A Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetics Following Administration of IN-M00002 Tablet and Co-administration of Tegoprazan and Naproxen, and to Evaluate Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers

Start Date27 Dec 2025

Sponsor / Collaborator

HK inno.N Corp.

KCT0011041

/ Not yet recruitingPhase 3IIT

A phase 3, randomized, double-blind, placebo-controlled, multicenter, superiority, investigator-initiated trial of Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy

Start Date30 Nov 2025

Sponsor / Collaborator

Hanyang University Guri Hospital

NCT07242443

/ Not yet recruitingPhase 4IIT

A Randomized Controlled Trial Comparing Tegoprazan 50 mg BID Combined With Amoxicillin 1 g TID Versus Tegoprazan 50 mg BID Combined With Amoxicillin 1.5 g BID for the Eradication of Helicobacter Pylori

This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin.
One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount.
A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.

Start Date20 Nov 2025

Sponsor / Collaborator

The First People's Hospital of Hangzhou

100 Clinical Results associated with Tegoprazan

100 Translational Medicine associated with Tegoprazan

100 Patents (Medical) associated with Tegoprazan

142

Literatures (Medical) associated with Tegoprazan

01 Dec 2025·BIOMEDICAL CHROMATOGRAPHY

A Novel UPLC–MS/MS Method for Determining Tegoprazan in Rat Plasma: An Application in a Rat Pharmacokinetic Study

Article

Author: Wang, Yu ; Lin, Manjie ; Xu, Mengjie ; Weng, Qinghua ; Cai, Yize

ABSTRACT:

Tegoprazan (TEG) is a commonly used drug in the treatment of gastroesophageal reflux disease. This work aimed to develop and validate an ultra‐high‐performance liquid chromatography–tandem mass Spectrometry (UPLC–MS/MS) method to determine the levels of TEG in rat plasma and to apply it for a rat pharmacokinetic study. Electrospray ionization source (ESI) positive and multiple reaction monitoring (MRM) mode were selected. The internal standard revaprazan (REV) and TEG were analyzed separately on a Waters ACQUITY UPLC BEH column. Gradient elution with a flow rate of 0.5 mL/min was used. Accuracy and precision were from −8.5% to 12.2%. Linearity was from 2 to 1000 ng/mL. IS‐normalized recovery ranged from 109.3% to 113.6%. IS‐normalized matrix effect was from 99.0% to 102.8%. The coefficient of variation of matrix effect was less than 10%. Dilution integrity showed that a tenfold dilution also met the guidelines. In the rat pharmacokinetic study, AUC(0 − ∞) and Cmax of TEG were 9129.6 ± 1823.3 μg/L*h and 2513.2 ± 707.0 ng/mL, respectively. Tmax and T1/2 were 1.8 ± 1.1 h and 1.6 ± 0.8 h, respectively. We finally established a rapid and robust UPLC–MS/MS quantitative analysis of TEG in rat plasma. Rat pharmacokinetics indicated that TEG was absorbed quickly and fast reached the maximum concentration.

01 Nov 2025·Therapeutic Advances in Gastroenterology

Comparison of tegoprazan-based high-dose dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a prospective, multicentre, randomised controlled trial in Gansu Province, a high-resistance region of China

Article

Author: Yu, Yi ; Wang, Yuanyuan ; Xie, Baoyuan ; Yang, Lihong ; Yang, Jinxia ; Gao, Liping ; Chen, Xinglan ; Dong, Yeze ; Fan, Hong ; Wu, Ronggui ; Zhang, Dekui ; Xie, Ni ; Zhang, Xiuhong

Background::

Potassium-competitive acid blocker-based regimens, such as tegoprazan, have demonstrated promising efficacy for Helicobacter pylori eradication. In regions with high antibiotic resistance, such as Gansu Province, bismuth-containing quadruple therapy (BQT) remains the recommended first-line treatment. However, evidence on the efficacy and safety of high-dose tegoprazan–amoxicillin dual therapy (TA) remains limited.

Objectives::

To compare the eradication rates and safety profiles of TA and BQT.

Design::

Prospective, multicentre, randomised controlled trial.

Methods::

Patients were enrolled from 10 centres across Gansu Province, China, between September and December 2024. Participants were randomised 1:1 to receive either BQT (esomeprazole 20 mg twice daily + bismuth potassium citrate 600 mg twice daily + amoxicillin 1000 mg twice daily + metronidazole 400 mg four times daily) or TA (tegoprazan 50 mg twice daily + amoxicillin 750 mg four times daily) for 14 days. The primary outcome was eradication rate. Secondary outcomes included adverse event (AE) rates, treatment compliance and cost-effectiveness.

Results::

A total of 288 patients were randomised, with baseline characteristics well balanced between the TA and BQT groups ( p > 0.05). Eradication rates for TA versus BQT were 68.06% (98/144) versus 81.25% (117/144) (difference, −13.19%; 95% confidence interval (CI): −22.95 to −3.43; p = 0.009; non-inferiority p = 0.736) in the intention-to-treat analysis; 69.01% (98/142) versus 81.82% (117/143; difference, −12.81%; 95% CI: −22.70 to −2.90; p = 0.011; non-inferiority p = 0.711) in the modified intention-to-treat analysis; and 72.59% (98/135) versus 89.31% (117/131; difference, −16.72%; 95% CI: −26.01 to −7.43; p < 0.001; non-inferiority p = 0.924) in the per-protocol analysis. AEs were less frequent with TA (8.30% vs 25.70%, p < 0.0001), with similar compliance rates (95.07% vs 91.61%, p = 0.241). Multivariate analysis indicated that long-term residence in the southern region of Gansu Province (including Longnan City and Tianshui) was significantly associated with higher eradication rates compared with the Hexi region (adjusted odds ratio = 5.46, p = 0.04), suggesting that geographical factors independently influenced treatment outcomes.

Conclusion::

TA did not achieve non-inferiority to BQT and yielded significantly lower eradication rates. The inferior eradication efficacy of TA precludes its recommendation as a first-line therapy in high-resistance settings, such as Gansu.

Trial registration::

This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2400081873.

01 Nov 2025·JGH Open

Tegoprazan Versus Proton Pump Inhibitors for Erosive Esophagitis: A Meta‐Analysis of Noninferiority Randomized Controlled Trials

Review

Author: Ijaz, Azka ; Mehmood, Qasim ; Safiullah, Muhammad ; Shahid, Ishmal Fatima ; Shahriar, Zahin ; Bhatti, Muhammad Imaz

ABSTRACT:

Purpose:

Proton pump inhibitors (PPIs) remain the standard treatment option for erosive esophagitis (EE) but have notable limitations due to side effects associated with long‐term use. Tegoprazan, a novel potassium‐competitive acid suppressant (P‐CAB), may provide an alternative treatment option. In this study, we aim to evaluate the healing rates of EE using tegoprazan versus PPIs, along with their respective safety profiles.

Methods:

A comprehensive literature search was conducted in PubMed, Embase, and ClinicalTrials.gov from inception to March 2025. Risk of bias was evaluated using the Cochrane RoB 2.0 tool. Pooled estimates were calculated using random‐effects models in Review Manager 5.4.

Results:

Three RCTs encompassing a total of 766 patients were included in the analysis. Tegoprazan demonstrated comparable healing rates to PPIs at both 4 weeks (risk ratio [RR] 1.05; 95% confidence interval [CI]: 0.99–1.11; p = 0.12) and 8 weeks (RR 1.02; 95% CI: 0.98–1.06; p = 0.35). Subgroup analyses by dose (50 and 100 mg) showed no significant differences. While overall adverse event rates were similar between groups, the incidence of headache was numerically lower in the tegoprazan group (1.3% vs. 4.2%; RR = 0.40; 95% CI: 0.08–2.00; p = 0.26), though this difference was not statistically significant.

Conclusion:

Tegoprazan shows comparable efficacy and safety to standard PPIs for treating EE. While healing rates were slightly higher, particularly with the 100 mg dose, the differences were not statistically significant. Tegoprazan may be a suitable alternative for patients intolerant to PPIs, though larger, long‐term, multiethnic studies are warranted to confirm these findings and assess patient‐centered outcomes.

News (Medical) associated with Tegoprazan

12 Jan 2026

·www.biospace.com

Sebela Pharmaceuticals® Announces Submission of New Drug Application to FDA for Tegoprazan for the Treatment of Gastroesophageal Reflux Disease

Key Highlights: Sebela Pharmaceuticals ® submitted its New Drug Application (NDA) for tegoprazan on January 9, 2026. The NDA seeks approval for three indications: Non-Erosive Reflux Disease (NERD), Erosive Esophagitis (EE) Healing, and EE Maintenance Once approved, tegoprazan will be the first Potassium-Competitive Acid Blocker (P-CAB) to demonstrate superiority in EE healing across all severity grades (LA Grades A-D) and at all time points versus a proton pump inhibitor (PPI) In NERD, tegoprazan achieved meaningful improvement in 24-hour heartburn, overnight heartburn, and regurgitation, the hallmark symptoms of GERD, versus placebo Tegoprazan has demonstrated rapid acid control (pH>4) within 45 minutes Safety and tolerability for tegoprazan was favorable across all studies, with adverse events occurring at similar rates to study comparators and mean serum gastrin levels remaining within normal limits (0-180 pg/ml) throughout treatment Tegoprazan has already received marketing authorization in 21 countries worldwide. US approval anticipated in January 2027 BRAINTREE, Mass. , Jan. 12, 2026 /PRNewswire/ -- Braintree Laboratories, Inc. a part of Sebela Pharmaceuticals® and a leading manufacturer of gastroenterology pharmaceutical products, announced that it submitted a New Drug Application (NDA) on January 9, 2026 to the U.S. Food and Drug Administration (FDA) for tegoprazan, a novel potassium-competitive acid blocker (P-CAB), for the treatment of adults with gastroesophageal reflux disease (GERD). The NDA seeks simultaneous approval for three indications: treatment of heartburn associated with non-erosive reflux disease (NERD), healing of erosive esophagitis (EE), and maintenance of EE healing. The NDA submission is supported by robust data from the pivotal Phase 3 TRIUMpH clinical program, which enrolled over 2,000 US patients and demonstrated tegoprazan's clinical superiority over a PPI across multiple endpoints. All endpoints were evaluated under a prespecified hierarchical multiple testing procedure. In NERD, tegoprazan demonstrated superiority over placebo for the percentage of 24-hour heartburn-free days (p4) within 45 minutes. Tegoprazan has received marketing authorization in 21 countries worldwide. If approved by the FDA, tegoprazan would be indicated in the US for the treatment of heartburn in NERD and for the healing and maintenance of healing of EE in adults. About Sebela Pharmaceuticals At Sebela Pharmaceuticals, we are building a leading gastroenterology company in the US and developing innovative products in women's health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been innovating, developing, manufacturing and commercializing gastroenterology products for over 40 years. Braintree's lead program is tegoprazan, a novel potassium competitive acid blocker (P-CAB) which has completed its Phase 3 program in gastroesophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). In addition, Sebela Women's Health obtained FDA approval for Miudella® in 2025, the first non-hormonal intra-uterine device (IUD) for contraception to be approved in over 40 years. Miudella was recently featured in Time Magazine's Best Inventions of 2025. Sebela Women's Health also has another next-generation hormonal IUD for contraception in late-stage clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland. For more information, visit . Forward-looking Statements This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals and Braintree Laboratories under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "may", "will", "forecast," "estimated," "expected," and "intend," among others. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to obtaining FDA approval of tegoprazan; the development, launch, introduction and commercial potential of tegoprazan; growth and opportunity, including peak sales and the potential demand for tegoprazan, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that the NDA discussed in this press release will be approved or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and neither Sebela Pharmaceuticals nor Braintree Laboratories agree to undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. References: 1 El-Serag HB, et al. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014. 2 Chey WD, et al. Patient and physician satisfaction with proton pump inhibitors (PPIs): are there opportunities for improvement? Dig Dis Sci. 2010. 3 Armstrong D, et al. Symptom Profile, Proton Pump Inhibitor Therapy, and Diagnostic Testing in Patients with Persistent Reflux-Like Symptoms: Results from a Population-Based Survey. Foregut. 2023. † Dr. Katz has served as a paid consultant for Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals. View original content to download multimedia: SOURCE Sebela Pharmaceuticals

Phase 3NDADrug ApprovalClinical ResultBiosimilar

15 Dec 2025

·www.inno-n.com

HK inno.N Acquires Japanese Business Rights for K-CAB and Equity Stake in RaQualia

HK inno.N Acquires Japanese Business Rights for K-CAB and Equity Stake in RaQualia - HK inno.N acquires Japanese business rights for K-CAB from RaQualia, a Japanese drug discovery firm. - The company secures global business rights for K-CAB in top markets, including Japan (the world’s 3rd largest), following successful entries into China and the U.S. - HK inno.N acquires additional newly issued shares in RaQualia, increasing its total equity stake to 15.95% and accelerating new drug development. Photo. Left: HK inno.N BI _ Right: RaQualia CI HK inno.N announced on December 15th that it signed an agreement to acquire the Japanese business rights for K-CAB (active ingredient: tegoprazan), a novel treatment for gastroesophageal reflux disease (GERD), from RaQualia Pharma Inc., a Japanese drug discovery firm. The agreement also includes the acquisition of additional newly issued shares of RaQualia through a third-party allotment paid-in capital increase. Through this agreement, HK inno.N secures the development, manufacturing, and sales rights for K-CAB in the Japanese market. Additionally, by acquiring 1,555,900 shares of RaQualia, the company increased its equity stake by 5.98%.. This marks the second acquisition following the first acquisition of newly issued shares in March this year, and HK inno.N now holds a total of 15.95% stake as the largest shareholder of RaQualia. RaQualia, founded in 2008 by former researchers from Pfizer Japan, licensed the K-CAB compound, a novel treatment for gastroesophageal reflux disease (GERD), to HK inno.N in 2010. . The company currently holds a diversified pipeline for 18 drug candidates, spanning therapeutic areas such as gastrointestinal disorders, pain, and oncology. With this agreement, HK inno.N has successfully secured the business rights for K-CAB in the world’s first,t second, and third largest pharmaceutical markets—the U.S., China, and Japan—further raising expectations for its global growth. The peptic ulcer medications market in Japan is worth approximately KRW 2 trillion (USD 1,227 million), making it the world's third-largest market. While K-CAB is not currently marketed in Japan, this agreement paves the way for its market entry. “This agreement will enhance our innovative new drug portfolio by combining the R&D capabilities of both companies, further boosting the global market competitiveness of K-CAB,” said Dalwon Kwak, CEO of HK inno.N.. “Through our strategic partnership with RaQualia, we will conduct joint research on additional new drug pipelines, thus solidifying our standing in the global pharmaceutical market,” he added. K-CAB, a novel agent for GERD treatment, is the 30th new drug of South Korea developed by HK inno.N. Following its first launch in South Korea in March 2019, K-CAB recorded the cumulative outpatient prescription sales amounting to KRW 902.2 billion up to November this year. The drug has been licensed or distributed to 54 countries, including China and the U.S. (the figure includes South Korea), and has been officially launched in 18 countries to date. (The end) (Reference Information) Size of the peptic ulcer medications market in Japan: USD 1,227 million (based on the exchange rate 1,460 won/dollar) (source: IQVIA 2024 MAT)

AcquisitionDrug ApprovalLicense out/inBiosimilar

27 Nov 2025

·www.inno-n.com

Dr. Felice Schnoll-Sussman, Highlights K-CAB’s U.S. Market Potential at KDDW 2025

HK inno.N Invites Key Investigator of K-CAB U.S. Clinical Trials to Highlight Market Potential at KDDW 2025 Dr. Felice Schnoll-Sussman, lead investigator of K-CAB’s U.S. clinical trials, presents comparative clinical data on P-CAB therapies at KDDW 2025. Dr. Schnoll-Sussman: “K-CAB’s rapid onset of action within one hour and its flexibility to be taken regardless of meals will be key advantages in the U.S. prescription market.” Photo. Dr. Felice Schnoll-Sussman, the lead investigator of K-CAB’s U.S. clinical trials, delivering a lecture at KDDW 2025. HK inno.N announced on the 27th that Dr. Felice Schnoll-Sussman, the lead investigator of the U.S. Phase 3 clinical trials for its gastroesophageal reflux disease (GERD) treatment, K-CAB (active ingredient: tegoprazan), was invited to speak at the 9th Korea Digestive Disease Week (KDDW 2025). During the event, Dr. Schnoll-Sussman delivered a lecture on the clinical data of K-CAB, a novel P-CAB (Potassium-Competitive Acid Blocker) therapy. Held from November 13 to 15 at the Grand Walkerhill Hotel in Seoul, KDDW 2025 brought together over 2,000 researchers from Korea and abroad to share the latest insights into digestive diseases. Dr. Schnoll-Sussman, a Clinical Professor of Medicine at Weill Cornell Medical College and Director of the Jay Monahan Center for Gastrointestinal Health, served as a keynote speaker during the session. Dr. Soo-Heon Park, a professor of gastroenterology at the Catholic University of Korea’s Yeouido St. Mary’s Hospital and former president of the Korean Society of Gastroenterology and Helicobacter, chaired the session. The session, titled “Beyond the PPI: Real-World Lessons from P-CAB Use in Complex Reflux and Acid-Related Disorders,” featured Dr. Schnoll-Sussman’s presentation on the latest insights into GERD treatment from the perspective of U.S. clinical practice. She also highlighted the potential impact of K-CAB, a P-CAB therapy, on the U.S. market. Dr. Schnoll-Sussman noted, “There is a growing understanding and adoption of P-CAB therapies among U.S. gastroenterologists. P-CAB medications are expected to become the first-line treatment for patients with moderate to severe GERD (LA Grades C and D), as well as for those who do not achieve sufficient symptom relief with PPIs, such as patients with Helicobacter pylori infections or LA Grades A and B GERD.” She added, “Many GERD patients in the U.S. seek rapid symptom relief, especially for nighttime heartburn or post-meal discomfort. Compared to PPIs, P-CAB therapies offer faster onset of action. Notably, K-CAB demonstrates the fastest onset of action within one hour of administration, even among P-CAB therapies. This characteristic will be a significant competitive advantage for K-CAB in the U.S. market.” K-CAB was licensed out to U.S.-based gastrointestinal specialty pharmaceutical company Sebela Pharmaceuticals in 2021. Since then, three Phase 3 clinical trials in the U.S. have been successfully completed, meeting both primary and secondary endpoints in studies for the treatment of erosive esophagitis (EE) and non-erosive reflux disease (NERD). In the maintenance therapy trial for EE, K-CAB met its primary endpoint by demonstrating a high remission maintenance rate over 24 weeks. Tegoprazan showed non-inferiority to lansoprazole across all patient groups (LA Grades A–D) and even achieved statistically superior results. In patients with moderate to severe esophagitis (LA Grades C–D), tegoprazan demonstrated significant improvement compared to lansoprazole, with the 100 mg dose achieving statistical superiority. Based on these results, Sebela is preparing to submit a New Drug Application (NDA) to the U.S. FDA by the end of this year. K-CAB, developed by HK inno.N, is South Korea’s 30th novel drug. Since its domestic launch in March 2019, it has achieved cumulative prescription sales of KRW 883.9 billion as of October 2025, making it the top-selling peptic ulcer treatment in South Korea. Its key features include rapid onset of action, proven safety for long-term use of up to six months, and the flexibility to be taken regardless of meals. K-CAB has been licensed or exported to 54 countries, with launches in 18 of them to date. [Reference Information] ■ Phase 3 Clinical Trial for Erosive Esophagitis (EE) (NCT05587309) A large-scale, multicenter, double-blind study involving 1,250 participants (including 463 patients with LA Grades C/D esophagitis) to compare the safety and efficacy of tegoprazan and lansoprazole in healing, maintenance, and relief of heartburn symptoms in EE. Primary Endpoints: Healing phase (up to 8 weeks): Endoscopic healing rate. Maintenance phase (24 weeks): Endoscopic healing maintenance rate (remission maintenance rate). Secondary Endpoints: Percentage of 24-hour heartburn-free days. ■ Phase 3 Clinical Trial for Non-Erosive Reflux Disease (NERD) (NCT05587322) A large-scale, multicenter, double-blind study involving 800 participants to compare the safety and efficacy of tegoprazan and placebo. The primary endpoint was the percentage of 24-hour heartburn-free days, with secondary endpoints including the percentage of nighttime heartburn-free days and acid regurgitation-free days. Primary Endpoint: Percentage of 24-hour heartburn-free days. Secondary Endpoints: Percentage of nighttime heartburn-free days and acid regurgitation-free days. ■ Gastroesophageal Reflux Disease (GERD) GERD is a chronic condition in which stomach contents flow back into the esophagus, causing symptoms such as heartburn and acid regurgitation. If left untreated, it can lead to complications. Approximately 65 million people in the U.S. are affected by GERD. While PPIs are the most commonly used treatment, 35–54% of patients do not achieve complete symptom relief, highlighting the limitations of current therapies. GERD is classified into two types based on endoscopic findings: Erosive Esophagitis (EE): GERD with visible mucosal damage or esophagitis detected through endoscopy. Non-Erosive Reflux Disease (NERD): GERD with symptoms but no visible mucosal damage or esophagitis on endoscopy. ■ LA Classification (The Los Angeles Classification) A diagnostic criterion for erosive esophagitis first introduced by the Los Angeles World Congress of Gastroenterology. It categorizes esophagitis into Grades A through D based on the size and extent of mucosal damage. ■ P-CAB (Potassium-Competitive Acid Blocker) P-CABs, such as HK inno.N’s K-CAB (tegoprazan), inhibit acid secretion by directly competing with potassium ions at the proton pump without requiring activation by stomach acid. This allows for administration regardless of meals and provides rapid and potent acid suppression from the first dose, with prolonged efficacy, particularly in suppressing nighttime acid secretion. ■ PPI (Proton Pump Inhibitor) PPIs, such as lansoprazole, irreversibly inhibit the proton pump (H+/K+-ATPase) involved in the final stage of acid secretion in the stomach. As prodrugs, PPIs require activation by stomach acid and must be taken before meals. They typically take 3–5 days of repeated dosing to achieve maximum efficacy.(End)

Phase 3Clinical ResultDrug Approval

100 Deals associated with Tegoprazan

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A02BC	DB16690

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Erosive gastro-esophageal reflux disease	India	Dr. Reddy's Laboratories Ltd.	17 Sep 2025
Non-erosive gastro-esophageal reflux disease	India	Dr. Reddy's Laboratories Ltd.	17 Sep 2025
Stomach Ulcer	India	Dr. Reddy's Laboratories Ltd.	17 Sep 2025
Duodenal Ulcer	China	Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.	14 Nov 2023
Esophagitis, Peptic	China	Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.	08 Apr 2022
Gastroesophageal Reflux	South Korea	HK inno.N Corp.	05 Jul 2018
Helicobacter pylori infection	South Korea	HK inno.N Corp.	05 Jul 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Erosive esophagitis	NDA/BLA	United States	Sebela Pharmaceuticals, Inc.	09 Jan 2026
Non-erosive reflux disease	NDA/BLA	United States	Sebela Pharmaceuticals, Inc.	09 Jan 2026
Liver Injury	Phase 1	United States	HK inno.N Corp.	08 Sep 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05933031 (NEWS) Manual	Phase 2	Helicobacter pylori infection	382	Tegoprazan 50 mgTegoprazan 50 mg + Amoxicillin + Clarithromycin	jamukmfohs(ixmzzqaegr) = egswpgjghi oedmhfpgxp (chjpeefsyn )	Non-inferior	15 Oct 2025
				Tegoprazan 100 mgTegoprazan 100 mg+Amoxicillin+Clarithromycin	jamukmfohs(ixmzzqaegr) = qoqngmdmcy oedmhfpgxp (chjpeefsyn )
NCT03615677 (Pubmed \| Chin Med J (Engl))	Phase 3	Erosive esophagitis	261	Tegoprazan 50 mg/day	ddcryfcvam(phxgcqvaxq) = uadftgcyal ynxbnkwhsi (hofeioheph )	Positive	05 Oct 2025
				Esomeprazole 40 mg/day	ddcryfcvam(phxgcqvaxq) = zedpifddcz ynxbnkwhsi (hofeioheph )
NCT04128917 (Pubmed \| Gut Liver)	Phase 3	Helicobacter pylori infection	102	Tegoprazan 50 mg	udhgnfyfdg(didiyyauoc) = ymnbplkpmu jsetulcljq (xhyigrvrav, 43.93 - 77.28)	Positive	15 Sep 2025
				Tegoprazan 100 mg	udhgnfyfdg(didiyyauoc) = dxefklpijk jsetulcljq (xhyigrvrav, 64.84 - 92.74)
NCT05577468 (Pubmed \| Chin Med J (Engl))	Phase 3	Helicobacter pylori infection First line	561	Tegoprazan-based TTPB	lofdywqelg(nveiayjotl) = tafhsljphn yppnhchibh (pkgsbdmnuj ) View more	Non-inferior	22 Aug 2025
				Esomeprazole-based TTPB	lofdywqelg(nveiayjotl) = utqmsjlxwc yppnhchibh (pkgsbdmnuj ) View more
NCT05883306 (Pubmed \| Expert Opin Drug Metab Toxicol)	Phase 1	-	6	Tegoprazan 50 mg/150 μCi	cbqjgvhfrn(ylvxdysllf) = cuusmdwxvg gofxrxivnk (acrakxobuf ) View more	-	13 May 2025
NCT05267743 (Pubmed)	Phase 4	Non-erosive gastro-esophageal reflux disease	218	替戈拉生	ujegymbfem(oqvonfdpur) = mxujryspiu dfdufrlcup (pwvibxewjb )	Non-inferior	25 Nov 2024
				兰索拉唑	ujegymbfem(oqvonfdpur) = fvhjxuoevh dfdufrlcup (pwvibxewjb )
UEGW2024	Not Applicable	-	-	Esomeprazole-containing sequential therapy	vfttpwltkx(yhqvleuene) = In tegoprazan-containing sequential, nausea was more prevalent (23.3%, 27/202), which was statistically higher than esomeprazole-containing sequential (14.2%, 29/204) (p = 0.022) zndgbmckgi (lbjoakjvhh )	-	13 Oct 2024
				Tegoprazan-containing sequential therapy
UEGW2024	Not Applicable	Helicobacter pylori infection First line	80	Tegoprazan-based BQT	klumxynjub(xmswaheddp) = There was no significant difference in the rate of adverse events between the TBMT and OBMT groups (42.5% vs. 55,5%, p = 0.37). Nausea was the most common adverse effect (37.5% vs 40%, p=0.92) , followed by abdominal pain (12.5% vs 17.5%, p=0.16%) sjiofrdkmw (qnhpyxmhny )	Positive	13 Oct 2024
				Omeprazole-based BQT
UEGW2024	Not Applicable	-	-	Tegoprazan 50mg	cfitrlxtes(nkzviyqhzg) = No significant differences in the incidence of adverse events between the trial group and the placebo group. No severe adverse events occurred in this study. nvnhhqwrim (qvpmbhdazs )	-	13 Oct 2024
				Placebo
NCT05010954 (Pubmed \| Curr Med Res Opin) Manual	Phase 3	Duodenal Ulcer	399	Tegoprazan 50 mg	rfqszdebcu(zyrhlwtjwg) = hpyajxttka whpzjdkchs (srgcmgtode ) View more	Non-inferior	08 Oct 2024
				Lansoprazole 30 mg	rfqszdebcu(zyrhlwtjwg) = lpssmwcaut whpzjdkchs (srgcmgtode ) View more

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