Delving into the Latest Updates on Tegoprazan with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

K-CAB, 特戈拉赞, BLI-5100

+ [8]

Target

H+/K+ ATPase

Action-

Mechanism

P-CAB(Potassium-competitive acid blockers)

Therapeutic Areas

Infectious DiseasesDigestive System DisordersMouth and Tooth Diseases+ [2]

Active Indication

Erosive gastro-esophageal reflux diseaseNon-erosive gastro-esophageal reflux diseaseStomach Ulcer+ [5]

Inactive Indication

Liver InjuryNon-erosive reflux disease

Originator Organization

Pfizer Inc.

Active Organization

Braintree Laboratories, Inc.

RaQualia Pharma, Inc.

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

+ [2]

Inactive Organization-

License Organization

Dr. Reddy's Laboratories Ltd.

RaQualia Pharma, Inc.

Pharmaniaga Bhd.

+ [10]

Drug Highest PhaseApproved

First Approval Date

South Korea (05 Jul 2018),

Gastroesophageal RefluxHelicobacter pylori infection

Regulation-

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Structure/Sequence

Molecular FormulaC20H19F2N3O3

InChIKeyCLIQCDHNPDMGSL-HNNXBMFYSA-N

CAS Registry942195-55-3

Current first-line Helicobacter pylori eradication protocols involve multidrug regimens comprising a proton pump inhibitor (PPI) or bismuth agent combined with dual antibiotics (e.g., clarithromycin, amoxicillin, quinolones, furazolidone, nitroimidazoles, or tetracycline) administered for 7-14 days. In China, the bismuth-containing quadruple therapy (BQT) remains the standard first-line treatment for H. pylori infection. However, BQT implementation is challenged by polypharmacy burdens, substantial adverse events, and suboptimal treatment adherence. Emerging evidence suggests that simplified dual therapies pairing acid suppressants (PPIs or potassium-competitive acid blockers [P-CABs]) with high-dose amoxicillin achieve comparable eradication rates to BQT while demonstrating superior tolerability and adherence profiles. Notably, the comparative efficacy of tetracycline-based versus amoxicillin-based dual regimens remains unexamined in controlled clinical trials. Our preliminary investigations established that optimized PPI-amoxicillin dual therapy achieves >90% eradication rates in treatment-naïve populations. Building on these findings, this prospective randomized controlled trial will comparatively assess the effectiveness of tegoprazan-a novel P-CAB exhibiting potent acid inhibition-when co-administered with either amoxicillin or tetracycline in H. pylori-positive adults. The investigation aims to establish an evidence framework for streamlining eradication protocols through pharmacodynamic optimization while mitigating antimicrobial resistance development.

Start Date10 Jun 2025

Sponsor / Collaborator

Zhongshan Hospital Xiamen University

100 Clinical Results associated with Tegoprazan

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100 Translational Medicine associated with Tegoprazan

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100 Patents (Medical) associated with Tegoprazan

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139

Literatures (Medical) associated with Tegoprazan

05 Oct 2025·CHINESE MEDICAL JOURNAL

Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, double-blind, non-inferiority phase Ⅲ trial

Article

Author: Xue, Qian ; Liu, Fei ; Zhan, Qiang ; Zhang, Zhenyu ; Lyu, Shengxiang ; Shao, Dong ; Du, Yiqi ; Zhong, Liang ; Liu, Deliang ; Lu, Lungen ; Li, Zhaoshen ; Song, Yingxiao ; Chen, Weixing ; Yang, Xiaozhong ; Ding, Yanbing ; Huang, Zhiming ; Li, Xing ; Zhu, Huiyun

Abstract:

Background::

An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs. esomeprazole in patients with EE in China.

Methods::

This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs. esomeprazole 40 mg/day. This study was conducted in 32 sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement.

Results::

A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs. 92.8%, difference: −1.7%, 95% confidence interval [CI]: −8.5%, 5.0%, P = 0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P >0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients’ diaries, were similar between the two groups (all P >0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively.

Conclusion::

Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40 mg/day.

Trial Registration::

ClinicalTrials.gov, NCT03615677.

15 Sep 2025·Gut and Liver

Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Helicobacter pylori Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study

Article

Author: Hong, Su Jin ; Choi, Il Ju ; Kim, Jae Gyu ; Park, Jae Yong ; Jeon, Seong Woo ; Kim, Gwang Ha ; Shin, Sung Kwan

Background/Aims:

Triple therapy with vonoprazan, a potassium-competitive acid blocker, has shown an acceptable eradication rate. The aim of this study was to evaluate the efficacy and safety of tegoprazan-based triple therapy compared with those of vonoprazan-based triple therapy for Helicobacter pylori eradication.

Methods:

This randomized, double-blind, active-controlled, multicenter pilot study included treatment-naive adults with H. pylori infection. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC 1), tegoprazan 100 mg (TAC 2), or vonoprazan 20 mg (VAC) with amoxicillin 1,000 mg plus clarithromycin 500 mg twice daily for 10 days. The primary outcome was the eradication rate.

Results:

Of the 102 enrolled participants, 97 completed the study. The eradication rates in the full analysis set were 60.61% (95% confidence interval [CI], 43.93% to 77.28%), 78.79% (95% CI, 64.84% to 92.74%), and 84.85% (95% CI, 72.62% to 97.08%) in TAC 1, TAC 2, and VAC, respectively. The eradication rates in the per-protocol set were 66.67% (95% CI, 49.80% to 83.54%), 86.67% (95% CI, 74.50% to 98.83%), and 87.50% (95% CI, 76.04% to 98.96%) in TAC 1, TAC 2, and VAC, respectively. In the full analysis set, the eradication rate differences were -6.06% (95% CI, -24.61% to 12.49%) between TAC 2 and VAC and -24.24% (95% CI, -44.92% to -3.56%) between TAC 1 and VAC. In the per-protocol set, the eradication rate differences were -0.83% (95% CI, -19.97% to 17.37%) between TAC 2 and VAC and -20.83% (95% CI, -41.23% to -0.44%) between TAC 1 and VAC. All therapies were well tolerated with no notable safety differences.

Conclusions:

After 10 days, tegoprazan 100 mg showed eradication rates comparable to those of vonoprazan 20 mg, while 50 mg may be insufficient. These findings support future research to optimize tegoprazan dosing in clinical practice (ClinicalTrials.gov; NCT04128917).

01 Sep 2025·KOREAN JOURNAL OF INTERNAL MEDICINE

Effect of tegoprazan on temporal variability of platelet reactivity in patients treated with clopidogrel after coronary stenting

Article

Author: Kim, Yongcheol ; Lee, Oh-Hyun ; Im, Eui ; Cho, Deok-Kyu ; Roh, Ji Woong

Background/Aims: Data on the interactions between clopidogrel and tegoprazan are limited. We compared the effects of tegoprazan and proton-pump inhibitors (PPIs) on platelet reactivity.Methods: Using database data from March 2020 to January 2023, we retrospectively evaluated 262 patients who were taking either tegoprazan (n = 107) or PPIs (n = 155) combined with dual antiplatelet therapy, including aspirin and clopidogrel, after percutaneous coronary intervention. Platelet reactivity was assessed using VerifyNow P2Y₁₂ assays.Results: Platelet reaction unit (PRU) values at 3 (157 ± 8 vs. 162 ± 6, p = 0.659), 6 (167 ± 9 vs. 158 ± 7, p = 0.370), and 12 months (155 ± 10 vs. 164 ± 7, p = 0.448) were similar between groups. The prevalence of high on-treatment platelet reactivity, defined as ≥ 253 PRU, was also similar between the groups at 3 (10.3% vs. 10.2%, p = 0.976), 6 (7.0% vs. 8.2%, p = 1.000), and 12 months (4.3% vs. 9.0%, p = 0.503).Conclusions: There was no significant difference in platelet reactivity between the tegoprazan and PPI groups in patients undergoing PCI and receiving dual antiplatelet therapy with clopidogrel.

19

News (Medical) associated with Tegoprazan

17 Sep 2025

·pharma.economictimes.indiatimes.com

Dr Reddy’s debuts in-licensed acid blocker Tegoprazan in India

Hyderabad: Expanding its gastrointestinal portfolio in India, Dr Reddy’s Laboratories has announced the launch of its in-licensed novel molecule ‘ Tegoprazan ’, under the brand name ‘ Pcab ’ in India. Tegoprazan is a potassium-competitive acid blocker (P-CAB) which blocks H⁺/K⁺-ATPase enzyme , — a protein pomp responsible for the production of gastric acid. The drug is indicated for the treatment of acid peptic diseases (APD) such as Gastric Ulcer, Erosive Gastroesophageal Reflux Disease (GERD) and Non-Erosive Gastroesophageal Reflux Disease (NERD). Unlike the traditional proton pump inhibitors, Tegoprazan induces fast onset of action and can control gastric pH for a prolonged period. “Our partnership with HK inno.N Corporation for Tegoprazan brings together complementary strengths to enhance patient access to an innovative molecule that addresses critical gaps in acid peptic disease management and improves outcomes., “said M.V. Ramana, CEO Branded Markets (India and Emerging Markets), Dr.Reddy’s. Tegoprazan is developed by South Korea-based HK inno.N Corporation and in 2022, the Hyderabad-based drugmaker obtained the drug's India and select emerging markets commercial rights for an undisclosed amount. Currently the drug is approved in 21 countries and further registration in several countries is under process. Besides Tegoprazan, other approved P-CABs include 'Takecab,' marketed by Japanese biopharma company Takeda. However, Dr. Reddy’s formulation will be available in a 50 mg dose, whereas competing products are marketed in 10 mg and 20 mg strengths. According to the company release, APD affects around 38 per cent of the country’s total population. Data from the domestic market sales tracker PharmaTrac suggest that the gastrointestinal therapies represents the second largest drug market in India after cardiac, with a moving annual turnover of (MAT) Rs 28,263 crore as of August this year. By Online Bureau ,

Drug ApprovalBiosimilarLicense out/in

17 Sep 2025

·pharma.economictimes.indiatimes.com

Dr Reddy’s debuts in-licensed acid blocker Tegoprazan in India

Hyderabad: Expanding its gastrointestinal portfolio in India, Dr Reddy’s Laboratories has announced the launch of its in-licensed novel molecule ‘ Tegoprazan ’, under the brand name ‘ Pcab ’ in India. Tegoprazan is a potassium-competitive acid blocker (P-CAB) which blocks H⁺/K⁺-ATPase enzyme , — a protein pomp responsible for the production of gastric acid. The drug is indicated for the treatment of acid peptic diseases (APD) such as Gastric Ulcer, Erosive Gastroesophageal Reflux Disease (GERD) and Non-Erosive Gastroesophageal Reflux Disease (NERD). Unlike the traditional proton pump inhibitors, Tegoprazan induces fast onset of action and can control gastric pH for a prolonged period. “Our partnership with HK inno.N Corporation for Tegoprazan brings together complementary strengths to enhance patient access to an innovative molecule that addresses critical gaps in acid peptic disease management and improves outcomes., “said M.V. Ramana, CEO Branded Markets (India and Emerging Markets), Dr.Reddy’s. Tegoprazan is developed by South Korea-based HK inno.N Corporation and in 2022, the Hyderabad-based drugmaker obtained the drug's India and select emerging markets commercial rights for an undisclosed amount. Currently the drug is approved in 21 countries and further registration in several countries is under process. Besides Tegoprazan, other approved P-CABs include 'Takecab,' marketed by Japanese biopharma company Takeda. However, Dr. Reddy’s formulation will be available in a 50 mg dose, whereas competing products are marketed in 10 mg and 20 mg strengths. According to the company release, APD affects around 38 per cent of the country’s total population. Data from the domestic market sales tracker PharmaTrac suggest that the gastrointestinal therapies represents the second largest drug market in India after cardiac, with a moving annual turnover of (MAT) Rs 28,263 crore as of August this year. By Online Bureau ,

Drug ApprovalBiosimilarLicense out/in

18 Aug 2025

·www.raqualia.com

Interview with Masaki Sudo, President & CEO of RaQualia Pharma Inc., featured on The Worldfolio

An interview with Masaki Sudo, President & CEO of RaQualia Pharma Inc., has been published by The Worldfolio , a global news media agency specializing in industrial and business coverage. The article highlights the core strengths of Japan’s pharmaceutical industry, including its adaptation to emerging therapeutic modalities. It also presents RaQualia’s focused therapeutic areas and upcoming key milestones, as well as future business development plans for tegoprazan. The Worldfolio: How RaQualia Turns Molecules into Meaning https://www.theworldfolio.com/interviews/how-raqualia-turns-molecules-into-meaning/6983/ Cookie Policy We use cookies to provide you with a better browsing experience. Please confirm that you agree to our use of cookies by clicking Yes. If you continue to browse this website even without agreeing to our use of cookies, we consider that you have consented to our use of cookies. Privacy Policy © RaQualia Pharma Inc. All rights reserved.

100 Deals associated with Tegoprazan

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A02BC	DB16690

R&D Status

Approved

10 top approved records.

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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.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-erosive reflux disease	Phase 3	United States	HK inno.N Corp.	22 Sep 2015
Erosive esophagitis	Phase 3	United States	HK inno.N Corp.	01 May 2015
Liver Injury	Phase 1	United States	HK inno.N Corp.	08 Sep 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03615677 (Pubmed \| Chin Med J (Engl))	Phase 3	Erosive esophagitis	261	Tegoprazan 50 mg/day	irjqpmqvmn(dxtedxgmnb) = srrszjzywk znagtcuwgn (hcouzlvble )	Positive	05 Oct 2025
				Esomeprazole 40 mg/day	irjqpmqvmn(dxtedxgmnb) = ghchsqmilk znagtcuwgn (hcouzlvble )
NCT04128917 (Pubmed \| Gut Liver)	Phase 3	Helicobacter pylori infection	102	Tegoprazan 50 mg	mjcnyqqkoc(lztqpnxpkt) = zejstybozq vnxxgyxnmv (vidzjiygfp, 43.93 - 77.28)	Positive	15 Sep 2025
				Tegoprazan 100 mg	mjcnyqqkoc(lztqpnxpkt) = uzozmavbdc vnxxgyxnmv (vidzjiygfp, 64.84 - 92.74)
NCT05577468 (Pubmed \| Chin Med J (Engl))	Phase 3	Helicobacter pylori infection First line	561	Tegoprazan-based TTPB	qwkmdpnkmi(jlytsiunvd) = liqjvqezcl papbspxbjj (tipprpthln ) View more	Non-inferior	22 Aug 2025
				Esomeprazole-based TTPB	qwkmdpnkmi(jlytsiunvd) = ogirtbhhos papbspxbjj (tipprpthln ) View more
NCT05883306 (Pubmed \| Expert Opin Drug Metab Toxicol)	Phase 1	-	6	Tegoprazan 50 mg/150 μCi	vaumjzzsve(guyhgoiupn) = doitwnzhjh rvrtwreuqd (eiidozzcud ) View more	-	13 May 2025
NCT05267743 (Pubmed)	Phase 4	Non-erosive gastro-esophageal reflux disease	218	替戈拉生	qqvkeudeta(rgmyutdsgn) = pwpejnbrlj stjdvucdgs (ffmuvqwjqk )	Non-inferior	25 Nov 2024
				兰索拉唑	qqvkeudeta(rgmyutdsgn) = nwnzwihjvj stjdvucdgs (ffmuvqwjqk )
UEGW2024	Not Applicable	Helicobacter pylori infection First line	80	Tegoprazan-based BQT	ejboqvjthg(cdyyglrxmp) = 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%) uqurmobjsz (ggglyqjdhl )	Positive	13 Oct 2024
				Omeprazole-based BQT
UEGW2024	Not Applicable	-	-	Tegoprazan 50mg	tfacfhvonn(mloacfohpr) = 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. hlyikjbzoj (svsmlpxgdg )	-	13 Oct 2024
				Placebo
UEGW2024	Not Applicable	-	-	Esomeprazole-containing sequential therapy	yzvmrhvidw(rpksfrgkiy) = 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) lggmazzxlp (axmkwyfalg )	-	13 Oct 2024
				Tegoprazan-containing sequential therapy
NCT05010954 (Pubmed \| Curr Med Res Opin) Manual	Phase 3	Duodenal Ulcer	399	Tegoprazan 50 mg	eotxnpiope(fjxxywvfbx) = tfpnqolplj ofdfapbfvf (kxposoguje ) View more	Non-inferior	08 Oct 2024
				Lansoprazole 30 mg	eotxnpiope(fjxxywvfbx) = clqigqtwdi ofdfapbfvf (kxposoguje ) View more
NCT03615677 (Pubmed)	-	Esophagitis, Peptic	261	替戈拉生	rmvdchcron(ubyiuygkjo) = dyvqorghjl fwzicrgvjy (xuyhvaiusy )	Non-inferior	01 Oct 2024
				艾司奥美拉唑	rmvdchcron(ubyiuygkjo) = aykwbtxllv fwzicrgvjy (xuyhvaiusy )