Drug intelligence / Profile preview

cimaglermin alfa

Development stage
Phase 1
Lead developer
Acorda Therapeutics
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

Cimaglermin alfa (GGF2) is a recombinant human protein and a member of the neuregulin-1 (NRG1) family, specifically the glial growth factor 2 isoform. Developed by Acorda Therapeutics, it is being investigated as a potential treatment for heart failure, particularly heart failure with reduced ejection fraction (HFrEF). The drug acts as an agonist for the ErbB3 and ErbB4 receptor tyrosine kinases. Upon binding, these receptors heterodimerize with ErbB2, activating intracellular signaling pathways such as PI3K/Akt and MAPK, which are essential for cardiomyocyte survival, repair, and structural maintenance. Clinical development has included Phase 1 and Phase 2 trials, though progress has been impacted by safety concerns regarding hepatotoxicity. A specific Phase 1b study (GGF2-104) was conducted to evaluate the drug-drug interaction (DDI) effect of a single intravenous infusion of cimaglermin alfa on the pharmacokinetics of midazolam in patients with heart failure.

Other names
Glial Growth Factor 2recombinant human glial growth factor 2rhGGF2rhGGF-2rhGGF 2Neuregulin 1 beta 3Neuregulin1 beta 3Neuregulin-1 beta 3
02

Targets

ERBB4 (Erb-b2 receptor tyrosine kinase 4)

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