Etelcalcetide Hydrochloride

Etelcalcetide Hydrochloride API
I-Etelcalcetide Hydrochloride yinoveli yokwenziwa kwe-peptide calcimimetic ephuhliselwe unyango lwe-hyperparathyroidism yesibini (SHPT) kwizigulana ezinesifo sezintso ezingapheliyo (CKD) eziphantsi kwe-hemodialysis. I-SHPT yingxaki eqhelekileyo kunye neyona nto inzima kwizigulane ze-CKD, ezibonakaliswe ngamanqanaba aphezulu e-parathyroid hormone (PTH), ukuphazamiseka kwe-calcium-phosphate metabolism, kunye nomngcipheko wethambo kunye nesifo senhliziyo.

I-Etelcalcetide imele isizukulwana sesibini se-calcimimetic, elawulwa nge-intravenously, kwaye inikezela ngeenzuzo kunyango lwangaphambili lomlomo olufana ne-cinacalcet ngokuphucula ukuthotyelwa kunye nokunciphisa imiphumo emibi yesisu.

Indlela yokwenza
I-Etelcalcetide isebenza ngokubopha kunye nokusebenzisa i-calcium-sensing receptor (CaSR) efumaneka kwiiseli ze-parathyroid gland. Oku kulinganisa ifuthe le-physiological of extracellular calcium, ekhokelela ku:

Ukucinywa kwemfihlo ye-PTH

Ukunciphisa kwi-serum calcium kunye namanqanaba e-phosphate

Ukuphucula ibhalansi yamaminerali kunye ne-bone metabolism

Njenge-peptide-based activator ye-allosteric yeCaSR, i-Etelcalcetide ibonisa ukucaca okuphezulu kunye nomsebenzi oqhubekayo emva kokulawulwa kwe-intravenous post-dialysis.

UPhando lweKlinikhi kunye neMpembelelo yoNyango
I-Etelcalcetide ihlolwe ngokubanzi kwizilingo zekliniki zesigaba se-3, kuquka i-EVOLVE, AMPLIFY, kunye nezifundo ze-EQUIP. Iziphumo eziphambili ziquka:

Ukunciphisa okubalulekileyo kunye nokuqhubekayo kumanqanaba e-PTH kwizigulane ze-CKD kwi-hemodialysis

Ukulawulwa okusebenzayo kwe-serum calcium kunye ne-phosphorus, igalelo ekuphuculeni i-bone-mineral homeostasis

Ukunyamezela okungcono xa kuthelekiswa ne-calcimimetics yomlomo (i-nausea encinci kunye nokugabha)

Ukuphucula ukuthotyelwa kwesigulane ngenxa yolawulo lwe-IV kathathu ngeveki ngexesha leeseshoni ze-dialysis

Ezi zibonelelo zenza i-Etelcalcetide ibe yindlela ebalulekileyo yonyango ye-nephrologists elawula i-SHPT kwi-dialysis populations.

Umgangatho kunye nokuVeliswa
Eyethu Etelcalcetide Hydrochloride API:

Idityaniswe nge-solid-phase peptide synthesis (SPPS) ngokucoceka okuphezulu

Iyahambelana nemigaqo yodidi loxubo-mayeza, olulungele imixube etofwayo

Ibonisa amanqanaba asezantsi ezinyibilikisi ezishiyekileyo, ukungcola, kunye ne-endotoxins

Ngaba i-scalable kwimveliso yebhetshi enkulu ehambelana ne-GMP