Etelcalcetide

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Etelcalcetide yog ib qho hluavtaws peptide calcimimetic siv rau kev kho mob ntawm theem nrab hyperparathyroidism (SHPT) hauv cov neeg mob uas muaj kab mob raum (CKD) ntawm hemodialysis. Nws ua haujlwm los ntawm kev ua kom cov calcium-sensing receptor (CaSR) ntawm cov hlwb parathyroid, yog li txo qis parathyroid hormone (PTH) qib thiab txhim kho cov metabolism hauv cov ntxhia. Peb cov high-purity Etelcalcetide API yog tsim los ntawm solid-phase peptide synthesis (SPPS) raws li GMP-raws li tej yam kev mob, haum rau txhaj tshuaj formulations.

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Etelcalcetide API

Etelcalcetideyog ib qho tshiab, hluavtawscalcimimetic peptidepom zoo rau kev kho mob ntawmtheem nrab hyperparathyroidism (SHPT)nyob rau hauv cov neeg laus nrogmob raum mob (CKD)txaishemodialysis. SHPT yog ib qho teeb meem loj heev ntawm cov kab mob hauv lub raum kawg, tshwm sim los ntawm kev cuam tshuam ntawm calcium, phosphorus, thiab vitamin D metabolism. Persistent elevation ntawmParathyroid hormone (PTH)tuaj yeem ua raulub raum osteodystrophy, vascular calcification, kab mob plawv, thiab nce kev tuag.

Etelcalcetide muaj ibhom phiaj, tsis yog phais kev xaivlos tswj PTH qib hauv cov neeg mob lim ntshav, sawv cev rau tiam thib ob calcimimetic nrogtxawv qhov zootshaj kev kho qhov ncauj zoo li cinacalcet.

Mechanism ntawm Action

Etelcalcetide yog ibhluavtaws peptide agonistntawmCalcium-sensing receptor (CaSR), nyob rau saum npoo ntawm cov qog nqaij hlav parathyroid. Nws ua raws li qhov kev txiav txim ntawm cov calcium extracellular los ntawm allosterically activating CaSR, yog li:

Txhawb nqa parathyroid hormone (PTH) tso tawm
Txo cov ntshav cov calcium thiab phosphorus concentrations
Txhim kho calcium-phosphate homeostasis
Txo qhov kev pheej hmoo ntawm pob txha hloov pauv txawv txav thiab vascular calcification

Tsis zoo li qhov ncauj calcimimetics, Etelcalcetide yog tswj hwmtxhaj tshuajtom qab hemodialysis, uas txhim kho kev kho mob thiab txo cov kev mob tshwm sim hauv plab hnyuv.

Kev Tshawb Fawb Kev Tshawb Fawb thiab Kev Ua Tau Zoo

Etelcalcetide tau raug soj ntsuam hauv ntau qhov kev sim tshuaj Phase 3, suav nrogob qhov tseem ceeb randomized tswj kev tshawb fawbluam tawm nyob rau hauvLub LancetthiabNew England Journal of Medicine. Cov kev tshawb fawb no tau koom nrog ntau dua 1000 tus neeg mob hemodialysis nrog kev tswj tsis tau SHPT.

Cov txiaj ntsig tseem ceeb hauv kev kho mob muaj xws li:

Kev txheeb cais tseem ceeb txo qis hauv PTH qib(> 30% hauv feem ntau ntawm cov neeg mob)
Superior tswj ntawmCov khoom lag luam phosphorus thiab calcium-phosphate (Ca × P)
Zoo dua tag nrho biochemical teb tus nqipiv rau cinacalcet
Zoo dua tus neeg mob ua rawsvim yog peb lub lis piam tom qab kev lim ntshav IV kev tswj hwm
Txo cov pob txha turnover markers(piv txwv li, pob txha tshwj xeeb alkaline phosphatase)

Cov txiaj ntsig no txhawb nqa Etelcalcetide ua ib qhothawj kab txhaj tshuaj calcimimeticrau kev tswj SHPT hauv cov neeg mob lim ntshav.

API Manufacturing thiab Zoo

PebEtelcalcetide APIyog tsim los ntawmsolid-phase peptide synthesis (SPPS), kom ntseeg tau siab yield, purity, thiab molecular stability. API:

Conforms rau stringentGMP thiab ICH Q7 tus qauv
Yog haum rau siv nyob rau hauvcov tshuaj txhaj tshuaj
Tau txais kev tshuaj ntsuam xyuas dav dav, suav nrog HPLC, cov kuab tshuaj seem, cov hlau hnyav, thiab qib endotoxin
Muaj nyob rau hauvpilot thiab coj mus muag teev

Kev kho muaj peev xwm thiab qhov zoo

Kev kho tsis yog hormonalrau SHPT hauv cov neeg mob CKD ntawm kev lim ntshav
Txoj kev IV ua kom muaj kev ua raws cai, tshwj xeeb tshaj yog rau cov neeg mob uas muaj lub nra hnyav lossis GI intolerance
Tej zaum yuav pab txo tauteeb meem mus ntevkab mob ntawm pob txha thiab pob txha (CKD-MBD)
Tau tshaj phosphate binders, vitamin D analogs, thiab kev saib xyuas tus qauv dialysis