HRP20220317T1 - Otkrivanje i liječenje nedostatka hormona rasta - Google Patents

Otkrivanje i liječenje nedostatka hormona rasta Download PDF

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Publication number
HRP20220317T1
HRP20220317T1 HRP20220317TT HRP20220317T HRP20220317T1 HR P20220317 T1 HRP20220317 T1 HR P20220317T1 HR P20220317T T HRP20220317T T HR P20220317TT HR P20220317 T HRP20220317 T HR P20220317T HR P20220317 T1 HRP20220317 T1 HR P20220317T1
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HR
Croatia
Prior art keywords
use according
child
mini
hrd
oral dose
Prior art date
Application number
HRP20220317TT
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English (en)
Inventor
Michael THORNER
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Lumos Pharma 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.)
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Publication date
Application filed by Lumos Pharma Inc. filed Critical Lumos Pharma Inc.
Publication of HRP20220317T1 publication Critical patent/HRP20220317T1/hr

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    • 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
    • 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
    • A61K31/438The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
    • 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
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575Hormones
    • G01N2333/61Growth hormones [GH] (Somatotropin)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575Hormones
    • G01N2333/65Insulin-like growth factors (Somatomedins), e.g. IGF-1, IGF-2

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1. MK-0677 za uporabu u postupku liječenja nedostatka hormona rasta (HRD) kod djece, naznačen time, da se terapijski učinkovita količina MK-0677 primjenjuje kod djeteta za koje je poznato da je niskog rasta i ekvivalentni potencijal rasta u usporedbi s rhHR, pri čemu dijete ima ekvivalentni potencijal rasta u usporedbi s rhHR kada dijete ima: i. pik serumskog HR >5 g/L u odgovoru na pojedinačnu oralnu dozu MK-0677; ii. osnovni serumski IGF-I od >30 ng/mL.
2. MK-0677 za uporabu sukladno patentnom zahtjevu 1, naznačen time, da je primjenjena pojedinačna, oralna doza MK-0677 od 0,8 mg/kg/d.
3. MK-0677 za uporabu sukladno patentnom zahtjevu 1, naznačen time, da se mini tablete, koje sadrže: MK-0677 uzimaju oralno.
4. MK-0677 za uporabu sukladno patentnom zahtjevu 3, gdje mini tableta sadrži: 2 mg MK-0677.
5. MK-0677 za uporabu sukladno patentnom zahtjevu 1, gdje se liječi pedijatrijski HRD.
6. MK-0677 za uporabu sukladno patentnom zahtjevu 1, naznačen time, da oralna primjena, nadalje sadrži: davanje pomoću uređaja koji može izdati barem jednu MK-0677 mini tabletu.
7. MK-0677 za uporabu u postupku liječenja HRD kod djece sukladno patentnom zahtjevu 1, naznačen time, da liječenje sadrži: a. testiranje djeteta za koje je poznato da je niskog rasta HRD uporabom teranostičkog testa; i, b. oralnu primjenu terapijski učinkovite količine MK-0677 kod djeteta za koje je utvrđeno da je niskog rasta i ekvivalentan potencijal rasta u usporedbi s rhHR; gdje dijete ima ekvivalentan potencijal rasta u usporedbi s rhHR kada dijete ima: i. serumski pik HR >5 g/L u odgovoru na pojedinačnu oralnu dozu MK-0677; ii. osnovni serumski IGF-I od >30 ng/mL.
8. MK-0677 za uporabu sukladno patentnom zahtjevu 7, gdje je primijenjena pojedinačna, oralna doza MK-0677 od 0,8 mg/kg/d.
9. MK-0677 za uporabu sukladno patentnom zahtjevu 7, gdje se mini tablete, koje sadrže: MK-0677 uzimaju oralno.
10. MK-0677 za uporabu sukladno patentnom zahtjevu 9, naznačen time, da mini tableta sadrži: 2 mg MK-0677.
11. MK-0677 za uporabu sukladno patentnom zahtjevu 7, naznačen time, da oralna primjena, nadalje sadrži: davanje pomoću uređaja koji može izdati barem jednu MK-0677 mini tabletu.
12. MK-0677 za uporabu sukladno patentnom zahtjevu 7, gdje je liječen pedijatrijski HRD.
13. MK-0677 za uporabu sukladno patentnom zahtjevu 7, gdje teranostički test, sadrži: iii. testiranje na pik HR u serumu >5 g/L kao odgovor na jednu oralnu dozu MK-0677; i, iv. testiranje na osnovni serumski IGF-I od >30 ng/mL.
14. MK-0677 za uporabu sukladno patentnom zahtjevu 13, naznačen time, da je pojedinačna, oralna doza MK-0677 od 0,8 mg/kg/d primijenjena u koraku (i).
HRP20220317TT 2015-09-21 2016-09-21 Otkrivanje i liječenje nedostatka hormona rasta HRP20220317T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562221191P 2015-09-21 2015-09-21
US201662289221P 2016-01-30 2016-01-30
EP16849470.6A EP3352752B1 (en) 2015-09-21 2016-09-21 Detecting and treating growth hormone deficiency
PCT/US2016/052800 WO2017053373A1 (en) 2015-09-21 2016-09-21 Detecting and treating growth hormone deficiency

Publications (1)

Publication Number Publication Date
HRP20220317T1 true HRP20220317T1 (hr) 2022-05-13

Family

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Application Number Title Priority Date Filing Date
HRP20220317TT HRP20220317T1 (hr) 2015-09-21 2016-09-21 Otkrivanje i liječenje nedostatka hormona rasta

Country Status (23)

Country Link
US (3) US9763919B2 (hr)
EP (3) EP3352752B1 (hr)
JP (4) JP6816149B2 (hr)
KR (3) KR20230116961A (hr)
CN (2) CN116459250A (hr)
AU (4) AU2016328969B2 (hr)
CA (1) CA2998523C (hr)
CY (1) CY1125183T1 (hr)
DK (2) DK3352752T3 (hr)
ES (2) ES2967259T3 (hr)
FI (1) FI3939590T3 (hr)
HK (1) HK1263178A1 (hr)
HR (1) HRP20220317T1 (hr)
HU (2) HUE057831T2 (hr)
IL (1) IL258224B (hr)
LT (1) LT3352752T (hr)
PL (2) PL3939590T3 (hr)
PT (2) PT3939590T (hr)
RS (1) RS62988B1 (hr)
SG (2) SG10202010598SA (hr)
SI (1) SI3352752T1 (hr)
UA (1) UA123865C2 (hr)
WO (1) WO2017053373A1 (hr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11234969B2 (en) * 2016-01-30 2022-02-01 Lumos Pharma, Inc. Detecting and treating growth hormone deficiency
RS62988B1 (sr) * 2015-09-21 2022-03-31 Lumos Pharma Inc Otkrivanje i lečenje nedostatka hormona rasta
US10288629B1 (en) * 2017-12-19 2019-05-14 Aeterna Zentaris, Inc. Method of assessing growth hormone deficiency in humans by a macimorelin containing composition
US11644474B2 (en) * 2020-07-22 2023-05-09 Æterna Zentaris Gmbh Use of macimorelin in assessing growth hormone deficiency in children
WO2024096892A1 (en) * 2022-11-03 2024-05-10 Lumos Pharma, Inc. Compactable oral formulations of ibutamoren

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994000759A1 (en) * 1992-06-29 1994-01-06 University Of South Florida Diagnostic procedure for evaluating short stature etiology
US5756507A (en) * 1995-12-14 1998-05-26 Merck & Co., Inc. Antagonists of gonadotropin releasing hormone
DE69836386T2 (de) * 1997-08-22 2007-10-11 Kaken Pharmaceutical Co., Ltd. Amide zur Förderung der Ausschüttung von Wachstumshormonen
ES2333097T3 (es) * 2000-05-31 2010-02-17 Raqualia Pharma Inc Uso de secretagogos de la hormona de crecimiento para estimular la motilidad gastrointestinal.
AR029941A1 (es) 2000-06-13 2003-07-23 Zentaris Gmbh Compuestos utiles para elevar el nivel plasmatico de la hormona del crecimiento y las composiciones farmaceuticas que las contienen
BRPI0414175A (pt) * 2003-09-19 2006-10-31 Pfizer Health Ab método melhorado de tratamento de distúrbios do crescimento
SI1689757T1 (sl) * 2003-11-12 2015-01-30 Sino-Med International Alliance, Inc. Heterociklične spojine boronske kisline
GB0603295D0 (en) 2006-02-18 2006-03-29 Ardana Bioscience Ltd Methods and kits
WO2013163455A2 (en) * 2012-04-25 2013-10-31 The Regents Of The University Of California A drug screening platform for rett syndrome
RS62988B1 (sr) * 2015-09-21 2022-03-31 Lumos Pharma Inc Otkrivanje i lečenje nedostatka hormona rasta

Also Published As

Publication number Publication date
EP3352752B1 (en) 2021-12-22
JP2024026112A (ja) 2024-02-28
HK1263178A1 (zh) 2020-01-31
CA2998523C (en) 2023-08-01
US10898472B2 (en) 2021-01-26
AU2020233715B2 (en) 2021-09-30
US20180071266A1 (en) 2018-03-15
AU2016328969A1 (en) 2018-04-26
UA123865C2 (uk) 2021-06-16
CY1125183T1 (el) 2023-06-09
KR20220047407A (ko) 2022-04-15
RS62988B1 (sr) 2022-03-31
JP6816149B2 (ja) 2021-01-20
DK3939590T3 (da) 2023-12-18
PT3939590T (pt) 2024-01-23
SG10201902424TA (en) 2019-04-29
JP2021063096A (ja) 2021-04-22
US10105352B2 (en) 2018-10-23
SG10202010598SA (en) 2020-11-27
US20170079961A1 (en) 2017-03-23
KR102385669B1 (ko) 2022-04-13
FI3939590T3 (fi) 2023-12-14
WO2017053373A1 (en) 2017-03-30
EP3939590B1 (en) 2023-11-29
PT3352752T (pt) 2022-03-09
LT3352752T (lt) 2022-04-11
AU2021254600A1 (en) 2021-11-18
CN108348501A (zh) 2018-07-31
AU2024201658A1 (en) 2024-04-04
PL3939590T3 (pl) 2024-03-25
CA2998523A1 (en) 2017-03-30
HUE065224T2 (hu) 2024-05-28
JP2022163012A (ja) 2022-10-25
US9763919B2 (en) 2017-09-19
KR102560838B1 (ko) 2023-07-27
EP4296679A2 (en) 2023-12-27
SI3352752T1 (sl) 2022-05-31
AU2021254600B2 (en) 2024-02-15
JP2018529766A (ja) 2018-10-11
EP3352752A4 (en) 2019-06-12
ES2967259T3 (es) 2024-04-29
KR20230116961A (ko) 2023-08-04
KR20180082428A (ko) 2018-07-18
AU2016328969B2 (en) 2020-10-08
JP7389862B2 (ja) 2023-11-30
PL3352752T3 (pl) 2022-04-19
DK3352752T3 (da) 2022-02-28
US20190015394A1 (en) 2019-01-17
EP3352752A1 (en) 2018-08-01
HUE057831T2 (hu) 2022-06-28
EP4296679A3 (en) 2024-04-10
CN116459250A (zh) 2023-07-21
EP3939590A1 (en) 2022-01-19
ES2908423T3 (es) 2022-04-29
IL258224A (en) 2018-05-31
JP7104768B2 (ja) 2022-07-21
IL258224B (en) 2021-10-31
AU2020233715A1 (en) 2020-10-22

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