HK inno.N's (195940) gastroesophageal reflux disease treatment "K-CAB" can now be used to prevent peptic ulcers in patients taking anti-inflammatory painkillers over the long term. With its indications expanded to six, the drug has secured the broadest therapeutic range among Korea's potassium-competitive acid blockers (P-CAB).
HK inno.N said on the 27th that K-CAB (generic name tegoprazan) received additional approval from the Ministry of Food and Drug Safety for the indication of "prevention of peptic ulcers associated with the administration of non-steroidal anti-inflammatory drugs (NSAIDs)." Since its launch in 2019, K-CAB has maintained the top spot in domestic outpatient prescription sales among peptic ulcer treatments. In April, it became the first single-agent Korean-developed new drug to surpass 1 trillion won in cumulative outpatient prescription sales.
With this approval, K-CAB now holds a total of six indications, adding peptic ulcer prevention to the treatment of erosive and non-erosive gastroesophageal reflux disease, gastric ulcer treatment, Helicobacter pylori eradication therapy, and maintenance therapy. This is the largest number of indications among domestic P-CAB treatments.
The new indication was added based on the results of a clinical trial targeting patients taking anti-inflammatory painkillers over the long term. In the study, which compared the efficacy of K-CAB 25 mg with lansoprazole 15 mg, a proton pump inhibitor (PPI), K-CAB demonstrated non-inferiority in preventing gastric and duodenal ulcers at 24 weeks. At 12 weeks, the proportion of patients without heartburn symptoms was also higher in the K-CAB group.
A total of 11 anti-inflammatory painkillers, including pelubiprofen, naproxen, meloxicam, and celecoxib, were used in the trial. HK inno.N explained that it confirmed safety and prescription usability even when combined with various types of NSAIDs.
Building on this expansion of indications, the company plans to accelerate its push into the market for prescribing gastric protectants alongside anti-inflammatory painkillers. As the number of patients with arthritis and chronic pain rises due to aging, cases of long-term use of anti-inflammatory painkillers are increasing, and the company expects the related market to expand as well.
Overseas expansion is also growing. K-CAB has signed technology export or finished-product supply contracts with 55 countries and is sold in 20 countries, including South Korea, China, and Latin America. In the United States, partner Sebela Pharmaceuticals applied for new drug approval to the U.S. Food and Drug Administration (FDA) in January this year, and the review is underway.
