Ichiza elitsha elingundoqo le-Antidiabetic

Unjingalwazi u-Kyong Soo Park weSibhedlele seNyuvesi yeSizwe yaseSeoul njengomphandi oququzelelayo kunye nabaphandi abaziinqununu abavela kumaziko angama-22 baye bathatha inxaxheba kwisigaba sesi-3 solingo lwezonyango lwe-Enavogliflozin njenge-monotherapy (i-ENHANCE-A study). Uphononongo luqhutywe njenge-multicenter, i-randomized, i-double-blind, i-placebo-controlled, kunye novavanyo lokuqinisekisa unyango olubandakanya izigulane ze-160 ezinesifo sikashukela sohlobo lwe-2. Isiphelo esiphambili yayikukuphanda umahluko phakathi kweqela le-Enavogliflozin kunye neqela le-placebo kutshintsho olusisiseko lwe-glycated hemoglobin (HbA1c). Ngokutsho kwengxelo ephezulu, kwabonwa kwangaphambili ukuba yi-0.99% p kwiiveki ze-24 ukususela ekulawuleni imveliso yophando, eqinisekisa ukubaluleka kwezibalo (P-value <0.001). I-HbA1c, eyimveliso yokugqibela ye-hemoglobin edityaniswe neswekile yegazi, ngumlinganiselo osemgangathweni wegolide wokumisela ubungqongqo besifo seswekile.

Ukongeza, bekukho isiphumo sophononongo esihle esabonwa kwesinye isigaba sesithathu solingo lwezonyango lonyango oludityanisiweyo lwe-Enavogliflozin kunye ne-metformin yi-Daewoong Pharmaceutical (ENHANCE-M). Uphononongo lwe-ENHANCE-M luqhutywe nguNjingalwazi uGun Ho Yoon weYunivesithi yamaKatolika yaseKorea iSibhedlele saseSeoul St. Ulingo lwenziwe kunye nezigulane ezingama-3 ezinesifo sikashukela sohlobo lwe-23 ezinolawulo olunganelanga lweglucose yegazi ngeMetformin. Ngokusekelwe kwiziphumo malunga notshintsho olusisiseko lwe-HbA200c. Iqela lezigulana elanikwa i-Enavogliflozin kunye ne-Metformin libonise ngempumelelo ukungathobeki kwalo kwiqela elalilawulwa ngaxeshanye ne-Dapagliflozin kunye ne-metformin. Iziphumo zokhuseleko kwiqela elilawulwa nge-Enavogliflozin nazo zaqinisekiswa njengoko kungabikho ziganeko zibi zingalindelekanga okanye iziphumo ezibi kwiziyobisi.

Abaphandi bathi, "Isigaba sesi-3 solingo lweklinikhi ye-Enavogliflozin monotherapy (ENHANCE-A) kunye ne-Metformin yonyango oludityanisiweyo (ENHANCE-M) kunye nenani elipheleleyo lama-360 abathathi-nxaxheba baseKorea babonise isiphumo esibalaseleyo sokwehliswa kweglucose kunye nokhuseleko lwechiza. I-Enavogliflozin iya kuba lolona khetho lubalaseleyo lonyango kwizigulana ezinesifo seswekile esi-2 ukuba iziphumo ezifanayo ziqinisekisiwe kolunye unyango oludibeneyo.

Njengoko iziphumo ezibalulekileyo zafunyanwa kuzo zombini iimvavanyo ze-monotherapy kunye ne-Metformin yonyango oludibeneyo, u-Daewoong uyonwabile ukukhupha inhibitor entsha ye-SGLT-2 okokuqala eMzantsi Korea. UDaewoong uceba ukwenza isicelo kwangoko sokwamkelwa kwechiza elitsha kwaye aqalise kungekuphela nje i-Enavogliflozin kunye kodwa ne-Enavogliflozin/Metformin-fixed-dose-combination (FDC) ichiza ngo-2023. Ngeli xesha, i-Daewoong yayisele ivunyiwe kuphononongo lwe-phase-1 ukuvavanya uphononongo lwe-bioequivalence I-FDC ye-Enavogliflozin kunye ne-Metformin ngoJanuwari ka-2022.

“Ngempumelelo yolingo lwezonyango lwakutsha nje, kulindeleke ukuba sibonelele izigulana zalapha elona yeza litsha lelizwe elikwiKlasi yesifo seswekile kungekudala,” utshilo uSengho Jeon, i-CEO yeDaewoong Pharmaceutical. "Siza kuzama ukukhulula iyeza lesizukulwana esilandelayo kwaye sincede abo banesifo seswekile kunye neengxaki, ngelixa sigcina ukukhula kwenkampani."