AU2022277557B2 - Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment - Google Patents

Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment Download PDF

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Publication number
AU2022277557B2
AU2022277557B2 AU2022277557A AU2022277557A AU2022277557B2 AU 2022277557 B2 AU2022277557 B2 AU 2022277557B2 AU 2022277557 A AU2022277557 A AU 2022277557A AU 2022277557 A AU2022277557 A AU 2022277557A AU 2022277557 B2 AU2022277557 B2 AU 2022277557B2
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AU
Australia
Prior art keywords
testosterone
subject
steady state
serum
serum value
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
AU2022277557A
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English (en)
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AU2022277557A1 (en
Inventor
James S. BERNSTEIN
Om Dhingra
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.)
Marius Pharmaceuticals LLC
Original Assignee
Marius Pharmaceuticals LLC
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Filing date
Publication date
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Publication of AU2022277557A1 publication Critical patent/AU2022277557A1/en
Application granted granted Critical
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Priority to AU2024227786A priority Critical patent/AU2024227786A1/en
Assigned to Marius Pharmaceuticals, Inc. reassignment Marius Pharmaceuticals, Inc. Request to Amend Deed and Register Assignors: MARIUS PHARMACEUTICALS LLC
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
    • 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
    • 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
    • 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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • 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)
AU2022277557A 2021-05-19 2022-05-18 Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment Active AU2022277557B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024227786A AU2024227786A1 (en) 2021-05-19 2024-10-31 Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024227786A Division AU2024227786A1 (en) 2021-05-19 2024-10-31 Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment

Publications (2)

Publication Number Publication Date
AU2022277557A1 AU2022277557A1 (en) 2023-06-08
AU2022277557B2 true AU2022277557B2 (en) 2024-08-01

Family

ID=84140782

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2022277557A Active AU2022277557B2 (en) 2021-05-19 2022-05-18 Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment
AU2024227786A Pending AU2024227786A1 (en) 2021-05-19 2024-10-31 Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024227786A Pending AU2024227786A1 (en) 2021-05-19 2024-10-31 Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment

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
JP2024521127A (ja) 2024-05-28
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

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FGA Letters patent sealed or granted (standard patent)
HB Alteration of name in register

Owner name: MARIUS PHARMACEUTICALS, INC.

Free format text: FORMER NAME(S): MARIUS PHARMACEUTICALS LLC