ES2983643T3 - Terapia oral con tridecanoato de testosterona - Google Patents
Terapia oral con tridecanoato de testosterona Download PDFInfo
- Publication number
- ES2983643T3 ES2983643T3 ES17876230T ES17876230T ES2983643T3 ES 2983643 T3 ES2983643 T3 ES 2983643T3 ES 17876230 T ES17876230 T ES 17876230T ES 17876230 T ES17876230 T ES 17876230T ES 2983643 T3 ES2983643 T3 ES 2983643T3
- Authority
- ES
- Spain
- Prior art keywords
- testosterone
- fixed dose
- dose
- dosing regimen
- daily
- 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.)
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- 238000002560 therapeutic procedure Methods 0.000 title claims description 35
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- 238000011285 therapeutic regimen Methods 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 150000003611 tocopherol derivatives Chemical class 0.000 description 1
- 235000013619 trace mineral Nutrition 0.000 description 1
- 239000011573 trace mineral Substances 0.000 description 1
- UWHZIFQPPBDJPM-BQYQJAHWSA-N trans-vaccenic acid Chemical compound CCCCCC\C=C\CCCCCCCCCC(O)=O UWHZIFQPPBDJPM-BQYQJAHWSA-N 0.000 description 1
- 238000005809 transesterification reaction Methods 0.000 description 1
- PHYFQTYBJUILEZ-IUPFWZBJSA-N triolein Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CCCCCCCC)COC(=O)CCCCCCC\C=C/CCCCCCCC PHYFQTYBJUILEZ-IUPFWZBJSA-N 0.000 description 1
- 229940117972 triolein Drugs 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
- 150000003710 vitamin D derivatives Chemical class 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 150000003712 vitamin E derivatives Chemical class 0.000 description 1
- 229940046008 vitamin d Drugs 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
- 239000002888 zwitterionic surfactant Substances 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662428167P | 2016-11-30 | 2016-11-30 | |
| US201662428317P | 2016-11-30 | 2016-11-30 | |
| PCT/US2017/064083 WO2018102618A1 (en) | 2016-11-30 | 2017-11-30 | Oral testosterone tridecanoate therapy |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2983643T3 true ES2983643T3 (es) | 2024-10-24 |
Family
ID=62240656
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES17876230T Active ES2983643T3 (es) | 2016-11-30 | 2017-11-30 | Terapia oral con tridecanoato de testosterona |
Country Status (6)
| Country | Link |
|---|---|
| US (6) | US20180153905A1 (enExample) |
| EP (1) | EP3548037B1 (enExample) |
| JP (1) | JP2020500864A (enExample) |
| CA (1) | CA3078724A1 (enExample) |
| ES (1) | ES2983643T3 (enExample) |
| WO (1) | WO2018102618A1 (enExample) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8492369B2 (en) | 2010-04-12 | 2013-07-23 | Clarus Therapeutics Inc | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
| JP5887044B2 (ja) | 2005-04-15 | 2016-03-16 | クラルス セラピューティクス, インコーポレーテッドClarus Therapeutic, Inc. | 疎水性薬物のドラッグデリバリーシステムとその組成物 |
| CA3078724A1 (en) | 2016-11-30 | 2018-06-07 | Nachiappan Chidambaram | Oral testosterone tridecanoate therapy |
| WO2020018974A1 (en) * | 2018-07-20 | 2020-01-23 | Lipocine Inc. | Liver disease |
| US11931367B2 (en) | 2021-09-30 | 2024-03-19 | Lipocine Inc. | Oral (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate therapy |
| US12257257B2 (en) | 2023-07-27 | 2025-03-25 | Lipocine, Inc. | Testosterone dodecanoate compositions and methods |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140288039A1 (en) | 2009-01-08 | 2014-09-25 | Lipocine Inc. | Lipobalanced long chain testosterone prodrugs for oral delivery |
| US20130225544A1 (en) * | 2009-01-08 | 2013-08-29 | Lipocine Inc. | Lipobalanced long chain testosterone esters for oral delivery |
| TW201521731A (zh) | 2013-03-15 | 2015-06-16 | 利波辛股份有限公司 | 用於口服之脂平衡的長鏈睪固酮酯 |
| US10245273B2 (en) | 2013-12-26 | 2019-04-02 | Clarus Therapeutics, Inc. | Oral pharmaceutical products and methods of use combining testosterone esters with hypolipidemic agents |
| BR112017004127B1 (pt) | 2014-08-28 | 2023-04-11 | Lipocine Inc | Composição farmacêutica oral |
| CA3078724A1 (en) * | 2016-11-30 | 2018-06-07 | Nachiappan Chidambaram | Oral testosterone tridecanoate therapy |
-
2017
- 2017-11-30 CA CA3078724A patent/CA3078724A1/en active Pending
- 2017-11-30 ES ES17876230T patent/ES2983643T3/es active Active
- 2017-11-30 JP JP2019528756A patent/JP2020500864A/ja active Pending
- 2017-11-30 EP EP17876230.8A patent/EP3548037B1/en active Active
- 2017-11-30 WO PCT/US2017/064083 patent/WO2018102618A1/en not_active Ceased
- 2017-11-30 US US15/828,320 patent/US20180153905A1/en not_active Abandoned
-
2019
- 2019-12-26 US US16/727,737 patent/US10881670B2/en active Active - Reinstated
-
2020
- 2020-12-23 US US17/132,167 patent/US11672807B1/en active Active
-
2023
- 2023-05-02 US US18/310,784 patent/US11992496B1/en active Active
-
2024
- 2024-04-22 US US18/641,597 patent/US12161651B1/en active Active
- 2024-11-06 US US18/938,942 patent/US12303517B1/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US11672807B1 (en) | 2023-06-13 |
| US10881670B2 (en) | 2021-01-05 |
| US12161651B1 (en) | 2024-12-10 |
| EP3548037A1 (en) | 2019-10-09 |
| EP3548037B1 (en) | 2024-07-03 |
| US20200222426A1 (en) | 2020-07-16 |
| CA3078724A1 (en) | 2018-06-07 |
| JP2020500864A (ja) | 2020-01-16 |
| US11992496B1 (en) | 2024-05-28 |
| US12303517B1 (en) | 2025-05-20 |
| US20180153905A1 (en) | 2018-06-07 |
| WO2018102618A1 (en) | 2018-06-07 |
| EP3548037A4 (en) | 2020-07-29 |
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