Drug intelligence / Profile preview

dalcinonacog alfa

Development stage
Phase 3
Lead developer
Gyre Therapeutics
Modality
Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

Dalcinonacog alfa is a novel, next-generation recombinant human factor IX (FIX) variant developed for the prophylactic treatment of hemophilia B. It is engineered with three specific amino acid substitutions (Arg318Tyr, Arg338Glu, Thr343Arg), resulting in enhanced catalytic activity—specifically, a threefold increase in the activation speed of factor X compared to wild-type FIX, tenfold higher affinity for activated factor VIII (FVIIIa), and fifteenfold greater resistance to inhibition by antithrombin III. These modifications confer over twenty times the potency of recombinant wild-type FIX at equivalent dosing. Dalcinonacog alfa is administered subcutaneously and has demonstrated efficacy in raising FIX levels into the mild hemophilia range with prolonged half-life and favorable pharmacokinetics. The drug is being developed primarily for adult and pediatric patients with hemophilia B[1][3][4][5][6].

Brand names
ISU304ISU-304ISU 304DalcA
Other names
DalcAdalcinonacog alfa LA
02

Targets

ATIII (Antithrombin III)PS (Phosphatidylserine)F8 (Coagulation Factor VIIIa)F10 (Factor Xa)

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