The treatment paradigm for gastroesophageal reflux disease is rapidly shifting from proton pump inhibitors (PPIs) to potassium-competitive acid blockers (P-CABs). Major domestic pharmaceutical companies are expanding clinical trials or considering technology adoption of P-CABs to enter the market.
HK inno.N, leading the market, is laying the groundwork for long-term growth by extending its domestic patent. According to the pharmaceutical industry on the 18th, by the end of last year, P-CAB treatment accounted for 24.5% of the market share, a 5% increase from the first quarter’s 19.5%. Although PPIs still hold a higher market share, they have slower onset and must be taken on an empty stomach or before meals. In contrast, P-CABs can be taken regardless of meals and have longer duration, leading to a shift in prescriptions from PPIs to P-CABs at major hospitals.
The market potential is growing not only domestically but also internationally. HK inno.N’s new drug for gastroesophageal reflux disease, “K-CAB” (active ingredient tegoprazan), recently passed the final hurdle for a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) by obtaining positive results in a Phase 3 maintenance therapy trial in the U.S. Tegoprazan showed superior healing effects compared to PPIs (lansoprazole) in 2-week and 8-week treatments for all grades (LA A~D) of erosive esophagitis patients.
“K-CAB,” the 30th new drug developed by HK inno.N, was launched in Korea in March 2019, achieving cumulative prescription sales of 810.1 billion KRW by the first half of 2025, with sales rapidly increasing. K-CAB has signed technology export and finished product export contracts with 54 countries, including Korea, the U.S., China, Canada, and Australia, and has been launched in 17 of these countries.
Daewoong Pharmaceutical is closely following HK inno.N with “Fexuclue.” Onconic Therapeutics’ “Zacubo” is also rapidly growing.
Fexuclue recorded 78.8 billion KRW in outpatient prescriptions last year, with 43.2 billion KRW prescribed in the first half of this year.
Zacubo, launched last October, increased sales from 5.8 billion KRW last year to 16.4 billion KRW in the first half of this year.
Recognizing the potential of P-CAB drugs, domestic pharmaceutical companies are aiming to enter this market. Daewon Pharmaceutical, Hana Pharmaceutical, Huons, and United Pharm are focused on developing P-CAB new drugs.
Daewon Pharmaceutical is progressing the fastest among those conducting clinical trials. Last year, it began co-developing the P-CAB new drug candidate “DW4421” by obtaining technology from IlDong Pharmaceutical’s drug development subsidiary, UNOVIA.
Dong-A ST is also reportedly considering technology adoption for P-CABs. At the “Bio International Convention 2025” in Boston earlier this year, Dong-A ST’s head of research and development, Park Jae-hong, stated, “We are very interested in the next-generation drug candidates, especially P-CABs,” and added, “I think we need our own (P-CAB development) project.”