JPWO2021126884A5 - - Google Patents
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- JPWO2021126884A5 JPWO2021126884A5 JP2022537748A JP2022537748A JPWO2021126884A5 JP WO2021126884 A5 JPWO2021126884 A5 JP WO2021126884A5 JP 2022537748 A JP2022537748 A JP 2022537748A JP 2022537748 A JP2022537748 A JP 2022537748A JP WO2021126884 A5 JPWO2021126884 A5 JP WO2021126884A5
- Authority
- JP
- Japan
- Prior art keywords
- levosimendan
- human subject
- administration
- pharmaceutical composition
- subject
- 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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- WHXMKTBCFHIYNQ-SECBINFHSA-N levosimendan Chemical compound C[C@@H]1CC(=O)NN=C1C1=CC=C(NN=C(C#N)C#N)C=C1 WHXMKTBCFHIYNQ-SECBINFHSA-N 0.000 claims description 64
- 229960000692 levosimendan Drugs 0.000 claims description 64
- 230000002685 pulmonary effect Effects 0.000 claims description 32
- 238000001802 infusion Methods 0.000 claims description 24
- 239000002207 metabolite Substances 0.000 claims description 24
- 208000038003 heart failure with preserved ejection fraction Diseases 0.000 claims description 19
- 239000000203 mixture Substances 0.000 claims description 19
- 239000008194 pharmaceutical composition Substances 0.000 claims description 15
- 206010020772 Hypertension Diseases 0.000 claims description 13
- 238000009472 formulation Methods 0.000 claims description 13
- 230000001631 hypertensive effect Effects 0.000 claims description 13
- 230000001746 atrial effect Effects 0.000 claims description 8
- 230000006872 improvement Effects 0.000 claims description 5
- 210000004369 blood Anatomy 0.000 claims description 4
- 239000008280 blood Substances 0.000 claims description 4
- 239000002775 capsule Substances 0.000 claims description 4
- 238000012544 monitoring process Methods 0.000 claims description 4
- 230000003442 weekly effect Effects 0.000 claims description 3
- 206010003130 Arrhythmia supraventricular Diseases 0.000 claims description 2
- 206010047281 Ventricular arrhythmia Diseases 0.000 claims description 2
- 230000002411 adverse Effects 0.000 claims description 2
- 230000001684 chronic effect Effects 0.000 claims description 2
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims description 2
- 229940068196 placebo Drugs 0.000 claims description 2
- 239000000902 placebo Substances 0.000 claims description 2
- 238000013268 sustained release Methods 0.000 claims description 2
- 239000012730 sustained-release form Substances 0.000 claims description 2
- 230000002349 favourable effect Effects 0.000 claims 1
- 238000000034 method Methods 0.000 description 47
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 30
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 30
- 238000007920 subcutaneous administration Methods 0.000 description 22
- 238000002560 therapeutic procedure Methods 0.000 description 14
- 229940118365 Endothelin receptor antagonist Drugs 0.000 description 12
- 239000002327 cardiovascular agent Substances 0.000 description 12
- 229940125692 cardiovascular agent Drugs 0.000 description 12
- 239000002308 endothelin receptor antagonist Substances 0.000 description 12
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 10
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 10
- 229960004106 citric acid Drugs 0.000 description 10
- 239000012141 concentrate Substances 0.000 description 10
- 239000008121 dextrose Substances 0.000 description 10
- 229960004756 ethanol Drugs 0.000 description 10
- 239000003112 inhibitor Substances 0.000 description 10
- 229940114897 levosimendan 2.5 mg/ml Drugs 0.000 description 10
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 10
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 10
- 229940069328 povidone Drugs 0.000 description 10
- 229940124549 vasodilator Drugs 0.000 description 10
- 239000003071 vasodilator agent Substances 0.000 description 10
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- 239000011780 sodium chloride Substances 0.000 description 9
- 230000000747 cardiac effect Effects 0.000 description 8
- 230000007423 decrease Effects 0.000 description 8
- 239000003814 drug Substances 0.000 description 7
- 238000002360 preparation method Methods 0.000 description 7
- 230000009467 reduction Effects 0.000 description 7
- 230000006641 stabilisation Effects 0.000 description 7
- 238000011105 stabilization Methods 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- 102000002723 Atrial Natriuretic Factor Human genes 0.000 description 6
- 101800001288 Atrial natriuretic factor Proteins 0.000 description 6
- RPTUSVTUFVMDQK-UHFFFAOYSA-N Hidralazin Chemical compound C1=CC=C2C(NN)=NN=CC2=C1 RPTUSVTUFVMDQK-UHFFFAOYSA-N 0.000 description 6
- 102000003729 Neprilysin Human genes 0.000 description 6
- 108090000028 Neprilysin Proteins 0.000 description 6
- 230000004872 arterial blood pressure Effects 0.000 description 6
- 229960001123 epoprostenol Drugs 0.000 description 6
- KAQKFAOMNZTLHT-VVUHWYTRSA-N epoprostenol Chemical compound O1C(=CCCCC(O)=O)C[C@@H]2[C@@H](/C=C/[C@@H](O)CCCCC)[C@H](O)C[C@@H]21 KAQKFAOMNZTLHT-VVUHWYTRSA-N 0.000 description 6
- 210000001147 pulmonary artery Anatomy 0.000 description 6
- 239000013011 aqueous formulation Substances 0.000 description 5
- 239000002876 beta blocker Substances 0.000 description 5
- 229940097320 beta blocking agent Drugs 0.000 description 5
- 239000003085 diluting agent Substances 0.000 description 5
- 208000002815 pulmonary hypertension Diseases 0.000 description 5
- UUUHXMGGBIUAPW-UHFFFAOYSA-N 1-[1-[2-[[5-amino-2-[[1-[5-(diaminomethylideneamino)-2-[[1-[3-(1h-indol-3-yl)-2-[(5-oxopyrrolidine-2-carbonyl)amino]propanoyl]pyrrolidine-2-carbonyl]amino]pentanoyl]pyrrolidine-2-carbonyl]amino]-5-oxopentanoyl]amino]-3-methylpentanoyl]pyrrolidine-2-carbon Chemical compound C1CCC(C(=O)N2C(CCC2)C(O)=O)N1C(=O)C(C(C)CC)NC(=O)C(CCC(N)=O)NC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C1CCCN1C(=O)C(CC=1C2=CC=CC=C2NC=1)NC(=O)C1CCC(=O)N1 UUUHXMGGBIUAPW-UHFFFAOYSA-N 0.000 description 4
- 229940127291 Calcium channel antagonist Drugs 0.000 description 4
- 102000004270 Peptidyl-Dipeptidase A Human genes 0.000 description 4
- 108090000882 Peptidyl-Dipeptidase A Proteins 0.000 description 4
- 229940123333 Phosphodiesterase 5 inhibitor Drugs 0.000 description 4
- 102000011016 Type 5 Cyclic Nucleotide Phosphodiesterases Human genes 0.000 description 4
- 108010037581 Type 5 Cyclic Nucleotide Phosphodiesterases Proteins 0.000 description 4
- 239000000480 calcium channel blocker Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 102000008873 Angiotensin II receptor Human genes 0.000 description 3
- 108050000824 Angiotensin II receptor Proteins 0.000 description 3
- 101800001890 Atrial natriuretic peptide Proteins 0.000 description 3
- 108091006146 Channels Proteins 0.000 description 3
- LTMHDMANZUZIPE-AMTYYWEZSA-N Digoxin Natural products O([C@H]1[C@H](C)O[C@H](O[C@@H]2C[C@@H]3[C@@](C)([C@@H]4[C@H]([C@]5(O)[C@](C)([C@H](O)C4)[C@H](C4=CC(=O)OC4)CC5)CC3)CC2)C[C@@H]1O)[C@H]1O[C@H](C)[C@@H](O[C@H]2O[C@@H](C)[C@H](O)[C@@H](O)C2)[C@@H](O)C1 LTMHDMANZUZIPE-AMTYYWEZSA-N 0.000 description 3
- 206010019280 Heart failures Diseases 0.000 description 3
- 108020001621 Natriuretic Peptide Proteins 0.000 description 3
- 102000004571 Natriuretic peptide Human genes 0.000 description 3
- 229940099471 Phosphodiesterase inhibitor Drugs 0.000 description 3
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 3
- 102000007637 Soluble Guanylyl Cyclase Human genes 0.000 description 3
- 108010007205 Soluble Guanylyl Cyclase Proteins 0.000 description 3
- 239000012190 activator Substances 0.000 description 3
- 239000002170 aldosterone antagonist Substances 0.000 description 3
- 229940083712 aldosterone antagonist Drugs 0.000 description 3
- 229940125364 angiotensin receptor blocker Drugs 0.000 description 3
- NSQLIUXCMFBZME-MPVJKSABSA-N carperitide Chemical compound C([C@H]1C(=O)NCC(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@H](C(NCC(=O)N[C@@H](C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CSSC[C@@H](C(=O)N1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](N)CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(O)=O)=O)[C@@H](C)CC)C1=CC=CC=C1 NSQLIUXCMFBZME-MPVJKSABSA-N 0.000 description 3
- 208000029078 coronary artery disease Diseases 0.000 description 3
- 235000014113 dietary fatty acids Nutrition 0.000 description 3
- 229960005156 digoxin Drugs 0.000 description 3
- LTMHDMANZUZIPE-PUGKRICDSA-N digoxin Chemical compound C1[C@H](O)[C@H](O)[C@@H](C)O[C@H]1O[C@@H]1[C@@H](C)O[C@@H](O[C@@H]2[C@H](O[C@@H](O[C@@H]3C[C@@H]4[C@]([C@@H]5[C@H]([C@]6(CC[C@@H]([C@@]6(C)[C@H](O)C5)C=5COC(=O)C=5)O)CC4)(C)CC3)C[C@@H]2O)C)C[C@@H]1O LTMHDMANZUZIPE-PUGKRICDSA-N 0.000 description 3
- LTMHDMANZUZIPE-UHFFFAOYSA-N digoxine Natural products C1C(O)C(O)C(C)OC1OC1C(C)OC(OC2C(OC(OC3CC4C(C5C(C6(CCC(C6(C)C(O)C5)C=5COC(=O)C=5)O)CC4)(C)CC3)CC2O)C)CC1O LTMHDMANZUZIPE-UHFFFAOYSA-N 0.000 description 3
- 239000002934 diuretic Substances 0.000 description 3
- 239000002792 enkephalinase inhibitor Substances 0.000 description 3
- 229930195729 fatty acid Natural products 0.000 description 3
- 239000000194 fatty acid Substances 0.000 description 3
- 150000004665 fatty acids Chemical class 0.000 description 3
- 239000003119 guanylate cyclase activator Substances 0.000 description 3
- 229960002474 hydralazine Drugs 0.000 description 3
- 238000001990 intravenous administration Methods 0.000 description 3
- 229960003825 ivabradine Drugs 0.000 description 3
- ACRHBAYQBXXRTO-OAQYLSRUSA-N ivabradine Chemical compound C1CC2=CC(OC)=C(OC)C=C2CC(=O)N1CCCN(C)C[C@H]1CC2=C1C=C(OC)C(OC)=C2 ACRHBAYQBXXRTO-OAQYLSRUSA-N 0.000 description 3
- 239000000692 natriuretic peptide Substances 0.000 description 3
- 230000003647 oxidation Effects 0.000 description 3
- 238000007254 oxidation reaction Methods 0.000 description 3
- 239000011591 potassium Substances 0.000 description 3
- 229910052700 potassium Inorganic materials 0.000 description 3
- 229940127293 prostanoid Drugs 0.000 description 3
- 150000003814 prostanoids Chemical class 0.000 description 3
- 210000002966 serum Anatomy 0.000 description 3
- 239000008215 water for injection Substances 0.000 description 3
- JRWZLRBJNMZMFE-UHFFFAOYSA-N Dobutamine Chemical compound C=1C=C(O)C(O)=CC=1CCNC(C)CCC1=CC=C(O)C=C1 JRWZLRBJNMZMFE-UHFFFAOYSA-N 0.000 description 2
- 206010064911 Pulmonary arterial hypertension Diseases 0.000 description 2
- 239000002333 angiotensin II receptor antagonist Substances 0.000 description 2
- 238000007675 cardiac surgery Methods 0.000 description 2
- 230000009429 distress Effects 0.000 description 2
- 229940030606 diuretics Drugs 0.000 description 2
- 229960001089 dobutamine Drugs 0.000 description 2
- 208000038002 heart failure with reduced ejection fraction Diseases 0.000 description 2
- 210000005240 left ventricle Anatomy 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 150000002823 nitrates Chemical class 0.000 description 2
- 150000002826 nitrites Chemical class 0.000 description 2
- 238000013146 percutaneous coronary intervention Methods 0.000 description 2
- 230000035882 stress Effects 0.000 description 2
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 description 2
- 108090000312 Calcium Channels Proteins 0.000 description 1
- 102000003922 Calcium Channels Human genes 0.000 description 1
- 208000002330 Congenital Heart Defects Diseases 0.000 description 1
- 102000001554 Hemoglobins Human genes 0.000 description 1
- 108010054147 Hemoglobins Proteins 0.000 description 1
- 208000019693 Lung disease Diseases 0.000 description 1
- 229910002651 NO3 Inorganic materials 0.000 description 1
- NHNBFGGVMKEFGY-UHFFFAOYSA-N Nitrate Chemical compound [O-][N+]([O-])=O NHNBFGGVMKEFGY-UHFFFAOYSA-N 0.000 description 1
- IOVCWXUNBOPUCH-UHFFFAOYSA-M Nitrite anion Chemical compound [O-]N=O IOVCWXUNBOPUCH-UHFFFAOYSA-M 0.000 description 1
- 208000008166 Right Ventricular Dysfunction Diseases 0.000 description 1
- 206010039163 Right ventricular failure Diseases 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 229940044094 angiotensin-converting-enzyme inhibitor Drugs 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
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- 208000028831 congenital heart disease Diseases 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
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- 230000001882 diuretic effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000024924 glomerular filtration Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 208000026278 immune system disease Diseases 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 230000005976 liver dysfunction Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 239000002840 nitric oxide donor Substances 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 230000036470 plasma concentration Effects 0.000 description 1
- 239000003087 receptor blocking agent Substances 0.000 description 1
- 230000006814 right ventricular dysfunction Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 230000035488 systolic blood pressure Effects 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
Applications Claiming Priority (11)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201962948735P | 2019-12-16 | 2019-12-16 | |
US62/948,735 | 2019-12-16 | ||
US202062967920P | 2020-01-30 | 2020-01-30 | |
US62/967,920 | 2020-01-30 | ||
US202062988720P | 2020-03-12 | 2020-03-12 | |
US62/988,720 | 2020-03-12 | ||
US202063033773P | 2020-06-02 | 2020-06-02 | |
US63/033,773 | 2020-06-02 | ||
US202063064671P | 2020-08-12 | 2020-08-12 | |
US63/064,671 | 2020-08-12 | ||
PCT/US2020/065166 WO2021126884A1 (en) | 2019-12-16 | 2020-12-15 | LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HF-pEF) |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2023507626A JP2023507626A (ja) | 2023-02-24 |
JPWO2021126884A5 true JPWO2021126884A5 (zh) | 2023-12-22 |
Family
ID=76316595
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2022537748A Pending JP2023507626A (ja) | 2019-12-16 | 2020-12-15 | 駆出率が保たれた心不全を伴う肺高血圧症(PH-HF-pEF)を治療するためのレボシメンダン |
Country Status (6)
Country | Link |
---|---|
US (3) | US11969424B2 (zh) |
EP (1) | EP4076398A4 (zh) |
JP (1) | JP2023507626A (zh) |
AU (1) | AU2020408323A1 (zh) |
CA (1) | CA3161960A1 (zh) |
WO (1) | WO2021126884A1 (zh) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2021126884A1 (en) | 2019-12-16 | 2021-06-24 | Tenax Therapeutics, Inc. | LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HF-pEF) |
WO2023102452A1 (en) * | 2021-12-02 | 2023-06-08 | Tenax Therapeutics, Inc. | Use of a combination of levosimendan and an sglt-2 inhibitor to treat heart failure |
WO2023130028A1 (en) * | 2021-12-31 | 2023-07-06 | Tenax Therapeutics, Inc. | Oral formulations of levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction |
WO2023210634A1 (ja) * | 2022-04-28 | 2023-11-02 | 国立大学法人東海国立大学機構 | 拡張障害を伴う心不全の治療用医薬組成物 |
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FI973804A (fi) | 1997-09-26 | 1999-03-27 | Orion Yhtymae Oy | Levosimendaanin oraalisia koostumuksia |
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2020
- 2020-12-15 WO PCT/US2020/065166 patent/WO2021126884A1/en unknown
- 2020-12-15 CA CA3161960A patent/CA3161960A1/en active Pending
- 2020-12-15 AU AU2020408323A patent/AU2020408323A1/en active Pending
- 2020-12-15 US US17/122,921 patent/US11969424B2/en active Active
- 2020-12-15 JP JP2022537748A patent/JP2023507626A/ja active Pending
- 2020-12-15 EP EP20900848.1A patent/EP4076398A4/en active Pending
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2021
- 2021-08-24 US US17/410,897 patent/US11607412B2/en active Active
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2022
- 2022-11-18 US US18/057,116 patent/US11701355B2/en active Active
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