Bremelanotide
Bremelanotide API
Bremelanotideyog hluavtawsmelanocortin receptor agonisttsim rau kev kho mob ntawmhypoactive kev sib deev muaj siab tsis meej (HSDD) in cov poj niam premenopausal. Raws li thawj lub hauv paus kev kho mob tshwj xeeb tau pom zoo rau HSDD, Bremelanotide sawv cev rau kev nce qib tseem ceeb hauv poj niam kev noj qab haus huv.
Pom zoo los ntawm US FDA hauv 2019 raws li lub npe lag luamVyleesi, Bremelanotide muab cov kev xav tau ntawm kev xav tau, tsis yog tshuaj hormones rau cov poj niam uas muaj kev pheej hmoo tsis muaj kev sib deev, uas tsis tuaj yeem piav qhia los ntawm kev kho mob, puas siab puas ntsws, lossis kev sib raug zoo teeb meem.
PebBremelanotide APIyog tsim los ntawm solid-theem peptide synthesis (SPPS), kom ntseeg tau siab purity, tsis muaj impurities, thiab sib xws haum rau kev kho mob thiab kev lag luam txhaj tshuaj formulations.
Mechanism ntawm Action
Bremelanotide ua haujlwm los ntawmactivating melanocortin receptors, tshwj xeebMC4R (melanocortin-4 receptor)hauvcentral paj hlwb. Qhov kev ua kom no ntseeg tau los hloov kho txoj hauv kevhypothalamusuas koom nrog kev sib deev arousal thiab muaj siab.
Cov teebmeem tseem ceeb muaj xws li:
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Txhim khodopaminergic signaling, txhawb kev nyiam kev sib deev
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Tiv thaiv txoj hauv kev inhibitory cuam tshuam rau libido
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Central paj hlwb modulationtsis muaj kev cia siab rau cov tshuaj hormones kev sib deev (tsis yog-estrogenic, tsis yog-testosterone)
Cov txheej txheem no ua rau Bremelanotide txawv ntawm cov tshuaj hormonal ib txwm siv thiab tsim nyog rau cov poj niam dav dav.
Kev Tshawb Fawb Kev Tshawb Fawb & Cov txiaj ntsig
Bremelanotide tau raug tshuaj xyuas ntau yamTheem 2 thiab Theem 3 kev sim tshuaj, suav nrog ntau txhiab tus poj niam kuaj mob HSDD.
Cov txiaj ntsig tseem ceeb suav nrog:
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Kev txhim kho tseem ceebnyob rau hauv cov qhab nia siab deev ( ntsuas los ntawm FSFI-d)
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Kev txo qis hauv kev ntxhov siab ntsig txog kev ntshaw kev sib deev tsawg ( ntsuas los ntawm FSDS-DAO)
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Kev pib sai ntawm kev ua(hauv teev), tso cairaws li kev thov siv ua ntej kev sib deev
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Ua kom pom kev ua tau zoo hauv cov poj niamnrog thiab tsis muaj comorbid tej yam kev mob(e.g., kev nyuaj siab, ntxhov siab vim)
Hauv kev tshawb fawb soj ntsuam, mus txog25% -35%Cov neeg mob tau ntsib kev txhim kho tseem ceeb piv rau cov placebo.
Kev nyab xeeb thiab kam rau ua
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Cov kev mob tshwm sim feem ntau suav nrogxeev siab, yaug, thiabmob taub hau- feem ntau me me thiab txwv tus kheej.
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Tsis zoo li cov neeg ua haujlwm melanocortin ua ntej, Bremelanotide yogtsis cuam tshuam nrog kev nce ntshav siab lossis lub plawv dhianyob rau hauv feem ntau cov neeg mob.
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Raws li kev kho mob raws li qhov xav tau, nws zam kev cuam tshuam cov tshuaj hormones ntev thiab tuaj yeem siv tau yooj yim.
Manufacturing thiab Quality
PebBremelanotide API:
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Nws yog tsim los siv SPPS siab heev nrog kev ua haujlwm siab
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Ua tau raws li cov qauv thoob ntiaj teb nruj raupurity, tus kheej, thiab residual kuab tshuaj
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Nws yog tsim rau kev txhaj tshuaj formulation (xws li prefilled autoinjector cwjmem)
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Muaj nyob rau hauvpilot thiab coj mus muag-scale batch, txhawb nqa R & D thiab kev lag luam khoom
Kev kho muaj peev xwm
Tshaj li HSDD, Bremelanotide's mechanism tau ua rau muaj kev txaus siab rau lwm qhov ntawmKev sib deev thiab neuroendocrine modulation, suav nrog:
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Txiv neej deev hluas
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Kev puas siab puas ntsws
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Kev noj qab haus huv thiab kev tswj hwm lub zog (ntawm melanocortin system)
Nws cov yam ntxwv zoo peptide profile thiab lub hauv paus paj hlwb kev ua haujlwm txuas ntxiv txhawb kev loj hlob hauv cov chaw kho mob uas nyob ib sab.
