[go: up one dir, main page]

PE20241183A1 - Composiciones farmaceuticas de efruxifermina - Google Patents

Composiciones farmaceuticas de efruxifermina

Info

Publication number
PE20241183A1
PE20241183A1 PE2024000812A PE2024000812A PE20241183A1 PE 20241183 A1 PE20241183 A1 PE 20241183A1 PE 2024000812 A PE2024000812 A PE 2024000812A PE 2024000812 A PE2024000812 A PE 2024000812A PE 20241183 A1 PE20241183 A1 PE 20241183A1
Authority
PE
Peru
Prior art keywords
arginine
efruxifermina
pharmaceutical compositions
composition
efx
Prior art date
Application number
PE2024000812A
Other languages
English (en)
Inventor
Mariana N Dimitrova
Timothy P Rolph
Simon Eisele
James Bostick
Original Assignee
Akero 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 Akero Therapeutics Inc filed Critical Akero Therapeutics Inc
Publication of PE20241183A1 publication Critical patent/PE20241183A1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1825—Fibroblast growth factor [FGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Referido a una composicion farmaceutica, caracterizada porque comprende: (i) Efruxifermina (EFX); (ii) un azucar; (iii) aproximadamente 20 hasta aproximadamente 200 mM de arginina/arginina-HCl o arginina/acido glutamico; y (iv) un tensioactivo; en donde la composicion tiene un pH desde aproximadamente 6,9 hasta aproximadamente 8,1; y la concentracion de EFX es aproximadamente 25 hasta aproximadamente 150 mg/ml. Tambien se refiere a un proceso para preparar una composicion liofilizada, un metodo para reconstituir dicho compuesto liofilizado y su uso para tratar esteatohepatitis no alcoholica (NASH) o enfermedad de higado graso no alcoholica (NAFL), entre otros.
PE2024000812A 2021-10-13 2022-10-12 Composiciones farmaceuticas de efruxifermina PE20241183A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163255286P 2021-10-13 2021-10-13
PCT/US2022/077968 WO2023064808A1 (en) 2021-10-13 2022-10-12 Pharmaceutical compositions of efruxifermin

Publications (1)

Publication Number Publication Date
PE20241183A1 true PE20241183A1 (es) 2024-06-03

Family

ID=84329326

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2024000812A PE20241183A1 (es) 2021-10-13 2022-10-12 Composiciones farmaceuticas de efruxifermina

Country Status (15)

Country Link
US (1) US20250302919A1 (es)
EP (1) EP4415758A1 (es)
JP (1) JP2024538158A (es)
KR (1) KR20240099278A (es)
CN (1) CN118382460A (es)
AU (1) AU2022361936A1 (es)
CA (1) CA3233918A1 (es)
CL (1) CL2024001125A1 (es)
CO (1) CO2024005859A2 (es)
CR (1) CR20240192A (es)
IL (1) IL312073A (es)
MA (1) MA65161A1 (es)
MX (1) MX2024004463A (es)
PE (1) PE20241183A1 (es)
WO (1) WO2023064808A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025155843A1 (en) * 2024-01-19 2025-07-24 Akero Therapeutics, Inc. Method of treating liver or lung injury

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20190083A1 (ar) 2008-06-04 2017-06-16 Amgen Inc بولي ببتيدات اندماجية طافرة لـfgf21 واستخداماتها
CN102655877B (zh) 2009-05-05 2017-04-05 安姆根有限公司 Fgf21突变体及其用途
CN111195234B (zh) * 2018-11-16 2022-08-26 鲁南制药集团股份有限公司 一种重组FGF21-Fc融合蛋白冻干粉制剂

Also Published As

Publication number Publication date
IL312073A (en) 2024-06-01
AU2022361936A1 (en) 2024-05-09
US20250302919A1 (en) 2025-10-02
CR20240192A (es) 2024-09-13
WO2023064808A1 (en) 2023-04-20
JP2024538158A (ja) 2024-10-18
KR20240099278A (ko) 2024-06-28
CA3233918A1 (en) 2023-04-20
MX2024004463A (es) 2024-06-03
CL2024001125A1 (es) 2024-09-06
CO2024005859A2 (es) 2024-05-10
CN118382460A (zh) 2024-07-23
EP4415758A1 (en) 2024-08-21
MA65161A1 (fr) 2024-10-31

Similar Documents

Publication Publication Date Title
AR078558A1 (es) Excipiente estabilizante para una vacuna de virus completo inactivado
RU2007119724A (ru) Композиции, содержащие эктинэсайдин и дисахарид
RU2011127913A (ru) Составы, содержащие антитела
SI2198007T1 (en) Pharmaceutical compositions containing Clostridium difficile A and B toxoids
EA201790989A1 (ru) Стабильный препарат раствора белка, содержащего анти-vegf антитело в высокой концентрации
RU2008138646A (ru) Жидкая композиция g-csf
PE20141159A1 (es) Metodos para tratar o prevenir trastornos relacionados con el colesterol
AR067011A1 (es) Formulaciones de anticuerpos
CN101631563B (zh) 含有流感疫苗的冻干制剂及其制备方法
UA102166C2 (ru) Композиция для подкожного введения, которая содержит антитело к her2
HRP20110444T1 (hr) Formulacije paratiroidnih hormona i njihove uporabe
CA2272245A1 (en) Stable lyophilized pharmaceutical preparations of monoclonal or polyclonal antibodies
BRPI0608877B8 (pt) composição imunogênica de rotavírus líquida, uso de um antígeno de rotavírus, um açúcar e um carboxilato, e, método para a preparação de uma composição de rotavírus líquida
AR082257A1 (es) Composicion de inmunoglobulinas humanas concentradas, procedimiento
NZ598839A (en) Stabilized liquid and lyophilized adamts13 formulations
PE20141265A1 (es) Formulaciones liofilizadas de fgf-18
RU2018129077A (ru) Стабильная фармацевтическая композиция
PE20241183A1 (es) Composiciones farmaceuticas de efruxifermina
WO2018189436A1 (fr) Adjuvants dépourvus de cytokines pour milieux de culture cellulaire notamment pour fécondation in vitro, ou pour la culture de follicules, cellules germinales males ou embryons
CA2480226A1 (en) Stable pharmaceutical composition containing factor viii
RU2014124143A (ru) Стабильная композиция антитела, специфически связывающегося с her2 рецепторами, и способ ее получения
PH12021551307A1 (en) Protein solution formulation containing high concentration of an anti-vegf antibody
RU2008121716A (ru) Препараты
CN112656939A (zh) 一种针对血管内皮生长因子的人源化抗体的药物组合物
BR9908838A (pt) Uso de um glicocorticóide, processeo para tratar glomerulonefrite aguda ou crÈnica, e, composição farmacêutica para tratar glomerulonefrite