CA3125839C - Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome - Google Patents

Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome Download PDF

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Publication number
CA3125839C
CA3125839C CA3125839A CA3125839A CA3125839C CA 3125839 C CA3125839 C CA 3125839C CA 3125839 A CA3125839 A CA 3125839A CA 3125839 A CA3125839 A CA 3125839A CA 3125839 C CA3125839 C CA 3125839C
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Prior art keywords
formulation
katp channel
channel opener
drug
growth hormone
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CA3125839A
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English (en)
French (fr)
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CA3125839A1 (en
Inventor
Neil M. Cowen
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Essentialis Inc
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Essentialis Inc
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Priority to CA3210794A priority Critical patent/CA3210794A1/en
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D285/00—Heterocyclic compounds containing rings having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by groups C07D275/00 - C07D283/00
    • C07D285/15—Six-membered rings
    • C07D285/16—Thiadiazines; Hydrogenated thiadiazines
    • C07D285/18—1,2,4-Thiadiazines; Hydrogenated 1,2,4-thiadiazines
    • C07D285/20—1,2,4-Thiadiazines; Hydrogenated 1,2,4-thiadiazines condensed with carbocyclic rings or ring systems
    • C07D285/22—1,2,4-Thiadiazines; Hydrogenated 1,2,4-thiadiazines condensed with carbocyclic rings or ring systems condensed with one six-membered ring
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • 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
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D285/00—Heterocyclic compounds containing rings having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by groups C07D275/00 - C07D283/00
    • C07D285/15—Six-membered rings
    • C07D285/16—Thiadiazines; Hydrogenated thiadiazines
    • C07D285/18—1,2,4-Thiadiazines; Hydrogenated 1,2,4-thiadiazines
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Steroid Compounds (AREA)
CA3125839A 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome Active CA3125839C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3210794A CA3210794A1 (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201462080150P 2014-11-14 2014-11-14
US62/080,150 2014-11-14
US201562138245P 2015-03-25 2015-03-25
US62/138,245 2015-03-25
US201562170035P 2015-06-02 2015-06-02
US62/170,035 2015-06-02
US201562221359P 2015-09-21 2015-09-21
US62/221,359 2015-09-21
CA2966907A CA2966907C (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2966907A Division CA2966907C (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3210794A Division CA3210794A1 (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome

Publications (2)

Publication Number Publication Date
CA3125839A1 CA3125839A1 (en) 2016-05-19
CA3125839C true CA3125839C (en) 2023-10-24

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Application Number Title Priority Date Filing Date
CA3125839A Active CA3125839C (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome
CA3125835A Active CA3125835C (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome
CA2966907A Active CA2966907C (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome
CA3210794A Pending CA3210794A1 (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome

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CA3125835A Active CA3125835C (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome
CA2966907A Active CA2966907C (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome
CA3210794A Pending CA3210794A1 (en) 2014-11-14 2015-11-12 Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome

Country Status (19)

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US (8) US10058557B2 (enExample)
EP (1) EP3217963B1 (enExample)
JP (4) JP6709226B2 (enExample)
KR (4) KR102598666B1 (enExample)
CN (2) CN113599386B (enExample)
AU (2) AU2015346196B2 (enExample)
BR (1) BR112017009986A2 (enExample)
CA (4) CA3125839C (enExample)
DK (1) DK3217963T3 (enExample)
EA (1) EA036103B1 (enExample)
ES (1) ES2806977T3 (enExample)
HU (1) HUE050895T2 (enExample)
IL (1) IL252111B (enExample)
MX (2) MX393030B (enExample)
MY (1) MY187610A (enExample)
NZ (1) NZ768958A (enExample)
PL (1) PL3217963T3 (enExample)
SG (1) SG11201703721SA (enExample)
WO (1) WO2016077629A1 (enExample)

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AU2006335153B2 (en) 2006-01-05 2012-03-15 Essentialis, Inc. Salts of potassium ATP channel openers and uses thereof
JP6709226B2 (ja) 2014-11-14 2020-06-10 エッセンシャライズ インコーポレイテッド プラダー−ウィリ症候群またはスミス−マゲニス症候群を有する対象を処置するための方法
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WO2018204721A1 (en) 2017-05-05 2018-11-08 Nino Sorgente Methods and compositions for improving eye health
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WO2025057119A1 (en) * 2023-09-15 2025-03-20 Soleno Therapeutics, Inc. Methods of managing glycemic control in prader-willi syndrome patients

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PL3217963T3 (pl) 2020-10-19
HUE050895T2 (hu) 2021-01-28
CA3125835C (en) 2023-01-03
CN113599386B (zh) 2025-12-05
JP6955039B2 (ja) 2021-10-27
CN107106500A (zh) 2017-08-29
ES2806977T3 (es) 2021-02-19
US10874676B2 (en) 2020-12-29
JP6709226B2 (ja) 2020-06-10
US20200147100A1 (en) 2020-05-14
EP3217963A1 (en) 2017-09-20
JP2020073566A (ja) 2020-05-14
CA2966907A1 (en) 2016-05-19
AU2019202906B2 (en) 2020-05-21
JP7645913B2 (ja) 2025-03-14
CN107106500B (zh) 2021-07-30
WO2016077629A1 (en) 2016-05-19
KR20230049760A (ko) 2023-04-13
EP3217963A4 (en) 2018-07-04
JP2021193148A (ja) 2021-12-23
DK3217963T3 (da) 2020-07-20
US20240423996A1 (en) 2024-12-26
CA3125835A1 (en) 2016-05-19
CN113599386A (zh) 2021-11-05
AU2019202906A1 (en) 2019-05-16
MX393030B (es) 2025-03-24
IL252111A0 (en) 2017-07-31
US20250288593A1 (en) 2025-09-18
KR102517840B1 (ko) 2023-04-05
JP7232300B2 (ja) 2023-03-02
US12343348B2 (en) 2025-07-01
NZ768958A (en) 2021-07-30
IL252111B (en) 2021-09-30
US10456408B2 (en) 2019-10-29
KR20220124289A (ko) 2022-09-13
JP2017533972A (ja) 2017-11-16
CA3125839A1 (en) 2016-05-19
NZ731565A (en) 2021-06-25
US20210322434A1 (en) 2021-10-21
KR102452254B1 (ko) 2022-10-11
SG11201703721SA (en) 2017-06-29
KR102323613B1 (ko) 2021-11-09
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US20250120979A1 (en) 2025-04-17
JP2023056025A (ja) 2023-04-18
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