Etelcalcetide

Etelcalcetide API

Etelcalcetidehe moʻolelo, syntheticpeptide hoʻomaʻamaʻaaponoia no ka lapaau anahyperparathyroidism lua (SHPT)i nā maʻi makua meʻo ka maʻi maʻi kīkī mau loa (CKD)ka loaa anahemodialysis. ʻO ka SHPT kahi pilikia maʻamau a koʻikoʻi o ka maʻi renal pae hope, ma muli o ka hoʻohaunaele ʻana i ka calcium, phosphorus, a me ka metabolism vitamin D. Hoʻokiʻekiʻe mau oka hormone parathyroid (PTH)hiki ke alakai irenal osteodystrophy, vascular calcification, maʻi maʻi cardiovascular, a me ka nui o ka make.

Hāʻawi ʻo Etelcalcetide i kahikoho ʻia, non-surgical kohoe hoʻomalu i nā pae PTH i nā maʻi dialysis, e hōʻike ana i ka lua o ka hanauna calcimimetic mepono kūʻokoʻama luna o nā lāʻau lapaʻau waha e like me cinacalcet.

Mechanism of Action

ʻO ka Etelcalcetide kahisynthetic peptide agonisto kaka mea hoʻokipa calcium-sensing (CaSR), aia ma ka ʻili o nā pūnaewele parathyroid gland. Hoʻohālike ia i ka hana o ka calcium extracellular ma o ka allosterically ho'āla i ka CaSR, no laila:

• Ke kāohi nei i ka huna ʻana o ka hormone parathyroid (PTH).

• E ho'ēmi i ka nui o ka calcium a me ka phosphorus serum

• Hoʻonui i ka homeostasis calcium-phosphate

• E ho'ēmi i ka pilikia o ka hoʻololi ʻana o ka iwi a me ka calcification vascular

ʻAʻole like me ka calcimimetics waha, hāʻawi ʻia ʻo Etelcalcetidei loko o ke kokoma hope o ka hemodialysis, kahi e hoʻomaikaʻi ai i ka mālama ʻana a hoʻemi i nā hopena ʻaoʻao o ka ʻōpū.

Noiʻi a me ka Pono

Ua loiloi ʻia ʻo Etelcalcetide i nā hoʻokolohua lapaʻau Phase 3 he nui, meʻelua pivotal randomized controlled studypaʻi ʻia maʻO ka LancetaʻO ka New England Journal of Medicine. Ua pili kēia mau haʻawina ma luna o 1000 mau maʻi hemodialysis me ka SHPT i hoʻomalu ʻole ʻia.

Loaʻa nā hopena lapaʻau koʻikoʻi:

• ʻO nā hōʻemi nui o nā helu PTH(>30% i ka hapa nui o nā maʻi)

• Mana oi aku oserum phosphorus a me ka calcium-phosphate huahana (Ca × P)

• ʻOi aku ka nui o ka pane biochemical holoʻokoʻahoohalikeia me ka cinacalcet

• ʻOi aku ka maikaʻi o ka hoʻomanawanuima muli o ʻekolu pule ma hope o ka dialysis IV

• Hoemi i na hoailona huli iwi(e laʻa, iwi-specific alkaline phosphatase)

Kākoʻo kēia mau pōmaikaʻi iā Etelcalcetide ma ke ʻano helālani mua injectable calcimimeticno ka mālama ʻana i ka SHPT i nā maʻi dialysis.

Hana ʻia a me ka maikaʻi o ka API

ʻO kā mākouEtelcalcetide APIhana ʻia ma oka hana peptide synthesis (SPPS), e hōʻoia ana i ka hua kiʻekiʻe, ka maʻemaʻe, a me ka paʻa molecular. ʻO ka API:

• Kūlike me ke koʻikoʻiNā kūlana GMP a me ICH Q7

• He kūpono no ka hoʻohana ʻana i lokohuahana lāʻau injectable

• Loaʻa i ka hoʻāʻo analytical piha, me HPLC, koena solvents, metala kaumaha, a me nā pae endotoxin

• Aia mapailaka a me na unahi hana kalepa

ʻO ka hiki a me ka pono o ka lāʻau lapaʻau

• Lapaʻau ʻole-hormonalno ka SHPT i nā maʻi CKD ma ka dialysis

• ʻO ke ala IV e hōʻoia i ka hoʻokō, i nā poʻe maʻi me ke kaumaha o ka pila a i ʻole GI intolerance

• Hiki ke kōkua i ka hōʻeminā pilikia lōʻihiʻo ka maʻi mineral a me ka iwi (CKD-MBD)

• Hoʻohālikelike me nā mea hoʻopaʻa phosphate, nā analogs vitamin D, a me ka mālama dialysis maʻamau