SG11201901576QA - Dosage regimen for a controlled-release pth compound - Google Patents

Dosage regimen for a controlled-release pth compound

Info

Publication number
SG11201901576QA
SG11201901576QA SG11201901576QA SG11201901576QA SG11201901576QA SG 11201901576Q A SG11201901576Q A SG 11201901576QA SG 11201901576Q A SG11201901576Q A SG 11201901576QA SG 11201901576Q A SG11201901576Q A SG 11201901576QA SG 11201901576Q A SG11201901576Q A SG 11201901576QA
Authority
SG
Singapore
Prior art keywords
controlled
international
pth
pth compound
pct
Prior art date
Application number
SG11201901576QA
Inventor
Lars Holten-Andersen
Kennett Sprogøe
David Brian Karpf
Original Assignee
Ascendis Pharma Bone Diseases As
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 Bone Diseases As filed Critical Ascendis Pharma Bone Diseases As
Publication of SG11201901576QA publication Critical patent/SG11201901576QA/en

Links

Classifications

    • 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
    • A61K38/29Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/54Medicinal 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 compound
    • 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
    • A61K47/54Medicinal 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 compound
    • A61K47/545Heterocyclic compounds
    • 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
    • A61K47/58Medicinal 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 by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
    • 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
    • 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
    • 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
    • A61K47/61Medicinal 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 the organic macromolecular compound being a polysaccharide or a derivative 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
    • A61K47/50Medicinal 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
    • A61K47/62Medicinal 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 a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/645Polycationic or polyanionic oligopeptides, polypeptides or polyamino acids, e.g. polylysine, polyarginine, polyglutamic acid or peptide TAT
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/14Drugs for dermatological disorders for baldness or alopecia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

1 1-1 O O O GC O 1-1 C (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 05 April 2018 (05.04.2018) WIP0 I PCT °Ens °nolo omoiloonom m1111E11 oimIE (10) International Publication Number WO 2018/060310 Al (51) International Patent Classification: TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, A61K 38/29 (2006.01) A61K 47/34 (2017.01) KM, ML, MR, NE, SN, TD, TG). A61K 9/00 (2006.01) A61K 9/16 (2006.01) (21) International Application Number: PCT/EP2017/074592 Published: — with international search report (Art. 21(3)) — with sequence listing part of description (Rule 5.2(a)) (22) International Filing Date: 28 September 2017 (28.09.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 16191451.0 29 September 2016 (29.09.2016) EP 17155843.0 13 February 2017 (13.02.2017) EP (71) Applicant: ASCENDIS PHARMA BONE DISEASES A/ S [DK/DK]; Tuborg Boulevard 5, 2900 Hellerup (DK). (72) Inventors: HOLTEN-ANDERSEN, Lars; Rodtjornevej 8, st., 2720 Vanlose (DK). SPROGOE, Kennett; Vengestien 7, 2840 Holte (DK). KARPF, David Brian; 203 Sherland Ave., Mountain View, California 94043 (US). (74) Agent: BUCHEL, Edwin; Isenbruck Bosl Horschler LLP Patentanwalte, EASTSITE ONE, Seckenheimer LandstraBe 4, 68163 Mannheim (DE). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (54) Title: DOSAGE REGIMEN FOR A CONTROLLED-RELEASE PTH COMPOUND (57) : The present invention relates to a pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, wherein said pharmaceutical composition is administered no more frequent than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered every 24 hours required to maintain serum calcium within normal levels over said 24 hour period in humans.
SG11201901576QA 2016-09-29 2017-09-28 Dosage regimen for a controlled-release pth compound SG11201901576QA (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16191451 2016-09-29
EP17155843 2017-02-13
PCT/EP2017/074592 WO2018060310A1 (en) 2016-09-29 2017-09-28 Dosage regimen for a controlled-release pth compound

Publications (1)

Publication Number Publication Date
SG11201901576QA true SG11201901576QA (en) 2019-03-28

Family

ID=60051488

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201901576QA SG11201901576QA (en) 2016-09-29 2017-09-28 Dosage regimen for a controlled-release pth compound

Country Status (22)

Country Link
US (5) US11590207B2 (en)
EP (2) EP4275677A3 (en)
JP (3) JP7197468B2 (en)
KR (2) KR102627405B1 (en)
CN (2) CN117838873A (en)
BR (1) BR112019005533A2 (en)
CA (1) CA3037442A1 (en)
DK (1) DK3518960T3 (en)
ES (1) ES2959995T3 (en)
FI (1) FI3518960T3 (en)
HR (1) HRP20231079T1 (en)
HU (1) HUE063235T2 (en)
IL (2) IL304086A (en)
LT (1) LT3518960T (en)
MX (1) MX2019003181A (en)
NZ (1) NZ751969A (en)
PL (1) PL3518960T3 (en)
RS (1) RS64440B1 (en)
SG (1) SG11201901576QA (en)
SI (1) SI3518960T1 (en)
WO (1) WO2018060310A1 (en)
ZA (1) ZA201901811B (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2859412C (en) * 2011-12-14 2021-05-25 The Board Of Trustees Of The University Of Arkansas Delivery of therapeutic agents using bacterial collagen-binding polypeptide segments
MX2018009938A (en) * 2016-03-01 2019-03-14 Ascendis Pharma Bone Diseases As Pth prodrugs.
BR112019005793A2 (en) 2016-09-29 2019-06-18 Ascendis Pharma Bone Diseases As pth compounds with low peak-to-valley ratios
SI3518960T1 (en) * 2016-09-29 2023-11-30 Ascendis Pharma Bone Diseases A/S, Dosage regimen for a controlled-release pth compound
JP7397440B2 (en) 2017-02-10 2023-12-13 ザ ボード オブ トラスティーズ オブ ザ ユニバーシティ オブ アーカンソー Collagen-binding drug composition and method of use thereof
WO2019219896A1 (en) * 2018-05-18 2019-11-21 Ascendis Pharma Bone Diseases A/S Starting dose of pth conjugates
BR112021014581A2 (en) 2019-02-11 2021-12-14 Ascendis Pharma Bone Diseases As Liquid pharmaceutical formulations of pth conjugates
CN117586372A (en) * 2022-08-10 2024-02-23 成都奥达生物科技有限公司 Long-acting teriparatide compound

Family Cites Families (98)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5744444A (en) 1989-10-27 1998-04-28 Haemopep Pharma Gmbh HPTH-fragment-(1-37), the preparation thereof, medicaments containing same and the use thereof
US5567439A (en) * 1994-06-14 1996-10-22 Fuisz Technologies Ltd. Delivery of controlled-release systems(s)
MY120063A (en) 1997-12-09 2005-08-30 Lilly Co Eli Stabilized teriparatide solutions
US6624142B2 (en) 1997-12-30 2003-09-23 Enzon, Inc. Trimethyl lock based tetrapartate prodrugs
US20050124537A1 (en) * 2000-04-27 2005-06-09 Amgen Inc. Modulators of receptors for parathyroid hormone and parathyroid hormone-related protein
US20050148763A1 (en) * 2002-02-01 2005-07-07 Chugai Seiyaku Kabushiki Kaisha Peg-binding pth or peg-binding pth derivative
US6559293B1 (en) * 2002-02-15 2003-05-06 Transform Pharmaceuticals, Inc. Topiramate sodium trihydrate
US7122189B2 (en) 2002-08-13 2006-10-17 Enzon, Inc. Releasable polymeric conjugates based on aliphatic biodegradable linkers
US7332164B2 (en) 2003-03-21 2008-02-19 Enzon Pharmaceuticals, Inc. Heterobifunctional polymeric bioconjugates
WO2004089280A2 (en) 2003-04-08 2004-10-21 Yeda Research And Development Co. Ltd. Reversible pegylated drugs
US7690003B2 (en) 2003-08-29 2010-03-30 Fuller Jeffrey C System and method for increasing data throughput using thread scheduling
US20070203058A1 (en) 2003-09-19 2007-08-30 Novo Nordisk A/S Novel Glp-1 Derivatives
AU2005232371B2 (en) 2004-03-23 2010-10-14 Complex Biosystems Gmbh Polymeric prodrug with a self-immolative linker
JP2007537274A (en) 2004-05-10 2007-12-20 ナステック ファーマスーティカル カンパニー インク. Compositions and methods for enhancing mucosal delivery of parathyroid hormone
US7968085B2 (en) 2004-07-05 2011-06-28 Ascendis Pharma A/S Hydrogel formulations
CN1597697A (en) 2004-07-19 2005-03-23 中国药科大学 Human parathyrin 1.34 peptide related peptide-Pro-Pro-[Arg11 hPTH (1.34)-Pro-Pro
US20060069021A1 (en) 2004-08-13 2006-03-30 Nastech Pharmaceutical Company Inc. Compositions and methods for intranasal administration of inactive analogs of PTH or inactivated preparations of PTH or PTH analogs
JP2008511611A (en) * 2004-08-30 2008-04-17 ルナメツド・インコーポレーテツド Therapeutic 4-phenylbutyric acid controlled release formulation
EP1736059A1 (en) 2005-06-21 2006-12-27 Fuji Oil Europe Structuring granular composition
GB2427360A (en) 2005-06-22 2006-12-27 Complex Biosystems Gmbh Aliphatic prodrug linker
CN1298386C (en) 2005-08-31 2007-02-07 上海交通大学 Prepn process of slow release parathyroid hormone microballoon
US8450269B2 (en) 2006-02-03 2013-05-28 Prolor Biotech Ltd. Long-acting growth hormone and methods of producing same
WO2007106597A2 (en) 2006-03-15 2007-09-20 Alza Corporation Method for the transdermal delivery of parathyroid hormone agents for treating osteopenia
MX2009002859A (en) 2006-09-15 2009-03-30 Enzon Pharmaceuticals Inc Hindered ester-based biodegradable linkers for oligonucleotide delivery.
DK2084183T3 (en) * 2006-10-13 2010-08-16 Lilly Co Eli Pegylated PTH as PTH receptor modulators and applications thereof
US8101729B2 (en) * 2007-03-19 2012-01-24 Henry Joseph Niemczyk Pegylated amino acid derivatives and the process to synthesize the same
EP2155874B1 (en) 2007-04-09 2016-05-11 The Board Of Trustees Of The University Of Arkansas Fusion proteins of collagen-binding domain and parathyroid hormone
DE602008005596D1 (en) 2007-06-21 2011-04-28 Univ Muenchen Tech BIOLOGICALLY ACTIVE PROTEINS WITH INCREASED IN VIVO AND / OR IN VITRO STABILITY
US20090016985A1 (en) 2007-07-11 2009-01-15 Enzon Pharmaceuticals, Inc. Polymeric drug delivery system containing a multi-substituted aromatic moiety
US7633977B2 (en) 2007-08-08 2009-12-15 Wisconsin Alumni Research Foundation Multispectral laser with improved time division multiplexing
EP2052736A1 (en) 2007-10-26 2009-04-29 Nycomed Danmark ApS Parathyroid hormone formulations und uses thereof
PT2237799T (en) 2008-02-01 2019-07-05 Ascendis Pharma As Prodrug comprising a self-cleavable linker
SI3050576T1 (en) 2008-04-29 2021-08-31 Ascendis Pharma Endocrinology Division A/S Pegylated recombinant human growth hormone compounds
US20110105413A1 (en) 2008-05-23 2011-05-05 Enzon Pharmaceuticals, Inc. Polymeric systems containing intracellular releasable disulfide linker for the delivery of oligonucleotides
WO2009156481A1 (en) 2008-06-25 2009-12-30 Ascendis Pharma As Pegylated bnp
WO2010022171A1 (en) 2008-08-19 2010-02-25 Ferring International Center S.A. Peptidic pth receptor agonists
WO2010091122A1 (en) 2009-02-03 2010-08-12 Amunix, Inc. Extended recombinant polypeptides and compositions comprising same
US9541331B2 (en) 2009-07-16 2017-01-10 Lockheed Martin Corporation Helical tube bundle arrangements for heat exchangers
SG178195A1 (en) * 2009-07-31 2012-03-29 Sanofi Aventis Deutschland Long acting insulin composition
WO2011012718A1 (en) 2009-07-31 2011-02-03 Ascendis Pharma As Prodrugs comprising an insulin linker conjugate
US20120191039A1 (en) * 2009-07-31 2012-07-26 Ascendis Pharma A/S Carrier linked pramipexole prodrugs
WO2011012723A1 (en) * 2009-07-31 2011-02-03 Ascendis Pharma As Injectable sustained release compositions comprising a pramipexole prodrug
LT2459220T (en) 2009-07-31 2020-12-28 Ascendis Pharma A/S Biodegradable polyethylene glycol based water-insoluble hydrogels
EP2459227B1 (en) 2009-07-31 2021-03-17 Ascendis Pharma A/S Prodrugs containing an aromatic amine connected by an amide bond to a carrier
TW201121601A (en) 2009-09-30 2011-07-01 Sanofi Aventis Deutschland Drive assembly, piston rod, drug delivery device, and use of a spring
WO2011039215A1 (en) 2009-09-30 2011-04-07 Sanofi-Aventis Deutschland Gmbh A mechanism for a drug delivery device
EP2485767A1 (en) * 2009-10-06 2012-08-15 Ascendis Pharma A/S Carrier linked paliperidone prodrugs
HUE038405T2 (en) 2009-12-15 2018-10-29 Ascendis Pharma Endocrinology Div A/S Dry growth hormone composition transiently linked to a polymer carrier
EP2519228A4 (en) 2009-12-31 2013-06-19 Enzon Pharmaceuticals Inc Polymeric conjugates of aromatic amine containing compounds including releasable urea linker
EP2525830B1 (en) * 2010-01-22 2016-05-11 Ascendis Pharma A/S Dipeptide-based prodrug linkers for aliphatic amine-containing drugs
WO2011089215A1 (en) 2010-01-22 2011-07-28 Ascendis Pharma As Dipeptide-based prodrug linkers for aromatic amine-containing drugs
EP2525831B1 (en) * 2010-01-22 2019-05-15 Ascendis Pharma A/S Carrier-linked carbamate prodrug linkers
US20110229580A1 (en) * 2010-03-22 2011-09-22 Indian Institute of Technology Bombay, School of Biosciences and Bioengineering Compositions and methods for nano-in-micro particles
EP2552967A4 (en) 2010-04-02 2014-10-08 Amunix Operating Inc Binding fusion proteins, binding fusion protein-drug conjugates, xten-drug conjugates and methods of making and using same
JP5977229B2 (en) 2010-05-05 2016-08-24 プロリンクス リミテッド ライアビリティ カンパニー Sustained release from macromolecular conjugates
DK2566334T3 (en) 2010-05-05 2018-07-23 Prolynx Llc MANAGED PHARMACEUTICAL RELEASE FROM SOLID CARRIERS
WO2011143406A2 (en) * 2010-05-13 2011-11-17 The General Hospital Corporation Parathyroid hormone analogs and uses thereof
EP3473261A1 (en) 2010-05-21 2019-04-24 XL-protein GmbH Biosynthetic proline/alanine random coil polypeptides and their uses
US8865220B2 (en) 2010-06-14 2014-10-21 Kaohsiung Medical University Method for controlled release of parathyroid hormone from encapsulated poly(lactic-glycolic)acid microspheres
US8989456B2 (en) 2010-06-30 2015-03-24 Nec Solution Innovators, Ltd. Attribute determining method, attribute determining apparatus, program, recording medium, and attribute determining system
US20120040320A1 (en) * 2010-08-13 2012-02-16 Nadeau Daniel A Injection Simulation Device and Methods Thereof
EP2438930A1 (en) 2010-09-17 2012-04-11 Sanofi-Aventis Deutschland GmbH Prodrugs comprising an exendin linker conjugate
BR112014003240A2 (en) * 2011-08-12 2017-03-01 Ascendis Pharma As sustained release prostacyclin composition
AU2012296950B2 (en) 2011-08-12 2016-09-22 Ascendis Pharma A/S Polymeric hyperbranched carrier-linked prodrugs
US9561287B2 (en) 2011-08-12 2017-02-07 Ascendis Pharma A/S Carrier-linked treprostinil prodrugs
US20140323402A1 (en) * 2011-08-12 2014-10-30 Ascendis Phama A/S Protein Carrier-Linked Prodrugs
EP3643306A3 (en) 2011-08-12 2020-08-26 Ascendis Pharma A/S Carrier-linked prodrugs having reversible carboxylic ester linkages
WO2013036857A1 (en) 2011-09-07 2013-03-14 Prolynx Llc Sulfone linkers
CA2849192C (en) * 2011-10-12 2019-09-24 Ascendis Pharma Ophthalmology Division A/S Prevention and treatment of ocular conditions
DE102011116960B3 (en) 2011-10-26 2012-10-25 Stahlbrandschutz Gmbh Intumescent paints
DE102011117182A1 (en) 2011-10-28 2013-05-02 Ruhrpumpen Gmbh Partial flow guide, in particular a magnetic coupling pump
US8883862B2 (en) 2012-01-12 2014-11-11 Kaohsiung Medical University Method for controlled release of parathyroid hormone from cross-linked hyaluronic acid hydrogel
CA2868925C (en) 2012-04-25 2020-01-21 Ascendis Pharma A/S Prodrugs of hydroxyl-comprising drugs
US9457096B2 (en) * 2012-07-06 2016-10-04 Consejo Nacional De Investigaciones Cientificas Y Tecnicas (Concet) Protozoan variant-specific surface proteins (VSP) as carriers for oral drug delivery
EP2890708B1 (en) 2012-08-28 2019-08-07 The Governors of the University of Alberta Parathyroid hormone, insulin, and related peptides conjugated to bone targeting moieties and methods of making and using thereof
US9855340B2 (en) * 2012-10-11 2018-01-02 Ascendis Pharma A/S Hydrogel prodrugs
MX363462B (en) 2012-10-11 2019-03-25 Ascendis Pharma As DIAGNOSIS, PREVENTION and TREATMENT OF DISEASES OF THE JOINT.
SG11201501914XA (en) * 2012-10-11 2015-05-28 Ascendis Pharma Ophthalmology Division As Vegf neutralizing prodrugs for the treatment of ocular conditions
EP2908845A1 (en) 2012-10-17 2015-08-26 Novo Nordisk Health Care AG Fatty acid acylated amino acids for growth hormone delivery
WO2014086961A1 (en) * 2012-12-07 2014-06-12 Ascendis Pharma A/S Carrier-linked prostanoid prodrugs
GB201303771D0 (en) * 2013-03-04 2013-04-17 Midatech Ltd Nanoparticles peptide compositions
AU2014257745B2 (en) * 2013-04-22 2018-10-04 Ascendis Pharma A/S Hydrogel-linked prodrugs releasing modified drugs
WO2015031709A1 (en) * 2013-08-30 2015-03-05 Perosphere, Inc. Rapid acting injectable formulations comprising a peptide and a vasodilatory agent
WO2015052155A1 (en) * 2013-10-08 2015-04-16 Ascendis Pharma A/S Protecting group comprising a purification tag
EP2868326A1 (en) * 2013-11-04 2015-05-06 Université Pierre et Marie Curie (Paris 6) Peptide inhibitors of TEAD/YAP-TAZ interaction
US11633487B2 (en) * 2014-08-06 2023-04-25 Ascendis Pharma A/S Prodrugs comprising an aminoalkyl glycine linker
JP6946182B2 (en) 2014-10-22 2021-10-06 エクステンド バイオサイエンシズ インコーポレーテッドExtend Biosciences, Inc Therapeutic Vitamin D Conjugate
SG11201705521YA (en) * 2015-01-09 2017-08-30 Ascendis Pharma Growth Disorders As Cnp prodrugs
AR105319A1 (en) * 2015-06-05 2017-09-27 Sanofi Sa PROPHARMS THAT INCLUDE A DUAL AGONIST GLU-1 / GLUCAGON CONJUGATE HIALURONIC ACID CONNECTOR
MX2018009938A (en) 2016-03-01 2019-03-14 Ascendis Pharma Bone Diseases As Pth prodrugs.
US20190224329A1 (en) 2016-09-29 2019-07-25 Ascendis Pharma Bone Diseases A/S Incremental Dose Finding in Controlled-Release PTH Compounds
SI3518960T1 (en) 2016-09-29 2023-11-30 Ascendis Pharma Bone Diseases A/S, Dosage regimen for a controlled-release pth compound
SG11201901534VA (en) 2016-09-29 2019-03-28 Ascendis Pharma Growth Disorders As Combination therapy with controlled-release cnp agonists
BR112019005793A2 (en) * 2016-09-29 2019-06-18 Ascendis Pharma Bone Diseases As pth compounds with low peak-to-valley ratios
TW201832783A (en) 2016-12-02 2018-09-16 法商賽諾菲公司 Conjugates comprising an glp-1/glucagon dual agonist, a linker and hyaluronic acid
WO2019219896A1 (en) 2018-05-18 2019-11-21 Ascendis Pharma Bone Diseases A/S Starting dose of pth conjugates
BR112021014581A2 (en) 2019-02-11 2021-12-14 Ascendis Pharma Bone Diseases As Liquid pharmaceutical formulations of pth conjugates
MX2022007371A (en) 2020-01-13 2022-07-12 Ascendis Pharma Bone Diseases As Hypoparathyroidism treatment.

Also Published As

Publication number Publication date
KR20190062496A (en) 2019-06-05
ZA201901811B (en) 2019-12-18
DK3518960T3 (en) 2023-09-04
CN109789189A (en) 2019-05-21
KR102627405B1 (en) 2024-01-18
BR112019005533A2 (en) 2019-06-18
PL3518960T3 (en) 2023-12-27
EP4275677A3 (en) 2024-01-10
CA3037442A1 (en) 2018-04-05
EP3518960B1 (en) 2023-07-19
US20200023041A1 (en) 2020-01-23
LT3518960T (en) 2023-09-11
US11590207B2 (en) 2023-02-28
RU2019112913A (en) 2020-10-30
IL265591B1 (en) 2023-08-01
US11890326B2 (en) 2024-02-06
MX2019003181A (en) 2019-08-05
IL304086A (en) 2023-08-01
NZ751969A (en) 2023-04-28
FI3518960T3 (en) 2023-10-04
RU2019112913A3 (en) 2021-01-18
ES2959995T3 (en) 2024-02-29
JP2024041859A (en) 2024-03-27
US20230321198A1 (en) 2023-10-12
RS64440B1 (en) 2023-09-29
EP4275677A2 (en) 2023-11-15
US20230248836A1 (en) 2023-08-10
US11918628B2 (en) 2024-03-05
HRP20231079T1 (en) 2023-12-22
HUE063235T2 (en) 2024-01-28
JP7418527B2 (en) 2024-01-19
SI3518960T1 (en) 2023-11-30
JP2019535648A (en) 2019-12-12
EP3518960A1 (en) 2019-08-07
AU2017336249A1 (en) 2019-03-21
CN117838873A (en) 2024-04-09
IL265591B2 (en) 2023-12-01
IL265591A (en) 2019-05-30
CN109789189B (en) 2024-01-23
JP2023017796A (en) 2023-02-07
WO2018060310A1 (en) 2018-04-05
JP7197468B2 (en) 2022-12-27
US20230381284A1 (en) 2023-11-30
KR20240013849A (en) 2024-01-30
US20240245755A1 (en) 2024-07-25

Similar Documents

Publication Publication Date Title
SG11201901576QA (en) Dosage regimen for a controlled-release pth compound
SG11201909325RA (en) 2-amino-quinoline derivatives
SG11201901558VA (en) Pth compounds with low peak-to-trough ratios
SG11201907451XA (en) Substituted imidazo-quinolines as nlrp3 modulators
SG11201909960UA (en) Methods for improving memory and cognition and for treating memory and cognitive disorders
SG11201907544VA (en) Jak inhibitors containing a 4-membered heterocyclic amide
SG11201806863WA (en) Tetracyclic pyridone compounds as antivirals
SG11201901534VA (en) Combination therapy with controlled-release cnp agonists
SG11201906436VA (en) Novel heterocyclic compound, its preparation method, and pharmaceutical composition comprising the same
SG11201908420WA (en) Compositions of plinabulin and use thereof
SG11201907804QA (en) Pharmaceutical composition comprising selexipag
SG11201908919XA (en) Combination therapies targeting pd-1, tim-3, and lag-3
SG11201907435PA (en) Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases
SG11201805954WA (en) Methods for modulating intestinal microbiota
SG11201809751XA (en) Egfr inhibitor compounds
SG11201808237UA (en) Substituted indole compound derivatives as dengue viral replication inhibitors
SG11201908326YA (en) Methods of treating neurodegenerative diseases
SG11201901850XA (en) Dopamine-b-hydroxylase inhibitors
SG11201908691PA (en) Compounds and methods for the treatment of parasitic diseases
SG11201804587QA (en) Isoindole compounds
SG11201906543RA (en) HDAC INHIBITORS-BASED ANTIBODY DRUG CONJUGATES (ADCs) AND USE IN THERAPY
SG11201806127XA (en) Pharmaceutical or nutritional combination comprising beta-hydroxy-betamethylbutyrate
SG11201907217RA (en) Pharmaceutical combinations for treating cancer
SG11201901249YA (en) Aza-indazole compounds for use in tendon and/or ligament injuries
SG11201901689YA (en) Compounds for treating diseases associated with a mitochondrial dysfonction