JP2017537089A5 - - Google Patents
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- Publication number
- JP2017537089A5 JP2017537089A5 JP2017526549A JP2017526549A JP2017537089A5 JP 2017537089 A5 JP2017537089 A5 JP 2017537089A5 JP 2017526549 A JP2017526549 A JP 2017526549A JP 2017526549 A JP2017526549 A JP 2017526549A JP 2017537089 A5 JP2017537089 A5 JP 2017537089A5
- Authority
- JP
- Japan
- Prior art keywords
- fumarate
- item
- pharmaceutical composition
- patient
- administration
- 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.)
- Granted
Links
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims description 388
- 238000000034 method Methods 0.000 claims description 374
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Natural products OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims description 350
- 239000008194 pharmaceutical composition Substances 0.000 claims description 267
- -1 fumaric acid compound Chemical class 0.000 claims description 188
- 239000001530 fumaric acid Substances 0.000 claims description 133
- 201000006417 multiple sclerosis Diseases 0.000 claims description 108
- 229960004419 dimethyl fumarate Drugs 0.000 claims description 99
- LDCRTTXIJACKKU-ONEGZZNKSA-N dimethyl fumarate Chemical compound COC(=O)\C=C\C(=O)OC LDCRTTXIJACKKU-ONEGZZNKSA-N 0.000 claims description 98
- 239000012453 solvate Substances 0.000 claims description 42
- NKHAVTQWNUWKEO-UHFFFAOYSA-N fumaric acid monomethyl ester Natural products COC(=O)C=CC(O)=O NKHAVTQWNUWKEO-UHFFFAOYSA-N 0.000 claims description 35
- NKHAVTQWNUWKEO-NSCUHMNNSA-N monomethyl fumarate Chemical compound COC(=O)\C=C\C(O)=O NKHAVTQWNUWKEO-NSCUHMNNSA-N 0.000 claims description 35
- 229940005650 monomethyl fumarate Drugs 0.000 claims description 35
- 210000004698 lymphocyte Anatomy 0.000 claims description 32
- 150000003839 salts Chemical class 0.000 claims description 31
- 238000004820 blood count Methods 0.000 claims description 22
- XLYMOEINVGRTEX-ONEGZZNKSA-N (e)-4-ethoxy-4-oxobut-2-enoic acid Chemical compound CCOC(=O)\C=C\C(O)=O XLYMOEINVGRTEX-ONEGZZNKSA-N 0.000 claims description 14
- 238000012423 maintenance Methods 0.000 claims description 14
- XLYMOEINVGRTEX-UHFFFAOYSA-N fumaric acid monoethyl ester Natural products CCOC(=O)C=CC(O)=O XLYMOEINVGRTEX-UHFFFAOYSA-N 0.000 claims description 11
- 239000003814 drug Substances 0.000 claims description 9
- 229940121164 dimethyl fumarate 240 mg Drugs 0.000 claims description 8
- 229940079593 drug Drugs 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 claims 1
- 208000024891 symptom Diseases 0.000 description 60
- 239000002775 capsule Substances 0.000 description 48
- 229940002612 prodrug Drugs 0.000 description 40
- 239000000651 prodrug Substances 0.000 description 40
- 239000002662 enteric coated tablet Substances 0.000 description 24
- 239000003826 tablet Substances 0.000 description 24
- 206010025327 Lymphopenia Diseases 0.000 description 15
- 231100001023 lymphopenia Toxicity 0.000 description 15
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 13
- 206010034719 Personality change Diseases 0.000 description 12
- 239000003937 drug carrier Substances 0.000 description 12
- 208000026526 progressive weakness Diseases 0.000 description 12
- 238000002560 therapeutic procedure Methods 0.000 description 12
- 238000012544 monitoring process Methods 0.000 description 11
- OHVDJSGPPQBUHP-SEPHDYHBSA-M C(\C=C\C(=O)[O-])(=O)O.C(C)[Mg+] Chemical compound C(\C=C\C(=O)[O-])(=O)O.C(C)[Mg+] OHVDJSGPPQBUHP-SEPHDYHBSA-M 0.000 description 10
- IEPRYMPWCNAHGK-SEPHDYHBSA-L C(\C=C\C(=O)[O-])(=O)[O-].C(C)[Cu+2] Chemical compound C(\C=C\C(=O)[O-])(=O)[O-].C(C)[Cu+2] IEPRYMPWCNAHGK-SEPHDYHBSA-L 0.000 description 10
- 238000007435 diagnostic evaluation Methods 0.000 description 9
- 230000000977 initiatory effect Effects 0.000 description 9
- 108010072051 Glatiramer Acetate Proteins 0.000 description 8
- 102000014150 Interferons Human genes 0.000 description 8
- 108010050904 Interferons Proteins 0.000 description 8
- FHEAIOHRHQGZPC-KIWGSFCNSA-N acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid Chemical compound CC(O)=O.C[C@H](N)C(O)=O.NCCCC[C@H](N)C(O)=O.OC(=O)[C@@H](N)CCC(O)=O.OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 FHEAIOHRHQGZPC-KIWGSFCNSA-N 0.000 description 8
- 230000006735 deficit Effects 0.000 description 8
- 208000035475 disorder Diseases 0.000 description 8
- 229960003776 glatiramer acetate Drugs 0.000 description 8
- 229940079322 interferon Drugs 0.000 description 8
- 210000000265 leukocyte Anatomy 0.000 description 8
- 230000009251 neurologic dysfunction Effects 0.000 description 8
- 208000015015 neurological dysfunction Diseases 0.000 description 8
- 238000012360 testing method Methods 0.000 description 8
- HOLCSWTUZCMEOZ-SEPHDYHBSA-M C(\C=C\C(=O)[O-])(=O)O.C(C)[Ca+] Chemical compound C(\C=C\C(=O)[O-])(=O)O.C(C)[Ca+] HOLCSWTUZCMEOZ-SEPHDYHBSA-M 0.000 description 7
- HPFLTDMCDFLXKI-SEPHDYHBSA-M C(\C=C\C(=O)[O-])(=O)O.C(C)[Zn+] Chemical compound C(\C=C\C(=O)[O-])(=O)O.C(C)[Zn+] HPFLTDMCDFLXKI-SEPHDYHBSA-M 0.000 description 7
- 125000000217 alkyl group Chemical group 0.000 description 7
- 239000001749 Calcium fumarate Substances 0.000 description 6
- 235000019296 calcium fumarate Nutrition 0.000 description 6
- 229910052739 hydrogen Inorganic materials 0.000 description 6
- 239000001257 hydrogen Substances 0.000 description 6
- 229940121152 dimethyl fumarate 120 mg Drugs 0.000 description 5
- 201000010099 disease Diseases 0.000 description 5
- XVSXVRARWVBWOC-SEPHDYHBSA-L C(\C=C\C(=O)[O-])(=O)[O-].C(C)[Zn+2] Chemical compound C(\C=C\C(=O)[O-])(=O)[O-].C(C)[Zn+2] XVSXVRARWVBWOC-SEPHDYHBSA-L 0.000 description 4
- 206010061296 Motor dysfunction Diseases 0.000 description 4
- 208000009668 Neurobehavioral Manifestations Diseases 0.000 description 4
- 206010037180 Psychiatric symptoms Diseases 0.000 description 4
- 108020005202 Viral DNA Proteins 0.000 description 4
- 206010047571 Visual impairment Diseases 0.000 description 4
- 238000009534 blood test Methods 0.000 description 4
- 210000001175 cerebrospinal fluid Anatomy 0.000 description 4
- 230000001149 cognitive effect Effects 0.000 description 4
- 230000002089 crippling effect Effects 0.000 description 4
- 230000007423 decrease Effects 0.000 description 4
- 230000001419 dependent effect Effects 0.000 description 4
- 238000011156 evaluation Methods 0.000 description 4
- 230000001900 immune effect Effects 0.000 description 4
- 230000007420 reactivation Effects 0.000 description 4
- 229940124597 therapeutic agent Drugs 0.000 description 4
- 208000029257 vision disease Diseases 0.000 description 4
- 230000004393 visual impairment Effects 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- HSMMIAMTCHYMSY-SEPHDYHBSA-M C(\C=C\C(=O)[O-])(=O)O.C(C)[Cu+] Chemical compound C(\C=C\C(=O)[O-])(=O)O.C(C)[Cu+] HSMMIAMTCHYMSY-SEPHDYHBSA-M 0.000 description 2
- 125000000118 dimethyl group Chemical group [H]C([H])([H])* 0.000 description 2
- 150000004677 hydrates Chemical class 0.000 description 2
- 210000003000 inclusion body Anatomy 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- HCGJDBPJBSKLJG-WOGKQDBSSA-J C(\C=C\C(=O)[O-])(=O)[O-].[Cu+2].[Cu+2].C(\C=C\C(=O)[O-])(=O)[O-] Chemical compound C(\C=C\C(=O)[O-])(=O)[O-].[Cu+2].[Cu+2].C(\C=C\C(=O)[O-])(=O)[O-] HCGJDBPJBSKLJG-WOGKQDBSSA-J 0.000 description 1
- 241000238366 Cephalopoda Species 0.000 description 1
- 206010025280 Lymphocytosis Diseases 0.000 description 1
- 208000034189 Sclerosis Diseases 0.000 description 1
- 206010036807 progressive multifocal leukoencephalopathy Diseases 0.000 description 1
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462080783P | 2014-11-17 | 2014-11-17 | |
| US62/080,783 | 2014-11-17 | ||
| US201562140255P | 2015-03-30 | 2015-03-30 | |
| US62/140,255 | 2015-03-30 | ||
| US201562232963P | 2015-09-25 | 2015-09-25 | |
| US62/232,963 | 2015-09-25 | ||
| PCT/US2015/060850 WO2016081355A1 (en) | 2014-11-17 | 2015-11-16 | Methods of treating multiple sclerosis |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018221109A Division JP6830941B2 (ja) | 2014-11-17 | 2018-11-27 | 多発性硬化症の治療方法 |
| JP2020150484A Division JP2020196760A (ja) | 2014-11-17 | 2020-09-08 | 多発性硬化症の治療方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017537089A JP2017537089A (ja) | 2017-12-14 |
| JP2017537089A5 true JP2017537089A5 (enExample) | 2018-12-27 |
| JP6786486B2 JP6786486B2 (ja) | 2020-11-18 |
Family
ID=54771192
Family Applications (5)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017526549A Active JP6786486B2 (ja) | 2014-11-17 | 2015-11-16 | 多発性硬化症の治療方法 |
| JP2018221109A Active JP6830941B2 (ja) | 2014-11-17 | 2018-11-27 | 多発性硬化症の治療方法 |
| JP2020150484A Withdrawn JP2020196760A (ja) | 2014-11-17 | 2020-09-08 | 多発性硬化症の治療方法 |
| JP2022145173A Withdrawn JP2022168243A (ja) | 2014-11-17 | 2022-09-13 | 多発性硬化症の治療方法 |
| JP2025079812A Pending JP2025109834A (ja) | 2014-11-17 | 2025-05-12 | 多発性硬化症の治療方法 |
Family Applications After (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018221109A Active JP6830941B2 (ja) | 2014-11-17 | 2018-11-27 | 多発性硬化症の治療方法 |
| JP2020150484A Withdrawn JP2020196760A (ja) | 2014-11-17 | 2020-09-08 | 多発性硬化症の治療方法 |
| JP2022145173A Withdrawn JP2022168243A (ja) | 2014-11-17 | 2022-09-13 | 多発性硬化症の治療方法 |
| JP2025079812A Pending JP2025109834A (ja) | 2014-11-17 | 2025-05-12 | 多発性硬化症の治療方法 |
Country Status (13)
| Country | Link |
|---|---|
| US (9) | US20170354630A1 (enExample) |
| EP (3) | EP3804711A1 (enExample) |
| JP (5) | JP6786486B2 (enExample) |
| KR (3) | KR20210111362A (enExample) |
| CN (6) | CN115531366A (enExample) |
| AU (4) | AU2015350213A1 (enExample) |
| CA (1) | CA2967619C (enExample) |
| EA (1) | EA038370B1 (enExample) |
| IL (2) | IL269885B (enExample) |
| MA (2) | MA40985A (enExample) |
| MX (1) | MX2017006473A (enExample) |
| WO (1) | WO2016081355A1 (enExample) |
| ZA (1) | ZA201703207B (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2942690A1 (en) | 2014-03-14 | 2015-09-17 | Biogen Ma Inc. | Dimethyl fumarate and vaccination regimens |
| MA40985A (fr) | 2014-11-17 | 2017-09-26 | Biogen Ma Inc | Méthodes de traitement de la sclérose en plaques |
| SG10201907289VA (en) | 2015-02-08 | 2019-09-27 | Alkermes Pharma Ireland Ltd | Monomethylfumarate prodrug compositions |
| KR102477372B1 (ko) | 2016-04-01 | 2022-12-13 | 놈스 테크놀로지스, 인크. | 인을 함유하는 개질된 이온성 액체 |
| WO2019018432A1 (en) | 2017-07-17 | 2019-01-24 | NOHMs Technologies, Inc. | ELECTROLYTES CONTAINING PHOSPHORUS |
| WO2020214693A1 (en) * | 2019-04-17 | 2020-10-22 | Ixchel Pharma, Llc | Prodrugs of monomethyl fumarate |
| JP7224067B2 (ja) * | 2019-05-31 | 2023-02-17 | キュラクル カンパニー リミテッド | フマル酸ジメチルを含有する腸溶性錠剤 |
| TW202116297A (zh) * | 2019-07-03 | 2021-05-01 | 西班牙商布爾奴爾法碼有限公司 | 組合療法之方法、組成物與套組 |
| CN111440771A (zh) * | 2020-03-17 | 2020-07-24 | 中山大学附属第三医院 | 一种含有clcn2纯合突变的白质脑病患者特异诱导多能干细胞系 |
| CA3182369A1 (en) | 2020-05-06 | 2021-07-22 | Imcyse Sa | Combination treatment for fumarate-related diseases |
| KR102713565B1 (ko) * | 2020-11-27 | 2024-10-07 | 주식회사 뷰노 | 의료 영상 기반의 뇌백질 병변 탐지 방법 |
| KR20220133807A (ko) * | 2021-03-25 | 2022-10-05 | 주식회사 큐라클 | 특정 약동학적 매개변수를 나타내는 디메틸푸마레이트를 유효성분으로 함유한 약학적 조성물 |
| KR102566549B1 (ko) * | 2021-06-08 | 2023-08-14 | 제이투에이치바이오텍 (주) | 3성분 프로드럭, 이의 약학적 조성물 및 의약 용도 |
| US20250181224A1 (en) * | 2023-12-01 | 2025-06-05 | Lemon Inc. | Implementing dialog-based image editing |
Family Cites Families (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4959389A (en) | 1987-10-19 | 1990-09-25 | Speiser Peter P | Pharmaceutical preparation for the treatment of psoriatic arthritis |
| DE19721099C2 (de) | 1997-05-20 | 1999-12-02 | Fumapharm Ag Muri | Verwendung von Fumarsäurederivaten |
| DE19853487A1 (de) | 1998-11-19 | 2000-05-25 | Fumapharm Ag Muri | Verwendung von Dialkylfumaraten |
| EP1799196B1 (en) | 2004-10-08 | 2016-06-22 | Forward Pharma A/S | Controlled release pharmaceutical compositions comprising a fumaric acid ester |
| LT2676967T (lt) * | 2006-02-28 | 2019-09-10 | Biogen Ma Inc. | Uždegiminių ir autoimuninių ligų gydymo būdai su natalizumabu |
| EP2139467B1 (en) * | 2007-02-08 | 2016-09-21 | Biogen MA Inc. | Neuroprotection in demyelinating diseases |
| EP2334378B1 (en) | 2008-08-19 | 2014-04-09 | XenoPort, Inc. | Prodrugs of methyl hydrogen fumarate, pharmaceutical compositions thereof, and methods of use |
| SMT202500065T1 (it) | 2010-01-11 | 2025-03-12 | Biogen Ma Inc | Saggio per anticorpi del virus jc |
| KR20140036257A (ko) * | 2011-05-26 | 2014-03-25 | 바이오겐 아이덱 엠에이 인코포레이티드 | 다발성 경화증 치료 및 미엘린 함량 보존 및/또는 증가 방법 |
| KR102292563B1 (ko) | 2011-05-31 | 2021-08-24 | 바이오젠 엠에이 인코포레이티드 | Pml의 위험을 판단하는 방법 |
| CN114146079A (zh) | 2012-02-07 | 2022-03-08 | 比奥根玛公司 | 含有富马酸二甲酯的药物组合物 |
| US20140057918A1 (en) | 2012-08-22 | 2014-02-27 | Xenoport, Inc. | Methods of Use for Monomethyl Fumarate and Prodrugs Thereof |
| US20150157590A9 (en) | 2012-11-05 | 2015-06-11 | Xenoport, Inc. | Cocrystals of (n,n-diethylcarbamoyl)methyl methyl (2e)but-2-ene-1,4-dioate |
| US9868690B2 (en) | 2012-12-21 | 2018-01-16 | Ratiopharm Gmbh | Prodrugs of monomethyl fumarate (MMF) |
| JP6506174B2 (ja) | 2012-12-21 | 2019-04-24 | バイオジェン エムエー インコーポレイテッド | 重水素置換されたフマル酸誘導体 |
| US8669281B1 (en) | 2013-03-14 | 2014-03-11 | Alkermes Pharma Ireland Limited | Prodrugs of fumarates and their use in treating various diseases |
| US20140322252A1 (en) | 2013-04-26 | 2014-10-30 | Michael Ruff | Peptides for Treating Alzheimers's Disease and Related Conditions |
| CA2919381A1 (en) | 2013-08-01 | 2015-02-05 | Xenoport, Inc. | Methods of administering monomethyl fumarate and prodrugs thereof having reduced side effects |
| US9636318B2 (en) | 2015-08-31 | 2017-05-02 | Banner Life Sciences Llc | Fumarate ester dosage forms |
| AU2015222880B2 (en) | 2014-02-28 | 2016-11-24 | Banner Life Sciences Llc | Controlled release enteric soft capsules of fumarate esters |
| US9326947B1 (en) | 2014-02-28 | 2016-05-03 | Banner Life Sciences Llc | Controlled release fumarate esters |
| US10098863B2 (en) | 2014-02-28 | 2018-10-16 | Banner Life Sciences Llc | Fumarate esters |
| CA2942690A1 (en) | 2014-03-14 | 2015-09-17 | Biogen Ma Inc. | Dimethyl fumarate and vaccination regimens |
| CA2962916C (en) | 2014-10-08 | 2021-06-15 | Banner Life Sciences Llc | Controlled release enteric soft capsules of fumarate esters |
| MA40985A (fr) | 2014-11-17 | 2017-09-26 | Biogen Ma Inc | Méthodes de traitement de la sclérose en plaques |
| WO2017040272A1 (en) | 2015-08-31 | 2017-03-09 | Banner Life Sciences Llc | Fumarate ester dosage forms |
| WO2017151184A1 (en) | 2016-02-29 | 2017-09-08 | Banner Life Sciences Llc | Fumarate ester dosage forms |
| US10523918B2 (en) | 2017-03-24 | 2019-12-31 | Samsung Electronics Co., Ltd. | System and method for depth map |
-
2015
- 2015-11-15 MA MA040985A patent/MA40985A/fr unknown
- 2015-11-16 EP EP20195649.7A patent/EP3804711A1/en not_active Withdrawn
- 2015-11-16 CN CN202211204481.9A patent/CN115531366A/zh active Pending
- 2015-11-16 WO PCT/US2015/060850 patent/WO2016081355A1/en not_active Ceased
- 2015-11-16 KR KR1020217028154A patent/KR20210111362A/ko not_active Ceased
- 2015-11-16 JP JP2017526549A patent/JP6786486B2/ja active Active
- 2015-11-16 EP EP22214115.2A patent/EP4215191A1/en active Pending
- 2015-11-16 EA EA201791101A patent/EA038370B1/ru unknown
- 2015-11-16 CN CN202110623846.0A patent/CN113368091A/zh active Pending
- 2015-11-16 KR KR1020247007355A patent/KR20240035912A/ko not_active Ceased
- 2015-11-16 IL IL269885A patent/IL269885B/en unknown
- 2015-11-16 MX MX2017006473A patent/MX2017006473A/es unknown
- 2015-11-16 CA CA2967619A patent/CA2967619C/en active Active
- 2015-11-16 AU AU2015350213A patent/AU2015350213A1/en not_active Abandoned
- 2015-11-16 CN CN202211204459.4A patent/CN115501218A/zh active Pending
- 2015-11-16 US US15/527,252 patent/US20170354630A1/en not_active Abandoned
- 2015-11-16 EP EP15804260.6A patent/EP3220907A1/en not_active Ceased
- 2015-11-16 CN CN201580072773.3A patent/CN107106530A/zh active Pending
- 2015-11-16 KR KR1020177016298A patent/KR102299842B1/ko not_active Expired - Fee Related
- 2015-11-16 CN CN202110624861.7A patent/CN113368093A/zh active Pending
- 2015-11-16 CN CN202110623848.XA patent/CN113368092A/zh active Pending
- 2015-11-16 MA MA053882A patent/MA53882A/fr unknown
-
2017
- 2017-05-09 ZA ZA2017/03207A patent/ZA201703207B/en unknown
- 2017-05-15 IL IL252296A patent/IL252296B/en unknown
- 2017-07-11 US US15/647,016 patent/US11129806B2/en active Active
- 2017-07-11 US US15/647,036 patent/US20180000770A1/en not_active Abandoned
-
2018
- 2018-07-24 US US16/043,641 patent/US20190008817A1/en not_active Abandoned
- 2018-10-29 US US16/173,723 patent/US10959972B2/en active Active
- 2018-11-27 JP JP2018221109A patent/JP6830941B2/ja active Active
-
2020
- 2020-07-22 US US16/936,398 patent/US11007166B2/en active Active
- 2020-09-08 JP JP2020150484A patent/JP2020196760A/ja not_active Withdrawn
- 2020-09-24 AU AU2020239734A patent/AU2020239734A1/en not_active Abandoned
- 2020-10-15 US US17/071,740 patent/US11007167B2/en active Active
-
2021
- 2021-05-17 US US17/321,788 patent/US11246850B2/en active Active
- 2021-11-15 AU AU2021269298A patent/AU2021269298A1/en not_active Abandoned
-
2022
- 2022-09-13 JP JP2022145173A patent/JP2022168243A/ja not_active Withdrawn
-
2024
- 2024-05-23 AU AU2024203437A patent/AU2024203437A1/en active Pending
-
2025
- 2025-02-07 US US19/048,181 patent/US20260007627A1/en active Pending
- 2025-05-12 JP JP2025079812A patent/JP2025109834A/ja active Pending
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