CA3219547A1 - Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment - Google Patents

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

Info

Publication number
CA3219547A1
CA3219547A1 CA3219547A CA3219547A CA3219547A1 CA 3219547 A1 CA3219547 A1 CA 3219547A1 CA 3219547 A CA3219547 A CA 3219547A CA 3219547 A CA3219547 A CA 3219547A CA 3219547 A1 CA3219547 A1 CA 3219547A1
Authority
CA
Canada
Prior art keywords
testosterone
subject
serum
value
steady state
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.)
Pending
Application number
CA3219547A
Other languages
English (en)
French (fr)
Inventor
Om Dhingra
James S. Bernstein
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
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 Marius Pharmaceuticals LLC filed Critical Marius Pharmaceuticals LLC
Publication of CA3219547A1 publication Critical patent/CA3219547A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/565—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
    • 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)
CA3219547A 2021-05-19 2022-05-18 Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment Pending CA3219547A1 (en)

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 (1)

Publication Number Publication Date
CA3219547A1 true CA3219547A1 (en) 2022-11-24

Family

ID=84140782

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3219547A Pending CA3219547A1 (en) 2021-05-19 2022-05-18 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
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

Similar Documents

Publication Publication Date Title
US20230398128A1 (en) Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment
US11426416B2 (en) Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
DK2558073T3 (en) ORAL testosterone ester FORMULATIONS AND METHODS FOR TREATMENT OF testosterone deficiency INCLUDING THE SAME
US20240180927A1 (en) Methods of Treating Testosterone Deficiency
US12605391B2 (en) Methods of treating testosterone deficiency
US20190365780A1 (en) High-strength testosterone undecanoate compositions
US12403146B2 (en) Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment
US20200038411A1 (en) Methods of treating testosterone deficiency
US20250319101A1 (en) Oral pharmaceutical compositions of progesterone and estradiol
WO2020210501A1 (en) Oral pharmaceutical products and methods of use combining testosterone esters with anti-hypertensive agents
AU2014265072B2 (en) Oral testosterone ester formulations and methods of treating testoterone deficiency comprising same

Legal Events

Date Code Title Description
MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 3RD ANNIV.) - STANDARD

Year of fee payment: 3

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250516

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250516

R00 Party data change recorded

Free format text: ST27 STATUS EVENT CODE: A-1-1-R10-R00-R113 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CHANGE OF ADDRESS OR METHOD OF CORRESPONDENCE REQUEST RECEIVED

Effective date: 20251029

R11 Change to the name of applicant or owner or transfer of ownership requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-R10-R11-R103 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CHANGE OF NAME REQUEST RECEIVED

Effective date: 20251029

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20251029

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U107 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REFUND REQUEST RECEIVED

Effective date: 20251031

R13 Change to the name of applicant or owner recorded

Free format text: ST27 STATUS EVENT CODE: A-1-1-R10-R13-R104 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CHANGE OF NAME REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260202