CA3201512A1 - Methods of improving the pharmacokinetics of migalastat - Google Patents

Methods of improving the pharmacokinetics of migalastat Download PDF

Info

Publication number
CA3201512A1
CA3201512A1 CA3201512A CA3201512A CA3201512A1 CA 3201512 A1 CA3201512 A1 CA 3201512A1 CA 3201512 A CA3201512 A CA 3201512A CA 3201512 A CA3201512 A CA 3201512A CA 3201512 A1 CA3201512 A1 CA 3201512A1
Authority
CA
Canada
Prior art keywords
migalastat
salt
patient
caffeine
hours
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
Application number
CA3201512A
Other languages
English (en)
French (fr)
Inventor
Franklin Johnson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amicus Therapeutics Inc
Original Assignee
Amicus Therapeutics Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Amicus Therapeutics Inc filed Critical Amicus Therapeutics Inc
Publication of CA3201512A1 publication Critical patent/CA3201512A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA3201512A 2022-12-13 2023-05-31 Methods of improving the pharmacokinetics of migalastat Pending CA3201512A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202263432235P 2022-12-13 2022-12-13
US63/432,235 2022-12-13
US18/315,928 US20240197706A1 (en) 2022-12-13 2023-05-11 Methods of improving the pharmacokinetics of migalastat
US18/315,928 2023-05-11

Publications (1)

Publication Number Publication Date
CA3201512A1 true CA3201512A1 (en) 2024-06-13

Family

ID=86646511

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3201512A Pending CA3201512A1 (en) 2022-12-13 2023-05-31 Methods of improving the pharmacokinetics of migalastat

Country Status (23)

Country Link
US (1) US20240197706A1 (https=)
EP (2) EP4667050A3 (https=)
JP (2) JP7757345B2 (https=)
KR (1) KR20240094973A (https=)
AU (1) AU2023396459A1 (https=)
CA (1) CA3201512A1 (https=)
CL (1) CL2025001743A1 (https=)
CO (1) CO2025009079A2 (https=)
DE (1) DE202023003007U1 (https=)
DK (1) DK4385509T3 (https=)
ES (1) ES3055214T3 (https=)
FI (1) FI4385509T3 (https=)
HR (1) HRP20251472T1 (https=)
IL (1) IL321404A (https=)
LT (1) LT4385509T (https=)
MX (1) MX2025006897A (https=)
PL (1) PL4385509T3 (https=)
PT (1) PT4385509T (https=)
RS (1) RS67478B1 (https=)
SI (1) SI4385509T1 (https=)
SM (1) SMT202500453T1 (https=)
TW (1) TW202423436A (https=)
WO (1) WO2024129220A1 (https=)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6274597B1 (en) 1998-06-01 2001-08-14 Mount Sinai School Of Medicine Of New York University Method of enhancing lysosomal α-Galactosidase A
AU2008232614A1 (en) 2007-03-30 2008-10-09 Amicus Therapeutics, Inc. Method for the treatment of Fabry disease using pharmacological chaperones
US9999618B2 (en) * 2007-04-26 2018-06-19 Amicus Therapeutics, Inc. Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
SI3470077T1 (sl) 2008-02-12 2020-12-31 Amicus Therapeutics, Inc. Postopek za napovedovanje odgovora na zdravljenje bolezni s farmakološkim spremljevalcem
CN103974619B (zh) * 2011-03-11 2017-02-15 阿米库斯治疗学公司 治疗法布里病的给药方案
EP4426846A4 (en) * 2021-11-03 2025-11-05 Sangamo Therapeutics Inc METHODS OF USING VIRAL VECTOR CONSTRUCTIONS FOR THE TREATMENT OF FABRY DISEASE

Also Published As

Publication number Publication date
SI4385509T1 (sl) 2026-01-30
PL4385509T3 (pl) 2026-02-16
WO2024129220A1 (en) 2024-06-20
FI4385509T3 (fi) 2025-12-05
DK4385509T3 (da) 2025-12-08
HRP20251472T1 (hr) 2026-01-02
MX2025006897A (es) 2025-07-01
LT4385509T (lt) 2025-12-29
EP4667050A3 (en) 2026-03-25
EP4385509B1 (en) 2025-09-03
KR20240094973A (ko) 2024-06-25
DE202023003007U1 (de) 2025-07-21
SMT202500453T1 (it) 2026-01-12
EP4385509A1 (en) 2024-06-19
JP7757345B2 (ja) 2025-10-21
PT4385509T (pt) 2025-11-25
TW202423436A (zh) 2024-06-16
JP2024084670A (ja) 2024-06-25
US20240197706A1 (en) 2024-06-20
JP2026031546A (ja) 2026-02-24
CO2025009079A2 (es) 2025-09-29
IL321404A (en) 2025-08-01
EP4667050A2 (en) 2025-12-24
RS67478B1 (sr) 2025-12-31
AU2023396459A1 (en) 2025-06-26
ES3055214T3 (en) 2026-02-10
CL2025001743A1 (es) 2025-10-03

Similar Documents

Publication Publication Date Title
US11278537B2 (en) Methods of treating Fabry patients having renal impairment
US20220313670A1 (en) Methods Of Treating Fabry Disease In Patients Having Renal Impairment
EP4103178B1 (en) Methods of treating fabry disease
US20240293387A1 (en) Methods of Treating Fabry Disease in Pediatric Patients
EP4385509B1 (en) Migalastat dosage regimen having improved pharmacokinetics
HK40110919A (en) Migalastat dosage regimen having improved pharmacokinetics
HK40110919B (en) Migalastat dosage regimen having improved pharmacokinetics
CN118488839A (zh) 改善米加司他的药代动力学的方法
US20260076951A1 (en) Methods of treating fabry disease in patients having renal impairment

Legal Events

Date Code Title Description
MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 2ND ANNIV.) - STANDARD

Year of fee payment: 2

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250507

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250507

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D11-D117 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION RECEIVED

Effective date: 20250926

D16 Fast track examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D16-D108 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ADVANCED EXAMINATION REQUESTED - PPH

Effective date: 20250926

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-P10-P11-P101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - VOLUNTARY AMENDMENT

Effective date: 20250926

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20250926

D00 Search and/or examination requested or commenced

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D00-D118 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20251001

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D11-D155 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ALL REQUIREMENTS FOR EXAMINATION DETERMINED COMPLIANT

Effective date: 20251001

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20251001

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20251001

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20251001

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20251001

D17 Fast track examination accepted

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D17-D112 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ADVANCED EXAMINATION DETERMINED COMPLIANT - PPH

Effective date: 20251029

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20251029

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20251118

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION

Effective date: 20260318

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260324

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20260331

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20260331

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20260409

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 3RD ANNIV.) - STANDARD

Year of fee payment: 3

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20260409

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20260409