 (en) * 2022-10-28 2024-05-16 Mallinckrodt Pharmaceuticals Ireland Limited Compositions for improving kidney function in patients with hepatorenal syndrome

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1188443A1 (en) * 2000-09-15 2002-03-20 Ferring BV Improved protocol for paracentesis
GB2478849A (en) * 2010-03-16 2011-09-21 Chiasma Inc Improved pharmecutical compositions and methods of delivery
US20160158159A1 (en) * 2008-09-17 2016-06-09 Chiasma Inc. Pharmaceutical compositions and related methods of delivery

Family Cites Families (11)

* 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
KR101194586B1 (ko) 2006-02-10 2012-10-25 훼링 비.브이. 신규 화합물
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
WO2014165607A2 (en) * 2013-04-02 2014-10-09 Stealth Peptides International, Inc. Aromatic-cationic peptide formulations, compositions and methods of use
JO3371B1 (ar) 2013-07-26 2019-03-13 Ferring Bv ناهضات مستقبل فاسوبريسين 2
AU2015335855A1 (en) * 2014-10-24 2017-05-18 Mallinckrodt Hospital Products IP Limited Method of treating patients with hepatorenal syndrome type 1
KR102345773B1 (ko) 2015-03-30 2021-12-31 서니브룩 리서치 인스티튜트 암 치료 방법
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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1188443A1 (en) * 2000-09-15 2002-03-20 Ferring BV Improved protocol for paracentesis
US20160158159A1 (en) * 2008-09-17 2016-06-09 Chiasma Inc. Pharmaceutical compositions and related methods of delivery
GB2478849A (en) * 2010-03-16 2011-09-21 Chiasma Inc Improved pharmecutical compositions and methods of delivery

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
Biecker, E., ' Portal hypertension and gastrointestinal bleeding; Diagnosis, prevention and management', World Journal of Gastroenterology, (2013-08-21), vol. 19, no. 31, pages 5035-5050, doi:10.3748/wjg.v19.i31.5035. *
Biecker, E., 'Diagnosis and therapy of ascites in liver cirrhosis', World Journal of Gastroenterology, (2011-01-01). vol. 17, no. 10, page 1237, doi:10.3748/wjg.v17.i10.1237 *
Fimiani, B. et al., (2011-08-02), vol. 22, pages 587-590, doi:10.1016/j.ejim.2011.06.013. *
Rittig, S. et al., ' The hemodynamic effects of triglycyl-lysine-vasopressin (glypressin) in patients with parkinsonism and orthostatic hypotension', Movement Disorders, (1991), no. 6, vol. 1, pages 21-28. *

Also Published As

Publication number Publication date
IL265761B1 (en) 2024-07-01
NZ751717A (en) 2025-05-02
AU2017345720A1 (en) 2019-04-11
ZA201901912B (en) 2023-10-25
JP2020500164A (ja) 2020-01-09
EP3528828B1 (en) 2025-01-29
IL265761A (en) 2019-06-30
JP2025020319A (ja) 2025-02-12
US10993984B2 (en) 2021-05-04
EP4516803A2 (en) 2025-03-05
AU2023255036A1 (en) 2023-11-16
ES3023754T3 (en) 2025-06-03
CA3037581A1 (en) 2018-04-26
EP3528828A1 (en) 2019-08-28
JP2023120445A (ja) 2023-08-29
IL265761B2 (en) 2024-11-01
EP3528828A4 (en) 2020-07-01
WO2018075897A1 (en) 2018-04-26
MA46586A (fr) 2019-08-28
EP4516803A3 (en) 2025-06-25
IL313083A (en) 2024-07-01
US20220313773A1 (en) 2022-10-06
US20190240284A1 (en) 2019-08-08
US20250000933A1 (en) 2025-01-02

Similar Documents

Publication Publication Date Title
US20250000933A1 (en) Terlipressin compositions and their methods of use
JP4659358B2 (ja) 経口インスリン療法
AU2016326749B2 (en) Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
WO2008098212A2 (en) Extended release formulations of glucagon and other peptides and proteins
RS66595B1 (sr) Puferisane formulacije eksendina (9-39)
TW201039840A (en) Composition for the treatment of prostate cancer
KR20160118292A (ko) 안정한 펩티드 제형물 및 제조 방법
CN116173188B (zh) 口服glp-1类似物固体脂质纳米粒及其制备方法和应用
US20170281607A1 (en) Pharmaceutical compositions and methods for the treatment of diabetes
KR20230026984A (ko) 비양성자성의 극성 용매 중의 안정한 지속 방출성 치료 조성물 및 그의 제조 방법
US12005049B2 (en) Methods of preventing cancer metastasis
KR20120138229A (ko) 정맥내 투여용 이부프로펜을 이용한 중증 환자의 치료
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
US12343383B2 (en) High concentration insulin formulation
CN118742305A (zh) 用于治疗疾病的口服奥曲肽
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
CN117298247A (zh) Mdp类似物在制备用于治疗炎症性肠病的药物中的用途
HK40101667B (en) Methods for producing stable therapeutic formulations in aprotic polar solvents
KR20230035600A (ko) Ghrh 유사체의 저-용량 약제학적 조성물 및 이들의 용도
CN114401724A (zh) 一种降糖药物组合物
JP2002193830A (ja) 経鼻投与用医薬製剤

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
HB Alteration of name in register

Owner name: AMRYT ENDO, INC.

Free format text: FORMER NAME(S): CHIASMA, INC.