Caregen (CEO Jung Yong-ji), a peptide-specialized biotech firm, introduced on the 18th that it has submitted a New Dietary Ingredient (NDI) registration software to the U.S. Meals and Drug Administration (FDA) for its oral peptide ‘Korglutide’.
Caregen submitted the appliance instantly after the shutdown was lifted, following a suspension of recent purposes because of the U.S. authorities shutdown that started on October 1st. The FDA has a process to reply with evaluate opinions inside 75 days of NDI receipt, and the corporate expects to substantiate the ultimate outcomes round January subsequent 12 months.
Caregen beforehand obtained FDA NDI approval for blood sugar management peptide ‘Deglusterol’ in 2022 and muscle well being peptide ‘Myoki’ in March 2025, making this Korglutide software its third artificial peptide NDI problem. Caregen is the one firm worldwide to have obtained FDA NDI approval for artificial peptides greater than twice.
Korglutide is a dual-agonist oral peptide that concurrently prompts GLP-1 receptors and IGF-1 receptors, with a mechanism to enhance each weight management and metabolic stability concurrently. By way of this NDI software, the corporate introduced plans to supply “a physique fat-focused weight administration resolution that can be utilized by folks worldwide” upon approval.
Caregen performed medical trials on 100 overweight sufferers to display the security and efficacy of Korglutide. The outcomes confirmed a median weight lack of 10.75% (roughly 9.3kg) in simply 12 weeks whereas sustaining muscle mass and reaching fat-focused weight discount.
Moreover, concentrating on the final wellness and physique form administration market, medical trials are ongoing with 200 adults who’ve regular BMI vary (22-26kg/㎡) however excessive physique fats proportion. Interim outcomes of this research confirmed knowledge of −10.1% weight reduction (roughly −5.9kg), −16.3% physique fats discount (−3.52kg), −13.5% visceral fats discount, and +2.8% enhance in muscle ratio with solely twice-daily oral administration for 12 weeks.
This confirmed vital variations in comparison with the placebo group (−2.0% weight, −2.4% physique fats), and no critical antagonistic reactions have been reported. The research is predicted to launch its remaining report inside the 12 months, and that is anticipated to be Caregen’s distinctive knowledge for weight management medical trials concentrating on wholesome people.
Korglutide has signed unique provide contracts with Canada, Thailand, Mexico, Turkey, Peru, Paraguay, Lebanon, Ecuador, and others, with commercialization underway.
Significantly in India, the well being authorities have granted a weight administration declare, formally recognizing the ingredient’s performance, and unique provide contracts are being pursued with Russia, Bangladesh, Saudi Arabia, and the United Arab Emirates. Moreover, negotiations for tech switch and native manufacturing are underway with three high international pharmaceutical corporations in India, with plans to pursue native unique provide chain institution and large-scale commercialization upon remaining contract signing.
In China, Yishijin Pharmaceutical Group is making ready medical trials with 10 thousand individuals (involving 1 thousand medical doctors), and market entry into China is predicted to speed up.
In Lebanon, prescriptions for overweight sufferers have begun at main hospitals, and gross sales at pharmacies and medical establishments are accelerating with continued constructive suggestions from native customers. Native companions are increasing market share by supplying Korglutide as a “weight administration product beneficial by medical professionals.”
Korglutide was developed as an oral weight administration resolution that may be taken with out the inconvenience or unwanted side effects of injections, and is being expanded into varied formulations together with stick powder, capsules, and sub-lingual movies. It’s attracting consideration from international corporations with the paradigm of “protected and sustainable weight reduction” and has secured differentiation by being appropriate for common shoppers who need to keep muscle whereas lowering solely fats.
Caregen is making ready a direct-to-consumer (D2C) technique for Korglutide in keeping with this NDI approval course of. The corporate notably plans instant entry into the North American market by means of Amazon, and goals to develop collaboration with international corporations and safe market dominance based mostly on the regulatory basis belief strengthened by NDI approval.
