HRP20201726T1 - Liječenje valunga i gubitka kostiju izazvanih terapijom uskraćivanja androgena pomoću cis-klomifena - Google Patents
Liječenje valunga i gubitka kostiju izazvanih terapijom uskraćivanja androgena pomoću cis-klomifena Download PDFInfo
- Publication number
- HRP20201726T1 HRP20201726T1 HRP20201726TT HRP20201726T HRP20201726T1 HR P20201726 T1 HRP20201726 T1 HR P20201726T1 HR P20201726T T HRP20201726T T HR P20201726TT HR P20201726 T HRP20201726 T HR P20201726T HR P20201726 T1 HRP20201726 T1 HR P20201726T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- cis
- use according
- clomiphene
- pharmaceutically acceptable
- Prior art date
Links
- GKIRPKYJQBWNGO-OCEACIFDSA-N clomifene Chemical compound C1=CC(OCCN(CC)CC)=CC=C1C(\C=1C=CC=CC=1)=C(\Cl)C1=CC=CC=C1 GKIRPKYJQBWNGO-OCEACIFDSA-N 0.000 title claims 11
- 208000033830 Hot Flashes Diseases 0.000 title claims 4
- 206010060800 Hot flush Diseases 0.000 title claims 4
- 238000009167 androgen deprivation therapy Methods 0.000 title claims 3
- 206010065687 Bone loss Diseases 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 12
- 150000003839 salts Chemical class 0.000 claims 10
- 239000007788 liquid Substances 0.000 claims 4
- 239000008188 pellet Substances 0.000 claims 4
- DYLIWHYUXAJDOJ-OWOJBTEDSA-N (e)-4-(6-aminopurin-9-yl)but-2-en-1-ol Chemical compound NC1=NC=NC2=C1N=CN2C\C=C\CO DYLIWHYUXAJDOJ-OWOJBTEDSA-N 0.000 claims 2
- 239000002775 capsule Substances 0.000 claims 2
- 229960003608 clomifene Drugs 0.000 claims 2
- 239000006071 cream Substances 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- -1 elixir Substances 0.000 claims 2
- 239000000839 emulsion Substances 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 239000000499 gel Substances 0.000 claims 2
- 238000010255 intramuscular injection Methods 0.000 claims 2
- 239000007927 intramuscular injection Substances 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- 239000000829 suppository Substances 0.000 claims 2
- 239000000725 suspension Substances 0.000 claims 2
- 239000003826 tablet Substances 0.000 claims 2
- 208000010392 Bone Fractures Diseases 0.000 claims 1
- 208000001132 Osteoporosis Diseases 0.000 claims 1
- 239000003098 androgen Substances 0.000 claims 1
- 210000000988 bone and bone Anatomy 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 230000005764 inhibitory process Effects 0.000 claims 1
- 229910052500 inorganic mineral Inorganic materials 0.000 claims 1
- 239000011707 mineral Substances 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 230000009467 reduction Effects 0.000 claims 1
- 230000001629 suppression Effects 0.000 claims 1
- 230000000699 topical effect Effects 0.000 claims 1
Classifications
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Physical Education & Sports Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Dermatology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (15)
1. Farmaceutski pripravak koji sadrži klomifen ili njegovu farmaceutski prihvatljivu sol koji sadrži i trans-izomer i cis-izomer u omjeru trans: cis u rasponu od 10 : 90 do 0 : 100, naznačen time što je za uporabu u liječenju valunga.
2. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što se navedeni pripravak primjenjuje intravenski, intraarterijski, intranazalnim raspršivačem ili intramuskularnim ubrizgavanjem subjektu navedenog farmaceutskog pripravka u tekućem obliku; potkožnim implantiranjem subjektu peleta koji sadrži navedeni farmaceutski pripravak; oralnim davanjem subjektu navedenog farmaceutskog pripravka u tekućem ili krutom obliku; ili topikalnim nanošenjem na površinu kože subjekta navedenog farmaceutskog pripravka.
3. Pripravak za uporabu prema patentnom zahtjevu 2, naznačen time što je navedeni farmaceutski pripravak peleta, tableta, kapsula, otopina, suspenzija, emulzija, eliksir, gel, krema, čepić ili parenteralna formulacija.
4. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što se navedeni cis-klomifen ili njegova farmaceutski prihvatljiva sol primjenjuje u dozi od 5 mg dnevno.
5. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što se navedeni cis-klomifen ili njegova farmaceutski prihvatljiva sol primjenjuje u dozi od 15 mg dnevno.
6. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što se navedeni cis-klomifen ili njegova farmaceutski prihvatljiva sol primjenjuje u dozi od 25 mg dnevno.
7. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što se navedeni cis-klomifen ili njegova farmaceutski prihvatljiva sol primjenjuje u dozi od 50 mg dnevno.
8. Farmaceutski pripravak koji sadrži klomifen ili njegovu farmaceutski prihvatljivu sol koji sadrži i trans-izomer i cis-izomer u omjeru trans: cis u rasponu od 10 : 90 do 0 : 100 naznačen time što je za uporabu u suzbijanju, inhibiciji ili smanjenju rizika od poremećaja kod subjekta koji se podvrgava terapiji za uskraćivanje androgena, pri čemu poremećaj su valunzi.
9. Pripravak za uporabu prema patentnom zahtjevu 8, naznačen time što se navedeni pripravak primjenjuje intravenski, intraarterijski, intranazalnim raspršivačem ili intramuskularnim ubrizgavanjem subjektu navedenog farmaceutskog pripravka u tekućem obliku; potkožnim implantiranjem subjektu peleta koji sadrži navedeni farmaceutski pripravak; oralnim davanjem navedenom subjektu navedenog farmaceutskog pripravka u tekućem ili krutom obliku; ili topikalnim nanošenjem na površinu kože navedenog subjekta navedenog farmaceutskog pripravka.
10. Pripravak za uporabu prema patentnom zahtjevu 8, naznačen time što je navedeni farmaceutski pripravak peleta, tableta, kapsula, otopina, suspenzija, emulzija, eliksir, gel, krema, čepić ili parenteralna formulacija.
11. Pripravak za uporabu prema patentnom zahtjevu 8, naznačen time što se navedeni cis-klomifen ili njegova farmaceutski prihvatljiva sol primjenjuje u dozi od 5 mg dnevno.
12. Pripravak za uporabu prema patentnom zahtjevu 8, naznačen time što se navedeni cis-klomifen ili njegova farmaceutski prihvatljiva sol primjenjuje u dozi od 15 mg dnevno.
13. Pripravak za uporabu prema patentnom zahtjevu 8, naznačen time što se navedeni cis-klomifen ili njegova farmaceutski prihvatljiva sol primjenjuje u dozi od 25 mg dnevno.
14. Pripravak za uporabu prema patentnom zahtjevu 8, naznačen time što se navedeni cis-klomifen ili njegova farmaceutski prihvatljiva sol primjenjuje u dozi od 50 mg dnevno.
15. Pripravak za uporabu prema patentnom zahtjevu 1 ili 8, naznačen time što se liječenje valunga provodi kod pacijenta koji se podvrgava terapiji deprivacije androgena i liječenje dalje uključuje liječenje, prevenciju, suzbijanje, inhibiciju ili smanjenje rizika od osteoporoze izazvane lišavanjem androgena, prijeloma kostiju i/ili gubitka mineralne gustoće kostiju.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462028540P | 2014-07-24 | 2014-07-24 | |
| EP15824708.0A EP3171866B1 (en) | 2014-07-24 | 2015-07-23 | Treating androgen deprivation therapy induced hot flashes and bone loss using cis-clomiphene |
| PCT/US2015/041761 WO2016014812A1 (en) | 2014-07-24 | 2015-07-23 | Treating androgen deprivation therapy induced hot flashes and bone loss using cis-clomiphene |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20201726T1 true HRP20201726T1 (hr) | 2021-01-08 |
Family
ID=55163768
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201726TT HRP20201726T1 (hr) | 2014-07-24 | 2020-10-26 | Liječenje valunga i gubitka kostiju izazvanih terapijom uskraćivanja androgena pomoću cis-klomifena |
Country Status (19)
| Country | Link |
|---|---|
| US (3) | US9913815B2 (hr) |
| EP (2) | EP3769756A1 (hr) |
| JP (1) | JP6743001B2 (hr) |
| KR (2) | KR20170040797A (hr) |
| CN (2) | CN111346076A (hr) |
| AU (1) | AU2015292519B2 (hr) |
| CY (1) | CY1123861T1 (hr) |
| DK (1) | DK3171866T3 (hr) |
| ES (1) | ES2828305T3 (hr) |
| HR (1) | HRP20201726T1 (hr) |
| HU (1) | HUE051442T2 (hr) |
| IL (2) | IL249989B (hr) |
| LT (1) | LT3171866T (hr) |
| MX (1) | MX2017000886A (hr) |
| PL (1) | PL3171866T3 (hr) |
| PT (1) | PT3171866T (hr) |
| RU (2) | RU2020120156A (hr) |
| UA (1) | UA121971C2 (hr) |
| WO (1) | WO2016014812A1 (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20170040797A (ko) | 2014-07-24 | 2017-04-13 | 아스펜 파크 파마슈티컬스 인코포레이티드 | 시스-클로미펜을 이용하여 안드로겐 박탈 요법 유발된 일과성 열감 및 골 소실을 치료하는 방법 |
| FR3082842A1 (fr) * | 2018-06-21 | 2019-12-27 | Veru Inc. | Polymorphe de cis-clomiphene (zuclomiphene) et procedes d'utilisation de celui-ci |
| CA3098725A1 (en) | 2019-11-14 | 2021-05-14 | Apotex Inc. | Zuclpomiphene salts and crystalline forms thereof |
| CA3098552A1 (en) | 2019-11-14 | 2021-05-14 | Apotex Inc. | Processes for the preparation of zuclomiphene and intermediates thereof |
| CA3105944A1 (en) | 2020-01-22 | 2021-07-22 | Apotex Inc. | Crystalline forms of zuclomiphene citrate |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT951631B (it) | 1971-03-18 | 1973-07-10 | Richardson Merrell Spa | Composti utili per la separazione di isomeri ottici geometrici e strutturali e relativo procedimen to di sintesi |
| US4729999A (en) * | 1984-10-12 | 1988-03-08 | Bcm Technologies | Antiestrogen therapy for symptoms of estrogen deficiency |
| US20040214898A1 (en) | 2001-11-29 | 2004-10-28 | Steiner Mitchell S. | Methods for treating hot flashes |
| US20040213841A1 (en) * | 2001-11-29 | 2004-10-28 | Steiner Mitchell S | Methods for treating hot flashes and gynecomastia |
| EP1666033B1 (en) * | 2001-11-29 | 2008-12-31 | GTX, Inc. | Prevention and treatment of androgen-deprivation induced osteoporosis |
| US6762524B2 (en) * | 2002-08-01 | 2004-07-13 | Albert Six | Magnetic drive system for a vehicle differential |
| CN101151043B (zh) * | 2004-12-21 | 2013-09-04 | 南卡罗来纳州医科大学研究发展基金会 | 促进伤口愈合和组织再生的组合物和方法 |
| US8637706B2 (en) * | 2005-11-28 | 2014-01-28 | Gtx, Inc. | Nuclear receptor binding agents |
| US8158828B2 (en) * | 2005-11-28 | 2012-04-17 | Gtx, Inc. | Nuclear receptor binding agents |
| US20090215733A1 (en) * | 2008-02-26 | 2009-08-27 | Michael Charles Scally | Therapy for the prophylaxis or treatment of adverse body composition changes and/or decreased muscle strength after androgen or gnrh analogue intake |
| KR20170040797A (ko) * | 2014-07-24 | 2017-04-13 | 아스펜 파크 파마슈티컬스 인코포레이티드 | 시스-클로미펜을 이용하여 안드로겐 박탈 요법 유발된 일과성 열감 및 골 소실을 치료하는 방법 |
-
2015
- 2015-07-23 KR KR1020177005185A patent/KR20170040797A/ko not_active IP Right Cessation
- 2015-07-23 HU HUE15824708A patent/HUE051442T2/hu unknown
- 2015-07-23 US US15/327,726 patent/US9913815B2/en active Active
- 2015-07-23 LT LTEP15824708.0T patent/LT3171866T/lt unknown
- 2015-07-23 KR KR1020227044756A patent/KR20230005415A/ko not_active Application Discontinuation
- 2015-07-23 EP EP20190827.4A patent/EP3769756A1/en active Pending
- 2015-07-23 EP EP15824708.0A patent/EP3171866B1/en active Active
- 2015-07-23 WO PCT/US2015/041761 patent/WO2016014812A1/en active Application Filing
- 2015-07-23 ES ES15824708T patent/ES2828305T3/es active Active
- 2015-07-23 RU RU2020120156A patent/RU2020120156A/ru unknown
- 2015-07-23 DK DK15824708.0T patent/DK3171866T3/da active
- 2015-07-23 UA UAA201700302A patent/UA121971C2/uk unknown
- 2015-07-23 MX MX2017000886A patent/MX2017000886A/es unknown
- 2015-07-23 CN CN202010205589.4A patent/CN111346076A/zh active Pending
- 2015-07-23 JP JP2017525313A patent/JP6743001B2/ja active Active
- 2015-07-23 PT PT158247080T patent/PT3171866T/pt unknown
- 2015-07-23 AU AU2015292519A patent/AU2015292519B2/en active Active
- 2015-07-23 CN CN201580040181.3A patent/CN107072969B/zh active Active
- 2015-07-23 PL PL15824708T patent/PL3171866T3/pl unknown
- 2015-07-23 RU RU2017105837A patent/RU2725086C2/ru active
-
2017
- 2017-01-09 IL IL249989A patent/IL249989B/en unknown
-
2018
- 2018-01-25 US US15/879,861 patent/US10463635B2/en active Active
-
2019
- 2019-09-24 US US16/580,198 patent/US10758500B2/en active Active
-
2020
- 2020-10-26 HR HRP20201726TT patent/HRP20201726T1/hr unknown
- 2020-11-02 CY CY20201101032T patent/CY1123861T1/el unknown
-
2022
- 2022-01-20 IL IL290004A patent/IL290004A/en unknown
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