Nirmatrelvir
Nirmatrelvir ndi inhibitor ya SARS-CoV-2 main protease (Mpro), yomwe imatchedwanso 3C-like protease (3CLpro) kapena nsp5 protease. Kuletsa kwa SARS-CoV-2 Mpro kumapangitsa kuti zisakwanitse kukonza ma polyprotein precursors, kuteteza ma virus.
Nirmatrelvir inaletsa ntchito ya recombinant SARS-CoV-2 Mpro pakuyesa kwachilengedwe pazambiri zomwe zingatheke mu vivo. Nirmatrelvir idapezeka kuti imamanga mwachindunji ku SARS-CoV-2 Mpro yogwira ntchito ndi X-ray crystallography.
Ritonavir ndi HIV-1 protease inhibitor koma sagwira ntchito motsutsana ndi SARS-CoV-2 Mpro. Ritonavir imalepheretsa kagayidwe ka CYP3A-mediated ka nirmatrelvir, zomwe zimapangitsa kuchuluka kwa plasma kwa nirmatrelvir.
Mankhwalawa akulimbikitsidwa. Zapatsidwa chilolezo chogwiritsa ntchito mwadzidzidzi ndi FDA pochiza matenda ochepera mpaka pang'ono a coronavirus (COVID-19) mwa akulu ndi ana odwala (wazaka 12 ndi kupitilirapo olemera ma kilogalamu 40 kapena pafupifupi mapaundi 88) zotsatira zabwino zakuyezetsa mwachindunji kwa SARS-CoV-2, komanso omwe ali pachiwopsezo chachikulu chopitilira COVID-19, kuphatikiza kugona m'chipatala kapena kufa. Nirmatrelvir/ritonavir iyenera kuyambitsidwa posachedwa atapezeka ndi COVID-19 komanso mkati mwa masiku asanu chizindikiro chayamba.
Malangizo amachokera ku EPIC-HR, kuyesa kwachipatala kwa Phase2/3 komwe kumayesa mphamvu ya nirmaltrelivir/ritonavir vs. anthu omwe ali pachiwopsezo chodwala matenda oopsa amachepetsa chiopsezo chogonekedwa m'chipatala kapena kufa m'masiku 28 88%.





Malingaliro18Ma projekiti a Quality Consistency Evaluation omwe avomereza4,ndi6mapulojekiti akuvomerezedwa.

Dongosolo lotsogola lapadziko lonse lapansi loyang'anira bwino layala maziko olimba pakugulitsa.

Kuyang'anira kwabwino kumayendera nthawi yonse ya moyo wa chinthucho kuti zitsimikizire kuti zikuyenda bwino komanso zochiritsira.

Gulu la Professional Regulatory Affairs limathandizira zofunikira pakufunsira ndikulembetsa.


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