HRP20220317T1 - Otkrivanje i liječenje nedostatka hormona rasta - Google Patents
Otkrivanje i liječenje nedostatka hormona rasta Download PDFInfo
- 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
- Authority
- HR
- Croatia
- Prior art keywords
- use according
- child
- mini
- hrd
- oral dose
- Prior art date
Links
- 206010056438 Growth hormone deficiency Diseases 0.000 title claims 2
- 239000008185 minitablet Substances 0.000 claims 6
- 210000002966 serum Anatomy 0.000 claims 6
- 102000004218 Insulin-Like Growth Factor I Human genes 0.000 claims 3
- 108090000723 Insulin-Like Growth Factor I Proteins 0.000 claims 3
- 208000020221 Short stature Diseases 0.000 claims 2
Classifications
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- 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
- A61K31/435—Heterocyclic 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
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/438—The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/454—Non 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
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/2072—Pills, 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/74—Chemical 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/61—Growth hormones [GH] (Somatotropin)
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/65—Insulin-like growth factors (Somatomedins), e.g. IGF-1, IGF-2
Landscapes
- 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).
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
ID=58276481
Family Applications (1)
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)
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 |
Family Cites Families (10)
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 |
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2016
- 2016-09-21 RS RS20220218A patent/RS62988B1/sr unknown
- 2016-09-21 KR KR1020237025351A patent/KR20230116961A/ko not_active Application Discontinuation
- 2016-09-21 CN CN202310486498.6A patent/CN116459250A/zh active Pending
- 2016-09-21 JP JP2018534488A patent/JP6816149B2/ja active Active
- 2016-09-21 HR HRP20220317TT patent/HRP20220317T1/hr unknown
- 2016-09-21 ES ES21192867T patent/ES2967259T3/es active Active
- 2016-09-21 PL PL21192867.6T patent/PL3939590T3/pl unknown
- 2016-09-21 CA CA2998523A patent/CA2998523C/en active Active
- 2016-09-21 HU HUE16849470A patent/HUE057831T2/hu unknown
- 2016-09-21 SI SI201631495T patent/SI3352752T1/sl unknown
- 2016-09-21 LT LTEPPCT/US2016/052800T patent/LT3352752T/lt unknown
- 2016-09-21 ES ES16849470T patent/ES2908423T3/es active Active
- 2016-09-21 KR KR1020227011483A patent/KR102560838B1/ko active IP Right Grant
- 2016-09-21 PT PT211928676T patent/PT3939590T/pt unknown
- 2016-09-21 CN CN201680064316.4A patent/CN108348501A/zh active Pending
- 2016-09-21 EP EP16849470.6A patent/EP3352752B1/en active Active
- 2016-09-21 US US15/271,542 patent/US9763919B2/en active Active
- 2016-09-21 DK DK16849470.6T patent/DK3352752T3/da active
- 2016-09-21 AU AU2016328969A patent/AU2016328969B2/en active Active
- 2016-09-21 EP EP23207876.6A patent/EP4296679A3/en active Pending
- 2016-09-21 FI FIEP21192867.6T patent/FI3939590T3/fi active
- 2016-09-21 UA UAA201803953A patent/UA123865C2/uk unknown
- 2016-09-21 WO PCT/US2016/052800 patent/WO2017053373A1/en active Application Filing
- 2016-09-21 PL PL16849470T patent/PL3352752T3/pl unknown
- 2016-09-21 SG SG10202010598SA patent/SG10202010598SA/en unknown
- 2016-09-21 EP EP21192867.6A patent/EP3939590B1/en active Active
- 2016-09-21 SG SG10201902424TA patent/SG10201902424TA/en unknown
- 2016-09-21 HU HUE21192867A patent/HUE065224T2/hu unknown
- 2016-09-21 KR KR1020187010804A patent/KR102385669B1/ko active Application Filing
- 2016-09-21 DK DK21192867.6T patent/DK3939590T3/da active
- 2016-09-21 PT PT168494706T patent/PT3352752T/pt unknown
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2017
- 2017-09-18 US US15/706,991 patent/US10105352B2/en active Active
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2018
- 2018-03-19 IL IL258224A patent/IL258224B/en unknown
- 2018-09-20 US US16/136,967 patent/US10898472B2/en active Active
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2019
- 2019-02-01 HK HK19101897.1A patent/HK1263178A1/zh unknown
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2020
- 2020-09-17 AU AU2020233715A patent/AU2020233715B2/en active Active
- 2020-12-23 JP JP2020213095A patent/JP7104768B2/ja active Active
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2021
- 2021-10-21 AU AU2021254600A patent/AU2021254600B2/en active Active
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2022
- 2022-03-18 CY CY20221100219T patent/CY1125183T1/el unknown
- 2022-07-08 JP JP2022110116A patent/JP7389862B2/ja active Active
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2023
- 2023-11-17 JP JP2023195764A patent/JP2024026112A/ja active Pending
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2024
- 2024-03-14 AU AU2024201658A patent/AU2024201658A1/en active Pending
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