HK inno.N

“HK inno.N’s novel drug ‘K-CAB’ officially begins the U.S. New Drug Application (NDA) process for FDA approval.”

K-CAB, HK inno.N’s new novel drug for GERD treatment, submits an NDA to the U.S. FDA.

- HK inno.N's US partner Sebela filed an NDA application for K-CAB with the FDA on January 9 (local time).

- The NDA seeks approval for three indications: △ Treatment of non-erosive reflux disease (NERD) △ Treatment of erosive esophagitis (EE) △ Maintenance therapy following EE treatment.

- K-CAB has been approved in 22 countries including South Korea and expected to obtain U.S. approval in January 2027.

- First P-CAB-class treatment demonstrating superiority over PPIs in mild/moderate/severe EE

Photo. HK inno.N's novel drug series for gastroesophageal reflux disease, K-CAB

K-CAB, HK inno.N’s novel drug for gastroesophageal reflux disease (GERD) treatment, has officially entered the New Drug Application (NDA) process to obtain FDA approval in the U.S., the largest pharmaceutical market in the world.

HK inno.N announced on January 13 that its U.S. partner Braintree Laboratories, Inc., a pharmaceutical company specializing in developing, manufacturing, and marketing medicinal products in gastroenterology and an affiliate of Sebela Pharmaceuticals^®, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on January 9 (local time) for GERD treatment K-CAB (active ingredient: tegoprazan, hereinafter “tegoprazan”).

The NDA seeks simultaneous approval for three indications: △treatment of non-erosive reflux disease (NERD) △treatment of erosive esophagitis (EE) △maintenance therapy after treatment of EE.

The NDA submission is supported by robust data from pivotal phase 3 clinical studies under the ‘TRIUMpH Program’ with over 2,000 U.S. patients involved. The TRIUMpH clinical studies have demonstrated the superiority of tegoprazan in the P-CAB class over conventional proton pump inhibitor (PPI) therapy in multiple endpoints. All endpoints were analyzed according to a prespecified hierarchical multiple testing procedure.

In NERD patients, tegoprazan's statistically significant superiority over placebo was demonstrated in the proportion of 24-hour heartburn-free days (tegoprazan 100mg: p<0.0001, 50mg: p=0.0006), and tegoprazan was also superior to placebo in both the proportion of overnight heartburn-free days and the proportion of acid regurgitation-free days.

Also, in patients with EE of all grades (LA Grades A–D), tegoprazan demonstrated statistically significant superiority over lansoprazole, a PPI, at both Weeks 2 and 8 (tegoprazan 100mg: Week 2 p<0.0001, Week 8 p=0.0083).

Particularly in patients with severe EE (LA Grades C and D), tegoprazan also showed superiority at both Weeks 2 and 8, indicating its differentiated value in treating patients with severe conditions (tegoprazan 100mg: Week 2 p<0.0001, Week 8 p=0.0002).

In the 24-week maintenance phase following EE healing, tegoprazan also showed superiority in maintaining sustained healing in all patient groups, compared to PPI therapy (tegoprazan 100mg: p<0.0001, 50mg: p=0.0145). Moreover, tegoprazan demonstrated its great effectiveness in sustained healing and heartburn relief even in the severe patient group.

Sebela is planning to present full results from the TRIUMpH program at upcoming major conferences in 2026 and publish them in prestigious journals.

“We are pleased that K-CAB, a novel drug developed by our company in South Korea, enters the U.S. NDA process based on robust and strong clinical study results," said HK inno.N’s CEO Dal-won Kwak, adding, “we will actively pursue exports to Europe and development in Japan, aiming to establish K-CAB as a global best-in-class product leading the world markets.."

Alan Cooke, the CEO of Sebela Pharmaceuticals, commented, "Of approximately 65 million GERD patients in the U.S., 35% to 54% are suffering from inadequately controlled symptoms despite the availability of conventional therapies. Tegoprazan demonstrated superiority over conventional PPI therapy in sustained healing of patients with severe EE and achieved clinically significant improvements in 24-hour heartburn, overnight heartburn, and acid regurgitation among NERD patients." He added, "We look forward to obtaining U.S. regulatory approval by collaborating closely with the FDA and providing this innovative treatment option to patients and healthcare providers by January next year.”

“The emergence of P-CABs marked by rapid onset of action and sustained control of gastric acid pH compared to PPI represents an important advancement in gastric acid suppression therapy,” said Philip O. Katz, MD, of Weill Cornell Medical College, and “Based on the TRIUMpH data, tegoprazan is notable in demonstrating control of both heartburn and acid regurgitation in patients with NERD, as well as potential to improve healing rates in patients with severe EE. These results suggest that tegoprazan and other P-CABs may be helpful in addressing treatment gaps for patients with persistent symptoms despite conventional PPI therapy”, he added.

Tegoprazan is the active ingredient of K-CAB, South Korea's 30th domestic new drug developed by HK inno.N. As a novel P-CAB-class treatment for GERD, K-CAB has demonstrated superior efficacy over PPIs in △onset of action, △duration of therapeutic effect, and △sustained healing of EE. Since its launch in South Korea in March 2019, K-CAB has recorded cumulative outpatient prescription sales of KRW 923.3 billion, maintaining No. 1 ranking in outpatient prescription performance among domestic drugs for peptic ulcer.

K-CAB has signed agreements for tech transfer or finished product export with 55 countries. Among them, K-CAB has been approved in 22, including South Korea, and launched in 19 countries. (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

■ Phase 3 NERD study (NCT05587322)

This phase 3 NERD study enrolled 800 patients and was a large, multi-center, double-blind trial designed to assess the safety and efficacy of tegoprazan versus placebo over a 4-week period.. The primary endpoint was the proportion of 24-hour heartburn-free days, and the secondary endpoints were the proportion of overnight heartburn-free days and the proportion of acid regurgitation-free days. 

▶ Primary endpoint: proportion of 24-hour heartburn-free days (superior)

▶ Secondary endpoints: proportion of overnight heartburn-free days and proportion of acid regurgitation-free days (superior)

※ In both EE and NERD studies, Treatment-emergent adverse events (TEAEs) associated with tegoprazan occurred at a rate of less than 3% and were generally mild and transient.. The overall incidence rate of serious adverse events (SAEs) was less than 2% with tegoprazan, comparable to that in the control groups. The mean serum gastrin levels associated with tegoprazan remained within the normal range (0-180 pg/ml) throughout the treatment period.

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

▶ Non-erosive reflux disease (NERD)

: Presence of reflux symptoms with no 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).

Status of K-Cab entry into the world markets

Status of K-CAB outpatient prescription sales in Korea

(Based on: outpatient prescription sales / Unit: billion won)

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