JP2020512292A5 - - Google Patents
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- Publication number
- JP2020512292A5 JP2020512292A5 JP2019533167A JP2019533167A JP2020512292A5 JP 2020512292 A5 JP2020512292 A5 JP 2020512292A5 JP 2019533167 A JP2019533167 A JP 2019533167A JP 2019533167 A JP2019533167 A JP 2019533167A JP 2020512292 A5 JP2020512292 A5 JP 2020512292A5
- Authority
- JP
- Japan
- Prior art keywords
- delayed release
- linaclotide
- composition
- baseline
- use according
- 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
Links
- 230000003111 delayed Effects 0.000 claims description 67
- KXGCNMMJRFDFNR-WDRJZQOASA-N Linaclotide Chemical compound C([C@H](NC(=O)[C@@H]1CSSC[C@H]2C(=O)N[C@H]3CSSC[C@H](N)C(=O)N[C@H](C(N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=4C=CC(O)=CC=4)C(=O)N2)=O)CSSC[C@H](NC(=O)[C@H](C)NC(=O)[C@@H]2CCCN2C(=O)[C@H](CC(N)=O)NC3=O)C(=O)N[C@H](C(NCC(=O)N1)=O)[C@H](O)C)C(O)=O)C1=CC=C(O)C=C1 KXGCNMMJRFDFNR-WDRJZQOASA-N 0.000 claims description 47
- 229960000812 linaclotide Drugs 0.000 claims description 47
- 108010024409 linaclotide Proteins 0.000 claims description 47
- 239000000203 mixture Substances 0.000 claims description 46
- 239000007916 tablet composition Substances 0.000 claims description 43
- 208000004998 Abdominal Pain Diseases 0.000 claims description 33
- 229920000642 polymer Polymers 0.000 claims description 22
- 230000003442 weekly Effects 0.000 claims description 20
- 208000002193 Pain Diseases 0.000 claims description 16
- 206010010774 Constipation Diseases 0.000 claims description 13
- 208000002551 Irritable Bowel Syndrome Diseases 0.000 claims description 12
- 210000001015 Abdomen Anatomy 0.000 claims description 9
- 235000019764 Soybean Meal Nutrition 0.000 claims description 9
- 206010000060 Abdominal distension Diseases 0.000 claims description 8
- 206010060926 Abdominal symptom Diseases 0.000 claims description 8
- 239000003814 drug Substances 0.000 claims description 8
- 206010000059 Abdominal discomfort Diseases 0.000 claims description 7
- 229920003141 Eudragit® S 100 Polymers 0.000 claims description 7
- 206010012735 Diarrhoea Diseases 0.000 claims description 6
- 201000008286 diarrhea Diseases 0.000 claims description 6
- 239000003826 tablet Substances 0.000 claims description 6
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 5
- 229940079593 drugs Drugs 0.000 claims description 5
- 238000009505 enteric coating Methods 0.000 claims description 5
- 239000002702 enteric coating Substances 0.000 claims description 5
- 229960005261 Aspartic Acid Drugs 0.000 claims description 4
- 229920003139 Eudragit® L 100 Polymers 0.000 claims description 4
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims description 4
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims description 4
- 235000003704 aspartic acid Nutrition 0.000 claims description 4
- 239000011575 calcium Substances 0.000 claims description 4
- 230000002354 daily Effects 0.000 claims description 4
- 239000002552 dosage form Substances 0.000 claims description 4
- 230000000116 mitigating Effects 0.000 claims description 4
- PXHVJJICTQNCMI-UHFFFAOYSA-N nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 claims description 4
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 4
- 230000002269 spontaneous Effects 0.000 claims description 4
- 238000009498 subcoating Methods 0.000 claims description 4
- 210000002784 Stomach Anatomy 0.000 claims description 3
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims description 3
- 239000004475 Arginine Substances 0.000 claims description 2
- MTCFGRXMJLQNBG-UWTATZPHSA-N D-serine Chemical compound OC[C@@H](N)C(O)=O MTCFGRXMJLQNBG-UWTATZPHSA-N 0.000 claims description 2
- QIVBCDIJIAJPQS-SECBINFHSA-N D-tryptophane Chemical compound C1=CC=C2C(C[C@@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-SECBINFHSA-N 0.000 claims description 2
- 229920003134 Eudragit® polymer Polymers 0.000 claims description 2
- 229960002989 Glutamic Acid Drugs 0.000 claims description 2
- 229960000310 ISOLEUCINE Drugs 0.000 claims description 2
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims description 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 2
- XUJNEKJLAYXESH-REOHCLBHSA-N L-cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims description 2
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims description 2
- ZDXPYRJPNDTMRX-VKHMYHEASA-N L-glutamine Chemical compound OC(=O)[C@@H](N)CCC(N)=O ZDXPYRJPNDTMRX-VKHMYHEASA-N 0.000 claims description 2
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 claims description 2
- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims description 2
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims description 2
- COLNVLDHVKWLRT-QMMMGPOBSA-N L-phenylalanine Chemical compound OC(=O)[C@@H](N)CC1=CC=CC=C1 COLNVLDHVKWLRT-QMMMGPOBSA-N 0.000 claims description 2
- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 claims description 2
- AYFVYJQAPQTCCC-GBXIJSLDSA-N L-threonine Chemical compound C[C@@H](O)[C@H](N)C(O)=O AYFVYJQAPQTCCC-GBXIJSLDSA-N 0.000 claims description 2
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 claims description 2
- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims description 2
- 239000004472 Lysine Substances 0.000 claims description 2
- 229960005190 Phenylalanine Drugs 0.000 claims description 2
- 239000004473 Threonine Substances 0.000 claims description 2
- 235000004279 alanine Nutrition 0.000 claims description 2
- 229910052782 aluminium Inorganic materials 0.000 claims description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminum Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 2
- 235000001014 amino acid Nutrition 0.000 claims description 2
- 150000001413 amino acids Chemical class 0.000 claims description 2
- 229910052788 barium Inorganic materials 0.000 claims description 2
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium(0) Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 claims description 2
- 235000021152 breakfast Nutrition 0.000 claims description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 2
- 229910052791 calcium Inorganic materials 0.000 claims description 2
- 125000002091 cationic group Chemical group 0.000 claims description 2
- VYZAMTAEIAYCRO-UHFFFAOYSA-N chromium Chemical compound [Cr] VYZAMTAEIAYCRO-UHFFFAOYSA-N 0.000 claims description 2
- 229910052804 chromium Inorganic materials 0.000 claims description 2
- 239000011651 chromium Substances 0.000 claims description 2
- GUTLYIVDDKVIGB-UHFFFAOYSA-N cobalt Chemical compound [Co] GUTLYIVDDKVIGB-UHFFFAOYSA-N 0.000 claims description 2
- 229910052803 cobalt Inorganic materials 0.000 claims description 2
- 239000010941 cobalt Substances 0.000 claims description 2
- 235000018417 cysteine Nutrition 0.000 claims description 2
- 239000002662 enteric coated tablet Substances 0.000 claims description 2
- 238000009501 film coating Methods 0.000 claims description 2
- 235000013922 glutamic acid Nutrition 0.000 claims description 2
- 239000004220 glutamic acid Substances 0.000 claims description 2
- FYYHWMGAXLPEAU-UHFFFAOYSA-N magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 2
- 239000011777 magnesium Substances 0.000 claims description 2
- 229910052749 magnesium Inorganic materials 0.000 claims description 2
- PWHULOQIROXLJO-UHFFFAOYSA-N manganese Chemical compound [Mn] PWHULOQIROXLJO-UHFFFAOYSA-N 0.000 claims description 2
- 229910052748 manganese Inorganic materials 0.000 claims description 2
- 239000011572 manganese Substances 0.000 claims description 2
- 229910052759 nickel Inorganic materials 0.000 claims description 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 2
- 239000011591 potassium Substances 0.000 claims description 2
- 229910052700 potassium Inorganic materials 0.000 claims description 2
- 230000001681 protective Effects 0.000 claims description 2
- KEAYESYHFKHZAL-UHFFFAOYSA-N sodium Chemical compound [Na] KEAYESYHFKHZAL-UHFFFAOYSA-N 0.000 claims description 2
- 229910052708 sodium Inorganic materials 0.000 claims description 2
- 239000011734 sodium Substances 0.000 claims description 2
- 239000004474 valine Substances 0.000 claims description 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 2
- 239000011701 zinc Substances 0.000 claims description 2
- 229910052725 zinc Inorganic materials 0.000 claims description 2
- VVQNEPGJFQJSBK-UHFFFAOYSA-N 2-methyl-2-propenoic acid methyl ester Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims 2
- 229940117841 Methacrylic Acid Copolymer Drugs 0.000 claims 2
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- IWVKTOUOPHGZRX-UHFFFAOYSA-N methyl 2-methylprop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.COC(=O)C(C)=C IWVKTOUOPHGZRX-UHFFFAOYSA-N 0.000 claims 1
- 206010036772 Proctalgia Diseases 0.000 description 6
- 230000001684 chronic Effects 0.000 description 4
- 230000013872 defecation Effects 0.000 description 4
- 206010061173 Gastrointestinal motility disease Diseases 0.000 description 3
- 206010011796 Cystitis interstitial Diseases 0.000 description 2
- 208000005615 Interstitial Cystitis Diseases 0.000 description 2
- 208000009935 Visceral Pain Diseases 0.000 description 2
- 201000010874 syndrome Diseases 0.000 description 2
- 206010002644 Anorectal disease Diseases 0.000 description 1
- 206010058019 Cancer pain Diseases 0.000 description 1
- 206010009900 Colitis ulcerative Diseases 0.000 description 1
- 206010011401 Crohn's disease Diseases 0.000 description 1
- 208000007784 Diverticulitis Diseases 0.000 description 1
- 206010013554 Diverticulum Diseases 0.000 description 1
- 208000008665 Gastrointestinal Disease Diseases 0.000 description 1
- 206010061979 Genital pain Diseases 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 206010020853 Hypertonic bladder Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 210000002011 Intestinal Secretions Anatomy 0.000 description 1
- 208000002473 Lacerations Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000009722 Overactive Urinary Bladder Diseases 0.000 description 1
- 208000000450 Pelvic Pain Diseases 0.000 description 1
- 210000004197 Pelvis Anatomy 0.000 description 1
- 206010034310 Penile pain Diseases 0.000 description 1
- 206010036968 Prostatic pain Diseases 0.000 description 1
- 208000000851 Rectal Disease Diseases 0.000 description 1
- 206010036775 Rectal inflammations Diseases 0.000 description 1
- 210000004706 Scrotum Anatomy 0.000 description 1
- 206010066218 Stress urinary incontinence Diseases 0.000 description 1
- 210000001635 Urinary Tract Anatomy 0.000 description 1
- 230000003187 abdominal Effects 0.000 description 1
- 230000001154 acute Effects 0.000 description 1
- 201000005794 allergic hypersensitivity disease Diseases 0.000 description 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L cacl2 Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 1
- 159000000007 calcium salts Chemical class 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 201000009273 endometriosis Diseases 0.000 description 1
- 230000002496 gastric Effects 0.000 description 1
- 230000009610 hypersensitivity Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- IQSHMXAZFHORGY-UHFFFAOYSA-N methyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound COC(=O)C=C.CC(=C)C(O)=O IQSHMXAZFHORGY-UHFFFAOYSA-N 0.000 description 1
- 230000002980 postoperative Effects 0.000 description 1
- 230000001737 promoting Effects 0.000 description 1
- 230000001568 sexual Effects 0.000 description 1
- 230000001052 transient Effects 0.000 description 1
- 201000006704 ulcerative colitis Diseases 0.000 description 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022073214A JP2022093472A (ja) | 2016-12-21 | 2022-04-27 | リナクロチドの改変放出製剤または遅延放出製剤による過敏性腸症候群の処置方法 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662437566P | 2016-12-21 | 2016-12-21 | |
| US62/437,566 | 2016-12-21 | ||
| PCT/US2017/067814 WO2018119191A1 (en) | 2016-12-21 | 2017-12-21 | Methods of treating irritable bowel syndrome with modified or delayed release formulations of linaclotide |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022073214A Division JP2022093472A (ja) | 2016-12-21 | 2022-04-27 | リナクロチドの改変放出製剤または遅延放出製剤による過敏性腸症候群の処置方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2020512292A JP2020512292A (ja) | 2020-04-23 |
| JP2020512292A5 true JP2020512292A5 (zh) | 2021-02-04 |
Family
ID=61022424
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019533167A Pending JP2020512292A (ja) | 2016-12-21 | 2017-12-21 | リナクロチドの改変放出製剤または遅延放出製剤による過敏性腸症候群の処置方法 |
| JP2022073214A Pending JP2022093472A (ja) | 2016-12-21 | 2022-04-27 | リナクロチドの改変放出製剤または遅延放出製剤による過敏性腸症候群の処置方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022073214A Pending JP2022093472A (ja) | 2016-12-21 | 2022-04-27 | リナクロチドの改変放出製剤または遅延放出製剤による過敏性腸症候群の処置方法 |
Country Status (10)
| Country | Link |
|---|---|
| EP (1) | EP3558337A1 (zh) |
| JP (2) | JP2020512292A (zh) |
| CN (1) | CN110475564A (zh) |
| AU (1) | AU2017379082A1 (zh) |
| BR (1) | BR112019012689A2 (zh) |
| CA (1) | CA3048195A1 (zh) |
| EA (1) | EA201991531A1 (zh) |
| MA (1) | MA47112A (zh) |
| MX (2) | MX2019007574A (zh) |
| WO (1) | WO2018119191A1 (zh) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MA56128A (fr) * | 2019-06-10 | 2022-04-13 | Ironwood Pharmaceuticals Inc | Traitement de la douleur abdominale associée au syndrome du côlon irritable à diarrhée prédominante |
| MX2024006550A (es) * | 2021-11-29 | 2024-06-12 | Ironwood Pharmaceuticals Inc | Composiciones farmaceuticas para el tratamiento del dolor visceral. |
| WO2023196821A2 (en) * | 2022-04-04 | 2023-10-12 | Thomas Jefferson University | Targeting neuropod cell gucy2c to control visceral pain and appetite |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7371727B2 (en) | 2003-01-28 | 2008-05-13 | Microbia, Inc. | Methods and compositions for the treatment of gastrointestinal disorders |
| US7304036B2 (en) | 2003-01-28 | 2007-12-04 | Microbia, Inc. | Methods and compositions for the treatment of gastrointestinal disorders |
| KR20210043728A (ko) | 2008-08-15 | 2021-04-21 | 아이언우드 파마슈티컬스, 인코포레이티드 | 경구 투여를 위한 리나클로타이드-함유 제형 |
| US20130045239A1 (en) * | 2009-08-13 | 2013-02-21 | Ironwood Pharmaceuticals, Inc. | Method for Modulating the Pharmacodynamic Effect of Orally Administered Guanylate Cyclase Receptor Agonists |
| US8933030B2 (en) | 2010-02-17 | 2015-01-13 | Ironwwod Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| ES2919136T3 (es) * | 2010-08-11 | 2022-07-22 | Ironwood Pharmaceuticals Inc | Formulaciones estables de linaclotida |
| PL2776055T3 (pl) | 2011-08-17 | 2017-06-30 | Ironwood Pharmaceuticals, Inc. | Sposoby leczenia zaburzeń żołądkowo-jelitowych |
| WO2014113377A1 (en) * | 2013-01-15 | 2014-07-24 | Ironwood Pharmaceuticals, Inc. | Gastro-retentive sustained-release oral dosage form of a bile acid sequestrant |
| UA119335C2 (uk) * | 2013-12-11 | 2019-06-10 | Айронвуд Фармасьютикалз, Інк. | Композиції лінаклотиду з затриманим вивільненням |
| EP3302440B1 (en) * | 2015-06-05 | 2021-01-06 | Ironwood Pharmaceuticals, Inc. | Modified or targeted release formulations of linaclotide |
-
2017
- 2017-12-21 EP EP17833050.2A patent/EP3558337A1/en active Pending
- 2017-12-21 CA CA3048195A patent/CA3048195A1/en active Pending
- 2017-12-21 EA EA201991531A patent/EA201991531A1/ru unknown
- 2017-12-21 BR BR112019012689-9A patent/BR112019012689A2/pt unknown
- 2017-12-21 WO PCT/US2017/067814 patent/WO2018119191A1/en unknown
- 2017-12-21 CN CN201780087073.0A patent/CN110475564A/zh active Pending
- 2017-12-21 JP JP2019533167A patent/JP2020512292A/ja active Pending
- 2017-12-21 AU AU2017379082A patent/AU2017379082A1/en active Pending
- 2017-12-21 MX MX2019007574A patent/MX2019007574A/es unknown
- 2017-12-21 MA MA047112A patent/MA47112A/fr unknown
-
2019
- 2019-06-21 MX MX2023008839A patent/MX2023008839A/es unknown
-
2022
- 2022-04-27 JP JP2022073214A patent/JP2022093472A/ja active Pending
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