Drug intelligence / Profile preview

denecimig

Development stage
Phase 3
Lead developer
Novo Nordisk
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

MIM8 (denecimig) is an investigational, fully human bispecific IgG4 monoclonal antibody developed as a Factor VIIIa mimetic for the prophylactic treatment of hemophilia A, both in patients with and without inhibitors. It functions by bridging activated coagulation factors IXa and X, thereby mimicking the cofactor activity of endogenous factor VIIIa to restore thrombin generation and promote hemostasis. Compared to emicizumab, another FVIIIa-mimetic bispecific antibody, MIM8 features a monovalent anti-FIXa arm that enhances FIXa’s proteolytic activity for activating FX. Preclinical studies have shown that MIM8 can normalize thrombin generation at lower concentrations than emicizumab. The drug is administered subcutaneously and is being evaluated for once-weekly to once-monthly dosing regimens in phase 3 clinical trials (FRONTIER program). Developed by Novo Nordisk, MIM8 has demonstrated favorable safety and efficacy profiles in both adult/adolescent and pediatric populations[1][3][4][5][6][8].

Other names
MIM8MIM-8MIM 8
02

Targets

Coagulation Factor IXaF10 (Factor Xa)

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