JP2024521127A - テストステロン補充治療を実現するための好ましい経口ウンデカン酸テストステロン療法 - Google Patents

テストステロン補充治療を実現するための好ましい経口ウンデカン酸テストステロン療法 Download PDF

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Publication number
JP2024521127A
JP2024521127A JP2023572110A JP2023572110A JP2024521127A JP 2024521127 A JP2024521127 A JP 2024521127A JP 2023572110 A JP2023572110 A JP 2023572110A JP 2023572110 A JP2023572110 A JP 2023572110A JP 2024521127 A JP2024521127 A JP 2024521127A
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testosterone
subject
serum level
dose
steady
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JP2023572110A
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Japanese (ja)
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JPWO2022245933A5 (https=
JP2024521127A5 (https=
Inventor
ディングラ，オム
エス． バーンスタイン，ジェームズ
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マリウス ファーマシューティカルズ エルエルシー
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Publication of JPWO2022245933A5 publication Critical patent/JPWO2022245933A5/ja
Publication of JP2024521127A5 publication Critical patent/JP2024521127A5/ja
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    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens
    • 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
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
JP2023572110A 2021-05-19 2022-05-18 テストステロン補充治療を実現するための好ましい経口ウンデカン酸テストステロン療法 Pending JP2024521127A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163190609P 2021-05-19 2021-05-19
US63/190,609 2021-05-19
PCT/US2022/029819 WO2022245933A1 (en) 2021-05-19 2022-05-18 Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment

Publications (3)

Publication Number Publication Date
JP2024521127A true JP2024521127A (ja) 2024-05-28
JPWO2022245933A5 JPWO2022245933A5 (https=) 2025-05-27
JP2024521127A5 JP2024521127A5 (https=) 2025-05-27

Family

ID=84140782

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023572110A Pending JP2024521127A (ja) 2021-05-19 2022-05-18 テストステロン補充治療を実現するための好ましい経口ウンデカン酸テストステロン療法

Country Status (10)

Country Link
US (1) US20230398128A1 (https=)
EP (1) EP4340846A4 (https=)
JP (1) JP2024521127A (https=)
KR (1) KR20240027602A (https=)
AU (2) AU2022277557B2 (https=)
BR (1) BR112023024162A2 (https=)
CA (1) CA3219547A1 (https=)
IL (1) IL308658A (https=)
MX (1) MX2023013734A (https=)
WO (1) WO2022245933A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2519230T3 (pl) 2009-12-31 2019-05-31 Marius Pharmaceuticals Llc Modulacja rozpuszczalności, stabilności, absorpcji, metabolizmu i profilu farmakokinetycznego leków lipofilowych przez sterole
EP2968137B1 (en) 2013-03-15 2021-11-10 Marius Pharmaceuticals LLC Emulsion formulations
US12403146B2 (en) 2019-10-30 2025-09-02 Marius Pharmaceuticals, Inc. Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2519230T3 (pl) * 2009-12-31 2019-05-31 Marius Pharmaceuticals Llc Modulacja rozpuszczalności, stabilności, absorpcji, metabolizmu i profilu farmakokinetycznego leków lipofilowych przez sterole
US20200197412A1 (en) * 2018-12-20 2020-06-25 Clarus Therapeutics, Inc. Methods of treating testosterone deficiency
US11564933B2 (en) * 2019-04-12 2023-01-31 Tolmar, Inc. Methods of treating testosterone deficiency

Also Published As

Publication number Publication date
AU2022277557A1 (en) 2023-06-08
AU2024227786A1 (en) 2024-11-21
CA3219547A1 (en) 2022-11-24
WO2022245933A1 (en) 2022-11-24
IL308658A (en) 2024-01-01
KR20240027602A (ko) 2024-03-04
EP4340846A1 (en) 2024-03-27
WO2022245933A8 (en) 2023-01-26
MX2023013734A (es) 2024-02-07
US20230398128A1 (en) 2023-12-14
BR112023024162A2 (pt) 2024-02-06
EP4340846A4 (en) 2025-04-02
AU2022277557B2 (en) 2024-08-01

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