HK inno.N's K-CAB gains 6th indication, most among domestic P-CAB drugs

HK inno.N's gastroesophageal reflux disease drug K-CAB (tegoprazan) has secured its sixth approved indication — making it the domestic potassium-competitive acid blocker (P-CAB) with the most approved uses — after winning clearance for the prevention of peptic ulcers in patients on long-term nonsteroidal anti-inflammatory drugs (NSAIDs).

HK inno.N announced Monday that the Ministry of Food and Drug Safety had granted K-CAB a new indication for the prevention of peptic ulcers associated with NSAIDs use.

With the latest approval, K-CAB now holds six indications in total: treatment of erosive and non-erosive gastroesophageal reflux disease, treatment of gastric ulcers, combination antibiotic therapy for Helicobacter pylori eradication, maintenance therapy following treatment of erosive gastroesophageal reflux disease, and the newly added NSAIDs-related ulcer prevention. That is the highest number of indications among P-CAB drugs currently on the market in South Korea.

The new indication is expected to accelerate the shift from proton pump inhibitors (PPIs) to P-CAB drugs in the gastroprotective co-prescription market, as aging populations drive a rise in chronic pain patients and, with them, greater NSAIDs use.

The clinical trial supporting the new indication enrolled long-term NSAIDs users and compared K-CAB 25 mg against the PPI lansoprazole 15 mg, evaluating efficacy and safety in preventing gastric and duodenal ulcers. After 24 weeks of treatment, K-CAB demonstrated non-inferiority to lansoprazole, and its heartburn improvement rate at the 12-week mark was statistically significantly higher than that of the lansoprazole group.

The trial included 11 NSAIDs — among them pelubiprofen, naproxen and celecoxib — confirming the drug's flexibility for co-prescription with a wide range of anti-inflammatory agents and its safety over 24 weeks of use.

"Managing gastrointestinal side effects from long-term use of anti-inflammatory drugs is an unmet medical need worldwide," said Kwak Dal-won, chief executive of HK inno.N. "The robust clinical data secured through this new indication will serve as a core driver for K-CAB to become a global blockbuster new drug."

K-CAB, South Korea's 30th domestically developed new drug, has held the top spot in outpatient prescriptions for peptic ulcer treatments since its 2019 launch, driven by its rapid onset of action and long-term safety profile. In April, it became the first single domestically developed new drug to surpass 1 trillion won ($681 million) in cumulative outpatient prescription sales. The drug has licensing agreements in 55 countries and is available in 20 markets including China. In January, HK inno.N completed a new drug application with the US Food and Drug Administration through its American partner Sebela, putting it on the cusp of entering the US market.