JP2018514534A5 - - Google Patents
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- JP2018514534A5 JP2018514534A5 JP2017555791A JP2017555791A JP2018514534A5 JP 2018514534 A5 JP2018514534 A5 JP 2018514534A5 JP 2017555791 A JP2017555791 A JP 2017555791A JP 2017555791 A JP2017555791 A JP 2017555791A JP 2018514534 A5 JP2018514534 A5 JP 2018514534A5
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- Japan
- Prior art keywords
- composition
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- pharmaceutically acceptable
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- diameter
- Prior art date
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- 239000000203 mixture Substances 0.000 claims description 73
- 239000002245 particle Substances 0.000 claims description 36
- 229960001601 obeticholic acid Drugs 0.000 claims description 32
- ZXERDUOLZKYMJM-ZWECCWDJSA-N obeticholic acid Chemical compound C([C@@]12C)C[C@@H](O)C[C@H]1[C@@H](CC)[C@@H](O)[C@@H]1[C@@H]2CC[C@]2(C)[C@@H]([C@H](C)CCC(O)=O)CC[C@H]21 ZXERDUOLZKYMJM-ZWECCWDJSA-N 0.000 claims description 32
- 150000001413 amino acids Chemical class 0.000 claims description 23
- 150000002148 esters Chemical class 0.000 claims description 23
- 150000003839 salts Chemical class 0.000 claims description 23
- 208000008338 non-alcoholic fatty liver disease Diseases 0.000 claims description 11
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 8
- 208000019423 liver disease Diseases 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 7
- 208000008439 Biliary Liver Cirrhosis Diseases 0.000 claims description 6
- 208000033222 Biliary cirrhosis primary Diseases 0.000 claims description 6
- 208000012654 Primary biliary cholangitis Diseases 0.000 claims description 6
- 206010053219 non-alcoholic steatohepatitis Diseases 0.000 claims description 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 5
- 229920000080 bile acid sequestrant Polymers 0.000 claims description 4
- 239000003814 drug Substances 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 229940124531 pharmaceutical excipient Drugs 0.000 claims description 4
- RUDATBOHQWOJDD-UHFFFAOYSA-N (3beta,5beta,7alpha)-3,7-Dihydroxycholan-24-oic acid Natural products OC1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)CC2 RUDATBOHQWOJDD-UHFFFAOYSA-N 0.000 claims description 3
- 208000022309 Alcoholic Liver disease Diseases 0.000 claims description 3
- 208000005176 Hepatitis C Diseases 0.000 claims description 3
- 208000019425 cirrhosis of liver Diseases 0.000 claims description 3
- 239000000835 fiber Substances 0.000 claims description 3
- 208000010710 hepatitis C virus infection Diseases 0.000 claims description 3
- 238000010902 jet-milling Methods 0.000 claims description 3
- 230000000750 progressive effect Effects 0.000 claims description 3
- 208000010157 sclerosing cholangitis Diseases 0.000 claims description 3
- RUDATBOHQWOJDD-UZVSRGJWSA-N ursodeoxycholic acid Chemical compound C([C@H]1C[C@@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)CC1 RUDATBOHQWOJDD-UZVSRGJWSA-N 0.000 claims description 3
- 229960001661 ursodiol Drugs 0.000 claims description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 2
- 206010067125 Liver injury Diseases 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 231100000234 hepatic damage Toxicity 0.000 claims description 2
- 230000008818 liver damage Effects 0.000 claims description 2
- 229940079832 sodium starch glycolate Drugs 0.000 claims description 2
- 229920003109 sodium starch glycolate Polymers 0.000 claims description 2
- 239000008109 sodium starch glycolate Substances 0.000 claims description 2
- 239000002552 dosage form Substances 0.000 claims 2
- 229940009976 deoxycholate Drugs 0.000 claims 1
- KXGVEGMKQFWNSR-LLQZFEROSA-N deoxycholic acid Chemical compound C([C@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 KXGVEGMKQFWNSR-LLQZFEROSA-N 0.000 claims 1
- MXBCYQUALCBQIJ-RYVPXURESA-N (8s,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-11-methylidene-1,2,3,6,7,8,9,10,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol;(8r,9s,13s,14s,17r)-17-ethynyl-13-methyl-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthrene-3,17-diol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1.C1CC[C@@H]2[C@H]3C(=C)C[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 MXBCYQUALCBQIJ-RYVPXURESA-N 0.000 description 1
- 206010016654 Fibrosis Diseases 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000004761 fibrosis Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2021143835A JP2021183651A (ja) | 2015-04-27 | 2021-09-03 | オベチコール酸の組成物および使用方法 |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562153040P | 2015-04-27 | 2015-04-27 | |
| US62/153,040 | 2015-04-27 | ||
| US201662317933P | 2016-04-04 | 2016-04-04 | |
| US62/317,933 | 2016-04-04 | ||
| PCT/US2016/029369 WO2016176208A1 (en) | 2015-04-27 | 2016-04-26 | Compositions of obeticholic acid and methods of use |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021143835A Division JP2021183651A (ja) | 2015-04-27 | 2021-09-03 | オベチコール酸の組成物および使用方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018514534A JP2018514534A (ja) | 2018-06-07 |
| JP2018514534A5 true JP2018514534A5 (cg-RX-API-DMAC7.html) | 2019-05-16 |
| JP6941057B2 JP6941057B2 (ja) | 2021-09-29 |
Family
ID=57198868
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017555791A Active JP6941057B2 (ja) | 2015-04-27 | 2016-04-26 | オベチコール酸の組成物および使用方法 |
| JP2021143835A Pending JP2021183651A (ja) | 2015-04-27 | 2021-09-03 | オベチコール酸の組成物および使用方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021143835A Pending JP2021183651A (ja) | 2015-04-27 | 2021-09-03 | オベチコール酸の組成物および使用方法 |
Country Status (25)
Families Citing this family (47)
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| US9719068B2 (en) | 2010-05-06 | 2017-08-01 | Children's Hospital Medical Center | Methods and systems for converting precursor cells into intestinal tissues through directed differentiation |
| CN106661548B (zh) | 2014-05-28 | 2020-12-11 | 儿童医院医疗中心 | 用于经由定向分化将前体细胞转化为胃组织的方法和系统 |
| WO2016061464A1 (en) | 2014-10-17 | 2016-04-21 | Children's Hospital Center, D/B/A Cincinnati Children's Hospital Medical Center | In vivo model of human small intetine using pluripotent stem cells and methods of making and using same |
| PE20180690A1 (es) * | 2015-04-27 | 2018-04-23 | Intercept Pharmaceuticals Inc | Composiciones de acido obeticolico y metodos de uso |
| TW201735927A (zh) | 2016-03-31 | 2017-10-16 | 大日本住友製藥股份有限公司 | 有效成分之化學安定性優異之包膜錠 |
| KR102377338B1 (ko) * | 2016-04-13 | 2022-03-21 | 인터셉트 파마슈티컬즈, 인크. | 암의 치료 방법 |
| WO2017192997A1 (en) | 2016-05-05 | 2017-11-09 | Children's Hospital Medical Center | Methods for the in vitro manufacture of gastric fundus tissue and compositions related to same |
| AU2017290710A1 (en) * | 2016-06-29 | 2019-01-24 | Menlo Therapeutics Inc. | Use of neurokinin-1 antagonists to treat a variety of pruritic conditions |
| NZ753051A (en) * | 2016-11-04 | 2023-03-31 | Children’S Hospital Medical Center | Liver organoid compositions and methods of making and using same |
| CN108072729A (zh) * | 2016-11-18 | 2018-05-25 | 华北制药集团新药研究开发有限责任公司 | 一种测定奥贝胆酸片溶出度的方法 |
| KR102807995B1 (ko) | 2016-12-05 | 2025-05-16 | 칠드런즈 호스피탈 메디칼 센터 | 결장 유사장기 및 이를 제조 및 사용하는 방법 |
| CN108614038B (zh) * | 2016-12-13 | 2022-05-17 | 亚宝药业集团股份有限公司 | 一种测定奥贝胆酸原料药有关物质的方法 |
| CN106645497A (zh) * | 2017-01-03 | 2017-05-10 | 山东省药学科学院 | 一种奥贝胆酸及其制剂中有关物质的检测方法 |
| TW201832768A (zh) * | 2017-03-07 | 2018-09-16 | 英特賽普醫藥品公司 | 治療癌症的方法 |
| JP7248586B2 (ja) | 2017-04-14 | 2023-03-29 | チルドレンズ ホスピタル メディカル センター | 複数ドナー幹細胞組成物およびそれを作製する方法 |
| CA3070837A1 (en) | 2017-07-24 | 2019-01-31 | Intercept Pharmaceuticals, Inc. | Isotopically labeled bile acid derivatives |
| EP3694603A4 (en) | 2017-10-10 | 2021-07-14 | Children's Hospital Medical Center | ESOPHAGUS TISSUE AND / OR ORGANOID COMPOSITIONS AND METHOD FOR MANUFACTURING THEREOF |
| WO2019106043A1 (en) * | 2017-11-29 | 2019-06-06 | Hexal Ag | Pharmaceutical composition comprising obeticholic acid |
| US12379372B2 (en) | 2017-12-21 | 2025-08-05 | Children's Hospital Medical Center | Digitalized human organoids and methods of using same |
| CN108572251B (zh) * | 2018-05-31 | 2020-01-17 | 中国科学院昆明动物研究所 | 肝硬化早期小分子标志物及其应用 |
| SG11202100533VA (en) | 2018-07-26 | 2021-02-25 | Childrens Hospital Med Ct | Hepato-biliary-pancreatic tissues and methods of making same |
| GB201812382D0 (en) | 2018-07-30 | 2018-09-12 | Nzp Uk Ltd | Compounds |
| US11590161B2 (en) | 2018-08-13 | 2023-02-28 | Viscera Labs, Inc. | Therapeutic composition and methods |
| US11524029B2 (en) | 2018-08-13 | 2022-12-13 | Viscera Labs, Inc. | Therapeutic composition and methods |
| SG11202102431YA (en) | 2018-09-12 | 2021-04-29 | Childrens Hospital Med Ct | Organoid compositions for the production of hematopoietic stem cells and derivatives thereof |
| US20200147108A1 (en) * | 2018-11-08 | 2020-05-14 | Intercept Pharmaceuticals, Inc. | Methods of using obeticholic acid |
| CN109432431B (zh) * | 2018-12-14 | 2020-06-30 | 中国药科大学 | 一种含有sumo抑制剂的组合物及应用 |
| CN109655571B (zh) * | 2019-01-08 | 2021-07-13 | 丽珠集团新北江制药股份有限公司 | 一种奥贝胆酸的高效液相色谱分析方法 |
| CN109620812B (zh) * | 2019-01-16 | 2023-07-21 | 浙江华海药业股份有限公司 | 一种奥贝胆酸组合物的制备方法 |
| WO2020198383A1 (en) * | 2019-03-26 | 2020-10-01 | Intercept Pharmaceuticals, Inc. | Methods of diagnosis and treatment of liver diseases using obeticholic acid |
| WO2020198576A1 (en) * | 2019-03-28 | 2020-10-01 | The Board Of Trustees Of The University Of Illinois | Methods of modulating regulatory t cells |
| CA3141807A1 (en) | 2019-05-31 | 2020-12-03 | Children's Hospital Medical Center | Methods of generating and expanding hematopoietic stem cells |
| JP2022550312A (ja) * | 2019-09-30 | 2022-12-01 | ノバルティス アーゲー | Ｆｘｒアゴニストの使用を含む処置 |
| US20230114753A1 (en) * | 2020-03-06 | 2023-04-13 | Mili Healthcare Trade Dmcc, Limited Liability Company | Use of a group of markers for diagnosing and adjusting treatment of primary biliary cholangitis, pharmaceutical composition and solid dosage form for treating primary biliary cholangitis |
| CN111518152B (zh) * | 2020-04-23 | 2022-11-22 | 江西青峰药业有限公司 | 一种3α,7α-二羟基-6α-乙基-5β-胆烷-24-醛的制备方法及其应用 |
| US20230201222A1 (en) * | 2020-05-13 | 2023-06-29 | Children's Hospital Medical Center | Alleviation of liver injury by activating the signaling pathway mediated by farnesoid x receptor |
| CN111690731B (zh) * | 2020-05-22 | 2021-09-28 | 河南大学 | Fxr激动剂在治疗肝性脑病中的应用 |
| CN111812264B (zh) * | 2020-07-09 | 2021-06-15 | 苏州旭辉检测有限公司 | 一种去氧胆酸类化合物的生物样品分析方法 |
| WO2022051321A1 (en) | 2020-09-03 | 2022-03-10 | Coherus Biosciences, Inc. | Fixed dose combinations of chs-131 and a fxr agonist |
| WO2022076683A1 (en) * | 2020-10-07 | 2022-04-14 | Intercept Pharmaceuticals, Inc. | Methods of treating coronaviral infection with obeticholic acid |
| CN113143950B (zh) * | 2021-05-17 | 2023-04-18 | 河北医科大学第二医院 | 一种治疗肝病的药物组合物及其应用 |
| US20250161326A1 (en) * | 2022-01-28 | 2025-05-22 | Intercept Pharmaceuticals, Inc. | Combination therapy |
| WO2023181077A1 (en) * | 2022-03-24 | 2023-09-28 | Zenvision Pharma Llp | Stable liquid composition comprising obeticholic acid or salts thereof |
| US12343351B2 (en) | 2022-03-25 | 2025-07-01 | Rutgers, The State University Of New Jersey | Pulmonary function treatment |
| CN119136794A (zh) * | 2022-04-21 | 2024-12-13 | 英特塞普特医药品公司 | 法尼醇x受体激动剂的用途 |
| WO2024043842A1 (en) * | 2022-08-22 | 2024-02-29 | Pharmactive Ilac Sanayi Ve Ticaret A.S. | Pharmaceutical compositions comprising chenodeoxycholic acid (cdca) as active ingredient and other relevant excipients |
| WO2024104960A1 (en) | 2022-11-15 | 2024-05-23 | Synthon B.V. | Stable formulation comprising obeticholic acid |
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| US5023252A (en) | 1985-12-04 | 1991-06-11 | Conrex Pharmaceutical Corporation | Transdermal and trans-membrane delivery of drugs |
| ZA876640B (en) | 1986-09-26 | 1988-03-08 | Warner-Lambert Company | Treated lipid regulator |
| UA72207C2 (uk) | 1998-04-07 | 2005-02-15 | Брістол- Майєрс Сквібб Фарма Компані | Фармацевтична композиція ефавіренцу з добавкою дезінтегруючих агентів у вигляді швидкорозчинних капсул або таблеток та спосіб її виготовлення |
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| CN104188909A (zh) * | 2009-04-24 | 2014-12-10 | 伊休蒂卡有限公司 | 用于制备商品化纳米颗粒和微粒粉末的方法 |
| CN102985072A (zh) | 2010-04-20 | 2013-03-20 | 希普拉有限公司 | 药物组合物 |
| CN104781272A (zh) * | 2012-06-19 | 2015-07-15 | 英特塞普特医药品公司 | 奥贝胆酸的制备、用途和固体形式 |
| US9814733B2 (en) * | 2012-12-31 | 2017-11-14 | A,arin Pharmaceuticals Ireland Limited | Compositions comprising EPA and obeticholic acid and methods of use thereof |
| CN105592846A (zh) | 2013-03-15 | 2016-05-18 | 持田制药株式会社 | 用于治疗非酒精性脂肪性肝炎的组合物和方法 |
| EA030152B1 (ru) | 2013-05-14 | 2018-06-29 | Интерсепт Фармасьютикалз, Инк | 11-гидроксилпроизводные желчных кислот и их аминокислотные конъюгаты в качестве модуляторов фарнезоидных х-рецепторов |
| HRP20201953T1 (hr) * | 2013-09-11 | 2021-04-30 | Institut National De La Santé Et De La Recherche Médicale (Inserm) | Postupci i farmaceutski pripravci za liječenje virusne infekcije hepatitisom b |
| CN105801653B (zh) | 2014-12-30 | 2018-04-17 | 苏州晶云药物科技有限公司 | 奥贝胆酸的晶型a及其制备方法 |
| PE20180690A1 (es) | 2015-04-27 | 2018-04-23 | Intercept Pharmaceuticals Inc | Composiciones de acido obeticolico y metodos de uso |
-
2016
- 2016-04-24 PE PE2017002334A patent/PE20180690A1/es unknown
- 2016-04-26 IL IL294575A patent/IL294575A/en unknown
- 2016-04-26 EP EP21189718.6A patent/EP3971199A1/en not_active Withdrawn
- 2016-04-26 JP JP2017555791A patent/JP6941057B2/ja active Active
- 2016-04-26 CR CR20170492A patent/CR20170492A/es unknown
- 2016-04-26 WO PCT/US2016/029369 patent/WO2016176208A1/en not_active Ceased
- 2016-04-26 CN CN201680023889.2A patent/CN107531742A/zh active Pending
- 2016-04-26 AU AU2016255045A patent/AU2016255045B2/en active Active
- 2016-04-26 MA MA041999A patent/MA41999A/fr unknown
- 2016-04-26 BR BR112017023161-1A patent/BR112017023161A2/pt not_active Application Discontinuation
- 2016-04-26 KR KR1020177033948A patent/KR20170140325A/ko not_active Withdrawn
- 2016-04-26 IL IL255269A patent/IL255269B/en unknown
- 2016-04-26 SG SG11201708606VA patent/SG11201708606VA/en unknown
- 2016-04-26 EA EA201792354A patent/EA201792354A1/ru unknown
- 2016-04-26 EP EP16787000.5A patent/EP3288958A4/en not_active Withdrawn
- 2016-04-26 SG SG10202003110PA patent/SG10202003110PA/en unknown
- 2016-04-26 TN TNP/2017/000452A patent/TN2017000452A1/en unknown
- 2016-04-26 CA CA2983609A patent/CA2983609C/en active Active
- 2016-04-26 EP EP24154375.0A patent/EP4371616A3/en active Pending
- 2016-04-26 MX MX2017013805A patent/MX2017013805A/es unknown
- 2016-04-26 US US15/139,138 patent/US10052337B2/en active Active
- 2016-04-27 TW TW105113063A patent/TWI723017B/zh active
-
2017
- 2017-10-26 NI NI201700128A patent/NI201700128A/es unknown
- 2017-10-26 PH PH12017501956A patent/PH12017501956A1/en unknown
- 2017-10-26 CL CL2017002727A patent/CL2017002727A1/es unknown
- 2017-10-27 SV SV2017005555A patent/SV2017005555A/es unknown
- 2017-11-10 CO CONC2017/0011535A patent/CO2017011535A2/es unknown
- 2017-11-23 ZA ZA2017/07981A patent/ZA201707981B/en unknown
- 2017-11-24 EC ECIEPI201778433A patent/ECSP17078433A/es unknown
-
2018
- 2018-07-09 US US16/030,141 patent/US10646499B2/en active Active
-
2019
- 2019-01-15 US US16/248,512 patent/US10751349B2/en active Active
- 2019-10-08 US US16/596,741 patent/US20200046736A1/en not_active Abandoned
- 2019-10-08 US US16/596,216 patent/US20200046735A1/en not_active Abandoned
- 2019-10-09 US US16/597,412 patent/US20200054650A1/en not_active Abandoned
-
2020
- 2020-02-11 US US16/787,796 patent/US10758549B2/en active Active
- 2020-07-16 AU AU2020205315A patent/AU2020205315A1/en not_active Abandoned
-
2021
- 2021-09-03 JP JP2021143835A patent/JP2021183651A/ja active Pending
- 2021-12-06 US US17/542,923 patent/US20220133745A1/en not_active Abandoned
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