JP7564347B2 - 多発性硬化症を治療するためのｌｏｕ０６４ - Google Patents

多発性硬化症を治療するためのｌｏｕ０６４ Download PDF

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JP7564347B2
JP7564347B2 JP2023517239A JP2023517239A JP7564347B2 JP 7564347 B2 JP7564347 B2 JP 7564347B2 JP 2023517239 A JP2023517239 A JP 2023517239A JP 2023517239 A JP2023517239 A JP 2023517239A JP 7564347 B2 JP7564347 B2 JP 7564347B2
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lou064
treatment
pharmaceutical composition
btk
dose
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JP2023542878A (ja
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バッタチャリア，スヴィック
ビエス，ブルーノ
チェンニ，ブルーノ
エンド，ピーター
グラハム，ゴードン
ユンケ，マイケル
シン カラン，ラジェシュ
ドナ マン，アリソン
ピジョレット，エチエンヌ
ラップ，カリン
シン，キム－ヒエン
ユ，フイシン
ジャン，イン
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ノバルティス アーゲー
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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2023517239A 2021-09-03 2022-09-01 多発性硬化症を治療するためのｌｏｕ０６４ Active JP7564347B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024167085A JP2024178420A (ja) 2021-09-03 2024-09-26 多発性硬化症を治療するためのｌｏｕ０６４

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US202163240444P 2021-09-03 2021-09-03
US63/240,444 2021-09-03
US202163282363P 2021-11-23 2021-11-23
US63/282,363 2021-11-23
US202263304106P 2022-01-28 2022-01-28
US63/304,106 2022-01-28
US202263353866P 2022-06-21 2022-06-21
US63/353,866 2022-06-21
US202263369008P 2022-07-21 2022-07-21
US63/369,008 2022-07-21
PCT/IB2022/058205 WO2023031840A1 (en) 2021-09-03 2022-09-01 Lou064 for treating multiple sclerosis

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JP2024167085A Division JP2024178420A (ja) 2021-09-03 2024-09-26 多発性硬化症を治療するためのｌｏｕ０６４

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JP2023542878A JP2023542878A (ja) 2023-10-12
JP7564347B2 true JP7564347B2 (ja) 2024-10-08

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US (1) US20240350489A1 (https=)
EP (1) EP4395779A1 (https=)
JP (2) JP7564347B2 (https=)
KR (1) KR20240055038A (https=)
AU (1) AU2022337087A1 (https=)
CA (1) CA3229887A1 (https=)
IL (1) IL310975A (https=)
MX (1) MX2024002581A (https=)
TW (1) TW202310841A (https=)
WO (1) WO2023031840A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2021398051A1 (en) 2020-12-10 2023-07-27 Principia Biopharma Inc. Crystal form of tolebrutinib, preparation method therefor and use thereof
EP4522170A1 (en) * 2022-05-13 2025-03-19 Principia Biopharma Inc. Bruton tyrosine kinase inhibitors for use in the treatment of myelin oligodendrocyte glycoprotein antibody disease (mogad)
CN119744171A (zh) * 2022-06-24 2025-04-01 默克专利股份公司 自身免疫病和炎性疾病的治疗方案
US20250243170A1 (en) * 2024-01-26 2025-07-31 Novartis Ag Remibrutinib drug substance and drug product substantially free of nitrosamine impurity

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016538313A (ja) 2013-11-29 2016-12-08 ノバルティス アーゲー 新規なアミノピリミジン誘導体
WO2020028258A1 (en) 2018-07-31 2020-02-06 Loxo Oncology, Inc. Spray-dried dispersions and formulations of (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoro propan-2-yl)-1h-pyrazole-4-carboxamide
WO2020234779A1 (en) 2019-05-23 2020-11-26 Novartis Ag Crystalline forms of a btk inhibitor

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130197080A1 (en) * 2010-08-02 2013-08-01 Sanofi Use of teriflunomide for treating multiple sclerosis
MX2020007312A (es) * 2018-01-08 2021-01-08 G1 Therapeutics Inc Regimenes de dosificacion superior de g1t38.
MX2021014161A (es) 2019-05-23 2022-01-04 Novartis Ag Metodos de tratamiento del sindrome de sjogren utilizando un inhibidor de la tirosina quinasa de bruton.
HRP20251001T1 (hr) 2019-05-23 2025-10-24 Novartis Ag Inhibitor brutonove tirozin kinaze za upotrebu u liječenju kronične spontane urtikarije
WO2022081512A1 (en) * 2020-10-12 2022-04-21 Synubi Pharmaceuticals Llc Compositions and methods of treatment of neuroinflammatory diseases with bruton's tyrosine kinase inhibitors
TWI905371B (zh) * 2021-01-26 2025-11-21 瑞士商諾華公司 藥物組成物
EP4301365A1 (en) * 2021-03-03 2024-01-10 Janssen Pharmaceutica NV Combination therapy using a malt1 inhibitor and a btk inhibitor

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016538313A (ja) 2013-11-29 2016-12-08 ノバルティス アーゲー 新規なアミノピリミジン誘導体
WO2020028258A1 (en) 2018-07-31 2020-02-06 Loxo Oncology, Inc. Spray-dried dispersions and formulations of (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoro propan-2-yl)-1h-pyrazole-4-carboxamide
WO2020234779A1 (en) 2019-05-23 2020-11-26 Novartis Ag Crystalline forms of a btk inhibitor

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Martin KAUL et al.，"Remibrutinib (LOU064): A selective potent oral BTK inhibitor with promising clinical safety and pharmacodynamics in a randomized phase I trial"，Clinical and Translational Science，2021年04月09日，Vol.14，p.1756-1768，DOI: 10.1111/cts.13005
Ronen GABIZON et al.，"A Fast and Clean BTK Inhibitor"，Journal of Medicinal Chemistry，2020年，Vol.63，p.5100-5101，DOI:10.1021/acs.jmedchem.0c00597
Xavier MONTALBAN et al.，"Placebo-Controlled Trial of an Oral BTK Inhibitor in Multiple Sclerosis"，New England Journal of Medicine，2019年，Vol.380，No.25，p.2406-2417，DOI: 10.1056/NEJMoa1901981

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MX2024002581A (es) 2024-03-20
KR20240055038A (ko) 2024-04-26
TW202310841A (zh) 2023-03-16
EP4395779A1 (en) 2024-07-10
JP2023542878A (ja) 2023-10-12
JP2024178420A (ja) 2024-12-24
US20240350489A1 (en) 2024-10-24
IL310975A (en) 2024-04-01
AU2022337087A1 (en) 2024-03-14
WO2023031840A1 (en) 2023-03-09
CA3229887A1 (en) 2023-03-09

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