SG11202108735QA - Long-acting growth hormone dosage forms with superior efficacy to daily somatropin - Google Patents

Long-acting growth hormone dosage forms with superior efficacy to daily somatropin

Info

Publication number
SG11202108735QA
SG11202108735QA SG11202108735QA SG11202108735QA SG11202108735QA SG 11202108735Q A SG11202108735Q A SG 11202108735QA SG 11202108735Q A SG11202108735Q A SG 11202108735QA SG 11202108735Q A SG11202108735Q A SG 11202108735QA SG 11202108735Q A SG11202108735Q A SG 11202108735QA
Authority
SG
Singapore
Prior art keywords
somatropin
daily
long
dosage forms
growth hormone
Prior art date
Application number
SG11202108735QA
Other languages
English (en)
Inventor
Kennett Sprogøe
Original Assignee
Ascendis Pharma Endocrinology Div A/S
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 Ascendis Pharma Endocrinology Div A/S filed Critical Ascendis Pharma Endocrinology Div A/S
Publication of SG11202108735QA publication Critical patent/SG11202108735QA/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
SG11202108735QA 2019-03-04 2020-03-03 Long-acting growth hormone dosage forms with superior efficacy to daily somatropin SG11202108735QA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP19160459 2019-03-04
PCT/EP2020/055513 WO2020178273A1 (fr) 2019-03-04 2020-03-03 Formes posologiques d'hormone de croissance à action prolongée ayant une efficacité supérieure à une dose de somatropine quotidienne

Publications (1)

Publication Number Publication Date
SG11202108735QA true SG11202108735QA (en) 2021-09-29

Family

ID=65685219

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11202108735QA SG11202108735QA (en) 2019-03-04 2020-03-03 Long-acting growth hormone dosage forms with superior efficacy to daily somatropin

Country Status (10)

Country Link
US (1) US20220088147A1 (fr)
EP (1) EP3934625A1 (fr)
JP (1) JP2022522833A (fr)
CN (1) CN113573698A (fr)
AU (1) AU2020233198A1 (fr)
CA (1) CA3131817A1 (fr)
IL (1) IL285903A (fr)
MX (1) MX2021010286A (fr)
SG (1) SG11202108735QA (fr)
WO (1) WO2020178273A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102608645B1 (ko) * 2014-11-18 2023-12-01 아센디스 파마 엔도크리놀로지 디비전 에이/에스 신규한 중합체성 hGH 프로드러그
CN114920819A (zh) * 2022-06-16 2022-08-19 修正生物医药(杭州)研究院有限公司 重组人生长激素突变体、其聚乙二醇衍生物、聚乙二醇衍生物的制备方法及其药物用途

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW200526254A (en) 2003-09-19 2005-08-16 Novo Nordisk As Novel GLP-1 derivatives
US8377917B2 (en) 2004-03-23 2013-02-19 Complex Biosystems Gmbh Polymeric prodrug with a self-immolative linker
US8450269B2 (en) 2006-02-03 2013-05-28 Prolor Biotech Ltd. Long-acting growth hormone and methods of producing same
EA021222B8 (ru) 2007-06-21 2015-11-30 ИксЭль-ПРОТЕИН ГМБХ Биологически активные белки, имеющие повышенную стабильность in vivo и/или in vitro
PT3050576T (pt) 2008-04-29 2021-06-01 Ascendis Pharma Growth Disorders Div A/S Compostos recombinantes e peguilados da hormona de crescimento humana
WO2011123813A2 (fr) 2010-04-02 2011-10-06 Amunix Operating Inc. Protéines de fusion liantes, conjugués protéines de fusion liantes-médicaments, conjugués xten-médicaments et procédés pour les préparer et les utiliser
EP2571510B1 (fr) 2010-05-21 2018-08-08 XL-protein GmbH Polypeptides de bobine aléatoires en proline/alanine biosynthétique
EP2908845A1 (fr) 2012-10-17 2015-08-26 Novo Nordisk Health Care AG Acides aminés acylés par un acide gras pour l'administration d'hormone de croissance
KR102608645B1 (ko) * 2014-11-18 2023-12-01 아센디스 파마 엔도크리놀로지 디비전 에이/에스 신규한 중합체성 hGH 프로드러그
WO2016079302A1 (fr) * 2014-11-21 2016-05-26 Ascendis Pharma Growth Disorders Division A/S Formes galéniques d'hormone de croissance à action prolongée
WO2016109823A1 (fr) * 2015-01-02 2016-07-07 Amunix Operation Inc. Traitement d'un déficit en hormone de croissance pédiatrique avec analogues de l'hormone de croissance humaine

Also Published As

Publication number Publication date
MX2021010286A (es) 2021-09-23
JP2022522833A (ja) 2022-04-20
CA3131817A1 (fr) 2020-09-10
IL285903A (en) 2021-10-31
EP3934625A1 (fr) 2022-01-12
CN113573698A (zh) 2021-10-29
US20220088147A1 (en) 2022-03-24
AU2020233198A1 (en) 2021-09-02
WO2020178273A1 (fr) 2020-09-10

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