Isingeniso kwiSomaglutide
I-Somaglutide isizukulwana esitsha se-GLP-1 (iglucagon njenge-peptide-1) i-analog eyenziwe nguDaminol kunye neNovoNordisk.I-Somaglutide yindlela yokulinganisa ixesha elide eliphuhliswe ngokusekelwe kwisiseko esisisiseko seLilalutide, esinempembelelo engcono kunyango lwe-2 yeswekile.I-Novo Nordisk iye yagqiba izifundo ze-6 PChemicalbookbaseIIIa kwi-injection ye-Somaglutide, kwaye yangenisa isicelo esitsha sokubhaliswa kweziyobisi kwi-injection yeveki ye-Somaglutide kwi-US Food and Drug Administration (FDA) ngoDisemba 5, 2016, kunye nesicelo sokugunyazwa kwentengiso (MAA) ichiza laseYurophu Aulawulo (EMA).Ngakolunye uhlangothi, ukulungiswa komlomo kwansuku zonke kwe-Somaglutide okwangoku kwisigaba seklinikhi III.
Ukusetyenziswa
I-Somaglutide yindlela yokulinganisa ixesha elide eliphuhliswe ngokusekelwe kwisiseko esisisiseko se-liraglutide, enempembelelo engcono kunyango lwe-2 yeswekile.
Uphando
I-Semeglutide yi-analog entsha ye-GLP-1 efakwe ngaphantsi kwe-subcutaneously kanye ngeveki.I-Somaglutide yi-analog ye-GLP-1 yexesha elide eyenziwe nguNovo Nordisk ngexesha elinye / w i-injection subcutaneous.Xa kuthelekiswa ne-liraglutide, i-Somaglutide inekhonkco elide lamafutha kunye nokunyuka kwe-hydrophobicity.Nangona kunjalo, i-Somaglutide iguqulwe nge-PEG emfutshane ye-chain, kwaye i-hydrophilicity yayo iphuculwe kakhulu.Emva kokuguqulwa kwe-PEG, ayikwazi ukudibanisa ngokusondeleyo kunye ne-albumin, ukugubungela indawo ye-hydrolysis ye-DPP-4 enzyme, kodwa nokunciphisa ukukhutshwa kwezintso, ukwandisa ixesha le-biological half-life kunye nokufezekisa umphumo womjikelezo omde.I-Novo Nordisk's Somaglutide yaxhoma i-DPP-4's Sigliptin, kunye ne-GLP-1's umsunguli, i-exenatide yexesha elide (kufuneka ilungiselelwe ukukhuphisana nentloko kunye ne-Lily's trucity. Ukuxhatshazwa kuye kwaba kwimarike ixesha elide).Kuvavanyo, idosi ephezulu ye-Somicalbook yehla i-A1C1.6%, kwaye ukulahleka kwesisindo esikhulu kwakuyi-6 kg.I-Somaglutide yayisetyenziselwa ukuphanda ukusebenza kunye nokhuseleko lwe-1.0mg ye-Somaglutide xa kuthelekiswa ne-2.0mg Exenatide kanye ngeveki kwizigulane ze-813 ezine-2 yeswekile.Ixesha lovavanyo laliyiveki ze-56, kwaye izigulane zathatha i-1-2 iziyobisi ezichasene nesifo sikashukela ngomlomo ngexesha elifanayo.NgoDisemba 2017, i-FDA yavuma ngokusemthethweni i-GLP-1 ye-hypoglycemic drug Somaglutide ephuhliswe nguNovoNordisk ukuba ithengiswe phantsi kwegama lezorhweboc Ozempic.Ngokweenkcukacha zovavanyo lweklinikhi, i-Ozempic inokunciphisa inqanaba le-HbA1c xa kuthelekiswa ne-placebo, i-Januvia yaseMerck, i-Bydureon yase-AstraZeneca kunye neLantus yaseSanofi.Ichiza likwabonise ukukwazi ukunceda izigulane ukuba zinciphise umzimba.
Ixesha lokuposa: Dec-25-2022