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

Terlipressin compositions and their methods of use Download PDF

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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
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AU
Australia
Prior art keywords
terlipressin
subject
administered
capsule
daily
Prior art date
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Application number
AU2017345720A
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English (en)
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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
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Amryt Endo Inc
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Publication of AU2017345720A1 publication Critical patent/AU2017345720A1/en
Application granted granted Critical
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Priority to AU2023255036A priority Critical patent/AU2023255036B2/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

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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
    • A61K38/04—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)
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 AU2023255036B2 (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 AU2023255036B2 (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

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Family Applications (2)

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AU2017345720A Active AU2017345720B2 (en) 2016-10-21 2017-10-20 Terlipressin compositions and their methods of use
AU2023255036A Active AU2023255036B2 (en) 2016-10-21 2023-10-27 Terlipressin compositions and their methods of use

Family Applications After (1)

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AU2023255036A Active AU2023255036B2 (en) 2016-10-21 2023-10-27 Terlipressin compositions and their methods of use

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 (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
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
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
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 (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
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
JP2020500164A (ja) 2020-01-09
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

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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.