A South Korean drugmaker is seeking to crack one of the most entrenched corners of the U.S. prescription market, betting that a new approach to treating acid reflux can address the large share of patients left inadequately served by decades of standard therapy.
HK inno.N, a pharmaceutical company based in South Korea, said its U.S. partner has filed a New Drug Application with the Food and Drug Administration for K-CAB, a treatment for gastroesophageal reflux disease that has already been widely prescribed across Asia and other overseas markets. The application was submitted in early January by Braintree Laboratories, a gastrointestinal-focused drugmaker affiliated with Sebela Pharmaceuticals, which holds U.S. development and commercialization rights.
The filing seeks FDA approval for three indications in a single submission: non-erosive reflux disease, the active treatment of erosive esophagitis, and long-term maintenance therapy following healing. If the application proceeds under a standard review timeline, a regulatory decision is expected around January 2027.
For HK inno.N, the U.S. filing represents a critical milestone in the global expansion of K-CAB, whose active ingredient, tegoprazan, belongs to a newer class of acid-suppressing drugs designed to overcome the limitations of proton pump inhibitors. PPIs, which have dominated reflux treatment in the U.S. for decades, are effective for many patients but leave a sizable minority with persistent symptoms.
The FDA submission is supported by data from the Phase 3 TRIUMpH clinical program, which enrolled more than 2,000 patients in the United States. According to the companies, tegoprazan met all primary and secondary endpoints under a hierarchical statistical analysis plan and demonstrated superior performance to PPIs across multiple measures of symptom control and healing.
In patients with non-erosive reflux disease, tegoprazan increased the proportion of days free from continuous heartburn compared with placebo, while also reducing nighttime symptoms and acid regurgitation. Among patients with erosive esophagitis, the drug showed higher healing rates than lansoprazole at both early and later assessment points, with benefits observed across all disease severity grades, including advanced cases.
A separate 24-week maintenance study found that tegoprazan was more effective than PPIs at sustaining remission after healing, including in patients with severe disease—an area where long-term symptom control has remained a challenge for existing therapies.
The U.S. reflux market remains one of the largest and most stable in gastroenterology, but it is also marked by unmet need. Sebela estimates that roughly one-third to more than half of Americans with reflux disease fail to achieve adequate symptom relief with current treatments, creating an opening for therapies that offer more consistent acid control rather than incremental reformulations.
Sebela said it plans to present full results from the TRIUMpH program at major international medical conferences this year and submit the data to peer-reviewed journals, a process that could shape clinical and regulatory perceptions ahead of the FDA’s decision.
For HK inno.N, success in the U.S. would mark a rare breakthrough for a Korean-developed gastrointestinal drug in the world’s largest pharmaceutical market, positioning the company as a global player in an area long dominated by established Western therapies.
