HK inno.N

“Anticipating a Shift in the Global Paradigm of GERD Treatment with Proven Superiority over PPIs”

K-CAB, HK inno.N’s New GERD Treatment, Announces U.S. Phase 3 Clinical Trial Results at the 2026 DDW

- From Treatment to Maintenance of Erosive Esophagitis (EE): Clinical Superiority Confirmed over a PPI (lansoprazole)

- K-CAB now secures data for western populations, creating a springboard to leap into global P-CAB market dominance

- Anticipation Mounts for a Successful Market Entry ahead of the Product Launch in the U.S., the World's Largest Pharmaceutical Market

Photo. Sebela Pharmaceuticals, the U.S. partner of HK inno.N presents U.S. Phase 3 Clinical Trial Results of K-CAB at the 2026 Digestive Disease Week (DDW).

The results from US Phase 3 clinical trials for K-CAB (ingredient name: Tegoprazan), HK inno.N’s new gastroesophageal reflux disease (GERD) drug, have been presented recently, laying the groundwork for the product’s launch in the world's largest pharmaceutical market.

On May 4 and 5 (local time), Sebela Pharmaceuticals, the U.S. partner of HK inno.N, held a presentation on the healing and maintenance of erosive esophagitis (EE) with K-CAB (hereinafter tegoprazan) at the 2026 Digestive Disease Week (DDW), the world’s largest gastroenterology conference. Following last year's release of key results, Sebela disclosed the full study data for the first time at this event. Clinicians and researchers from around the globe attended the presentation, drawing considerable interest in tegoprazan, a new Potassium-Competitive Acid Blocker (P-CAB) class drug.

This presentation marks the first instance of a P-CAB class treatment demonstrating superiority over PPI (Proton Pump Inhibitor)-class drugs, based on the "TRIUMpH program"—the pivotal Phase 3 clinical trials previously highlighted by Sebela. Tegoprazan has paved the way for a paradigm shift away from PPIs, which have been the standard of care for GERD over decades, indicating the potential for a growing share in the global market and changes in future GERD treatment guidelines

The Phase 3 EE study was a large-scale trial conducted on 1,250 patients with EE. The study compared the efficacy and safety of tegoprazan 100 mg against the PPI-class drug lansoprazole 30 mg at Week 2 and Week 8.

Tegoprazan 100 mg demonstrated superior therapeutic efficacy in treating EE compared to lansoprazole 30 mg. The proportion of patients with complete healing at Week 8 was 84.6% for tegoprazan and 78.0% for lansoprazole, establishing both non-inferiority and superiority of tegoprazan over lansoprazole. The significant superiority of tegoprazan was also confirmed in the proportion of complete healing at Week 2, with values of 76.4% and 67.0%, respectively (tegoprazan 100 mg: p=0.0083 at Week 8; p<0.0001 at Week 2).

The efficacy of tegoprazan was particularly pronounced in healing outcomes in patients with severe EE (LA Grade C, D). The proportion of healing at Week 2 was 74.1% vs. 54.5%, and at Week 8, it was 83.2% vs. 68.0%, demonstrating superiority of tegoprazan over lansoprazole at both time points. In terms of the percentage of 24-hour heartburn-free days through Week 8, tegoprazan achieved non-inferiority in all grades of EE patients and showed significant superiority over lansoprazole in severe EE patients.

These results are recognized as the first instance among P-CAB class agents to prove superiority over a PPI. The significance of the finding lies in that therapeutic superiority of tegoprazan has been confirmed, which could not be clearly established with other existing P-CABs. Furthermore, as these results were derived from large-scale clinical trials conducted in the United States, they serve to provide scientific evidence for tegoprazan to present a new paradigm of GERD treatment in the global market.

Tegoprazan showed safety outcomes similar to lansoprazole in terms of incidences of adverse events and mean serum gastrin levels, which can affect gastric mucosal changes. The findings indicate that while tegoprazan maintains a safety profile comparable to the current standard-of-care PPIs, it provides more potent therapeutic efficacy. Consequently, as a next-generation GERD therapy that has achieved both safety and efficacy, tegoprazan is expected to garner substantial attention from both the medical community and the investment market.

Tegoprazan also demonstrated superiority as maintenance therapy for EE patients, distinguishing itself from existing agents. In terms of the primary endpoint—the proportion of patients with sustained complete healing at Week 24—tegoprazan showed superior results across patients of all LA grades, confirming its strong clinical competitiveness as long-term treatment. This achievement is highly significant as it demonstrates sustained therapeutic effects beyond its efficacy as the initial treatment—a feat that had not been clearly established by existing PPIs or even other agents of the same P-CAB class. The product’s superiority consistently demonstrated across all grades of patients supports tegoprazan as a next-generation therapeutic option that will benefit a wide range of GERD patients, regardless of their severity.

Professor Hyun-Soo Kim, President of the Korean Society of Gastroenterology (Gastroenterology, Yonsei University Wonju College of Medicine), who attended the US presentation in person, stated, "As the superiority of K-CAB over PPIs has been confirmed through this presentation, I expect to witness innovative changes in the future of GERD treatment, fueled by the presentation of new evidence." He added, "This is expected to serve as a major turning point in the perception of treatments with acid-suppressing agents in the global clinical settings."

Moo In Park, Chairman of the Korean Society of Neurogastroenterology and Motility (Professor of Gastroenterology at Kosin University College of Medicine), commented, "The impressive point is that K-CAB has achieved consistent excellence not only for acute care but also in the maintenance therapy stage." He continued, "We anticipate that K-CAB will clearly establish itself as the new solution for GERD treatment and influence future paradigm shifts."

An official from HL inno.N stated, "K-CAB has now obtained clinical data from Western populations in addition to the data accumulated in clinical settings in South Korea over the seven years since its domestic launch," and added, "Through the presented results, the clinical values of K-CAB have been confirmed, setting the stage for K-CAB as a leading global P-CAB product."

Tegoprazan is the active pharmaceutical ingredient of K-CAB, developed by HK inno.N, as the 30th new drug of South Korea. K-CAB, a P-CAB class new drug for GERD treatment, has demonstrated its superior efficacy over PPIs in △ onset of action △ duration of action △healing of EE and maintenance. Since its domestic launch in March 2019, it has achieved cumulative prescription sales of KRW 923.3 billion as of the end of 2025, firmly holding its position of the top-selling peptic ulcer treatment in South Korea.

K-CAB has been licensed or exported to 55 countries, with regulatory approvals in 23 countries including South Korea and market launches in 20 of them to date. Sebela Pharmaceuticals, HK inno.N’s U.S. partner, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in January this year. (END)

About TRIUMpH

The TRIUMpH program comprises phase 3 clinical studies evaluating tegoprazan in U.S. patients with gastroesophageal reflux disease (GERD), including △erosive esophagitis (EE) and △non-erosive reflux disease (NERD).All phase 3 studies were conducted as multi-center, double-blind trials involving U.S. patients representative of the country’s diverse demographics and racial composition.

■ Phase 3 EE study (NCT05587309)

This phase 3 EE study enrolled 1,250 patients, including 463 with LA Grade C/D, and was a large, multi-center, double-blind trial designed to assess the safety and efficacy of tegoprazan.This study consisted of an initial healing phase (Weeks 2 and 8/tegoprazan 100mg vs. lansoprazole 30mg) and a 24-week maintenance phase (tegoprazan 50mg and 100mg vs. lansoprazole 15mg).

▶ Primary endpoint

- Healing phase: proportion of patients achieving complete healing at Week 8

- Maintenance phase: proportion of patients maintaining complete healing at Week 24

▶ Secondary endpoints

- Healing phase: proportion of 24-hour heartburn-free days at Week 8

- Maintenance phase: proportion of 24-hour heartburn-free days at Week 24

■ DDW 2026 TRIUMpH-EE Oral Presentations

▶ Erosive Esophagitis Healing

Presenter: Felice Schnoll-Sussman, MD (Weill Cornell Medicine) 

Session Title: Clinical Advances in GERD

Session Date & Time: May 4, 2026, 8:00–9:30 AM CDT

Presentation Title: TEGOPRAZAN 100MG DEMONSTRATES SUPERIOR AND FASTER HEALING OF EROSIVE ESOPHAGITIS AND HEARTBURN RELIEF VERSUS LANSOPRAZOLE: RESULTS FROM THE PHASE 3 TRIUMPH STUDY

- Key results:

Proportion of patients with complete healing at Week 8: tegoprazan [84.6%] vs lansoprazole [78.0%] (Δ=6.6%); non‑inferiority achieved and superiority achieved; (p=0.0083).

Proportion of patients with complete healing at Week 2: tegoprazan [76.4%] vs lansoprazole [67.0%] (Δ=9.4%); superiority achieved (p<0.0001).

Healing outcomes in patients with severe EE (LA Grade C/D) at Weeks 2 and 8: Week 2: tegoprazan [74.1%] vs lansoprazole [54.5%] (Δ=19.6%); superiority achieved (p<0.0001); Week 8: tegoprazan [83.2%] vs lansoprazole [68.0%] (Δ=15.2%); superiority achieved (p=0.0002).

Percentage of 24‑hour heartburn‑free days through Week 8: tegoprazan [54.3%] vs lansoprazole [51.9%] (p<0.0001 for non-inferiority). In patients with severe EE (LA Grade C/D): tegoprazan [60.1%] vs lansoprazole [53.6%] (Δ=6.5%); superiority achieved (p=0.0289).

Tegoprazan 100mg was shown to be safe for the healing of EE, with no differences in treatment emergent adverse events (TEAEs) or adverse events of special interest (AESIs) versus lansoprazole 30mg. Mean serum gastrin levels remained within normal limits throughout the study.

▶ Erosive Esophagitis Maintenance of Healing

- Presenter: Felice Schnoll-Sussman, MD (Weill Cornell Medicine) 

- Session Title: Clinical Advances in GERD

- Session Date & Time: May 4, 2026, 8:00–9:30 AM CDT

- Presentation Title: TEGOPRAZAN 100MG DEMONSTRATES SUPERIOR AND FASTER HEALING OF EROSIVE ESOPHAGITIS AND HEARTBURN RELIEF VERSUS LANSOPRAZOLE: RESULTS FROM THE PHASE 3 TRIUMPH STUDY

- Key results:

Proportion of patients with sustained complete healing at Week 24 (all LA grades): tegoprazan 100 mg [69.4%], tegoprazan 50 mg [61.4%], lansoprazole 15 mg [50.6%] (Δs=18.8% & 10.8%, respectively) (non‑inferiority achieved; superiority achieved vs lansoprazole: 100 mg p<0.0001, 50 mg p=0.0145).

Sustained healing at Week 24 in patients with LA Grade C/D: tegoprazan 100 mg [76.4%] vs lansoprazole 15 mg [44.3%] (Δ=32.1%); superiority achieved (p<0.0001); tegoprazan 50 mg [57.9%] (Δ=13.6%) (p=0.061 for superiority).

Percentage of 24‑hour heartburn‑free days at 24 weeks for tegoprazan 100mg [72.9%] and 50mg [69.9%] versus lansoprazole [69.4%] (Δs=3.5% & 0.5%, respectively) (p<0.0001 for non-inferiority). In patients with severe EE (LA Grade C/D); tegoprazan 100mg [84.2%] vs lansoprazole [70.4%], superiority achieved (p=0.0018) (Δ=13.8%).

Rates of TEAEs and AESIs were low for both doses of tegoprazan and comparable to lansoprazole with no dose effect. Mean serum gastrin levels remained within the normal range for the duration of treatment.

Gastroesophageal reflux disease (GERD)

- A chronic disease that causes uncomfortable symptoms such as heartburn and acid regurgitation due to the reflux of gastric contents into the esophagus and may lead to complications when the symptoms become severe, thereby repeating improvement and aggravation of symptoms.

- GERD currently affects approximately 65 million people in the U.S. The primary symptoms include heartburn and acid regurgitation. Although conventional PPI-based treatments are commonly used, 35 to 54% of patients fail to achieve complete relief of symptoms with these treatments, indicating a significant unmet need in this population.

- Based on endoscopic findings, GERD is classified into erosive and non-erosive depending on whether oesophagitis is observed.

Erosive esophagitis (EE)

: Presence of reflux symptoms with mucosal lesions or oesophagitis observed as a result of endoscopic examination

The Los Angeles Classification (LA Grade)

- LA Grade is the diagnostic criteria for erosive esophagitis (EE), first introduced by the Los Angeles Gastroenterology Association. EE is graded from LA A to LA D based on the length of mucosal breaks and their circumferential extent.

P-CAB (Potassium Competitive Acid Blocker / HK inno.N K-CAB (Tegoprazan))

- The mechanism of P-CAB is to block the secretion of gastric acid by competitively binding directly to the potassium ions of the proton pump without the need for activation by gastric acid; i.e., by interfering with the binding of potassium ions to the proton pump.

- Therefore, P-CAB can be administered irrespective of food, provide a fast, strong effect of inhibiting gastric acid secretion from the first day of dosing, and have a long-acting property, compared to PPIs, ensuring superior prevention of overnight gastric acid secretion.

Proton Pump Inhibitors (PPI) / lansoprazole, etc.

- Gastric acid secretion is blocked by irreversible inhibition of the gastric proton pump (Hydrogen/Potassium Adenosine Triphosphatase; H+/K+-ATPase; Proton pump) involved in the final step of gastric acid secretion.

- PPIs are prodrugs that are activated by gastric acid and then bind to the proton pump for inhibition of gastric acid secretion; therefore, they should be administered before food, with the maximal effect achieved after repeated administration (3 to 5 days).

HK inno.N

HK inno.N was established as the pharmaceutical business division of CJ CheilJedang in 1984 and separated into CJ HealthCare Corp in 2014. After being incorporated as a subsidiary of Kolmar Group in 2018, the company was renamed HK inno.N Corp. in 2020. With a mission of "Heal the World for a Better Life," HK inno.N has advanced technologies and unrivaled expertise while specializing in prescription drugs, health supplements, and beauty products. In the business of prescription drugs, HK inno.N is focusing on creating innovative products aiming to reach global top markets, building on successful development of K-CAB, South Korea's 30th new drug, that has achieved blockbuster status. In the business of health and beauty, HK inno.N has also been committed to enhance its future growth potential through continuous expansions of its presence in the areas of beverages, health functional foods, and cosmetics, starting with launch of 'CONDITION' in the hangover cure market. www.inno-n.com

About Sebela Pharmaceuticals^®

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in women's health. Braintree Laboratories, Inc., an affiliate of Sebela Pharmaceuticals, has taken the lead in innovating, developing, manufacturing, and commercializing product categories in gastroenterology for over 40 years. The core pipeline for Braintree is a novel P-CAB tegoprazan which has completed phase 3 EE and NERD clinical trials. In 2025, Sebela Pharmaceuticals obtained FDA approval for Miudella®, a non-hormonal intrauterine device (IUD) indicated for prevention of pregnancy in women of childbearing potential. Sebela's Miudella is the first FDA-approved hormone-free IUD in over 40 years and was named to TIME’s Best Inventions of 2025 list. Sebela Pharmaceuticals also has another next-generational hormonal IUD for contraception under late-stage clinical development.

Sebela Pharmaceuticals has offices in in Roswell, GA; Braintree, MA; and Dublin, Ireland. www.sebelapharma.com