mecasermin rinfabate (Insmed Incorporated, 0456cf)

Mecasermin rinfabate is a recombinant human insulin-like growth factor-1 (rhIGF-1) complexed with its primary binding protein, recombinant human insulin-like growth factor binding protein-3 (rhIGFBP-3). This binary complex is designed to mimic the naturally occurring circulating form of IGF-1 in the human body, which significantly extends the half-life of the growth factor and modulates its interaction with the IGF-1 receptor. By providing IGF-1 in a stabilized complex, the drug reduces the risk of acute hypoglycemia compared to free IGF-1 administration. Originally developed by Insmed, it received FDA approval in 2005 for the treatment of growth failure in children with severe primary insulin-like growth factor-1 deficiency (Laron syndrome). However, following a patent settlement with Tercica (Genentech), Insmed withdrew the product from the market for growth disorders and pivoted to investigating it for other indications, including myotonic dystrophy type 1 (DM1) and amyotrophic lateral sclerosis (ALS). The complex was also licensed to Shire (now Takeda) for the treatment of retinopathy of prematurity (ROP) under the code SHP607.

Brand names

IPLEX

Other names

Recombinant human Insulin-like Growth Factor-I/Recombinant human Insulin-like Growth Factor Binding Protein-3rhIGF-I/rhIGFBP-3 complex