Komori
Other Disclosures4579RaQualia Pharma Inc.Pharmaceuticals

Notice Regarding the Presentation of Phase III Clinical Trial Data for the Gastric Acid Secretion Inhibitor Tegoprazan at the International Conference ACG 2026

At the international ACG 2026 meeting, detailed analysis results from the U.S. Phase III trial of tegoprazan in patients with NERD and post hoc analysis results from the Phase III trial in patients with EE were presented. In the NERD trial, heartburn-related measures were better than with placebo, and the presentation on the post hoc analysis of the EE trial received the ACG Presidential Award.

Worth reading
71In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
783
Cases (number of adult patients enrolled in the TRIUMpH-NERD trial)
Wording
Conditional
How definitive the wording is.

Announced details

Tegoprazan (marketed as K-CAB®) / TRIUMpH-NERD trial and TRIUMpH-EE trial
Applicable field (uses covered by this announcement)

Non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and gastroesophageal reflux disease (GERD)

Launch date2019 (launched in South Korea as K-CAB®, with actual sales recorded)
Contract DateSeptember 2010, November 2019 and December 2021
What the company reported numerically
Quantitative Effects

Percentage of days without 24-hour heartburn through Week 4 of the NERD trial: placebo, 17.3%; tegoprazan 50 mg, 26.2%; 100 mg, 30.1%. Percentage of days without nocturnal heartburn: placebo, 27.0%; 50 mg, 36.1%; 100 mg, 39.9%. Among confirmed GERD cases in the EE trial, the EE healing rate at Week 2 was 75.4% versus 60.7%, and the cumulative rate at Week 8 was 83.4% versus 72.7%.

Usage history

Cumulative sales in South Korea based on outpatient prescriptions exceeded ¥1 trillion in April 2026. Tegoprazan products are sold in 20 countries. Business activities, including development, manufacturing and sales, are conducted in 57 countries worldwide. A separate document states that marketing approval has been obtained in 24 countries worldwide.

Relationship between the counterparty and the company
RaQualia Pharma Inc.4579
Relationship with the Company

In September 2010, the Company entered into an exclusive license agreement with CJ HealthCare Corporation (now HK inno.N Corporation) covering tegoprazan in East Asia, and expanded the partnership to North America and Europe in November 2019. In December 2021, HK inno.N Corporation entered into a license agreement with Braintree Laboratories, Inc. covering exclusive development, manufacturing and commercialization rights in the United States and Canada. The Company is entitled to receive a portion of the revenue received by HK inno.N Corporation from its partners.

CounterpartyHK inno.N Corporation、Sebela Pharmaceuticals Inc.、Braintree Laboratories, Inc.

HK inno.N Corporation: headquartered in Osong, South Korea. Sebela Pharmaceuticals Inc.: headquartered in the state of Georgia, United States. Braintree Laboratories, Inc.: a division of the Sebela Pharmaceuticals group, with locations including Braintree, Massachusetts, United States, and Dublin, Ireland. It conducts research and development, manufacturing and commercialization of treatments in the gastrointestinal field.

Award/certification name

ACG Presidential Award

Awarding / certifying body

American College of Gastroenterology(ACG)

Registration number and expiry date

TRIUMpH-NERD trial: NCT05587322; TRIUMpH-EE trial: NCT05587309. Other information: Not disclosed

Location (as indicated in this announcement)

HK inno.N Corporation: Osong, South Korea. Sebela Pharmaceuticals Inc.: state of Georgia, United States. Braintree Laboratories, Inc.: Braintree, Massachusetts, United States; Dublin, Ireland; and other locations

Impact on Business Performance

The Company will receive no upfront payment in connection with this matter. The Company believes that it will contribute to enhancing value over the medium to long term.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

American College of Gastroenterology 2026 Annual Scientific Meeting, Lyon Consensus 2.0, Wakefield Research (Data on File, Braintree Laboratories, Inc., 2026), and other sources

Announced details
ItemDetails
Names of Products / Services CoveredTegoprazan (marketed as K-CAB®) / TRIUMpH-NERD trial and TRIUMpH-EE trial
CounterpartyHK inno.N Corporation、Sebela Pharmaceuticals Inc.、Braintree Laboratories, Inc.
Counterparty overviewHK inno.N Corporation: headquartered in Osong, South Korea. Sebela Pharmaceuticals Inc.: headquartered in the state of Georgia, United States. Braintree Laboratories, Inc.: a division of the Sebela Pharmaceuticals group, with locations including Braintree, Massachusetts, United States, and Dublin, Ireland. It conducts research and development, manufacturing and commercialization of treatments in the gastrointestinal field.
Relationship with the CompanyIn September 2010, the Company entered into an exclusive license agreement with CJ HealthCare Corporation (now HK inno.N Corporation) covering tegoprazan in East Asia, and expanded the partnership to North America and Europe in November 2019. In December 2021, HK inno.N Corporation entered into a license agreement with Braintree Laboratories, Inc. covering exclusive development, manufacturing and commercialization rights in the United States and Canada. The Company is entitled to receive a portion of the revenue received by HK inno.N Corporation from its partners.
Contract DateSeptember 2010, November 2019 and December 2021
Launch date2019 (launched in South Korea as K-CAB®, with actual sales recorded)
Applicable areaNon-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and gastroesophageal reflux disease (GERD)
Award/certification nameACG Presidential Award
Awarding / certifying bodyAmerican College of Gastroenterology(ACG)
Registration number and expiry dateTRIUMpH-NERD trial: NCT05587322; TRIUMpH-EE trial: NCT05587309. Other information: Not disclosed
LocationHK inno.N Corporation: Osong, South Korea. Sebela Pharmaceuticals Inc.: state of Georgia, United States. Braintree Laboratories, Inc.: Braintree, Massachusetts, United States; Dublin, Ireland; and other locations
Quantitative EffectsPercentage of days without 24-hour heartburn through Week 4 of the NERD trial: placebo, 17.3%; tegoprazan 50 mg, 26.2%; 100 mg, 30.1%. Percentage of days without nocturnal heartburn: placebo, 27.0%; 50 mg, 36.1%; 100 mg, 39.9%. Among confirmed GERD cases in the EE trial, the EE healing rate at Week 2 was 75.4% versus 60.7%, and the cumulative rate at Week 8 was 83.4% versus 72.7%.
Usage historyCumulative sales in South Korea based on outpatient prescriptions exceeded ¥1 trillion in April 2026. Tegoprazan products are sold in 20 countries. Business activities, including development, manufacturing and sales, are conducted in 57 countries worldwide. A separate document states that marketing approval has been obtained in 24 countries worldwide.
Impact on Business PerformanceThe Company will receive no upfront payment in connection with this matter. The Company believes that it will contribute to enhancing value over the medium to long term.
SourceAmerican College of Gastroenterology 2026 Annual Scientific Meeting, Lyon Consensus 2.0, Wakefield Research (Data on File, Braintree Laboratories, Inc., 2026), and other sources
Items this document does not state (3)
Contract ValueOffering priceLocation scale

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The trial results were presented at ACG 2026. The Company explained that this represents important progress in the development of tegoprazan's business in the United States and will contribute to enhancing value over the medium to long term.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice Regarding the Presentation of Phase III Clinical Trial Data for the Gastric Acid Secretion Inhibitor Tegoprazan at the International Conference ACG 2026 | RaQualia Pharma Inc. (4579) timely disclosure | Komori