Bremelanotide
Bremelanotide API
Bremelanotideiyenziwemelanocortin receptor agonistiphuhliselwe unyango lweukuphazamiseka komnqweno wesini (HSDD) in abafazi premenopausal. Njengonyango lokuqala olubambeleyo oluvunyiweyo lwe-HSDD, iBremelanotide imele ukuqhubela phambili okubalulekileyo kwimpilo yezesondo yabasetyhini.
Ivunywe yi-FDA yase-US ngo-2019 phantsi kwegama le-brandVyleesi, I-Bremelanotide inikezela ngesidingo, isisombululo esingekho sehomoni kubasetyhini abafumana ukunqongophala okuzingileyo komnqweno wesini, ongenakuchazwa ngemibandela yonyango, yengqondo, okanye yobudlelwane.
YethuBremelanotide APIiveliswa nge-solid-phase peptide synthesis (SPPS), iqinisekisa ukucoceka okuphezulu, ukungcola okuphantsi, kunye nokuhambelana okufanelekileyo kwimiqulu ye-injectable yeklinikhi kunye nezorhwebo.
Indlela yokwenza
I-Bremelanotide isebenza ngeisebenze i-melanocortin receptors, ngakumbiI-MC4R (isamkeli se-melanocortin-4)kwiinkqubo ye-nervous central. Oku kuvula kukholelwa ukuba kumodareyitha iindlela kwihypothalamusezibandakanyeka kwinkanuko yesini nakwiminqweno.
Iziphumo eziphambili ziquka:
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Iphuculweumqondiso we-dopaminergic, ukukhuthaza umdla wesini
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Ukunciphisa iindlela zokuthintela ezichaphazela i-libido
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Ukumodareyithwa kwenkqubo ye-nervous centralngaphandle kokuxhomekeka kwiihomoni zesini (ezingezo-estrogenic, ezingekho testosterone)
Lo matshini wenza i-Bremelanotide yahluke kunyango lwe-hormonal yesintu kwaye ilungele inani elibanzi labasetyhini.
Uphando lwezonyango kunye neziphumo
I-Bremelanotide iye yavavanywa ngokuphindaphindiweyoIsigaba sesi-2 kunye neSigaba sesi-3 solingo lwezonyango, ebandakanya amawaka amabhinqa afunyaniswa ene-HSDD.
Iziphumo eziphambili ziquka:
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Uphuculo olubalulekileyo ngokwezibalokumanqaku omnqweno wesini (alinganiswa yiFSFI-d)
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Ukunciphisa uxinzelelo olunxulumene nomnqweno wesondo ophantsi (ulinganiswa yi-FSDS-DAO)
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Ukuqala ngokukhawuleza kwesenzo(kwiiyure), ukuvumelaukusetyenziswa-kwimfuno phambi komsebenzi wesondo
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Ibonakaliswe ukusebenza kakuhle kwabasetyhinikunye nangaphandle kweemeko ze-commorbid(umzekelo, ukudakumba, ixhala)
Kwizifundo zeklinikhi, ukuya kuthi ga25%–35%Izigulana ziye zafumana ukuphucuka okunentsingiselo ngokuchasene ne-placebo.
Ukhuseleko kunye nokunyamezeleka
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Iziphumo eziqhelekileyo eziqhelekileyo ziqukaisicaphucaphu, ukugungxula, kwayeintloko ebuhlungu-ubumnene kwaye uyazibekela umda.
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Ngokungafaniyo neearhente zangaphambili ze-melanocortin, iBremelanotide injaloengahambelani nokunyuka okubalulekileyo kwixinzelelo lwegazi okanye izinga lentliziyokwizigulane ezininzi.
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Njengonyango olufunekayo, luthintela ukuvezwa kwehomoni engapheliyo kwaye inokusetyenziswa ngokuguquguqukayo.
Imveliso kunye noMgangatho
YethuBremelanotide API:
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Idityaniswe kusetyenziswa iSPPS ephucukileyo ngokusebenza okuphezulu
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Idibana nemigangatho engqongqo yehlabathi yeubunyulu, isazisi, kunye nezinyibilikisi ezishiyekileyo
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Ilungele ukwenziwa ngokutofwa (ezifana neepeni ze-autoinjector ezizaliswe kwangaphambili)
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Ifumaneka kwiiibhetshi zokulinga kunye nezorhwebo, exhasa zombini i-R&D kunye nonikezelo lwemarike
Amandla oNyango
Ngaphandle kwe-HSDD, indlela yeBremelanotide ibangele umdla kwezinye iindawo zengokwesondo kunye neuroendocrine modulation, kuquka:
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Ukungasebenzi kakuhle ngokwesondo kwamadoda
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Iziphazamiso ezinxulumene neemvakalelo
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Ukutya kunye nokulawulwa kwamandla (ngenkqubo ye-melanocortin)
Iprofayili yayo ye-peptide ebonakaliswe kakuhle kunye nomsebenzi we-nervous central iyaqhubeka nokuxhasa uphuhliso olunokwenzeka kwiindawo ezikufutshane zonyango.
