IL302203A - Intravenous Genaxolone formulations and their use in the treatment of epileptic seizures and other convulsive disorders - Google Patents

Intravenous Genaxolone formulations and their use in the treatment of epileptic seizures and other convulsive disorders

Info

Publication number
IL302203A
IL302203A IL302203A IL30220323A IL302203A IL 302203 A IL302203 A IL 302203A IL 302203 A IL302203 A IL 302203A IL 30220323 A IL30220323 A IL 30220323A IL 302203 A IL302203 A IL 302203A
Authority
IL
Israel
Prior art keywords
ganaxolone
pharmaceutical composition
cyclodextrin
status epilepticus
formulation
Prior art date
Application number
IL302203A
Other languages
English (en)
Hebrew (he)
Original Assignee
Marinus Pharmaceuticals 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 Marinus Pharmaceuticals Inc filed Critical Marinus Pharmaceuticals Inc
Publication of IL302203A publication Critical patent/IL302203A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • A61K31/573Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05Phenols
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
IL302203A 2015-02-06 2016-02-08 Intravenous Genaxolone formulations and their use in the treatment of epileptic seizures and other convulsive disorders IL302203A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562112943P 2015-02-06 2015-02-06
PCT/US2016/016977 WO2016127170A1 (en) 2015-02-06 2016-02-08 Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders

Publications (1)

Publication Number Publication Date
IL302203A true IL302203A (en) 2023-06-01

Family

ID=56564813

Family Applications (2)

Application Number Title Priority Date Filing Date
IL302203A IL302203A (en) 2015-02-06 2016-02-08 Intravenous Genaxolone formulations and their use in the treatment of epileptic seizures and other convulsive disorders
IL252848A IL252848B2 (en) 2015-02-06 2016-02-08 Intravenous Genaxolone Formulations and Their Use in the Treatment of Epileptic Seizures and Other Seizure Disorders

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL252848A IL252848B2 (en) 2015-02-06 2016-02-08 Intravenous Genaxolone Formulations and Their Use in the Treatment of Epileptic Seizures and Other Seizure Disorders

Country Status (8)

Country Link
US (4) US20160228454A1 (https=)
EP (2) EP4059522A1 (https=)
JP (4) JP2018504420A (https=)
CN (3) CN107427458A (https=)
AU (1) AU2016214996B2 (https=)
CA (2) CA3254865A1 (https=)
IL (2) IL302203A (https=)
WO (1) WO2016127170A1 (https=)

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US9549909B2 (en) 2013-05-03 2017-01-24 The Katholieke Universiteit Leuven Method for the treatment of dravet syndrome
JOP20200195A1 (ar) 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
EP4059522A1 (en) * 2015-02-06 2022-09-21 Marinus Pharmaceuticals, Inc. Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders
AR105044A1 (es) * 2015-06-18 2017-08-30 Sage Therapeutics Inc Soluciones de esteroides neuroactivos y sus métodos de uso, recipiente
EA036155B1 (ru) 2015-10-16 2020-10-06 Маринус Фармасьютикалс, Инк. Инъекционные составы нейростероида, содержащие наночастицы
PT4293009T (pt) 2015-12-22 2025-09-08 Zogenix International Ltd Composições de fenfluramina e métodos de preparação das mesmas
WO2017112701A1 (en) 2015-12-22 2017-06-29 Zogenix International Limited Metabolism resistant fenfluramine analogs and methods of using the same
HK1258616A1 (zh) 2016-03-08 2019-11-15 Sage Therapeutics, Inc. 神经活性类固醇、组合物、及其用途
EP4233861A3 (en) 2016-08-11 2023-10-11 Ovid Therapeutics, Inc. Compositions for treatment of essential tremor
AU2017315273B2 (en) 2016-08-24 2021-04-29 Zogenix International Limited Formulation for inhibiting formation of 5-HT 2B agonists and methods of using same
US10391105B2 (en) 2016-09-09 2019-08-27 Marinus Pharmaceuticals Inc. Methods of treating certain depressive disorders and delirium tremens
CN109890392A (zh) * 2016-10-14 2019-06-14 马瑞纳斯制药公司 施用神经类固醇以实现脑电图(eeg)爆发抑制的方法
EP3528807A4 (en) * 2016-11-22 2020-06-17 Ovid Therapeutics Inc METHOD FOR TREATING DEVELOPMENT DISORDERS AND / OR FALLS WITH FLUPIRTIN
US10682317B2 (en) 2017-09-26 2020-06-16 Zogenix International Limited Ketogenic diet compatible fenfluramine formulation
AU2018364659A1 (en) * 2017-11-10 2020-05-28 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treating genetic epileptic disoders
CN108535398B (zh) * 2018-04-04 2020-03-27 福州海王福药制药有限公司 一种采用反相高效液相色谱法分离盐酸噻加宾手性对映体的方法
EP3790537A1 (en) 2018-05-11 2021-03-17 Zogenix International Limited Compositions and methods for treating seizure-induced sudden death
EP3806835A1 (en) 2018-06-14 2021-04-21 Zogenix International Limited Compositions and methods for treating respiratory depression with fenfluramine
KR20210087952A (ko) * 2018-11-05 2021-07-13 오비드 테라퓨틱스 인크. 운동 장애들을 치료하기 위한 가복사돌, 가낙솔론 및 알로프레그나놀론의 사용
AU2019384963B2 (en) 2018-11-19 2022-05-26 Zogenix International Limited Methods of treating Rett syndrome using fenfluramine
US11266662B2 (en) 2018-12-07 2022-03-08 Marinus Pharmaceuticals, Inc. Ganaxolone for use in prophylaxis and treatment of postpartum depression
WO2020124090A1 (en) * 2018-12-14 2020-06-18 Eisai R&D Management Co., Ltd. Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds
WO2020157257A1 (en) * 2019-02-01 2020-08-06 H. Lundbeck A/S Injectable carbamazepine composition essentially free of 10-br-carbamazepine
CA3129648A1 (en) * 2019-02-15 2020-08-20 Saol International Limited Injectable formulations comprising phenol and cyclodextrin and uses thereof________________________________
EP3930841A4 (en) * 2019-02-25 2022-11-30 Zogenix International Limited FORMULATION TO IMPROVE SEIZURE CONTROL
US20200338090A1 (en) * 2019-04-29 2020-10-29 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
US20210260074A1 (en) * 2019-04-29 2021-08-26 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
SG11202112111WA (en) 2019-05-10 2021-11-29 Brii Biosciences Inc Pharmaceutical composition containing brexanolone, ganaxolone, or zuranolone, and use thereof
CN114728012A (zh) * 2019-08-05 2022-07-08 马瑞纳斯制药公司 用于治疗癫痫持续状态的加奈索酮
JP7780431B2 (ja) 2019-12-06 2025-12-04 マリナス ファーマシューティカルズ, インコーポレイテッド 結節性硬化症の治療での使用のためのガナキソロン
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WO2022109440A1 (en) * 2020-11-23 2022-05-27 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treatment of super refractory status epilepticus
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WO2023060020A1 (en) * 2021-10-04 2023-04-13 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treatment of established status epilepticus
CN114272216B (zh) * 2021-10-11 2023-07-04 浙江歌文达生物医药科技有限公司 一种2-氧代-1-吡咯烷衍生物的冻干制剂及其制备
CN116769070B (zh) * 2023-06-07 2025-07-01 浙江工业大学 一种功能化磁性纳米颗粒及作为手性萃取剂在液-液萃取拆分手性化合物中的应用

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EP4059522A1 (en) * 2015-02-06 2022-09-21 Marinus Pharmaceuticals, Inc. Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders
US10391105B2 (en) * 2016-09-09 2019-08-27 Marinus Pharmaceuticals Inc. Methods of treating certain depressive disorders and delirium tremens

Also Published As

Publication number Publication date
AU2016214996B2 (en) 2021-03-04
US20250325562A1 (en) 2025-10-23
JP2021155457A (ja) 2021-10-07
JP2023078301A (ja) 2023-06-06
CN115381772A (zh) 2022-11-25
CA3254865A1 (en) 2025-05-28
IL252848B2 (en) 2024-07-01
EP3253418A1 (en) 2017-12-13
JP7566961B2 (ja) 2024-10-15
US20240016817A1 (en) 2024-01-18
CN107427458A (zh) 2017-12-01
CA2973140A1 (en) 2016-08-11
JP2018504420A (ja) 2018-02-15
CA2973140C (en) 2025-09-16
US20230293549A1 (en) 2023-09-21
IL252848B1 (en) 2024-03-01
CN115487313A (zh) 2022-12-20
IL252848A0 (en) 2017-08-31
US20160228454A1 (en) 2016-08-11
AU2016214996A1 (en) 2017-06-29
JP7273897B2 (ja) 2023-05-15
WO2016127170A1 (en) 2016-08-11
JP2024178469A (ja) 2024-12-24
EP4059522A1 (en) 2022-09-21

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