{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["10(1)"],"submitter":["Lund J"],"pubmed_abstract":["<h4>Background</h4>Denecimig (Mim8, Novo Nordisk A/S) is a next-generation bispecific antibody designed to mimic activated factor (F)VIII and restore hemostasis in persons with hemophilia A. The extent to which activated FVIII mimetics, such as denecimig and emicizumab, can correct clotting deficiency remains unclear.<h4>Objectives</h4>To assess the <i>in vitro</i> FVIII bioequivalence of denecimig hemostatic activity using thrombin generation assays (TGAs).<h4>Methods</h4>Thrombin generation was analyzed in severe hemophilia A platelet-poor plasma, spiked with various levels of FVIII or with clinical doses of denecimig (5 μg/mL) or emicizumab (50 μg/mL), using a sequence-identical analog (SIA). TGA used 4 trigger conditions: tissue factor (TF), activated FXI, a combination of TF and activ"],"journal":["Research and practice in thrombosis and haemostasis"],"pagination":["103333"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12907708"],"repository":["biostudies-literature"],"pubmed_title":["Factor VIII &lt;i&gt;in vitro&lt;/i&gt; bioequivalence of denecimig (Mim8) hemostatic effect by thrombin generation assays."],"pmcid":["PMC12907708"],"pubmed_authors":["Jensen K","Ezban M","Lillicrap D","Lund J"],"additional_accession":[]},"is_claimable":false,"name":"Factor VIII &lt;i&gt;in vitro&lt;/i&gt; bioequivalence of denecimig (Mim8) hemostatic effect by thrombin generation assays.","description":"<h4>Background</h4>Denecimig (Mim8, Novo Nordisk A/S) is a next-generation bispecific antibody designed to mimic activated factor (F)VIII and restore hemostasis in persons with hemophilia A. The extent to which activated FVIII mimetics, such as denecimig and emicizumab, can correct clotting deficiency remains unclear.<h4>Objectives</h4>To assess the <i>in vitro</i> FVIII bioequivalence of denecimig hemostatic activity using thrombin generation assays (TGAs).<h4>Methods</h4>Thrombin generation was analyzed in severe hemophilia A platelet-poor plasma, spiked with various levels of FVIII or with clinical doses of denecimig (5 μg/mL) or emicizumab (50 μg/mL), using a sequence-identical analog (SIA). TGA used 4 trigger conditions: tissue factor (TF), activated FXI, a combination of TF and activ","dates":{"release":"2026-01-01T00:00:00Z","publication":"2026 Jan","modification":"2026-07-16T05:12:01.762Z","creation":"2026-07-09T10:36:51.576Z"},"accession":"S-EPMC12907708","cross_references":{"pubmed":["41704799"],"doi":["10.1016/j.rpth.2025.103333"]}}