NEUCARDINTM is a genetically engineered recombinant peptide fragment of neuregulin-1 (β2a isoform). It is expressed in E.coli , lyophilized for storage and used for the treatment of moderate to severe heart failure.
| Mechanisms : It has been shown that neuregulin-1 is importantly involved in development, differentiation and function of myocardial cells. Based on research on molecular and cellular level, Zensun found that NEUCARDINTM couldattenuate myofibrillar disarray in impaired myocardial cells and strengthen the intercalated disc connections between them. In addition, in vivo administration of NEUCARDINTM greatly reduced myocardial cell damage induced by ischemia, hypoxia or viral infection, allowing repair of sarcomere structure, with improvement in cardiac performance, hemodynamics and survival. |
Indications : NEUCARDINTM is indicated for the treatment of patients with intermediate to advanced heart failure and dilated cardiomyopathy.
Pharmacological Action : Using various animal models, including (1) rat sub-acute and chronic heart failure, (2) mouse viral myocarditis, (3) rat toxic myocarditis induced by adriamycin, and (4) dog congestive heart failure caused by constriction of inferior venue cava, it has been demonstrated that NEUCARDINTM improves impaired myocardial structure, decreases the extent of ischemia injury, and improves heart function and hemodynamics. This results in enhanced survival in these animal models.
Safety : Safety pharmacology studies indicate that NEUCARDINTM has no adverse effects on cardiovascular or respiratory system function in normal monkeys. Acute toxicity studies in mice showed that the minimum fatal dose was 3000 times the clinical equivalent dose. Safety evaluations in monkeys after administration of multiple doses of NEUCARDINTM revealed that a high dosage (above the therapeutic dose) could cause some local microcapillary vessel leakage, but no significant side effects had been found with doses in low to moderate ranges, indicating a safe therapeutic dosage range.
