A domestic corporation has developed a glucagon-like peptide-1 (GLP-1) based weight loss health functional food and has entered the Middle Eastern market. The company claimed that it provides similar weight loss effects as existing obesity treatment injectables such as Wegovy and Maunja while allowing consumption of one pouch daily without a prescription.
However, in major markets such as the United States, Europe, and Korea, ingredients proven to have 'therapeutic effects' are classified as pharmaceuticals rather than health functional foods, making it impossible for the same product to be released. Contrary to the company's claims, there are analyses suggesting that there will be restrictions on market expansion in the future.
CAREGEN announced on the 14th that its GLP-1 based health functional food 'Korglutide' has been officially registered and sales have begun in Lebanon. This is the first time that a GLP-1 analog component has been registered in a health functional food. The company also stated that it plans to complete the registration of the health functional food in Mexico by October and launch it in the market in November. To this end, it has signed a supply contract worth approximately $42 million (58 billion won) with the Mexican pharmaceutical company IFA Celtix.
The Wegovy from Denmark's Novo Nordisk and the Maunja injectable from the U.S. company Eli Lilly are drugs that mimic GLP-1, a hormone secreted in the small intestine after meals. They work by reducing appetite and increasing satiety to induce weight loss. CAREGEN claims that Korglutide operates on the same principle as existing GLP-1 analog injectables, but can be taken daily in an oral form without a prescription.
The company also announced that it conducted clinical trials with 100 obesity patients in India. According to the interim results released by the company, patients who took Korglutide once daily for 12 weeks showed an average weight loss effect of 9.46% and 8.15 kg. In particular, weight loss was primarily from fat without the muscle loss, a common side effect of existing obesity medications, and there was a significant improvement in the level of hemoglobin A1c (HbA1c), which indicates average blood sugar levels. The final results of Korglutide will be announced on the 29th.
Based on the company's description, Korglutide resembles a GLP-1 class obesity treatment, but has been registered as a health functional food that can be purchased at general pharmacies or supermarkets. Health functional foods are supplements that help improve health functions using materials or components that have beneficial effects on the human body.
CAREGEN claimed that its GLP-1 health functional food is safer and has fewer side effects than existing injectables. A company representative noted, "Existing GLP-1 injectables have a polymer structure composed of more than 30 amino acids, which raises concerns about side effects, while Korglutide is made of just 7 amino acids, making its structure simpler and less burdensome on the body."
The company stated that it plans to complete the registration of new dietary ingredients (NDI) with the U.S. Food and Drug Administration (FDA) within the year. NDI approval is a process that verifies the safety of new health functional food ingredients entering the U.S. market. It is also preparing for clinical trials in Italy for the European market, and said that product registrations in India and Ecuador are in the final stages.
However, the industry views that even if it is released as a health functional food in some countries, expanding into advanced markets like the United States and Europe will not be easy. Generally, major countries such as the United States and the European Union (EU) classify ingredients with 'therapeutic effects' as pharmaceuticals rather than health functional foods.
The U.S. Food and Drug Administration (FDA) considers products that claim therapeutic effects as pharmaceuticals and requires much stricter review criteria and clinical trial data. In Korea, according to the 'Enforcement Rules of the Act on Health Functional Foods' by the Ministry of Food and Drug Safety, ingredients that could be misunderstood as pharmaceuticals or have disease prevention or treatment effects are not recognized as health functional foods.
One industry representative stated, "Releasing it as a health functional food rather than a new drug may be the company's business strategy," while also expressing skepticism, saying, "If the therapeutic efficacy is that high, why are they not going through the approval process for a new drug like other pharmaceutical companies?"
There are also opinions questioning the scientific validity of Korglutide. An expert in GLP-1 class obesity medication development in Korea stated, "To properly stimulate GLP-1 receptors, a certain level of molecular structure is required, and a composition of 7 amino acids cannot properly implement this mechanism," adding, "Even if it claims to be GLP-1, if actual delivery or absorption in the body is not confirmed, the mechanism of action could be unclear."
Currently, domestic and foreign pharmaceutical and biotechnology corporations, including Novo Nordisk, Eli Lilly, Hanmi Pharmaceutical, and D&D Pharmatech, are developing oral obesity treatments and GLP-1 class obesity medications that improve side effects such as muscle loss. Currently, Lilly's recently completed phase 3 trial for Opoaglifron is the most advanced oral obesity treatment.