
donanemab

donanemab (yousan; development code lye3002813) anedi modati algimers vyaadhi purogatini mandagistundo ledho nirnayinchadaaniki moodava dasha clinical trialslo oka jeeva aushadham. algimers vyaadhiki prastutam nivaarana ledhaa vyaadhi-savarinche chikitsa ledhu. donanemab daani modati pareekshalalo saanukuula phalitaalanu choopinchindi. donanemabnu eli lillie und koo abhivruddhi chesindi. mariyu algimers vyaadhiki saadhyamayye chikitsagaa clinical abhivruddhilo undhi. 
donanemab, dheenini enn3piji anie kooda pilustaaru, idhi elukalalo utpatti ayye antibody, idhi asaadhaarana protein ayina amyloid beata (ebiti) nii lakshyamgaa chesukuntundi. algimers vyaadhiki kaaranam teliyakapoyinappatiki, amyloid pathologyni ardham chesukovadamlo purogati medadulo jama cheyabadina amyloid phalakaala parimaanam mariyu algimers vyaadhi abhivruddhi madhya sambandhaanni velladinchindi. donanemab amyloid falakaanni lakshyamgaa chesukuni, algimers vyaadhiki kaaranamayye adanapu proteinnu taggistundi.
abhivruddhi.
pindam dasalo dna inject cheyabadinanduna, manavatva pratirakshakaalanu pondadaaniki janyuparamaina elukalanu upayoginchaaru. upayoginchina elukalu maanavulato samaanamaina savarinchina janyu kramaanni kaligi unnaayi, idhi maanavulu utpatti chese vatiki janyuparamgaa saaruupyamaina pratiroedhakaalaku daariteestundi. donanemabnu srushtinchadaaniki pratirakshakaalanu utpatti cheyadaaniki, elukalaku oka nirdishta antigen, sweeya-kaani kanamtho inject cheyabadindi, idhi roganirodhaka pratispandananu prerepistundi. antigennu naasanam cheyadaaniki tella rakta kanaalu utpatti avtayi. bii kanaalu, ivi oka rakamaina tella rakta kanaalu, antigennu bandhinchadaaniki mariyu naasanam cheyadaaniki pratiroedhakaalanu utpatti chestaayi. utpatti cheyabadina pratirakshakaalu appudu cancer bii kanaalatoe kalapadaniki elukala nundi sekarinchabadataayi. eee hybrid kanam bii kanam yokka paniteerunu kaligi unna donanemab aushadhamgaa upayoginche monoclonal pratiroedhakaalanu utpatti chestundi.
donanemab mariyu aβ peptide.
amyloid imaging technologylo iteevali merugudalalu kanaaniki velupala unna adanapu aβ peptidenu algimers vyaadhi abhivruddhitho mudipettayi. beata peptide yokka adhika utpatti medadulooni konni bhagalalo falakaanni srushtistundi, idhi neuron prasaaraaniki antaraayam kaligistundi. donanemab karige mariyu karagani phalakam nirmaanampai daadi chestundi, vyaadhi purogatini mandagistundi.
vichaaranalu.
dasha I.
modati adhyayanam.
united states mariyu japaanlalo, lillie company mae 2013 nundi augustu 2016 varaku modati dasha adhyayananni nirvahinchindi. prati rogipai nirvahinchina saanukuula amyloid pempudu jantuvula skaan dwara telikapati algimers vyaadhi unna rogulapai eee adhyayanam nirvahinchabadindi. 100 mandhi paalgonevaariki nelaku 4 saarlu varaku donanemab thoo sirala dwara injection icchaaru. modati dasha bahula-saayudha adhyayanamlo bhaagamgaa undhi, idhi vividha pareekshalalo oka niyantrana samuuhaanni upayoginchindi. saanukuula phalitam rogulaku medadulo adhika amyloid protein undani suuchimchimdi, idhi algimers vyaadhi yokka prarambha sanketaanni suuchistumdi. prati nelaa 0 mii. graa./kilola nundi 10 mii. graa./kilola motaadulanu sagatu 74 samvatsaraala vayassulo purushulu mariyu phaladeekarana laeni mahilalaku inject cheyabaddaayi. pratikuula sanghatanalu lillie vichaarananu maarchadaaniki daariteese varaku nelawari naalugu injections sambhavinchaayi, injectionla sankhyanu nelaku 8 kii penchindi mariyu rogula motaadunu 0 mii. graa./kiloku 0.3 mii. graa./kiloku penchindi. motaadulalo maarpu anedi prajalaku andubaatulo unna phalitaalato palgonevari sankhya 37 document volunteerla nundi 9 mandhi paalgonevaariki taggadamtho kalipi undhi.
chikitsa pondina 37 mandiki mariyu placebo pondina 12 mandhi volunteerlaku pratikuula sanghatanalu unnayani lillie velladinchindi. raktapravaahamloki atikoddi motaadulo donanemab choppinchadam valla medadulooni phalakam bhaaram yokka prabhavanni taggistundi. mottam meeda kanugonna daani prakaram adhika motaadu medadulooni protein falakaalalo 40 saatam taggudalaku daariteesindi. vaariki oke motaadu icchinappudu etuvanti pratikuula lakshanaalu kanipinchaledu. donanemab chaalaa roganirodhaka saktini kaligi unnatlu kanugonabadindi, idhi roganirodhaka pratispandananu srushtistundi, idhi asalu antibody yokka saamarthyaanni penchutundi. vichaarana yokka tadupari bhaagamlo rogulu bahula motaadulanu pondinappudu, aruguru rogulaku chalanam, flushing, maikamu, daddurlu mariyu jwaramtho sahaa infusion reaction vachindi. rogulaku evarikee aria-ii ledhu, conny medadulo chinna raktasraavam migilipoyina aria-hetch kesulu unnaayi. aria-hetch thoo unna rendu kesulu lakshanarahitamgaa unnaayi. chaalaa mandhi prajalu aushadham yokka prabhavanni tagginche anty-drugg antibodiesnu abhivruddhi chesaaru, padhi rojula swalpa ardha-jeevitamto.
rendava adhyayanam.
rendava dasha modati adhyayanam december 2015loe united states mariyu japaanlalo nirvahinchabadindi. eee vichaaranalo 150 mandhi paalgoni, namuunaa parimaanaanni 50 mandhi penchaaru. nirvahinchina modati adhyayanamtho poliste eee paddhati maarchabadindi. eee vichaaranalo moodu ververu motaadu niyamaalanu upayoginchaaruh okati 10,20 ledhaa 40 mg/kg oke motaadutoe, marokati 24 vaaraala paatu prati itara vaaraaniki 10 mg/kg thoo, mariyu moodavadi 16 nelala paatu prati nelaa 10 ledhaa 20 mg/kg thoo. paalgonevaaru yaadrucchikamgaa 3:1 nishpattitoe placebo samuuham ledhaa nijamaina vichaaranalo bhaagamgaa empika cheyabaddaaru. eee vichaarana yokka lakshyam modatidaanitoe samanamga undhi, pradhanamgaa amyloid medadu phalakaalanu tagginchadamlo prabhavanni kolustundi.
motaadu perugudala rogalakshana aria-ii anubhavistunna rogulalo ekkuva saataaniki daariteesindi, idhi paalgonevaarilo 4 mandiloo 1 mandiki perigindi. donanemab kosam auto-antibodies kooda samasyaatmakamgaa marai, eee aushadhaanni sweeya-kaani kanamgaa gurtinchadam valla sareeram aushadhaaniki vyatiraekamgaa pooraadataaniki daariteesindi. auto-antibodies kindaku vachhe anty-drugg antibodies daadaapu prati rogilo utpatti cheyabaddaayi. amyloid pempudu jantuvula skaan pratikuulamgaa maaradamtho 16 nelala paatu nelawari motaadulanu teesukune rogulaku eee vichaarana saanukuula phalitaanni choopinchagaa, vichaarana augustu 2019loe mugisindi.
trail blazer-alz.
rendava dasha vichaarana paddhatigatamgaa modati dasha nundi bhinnamgaa untundi, idhi vyavadhi, donanemab mottam mariyu rogula sankhyanu maarustundi. 72 vaaraala paatu prati nelaa raktapravaahamloki choppinche donanemab parimaanam perigindi. donanemabnu choppinchi, placeboni choppinchina rogulu samanamga maararu, mottam 257 mandhi rogulatho 1:1 nishpattiki daggaragaa srushtinchaaru. modati moodu motaadulaku 700 mii. graa. mariyu aaa taruvaata prati motaaduku 1400 mii. graa. donanemabnu choppinchaaru. medadulooni phalakam mottaanni kolavadaniki pempudu jantuvula skaan kooda upayoginchabadindi. trail blazer-alz anedi placebo-niyantrita samuuhaanni meruguparachadaaniki upayoginche paddhati, endukante idhi yaadrucchikamgaa undhi. idhi donanemab yokka bhadrata mariyu saamarthyaanni anchanaa vesindi.
idhi amyloid cascade yokka ververu bhaagaalanu lakshyamgaa chesukune lillie kinda rendu prayogaatmaka aushadhaalanu kalipe prayogaanni kaligi undhi. eee rendava dasha vichaarana yokka lakshyam emitante, kevalam 18 nelala kaalaaniki matrame mariyu lillie yokka bays inhibitor lye3202626 thoo kalipi donanemab entha surakshitamainadi, sahinchadaginadi mariyu prabhaavavantamgaa undho chudatam. eee pays inhibitor nuu intraveenasga inject cheyabadina donanemabto polchithe noti dwara ivvabadindi. kevalam donanemab teesukune rogulu mariyu lillie yokka rendu mandulanu teesukune rogula madhya polikanu samarthavantamgaa chuudataaniki moodu ververu samuuhaalanu adhyayanam cheyadam dwara samarthavantamgaa saadhinchabadindi. oka samuuhaaniki donanemab injections mariyu noti dwara lillies bays inhibitornu andukunnaru, maroka samuuhaaniki donanemab injections matrame unnaayi, mariyu moodavadi placebo samuuham. kaneesam aaru nelalugaa ghnaapakaalu ksheenistunna mariyu cogstate bridging pareekshalo oka nirdishta parimiti kante ekkuva score chesina 375 mandini namodu cheyaalani idhi yochinchindi, ayithe 257 mandhi paalgonevaaru. donanemab teesukunnappudu pratikuula aushadha praticharyalapai (iadrs) oka avalokanam undhi mariyu skorlu placebo samuuhamtoe chaalaa pooli untaayi, gananeeyamaina vyatyaasaanni choopinchaledu. aria-ii kesulu unnaayi, conny lakshanaalu laenivi matrame unnaayi, idhi modati dasalo kanipinche rogalakshana rogula nundi merugudala. lillie donanemab kosam trials konasaaginchaalani nirnayinchukundi, conny 2018 octoberlo bays inhibitortho trialsnu nilipiveyaalani nirnayinchukundi. 2021loe trial blazer-alz trial puurtayimdi, idhi prakatana abhivruddhini mandagistunnanduna donanemab yokka prastuta vijayanni suuchistumdi; conny dushprabhaavaalu inca samasyaatmakamgaa unnanduna, marinta daryaaptu avasaram.
phalitaalu.
merugaina ghnaanam mariyu rojuvaaree karyakalapalanu nirvahinchagala saamarthyam dwara highlight cheyabadina phalakam sthaayi taggudala undhi. rendava dasha daani prabhavalanu mariyu daetaanu vivaramgaa vislaeshimchakumdaa praarambhamlo aasaajanaka phalitaalanu choopinchindi. placebo samuuham mariyu donanemab thoo nimpina rogula madhya phalitaalalo gananeeyamaina vyatyaasam ledani nirdhaarinchabadindi. rendava dasha taruvaata donanemab vichaarananu nilipivesindi.
dasha III.
october mariyu november 2020loe, lillie rendava adhyayanam cheyadaaniki trail blazer-aljnu vistarinchindi. idhi kenada, netherlands mariyu polland antataa 87 pradaesaalatoe nadapabadindi.
2023 maeloe, company thana moodava dasha adhyayanamlo eee aushadham algimers vyaadhi vegaanni 35 saatam tagginchagaladani choopinchindi. juulai 2023loe, donanemab thoo chikitsa pondina 1,736 mandhi vyaktula phalitaalu 76 varalalo algimers purogati mandaginchadaanni choopinchaayi, 24 saatam mandhi prajalu mastishka vaapunu pradarsinchaaru.
cerebral edema.
donanemab yokka pedda motaadulalo, kontamandi 'amyloid-sambandhita imaging asaadhaaranatalu edema ledhaa effusionlatho' (aria-ii) anie piluvabade mastishka vaapu (medadu vaapu) yokka oka roopaanni abhivruddhi chesaaru; veerilo kondaru lakshanaalu laenivaaru mariyu itarulu rogalakshanamgaa unnaaru. rogalakshana rogulalo pedda saatam mandhi vikaram yokka bhavalanu anubhavinchinanduna aushadhaanni nilipivesaaru.