Korean biotech firm Caregen has submitted regulatory paperwork to the U.S. Food and Drug Administration seeking approval for Korglutide, an oral peptide targeting weight management. The Seoul-based company filed the New Dietary Ingredient application immediately after the agency resumed accepting submissions following a government shutdown that began October 1.
Korglutide activates both GLP-1 and IGF-1 receptors, distinguishing it from injectable weight-loss medications that have dominated the obesity treatment market. The FDA typically provides review feedback within 75 days of receiving NDI applications, putting Caregen’s expected response around January.
This marks Caregen’s third attempt at securing FDA clearance for a synthetic peptide ingredient. The company previously obtained approvals for blood sugar peptide Deglusterol in 2022 and muscle health compound Myoki in March, making it the only firm globally to receive multiple FDA NDI approvals for synthetic peptides.
Clinical trials on 100 obese patients showed average weight loss of 10.75% over 12 weeks, according to the company. Caregen has signed supply contracts across nine countries including Canada, Thailand and Mexico, with commercialization already underway in some markets. Indian health authorities have granted weight management claims for the ingredient.
The company plans direct-to-consumer sales through Amazon if U.S. regulatory approval is secured.
