AU2020213265B2 - Methods of treating rheumatoid arthritis, chronic spontaneous urticaria, and systemic lupus erythematosis using an inhibitor of Bruton's tyrosine kinase - Google Patents

Methods of treating rheumatoid arthritis, chronic spontaneous urticaria, and systemic lupus erythematosis using an inhibitor of Bruton's tyrosine kinase Download PDF

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Publication number
AU2020213265B2
AU2020213265B2 AU2020213265A AU2020213265A AU2020213265B2 AU 2020213265 B2 AU2020213265 B2 AU 2020213265B2 AU 2020213265 A AU2020213265 A AU 2020213265A AU 2020213265 A AU2020213265 A AU 2020213265A AU 2020213265 B2 AU2020213265 B2 AU 2020213265B2
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fenebrutinib
patient
treatment
dose
pharmaceutically acceptable
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AU2020213265A1 (en
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Leslie CHINN
David James HADDON
Tamiko KATSUMOTO
Alyssa Morimoto
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Rheumatology (AREA)
  • Transplantation (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
AU2020213265A 2019-01-22 2020-01-21 Methods of treating rheumatoid arthritis, chronic spontaneous urticaria, and systemic lupus erythematosis using an inhibitor of Bruton's tyrosine kinase Active AU2020213265B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025201888A AU2025201888A1 (en) 2019-01-22 2025-03-17 Methods of treating rheumatoid arthritis, chronic spontaneous urticaria, and systemic lupus erythematosis using an inhibitor of bruton's tyrosine kinase

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962795477P 2019-01-22 2019-01-22
US62/795,477 2019-01-22
US201962913270P 2019-10-10 2019-10-10
US62/913,270 2019-10-10
PCT/US2020/014346 WO2020154252A1 (en) 2019-01-22 2020-01-21 Methods of treating rheumatoid arthritis, chronic spontaneous urticaria, and systemic lupus erythematosis using an inhibitor of bruton's tyrosine kinase

Related Child Applications (1)

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AU2025201888A Division AU2025201888A1 (en) 2019-01-22 2025-03-17 Methods of treating rheumatoid arthritis, chronic spontaneous urticaria, and systemic lupus erythematosis using an inhibitor of bruton's tyrosine kinase

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AU2020213265A1 AU2020213265A1 (en) 2021-07-22
AU2020213265B2 true AU2020213265B2 (en) 2025-01-16

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AU2020213265A Active AU2020213265B2 (en) 2019-01-22 2020-01-21 Methods of treating rheumatoid arthritis, chronic spontaneous urticaria, and systemic lupus erythematosis using an inhibitor of Bruton's tyrosine kinase
AU2025201888A Pending AU2025201888A1 (en) 2019-01-22 2025-03-17 Methods of treating rheumatoid arthritis, chronic spontaneous urticaria, and systemic lupus erythematosis using an inhibitor of bruton's tyrosine kinase

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Country Status (11)

Country Link
US (1) US12544372B2 (https=)
EP (1) EP3914250A1 (https=)
JP (3) JP2022523018A (https=)
KR (1) KR20210119457A (https=)
CN (3) CN113423401A (https=)
AU (2) AU2020213265B2 (https=)
CA (1) CA3125236A1 (https=)
IL (1) IL284779A (https=)
MX (2) MX2021008696A (https=)
TW (1) TW202042815A (https=)
WO (1) WO2020154252A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2021249129A1 (en) 2020-04-03 2022-10-20 F. Hoffmann-La Roche Ag Methods of treating relapsing Multiple Sclerosis using an inhibitor of Bruton's tyrosine kinase
WO2024235166A1 (zh) * 2023-05-12 2024-11-21 武汉人福创新药物研发中心有限公司 含有btk抑制剂的组合物及其用途

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX362591B (es) * 2010-11-05 2019-01-25 Novartis Ag Uso de antagonistas de il-17.
UA111756C2 (uk) 2011-11-03 2016-06-10 Ф. Хоффманн-Ля Рош Аг Сполуки гетероарилпіридону та азапіридону як інгібітори тирозинкінази брутона
EP4049660B1 (en) 2016-02-29 2025-02-19 F. Hoffmann-La Roche AG Dosage form compositions comprising an inhibitor of bruton's tyrosine kinase
JP2020514384A (ja) 2017-03-24 2020-05-21 ジェネンテック， インコーポレイテッド 自己免疫及び炎症性疾患を治療する方法

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
"Study: NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)", 18 October 2018, URL: https://clinicaltrials.gov/ct2/history/NCT02833350?V_21. *
"Study: NCT02908100 - Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus", 2018, URL: https://clinicaltrials.gov/ct2/history/NCT02908100?A=21&B=21&C=merged#StudyPageTop. *
"Study: NCT03137069 Efficacy and Safety of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU)", 28 November 2018, URL: https://clinicaltrials.gov/ct2/history/NCT03137069?A=17&B=17&C=merged#StudyPageTop. *
"Study: NCT03693625 - A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study", 17 December 2018, XP055685908. *
A. E. HERMAN ET AL: "Safety, Pharmacokinetics, and Pharmacodynamics in Healthy Volunteers Treated With GDC-0853, a Selective Reversible Bruton's Tyrosine Kinase Inhibitor", CLINICAL PHARMACOLOGY AND THERAPEUTICS, 2018, 103(6): 1020-1028. *
J. J. CRAWFORD ET AL: "Discovery of GDC-0853: A Potent, Selective, and Noncovalent Bruton's Tyrosine Kinase Inhibitor in Early Clinical Development", JOURNAL OF MEDICINAL CHEMISTRY. 2018, 61(6): 2227-2245. DOI: 10.1021/acs.jmedchem.7b01712. *

Also Published As

Publication number Publication date
AU2020213265A1 (en) 2021-07-22
MX2025013950A (es) 2026-03-02
IL284779A (en) 2021-08-31
MX2021008696A (es) 2021-08-19
TW202042815A (zh) 2020-12-01
CN113423401A (zh) 2021-09-21
KR20210119457A (ko) 2021-10-05
WO2020154252A1 (en) 2020-07-30
CN118662512A (zh) 2024-09-20
AU2025201888A1 (en) 2025-04-03
JP2022523018A (ja) 2022-04-21
CA3125236A1 (en) 2020-07-30
US12544372B2 (en) 2026-02-10
JP2026041743A (ja) 2026-03-10
EP3914250A1 (en) 2021-12-01
US20220047588A1 (en) 2022-02-17
CN118453606A (zh) 2024-08-09
JP2024099575A (ja) 2024-07-25

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