The aim of this study is to compare gastric pH right after endotracheal intubation for general anesthesia in patients pretreated with tegoprazan, famotidine, or placebo.

Start Date01 Mar 2025

Sponsor / Collaborator

Korea University Guro Hospital

[+2]

ChiCTR2400089417

/ SuspendedPhase 4IIT

Efficacy study of tegoprazan dual therapy and bismuth containing quadruple therapy for eradication of Helicobacter pylori

Start Date16 Sep 2024

Sponsor / Collaborator-

NCT06523764

/ Not yet recruitingPhase 4IIT

Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment : A Randomized Controlled Trial

The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Start Date01 Sep 2024

Sponsor / Collaborator

Xijing Hospital

100 Clinical Results associated with Tegoprazan

100 Translational Medicine associated with Tegoprazan

100 Patents (Medical) associated with Tegoprazan

116

Literatures (Medical) associated with Tegoprazan

01 Jan 2025·NEUROGASTROENTEROLOGY AND MOTILITY

Comparison of Tegoprazan and Lansoprazole in Patients With Erosive Esophagitis up to 4 Weeks: A Multi‐Center, Randomized, Double‐Blind, Active‐Comparator Phase 4 Trial

Article

Author: Shin, Jeong Eun ; Kim, Seung Young ; Cho, Jin Woong ; Lee, Ju Yup ; Shin, Cheol Min ; Jung, Hye‐Kyung ; Lee, Oh Young ; Kim, Do Hoon ; Lee, Ok Jae ; Park, Moo In ; Kim, Gwang Ha ; Lee, Sang Jin ; Park, Seon‐Young ; Lee, Sang Kil ; Youn, Young Hoon ; Hong, Su Jin ; Jeon, Seong Woo ; Sung, In Kyung ; Cho, Yu Kyung ; Choi, Suck Chei

ABSTRACT:

Background:

The aims of this study were to confirm the non‐inferiority of tegoprazan to lansoprazole up to week 4 in patients with erosive esophagitis (EE) and to evaluate its effectiveness in rapid mucosal healing and symptom relief at week 2.

Methods:

In this multi‐center, randomized, double‐blind, active‐comparator non‐inferiority trial, 218 patients with endoscopically confirmed EE (Los Angeles Classification Grades A–D) were randomly allocated to either the tegoprazan (50 mg) or lansoprazole (30 mg) group. The primary endpoint was the cumulative proportion of patients with healed EE up to week 4, as confirmed through endoscopy. The proportion of patients with healed EE at week 2 was also evaluated. Furthermore, CYP2C19 genotypes, symptoms, safety, and tolerability were assessed.

Key Results:

In the full‐analysis set, 103 and 109 participants in the tegoprazan and lansoprazole groups, respectively, were analyzed. The cumulative healing rates up to week 4 were 95.2% (98/103) and 86.2% (94/109) (difference [95% confidence interval], 8.91 [1.22–16.59]; p < 0.0001 for non‐inferiority and 0.0266 for superiority), while those at week 2 were 88.4% (91/103) and 82.6% (90/109) (5.78 [−3.66–15.22], p = 0.0005 for non‐inferiority) for tegoprazan and lansoprazole, respectively. Tegoprazan showed consistent healing rates regardless of CYP2C19 genotypes.

Conclusions and Inferences:

Tegoprazan was superior to lansoprazole in the treatment of EE up to 4 weeks. Further studies are necessary to confirm these findings and clarify the superiority of tegoprazan, especially in the treatment of severe EE.

Trial Registration:

ClinicalTrials.gov identifier: NCT05267743

01 Jan 2025·JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY

Comparative efficacy of Helicobacter pylori eradication therapy between tegoprazan‐based concomitant and bismuth quadruple therapies: A real‐world evidence

Article

Author: Park, Chan Hyuk ; Jung, Yoon Suk ; Jung, Byung Wook

Abstract:

Background and Aim:

Tegoprazan, a potassium‐competitive acid blocker, can be used as a substitute for proton pump inhibitors in Helicobacter pylori eradication therapy; some studies have reported improved efficacy. In Korea, where clarithromycin resistance rates are high, we aimed to compare the efficacies of tegoprazan‐based concomitant and bismuth quadruple therapies.

Methods:

We retrospectively analyzed data from patients with H. pylori infection who received either 10‐day tegoprazan‐based concomitant therapy or 14‐day tegoprazan‐based bismuth quadruple therapy as first‐line treatment. The primary outcome was H. pylori eradication rate, with secondary outcomes including adverse events and insufficient medication rates.

Results:

Among the 1082 patients included in the study, 620 and 462 were treated with tegoprazan‐based concomitant and bismuth quadruple therapies, respectively. Intention‐to‐treat analysis demonstrated no difference in eradication rates between the tegoprazan‐based concomitant and bismuth quadruple therapy groups (74.7% [95% confidence interval—CI, 71.1–78.0%] vs 74.7% [95% CI, 70.6–78.5%], P = 0.999). Per‐protocol analysis also showed similar eradication rates between the two groups (88.0% [95% CI, 85.0–90.6%] vs 89.7% [95% CI, 86.3–92.5%], P = 0.424). The overall adverse event rates (49.6% vs 39.2%, P = 0.001) and insufficient medication rates (4.8% vs 2.4%, P = 0.036) were higher in the bismuth quadruple therapy group than in the concomitant therapy group.

Conclusions:

The eradication rates of tegoprazan‐based 10‐day concomitant therapy and 14‐day bismuth quadruple therapy were comparable. However, because of its shorter treatment duration, better medical adherence, and lower incidence of adverse events, tegoprazan‐based concomitant therapy may be preferable in regions with high rates of clarithromycin and metronidazole resistance.

01 Jan 2025·Therapeutic Advances in Gastroenterology

The efficacy and safety of Vonoprazan and Tegoprazan in Helicobacter pylori eradication: a comprehensive systematic review and meta-analysis of randomized controlled trials

Article

Author: Xuan, Han ; Zhong, Li ; Zhang, Lei ; Wu, Wei ; Jin, Ting ; Zhang, Haixiang

Background::

Potassium-competitive acid blocker (P-CAB)-based therapies are emerging as promising alternatives for eradicating Helicobacter pylori infection. However, the comparative efficacy of P-CAB-based therapy versus proton-pump inhibitor (PPI)-based therapy in treating H. pylori infection remains uncertain.

Objectives::

This meta-analysis evaluated the efficacy and safety of P-CAB-based therapies, including Vonoprazan (VPZ) and Tegoprazan (TPZ), compared to PPI-based therapies for H. pylori infection. Subgroup analysis assessed the influence of drug history, experimental drug, treatment duration, combination therapies, and geographic regions on treatment outcomes.

Design::

Meta-analysis.

Data sources and methods::

Comprehensive searches were conducted in major databases, including PubMed, Embase, the Cochrane Library, and Web of Science, up to January 1, 2024. The primary outcome was the eradication rate, analyzed by intention-to-treat (ITT). Secondary outcomes included adverse events. Heterogeneity among studies was assessed using the χ2 test and the I2 test. I2 > 50% or p < 0.05 indicated significant heterogeneity.

Results::

The analysis totally included 28 randomized controlled trials (RCTs) comprising 37 studies and 8818 patients diagnosed with H. pylori infection. Of these, 14 RCTs, including 20 studies and 4286 patients, compared P-CAB-based therapy with 14-day bismuth-based quadruple therapy (BQT). P-CAB-based therapy exhibited superior eradication rates compared to both 14-day BQT and PPI-based therapy (ITT analysis: 87.0% vs 79.8%, risk ratio (RR) = 1.08, 95% CI: 1.04–1.12, p < 0.0001; and 85.6% vs 77.8%, RR = 1.09, 95% CI: 1.05–1.12, p < 0.00001, respectively). This enhanced efficacy was particularly pronounced in patients with clarithromycin-resistant infections (73.7% vs 41.5%, RR = 1.53, 95% CI: 1.07–2.20, p = 0.02). Subgroup analysis demonstrated higher eradication rates with P-CAB-based therapy in treatment-naïve participants, VPZ recipients, and those receiving 7- or 14-day regimens (dual, triple, or quadruple therapy). However, no significant differences were observed in treatment-experienced subgroups, TPZ recipients, or those on 10-day regimens. In addition, P-CAB-based therapy showed a lower incidence of adverse events than PPI-based treatments (RR = 0.73, 95% CI: 0.63–0.86, p < 0.0001).

Conclusion::

P-CAB-based therapies are more effective than traditional PPI-based treatments for eradicating H. pylori infection, with a reduced incidence of adverse events.

PROSPERO registration::

CRD42024503665.

News (Medical) associated with Tegoprazan

24 Jan 2025

·www.prnewswire.com

Sebela Women's Health Announces Publication of Phase 3 Pivotal Study Results for the Investigational Copper 175 mm² Intrauterine Device (IUD) in Contraception

ROSWELL, Ga., Jan. 24, 2025 /PRNewswire/ -- Sebela Women's Health Inc., a part of Sebela Pharmaceuticals, today announced Contraception published positive results online from the Phase 3 study of the investigational Copper 175mm2 intrauterine device (IUD), concluding that data from this trial support the efficacy, safety and tolerability of the Copper 175mm2 IUD during the first three years of use.1 "Publication of the results from the Phase 3 study of the Copper 175mm2 IUD in Contraception further supports the potential impact this hormone-free IUD option can have for women looking for a non-hormonal, long-acting birth control option," said Kelly Culwell, MD, Head of Research and Development, Sebela Women's Health. The investigational Copper 175mm2 IUD utilizes a flexible frame made of nitinol and contains less than half the copper of the currently available copper IUD (380mm2). The Phase 3 study was conducted at 42 research sites throughout the U.S. by the Copper 175mm2 IUD Phase 3 Clinical Investigator Group, and it was funded by Sebela Women's Health Inc. (Clinicaltrials.gov NCT03633799). Data subsets have previously been presented at major women's health meetings in the U.S., including the American College of Obstetrics and Gynecology annual meeting, and various past publications may have referred to the investigational product as VeraCept. The study is part of a New Drug Application currently under review by the U.S. Food and Drug Administration. The study remains ongoing to evaluate efficacy, safety and tolerability of the Copper 175mm2 IUD up to eight years. "This uniquely designed, flexible copper IUD would be the first new hormone-free IUD available in 40 years and would be a welcome addition to the clinician's armamentarium in the U.S.," said Principal Investigator and one of the study authors David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. "A wide range of birth control options should be available to all people that need them, and a lot of the people I care for prefer a non-hormonal, long-acting option." "In addition to the efficacy we saw in this study of the Copper 175mm2 IUD, it's also promising that bleeding and pain observed in some participants dramatically decreased after the first three months of use, as tolerability is a key aspect of a long-acting, non-hormonal option," Turok continued. For some people, long-acting reversible contraceptive (LARC) methods like intrauterine devices and contraceptive implants offer many advantages. They are recognized as the most effective contraceptive methods, they have few contraindications, and almost all patients are appropriate candidates for them, per American College of Obstetrics and Gynecology (ACOG).2 Study Details This single-arm trial recruited participants at risk of pregnancy aged 17-45 years at 42 U.S. centers to receive a Copper 175mm2 IUD. The trial assessed efficacy in participants ≤35 years old at enrollment and all safety outcomes in the entire population. The Pearl Index (pregnancies/100 person-years) was calculated through 3 years as the primary efficacy outcome. Secondary outcomes included pregnancy percentages by life-table analysis, placement success, safety (adverse events), and tolerability. Of 1620 enrollees, 1601 (98.8%) had successful IUD placement, with 1397 ≤35 years at enrollment. The pregnancy risk was about 1% per year, consistent with copper IUDs. The 1-year Pearl Index was 0.94 (95%CI 0.43-1.78) and the 3-year cumulative Pearl Index was 1.05 (95%CI 0.66-1.60). The most common adverse events included bleeding and pain similar to those seen with use of all IUDs. The incidence of these adverse events decreased over time. Over 3 years, 15.4% of participants discontinued due to bleeding or pain. Device expulsions occurred in 36 (2.2%) and 63 (3.9%) participants over 1 and 3 years, respectively. Eight related serious adverse events occurred, including five ectopic pregnancies and one each of uterine perforation, anemia, and uterine hemorrhage. About Sebela Pharmaceuticals Inc. Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. In addition to the investigational 175mm2 Copper intrauterine device (IUD), Sebela Women's Health has another next-generation, hormonal IUD for contraception in the late stages of clinical development. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 40 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has several gastroenterology programs in late-stage clinical development including Tegoprazan which belongs to a new class of drugs called potassium competitive acid blockers and is currently in Phase 3 trials for gastro-esophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland. Please visit sebelapharma.com for more information or call 844-732-3521. Forward Looking Statements This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Women's Health Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, as amended, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. There are a number of 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, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; 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 future clinical trials discussed in this press release will be completed or successful 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 to be 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, are based on current expectations, and Sebela Women's Health Inc. does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. References Creinin MD, Gawron LM, Roe AH, et al.; Copper 175mm2 IUD Phase 3 Clinical Investigator Group. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2024 Nov 22:110771. doi: 10.1016/ j.contraception.2024.110771. ACOG, Clinical Practice Bulletin #186, Nov. 2017 reaffirmed 2021; Committee Statement #5, April 2023. Accessed on Jan. 20, 2025: and Improving access to intrauterine devices and contraceptive implants. Committee Statement No. 5. American College of Obstetricians and Gynecologists. Obstet Gynecol 2023;141:866–72. SOURCE Sebela Pharmaceuticals Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical Result

06 Jan 2025

·www.inno-n.com

HK inno.N’s K-CAB enters Australian and New Zealand markets

January 6, 2024 HK inno.N’s K-CAB, new drug for Gastroesophageal Reflux Disease (GERD) treatment, enters Australian and New Zealand markets Signed a finished product export agreement for K-CAB with Southern XP, an Australian pharmaceutical company K-CAB has now entered 48 countries worldwide, including the US, China and Latin America... aiming for market entry into 100 countries by 2028 K-CAB, HK inno.N’s new drug for gastroesophageal reflux disease (GERD), is expanding its presence into Australian and New Zealand markets. HK inno.N announced on Monday (January 6th) that the company recently signed an agreement for exporting finished products of K-CAB tablets (active ingredient tegoprazan), its new GERD treatment, to Australia and New Zealand with Southern XP, an Australian pharmaceutical company. Under this agreement, Southern XP will hold exclusive rights to obtain regulatory approval and for commercialization of K-CAB in Australia and New Zealand. The agreement is applicable to the two products: ▲K-CAB tablet 50 mg and ▲K-CAB tablet 25 mg. Southern XP is based in Australia with over 20 years of experience in the pharmaceutical industry, specializing in obtaining the regulatory approvals for and distribution of pharmaceuticals in Australia and New Zealand. The pharmaceutical markets in the two countries are valued at approximately KRW 22 trillion in total as of 2023, of which the market for peptic ulcer medications is valued at about KRW 150 billion. HK inno.N’s CEO Dalwon Kwak commented, “The value of K-CAB as a new drug of South Korea is recognized across different continents worldwide, showing a steady increase in the product’s influence in the global market of peptic ulcer medications” and added, “With the target of market entry into 100 countries worldwide by 2028, K-CAB’s global competitiveness will continue to grow.” K-CAB, the 30th new drug of South Korea, is a P-CAB class new drug for GERD treatment. It is characterized by rapid onset of action within one hour after administration and proven efficacy and safety even with long-term use for up to six months. Following its first launch in South Korea, K-CAB succeeded in the market entry to a total of 48 countries worldwide, including the US and China. The product has been officially released in 15 countries to date, demonstrating its growing global market presence. K-CAB recorded a total outpatient prescription sales of KRW 177.7 billion from January to November of 2024 in South Korea. The product has been the steady No. 1 market leader in peptic ulcer medications for five consecutive years. [The End] [Reference information] ■ P-CAB: Potassium Competitive Acid Blocker ■ Source on the size of the Australian/New Zealand pharmaceutical market and peptic ulcer medications market: IQVIA data, 2023 ■ Overview of K-CAB’s market presence worldwide (48 countries in total): - South Korea, China, Mongolia, India, South Africa, the United States, Canada, Australia, New Zealand - 6 Southeast Asian countries: Indonesia, Thailand, Philippines, Vietnam, Singapore, Malaysia - 5 Eastern European countries: Russia, Kazakhstan, Uzbekistan, Ukraine, Belarus - 18 Central and South American countries: Brazil, Mexico, Argentina, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, Venezuela, Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, El Salvador - 10 Middle Eastern/North African countries ■ Countries with official product release of K-CAB (15 countries in total): South Korea, China, Philippines, Mongolia, Mexico, Indonesia, Singapore, Peru, Chile, Colombia, Dominican Republic, Guatemala, El Salvador, Nicaragua, Honduras

Drug ApprovalLicense out/in

12 Dec 2024

·www.inno-n.com

HK inno.N’s K-CAB launched in 6 additional Latin American countries

December 12, 2024 HK inno.N’s K-CAB, new drug for Gastroesophageal Reflux Disease (GERD) treatment, launched in 6 additional Latin American countries Product launch in 6 countries including ▲Dominican Republic ▲Nicaragua ▲Honduras … K-CAB now available in 15 countries worldwide Ranked 3rd in the Mexican market within a year of its launch… market share of 10% in sight HK inno.N announced on 12 December that K-CAB (tegoprazan) for gastroesophageal reflux disease (GERD), was launched in six additional Central and South American countries. The six countries in the region with the recent product launch of K-CAB are ▲Dominican Republic ▲Nicaragua ▲Honduras ▲Guatemala ▲El Salvador ▲Colombia. K-CAB already obtained the marketing authorization under the local product name "Ki-CAB" in September. K-CAB’s bold strides of market expansion in Latin America include 18 countries, either in the form of exporting finished products or technology export. Following its launch in Mexico and Peru last year, the product was released in Chile in the second half of this year and is now launched in 6 more countries in the continent, establishing its market presence across 9 countries of Latin America at a remarkable pace. Carnot, HK inno.N's partner that signed a contract with HK inno.N for exporting and distribution of K-CAB to 17 Latin American countries excluding Brazil, has been active in its marketing campaigns to lead the market growth of K-CAB (the local product name "Ki-CAB.") in the Central and South American markets. As part of the partnership, HK inno.N and Carnot have jointly hosted an academic conference for medical specialists in South Korea and Latin America since the last year. In October this year, a symposium was held in Bogota, Colombia, in celebration of K-CAB’s launch in the country. A number of eminent gastroenterologists from the Americas attended the event, gave presentations, and had lively discussions on the clinical benefits of K-CAB and the areas where it can be used as a new treatment option. Dr David A. Peura, an emeritus professor in gastroenterology at University of Verginia, Charlottesville, the U.S., presented in his lecture at the Colombia symposium, “K-CAB should be considered as an option for all cases of Helicobacter pylori eradication therapy requiring acid suppression.” Dr. Marcelo Vela of the Mayo Clinic in the U.S. reported, “K-CAB has a faster onset of action in suppressing gastric acid than other potassium competitive acid blockers (P-CAB) and has greater benefits than proton pump inhibitors (PPIs) in the treatment of GERD in patients with moderate to severe reflux esophagitis (LA grade B/C/D).” An official from Carnot stated, "K-CAB landed on its position as the top 3 peptic ulcer medicines in Mexico within a year from its launch and is close to achieving the 10% market share," and added, " the rapid pace of growth of K-CAB has had a positive impact on the Latin American market, and medical specialists in other countries in the continent where K-CAM has not been introduced yet have expressed great interest and expectations. HK inno.N’s CEO Dalwon Kwak commented, “K-CAB has quickly gained prominence in the Central and South American market, and our efforts to promote the value of the Korean new drug in the global peptic ulcer market will continue to expand, beyond Latin America.” K-CAB, the 30th new drug of South Korea, is a P-CAB class new drug for GERD treatment. It is characterized by rapid onset of action within one hour after administration and proven efficacy and safety even with long-term use for up to six months. Recently, the Mexican Association of Gastroenterology (the Asociación Mexicana de Gastroenterología) published a guideline recommending P-CAB class drugs from the early stage in the treatment course of GERD, which is expected to further increase the influence of K-CAB in the market of peptic ulcer medications in Central and South America. Following its first launch in South Korea, K-CAB succeeded in the market entry to a total of 46 countries worldwide, including the U.S. and China. The product has been officially released in 15 countries to date, demonstrating its growing global market presence. K-CAB recorded a total outpatient prescription sales of KRW 177.7 billion from January to November for this year alone in South Korea. The product has been the steady No. 1 market leader in peptic ulcer medications for four consecutive years since its launch. [The End] [Reference information] ■ P-CAB: Potassium Competitive Acid Blocker ■ PPI: Proton Pump Inhibitor ■ The Mexican Association of Gastroenterology: Asociación Mexicana de Gastroenterología ■ Overview of K-CAB’s market presence worldwide (46 countries in total): - South Korea, China, Mongolia, India, South Africa, the U.S, Canada - 6 Southeast Asian countries: Indonesia, Thailand, the Philippines, Vietnam, Singapore, Malaysia - 5 Eastern European countries: Russia, Kazakhstan, Uzbekistan, Ukraine, Belarus - 10 Middle Eastern/North African countries - 18 Central and South American countries (see below) ■ K-CAB’s market entry to Central and South America includes the following 18 countries: Brazil, Mexico, Argentina, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, Venezuela, Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, and El Salvador (Of these, Carnot is an exporter for 17 countries, which excludes Brazil). ■ Overview of K-CAB’s market presence in Central and South America - Technology transfer (1 country): Brazil - Product release (9 countries): Mexico, Peru, Colombia, Chile, Dominican Republic, Nicaragua, Honduras, Guatemala, and El Salvador.

Drug ApprovalLicense out/inBiosimilar

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
Duodenal Ulcer	CN	Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.	14 Nov 2023
Esophagitis, Peptic	CN	Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.	08 Apr 2022
Gastroesophageal Reflux	KR	HK inno.N Corp.	05 Jul 2018
Helicobacter pylori infection	KR	HK inno.N Corp.	05 Jul 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Peptic Ulcer	Phase 3	KR	HK inno.N Corp.	07 May 2021
Stomach Ulcer	Phase 3	KR	HK inno.N Corp.	01 May 2016
Non-erosive gastro-esophageal reflux disease	Phase 3	KR	HK inno.N Corp.	22 Sep 2015
Non-erosive reflux disease	Phase 3	KR	HK inno.N Corp.	22 Sep 2015
Erosive esophagitis	Phase 3	KR	HK inno.N Corp.	01 May 2015
Liver Injury	Phase 1	KR	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


UEGW2024	Not Applicable	-	-	Esomeprazole-containing sequential therapy	pjumkildld(pvjpbdjglv) = 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) ugpjpebxwe (izclbivxem )	-	13 Oct 2024
				Tegoprazan-containing sequential therapy
UEGW2024	Not Applicable	Helicobacter pylori infection First line	80	Tegoprazan-based BQT	fhyksmnqvs(ygsiyagxaf) = 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%) wfxarsjdpf (wagwdffeuh )	Positive	13 Oct 2024
				Omeprazole-based BQT
UEGW2024	Not Applicable	-	-	Tegoprazan 50mg	frubyjokxi(dfwmbxylpd) = 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. jptehvgxep (cmkazugmce )	-	13 Oct 2024
				Placebo
NCT05010954 (Pubmed \| Curr Med Res Opin) Manual	Phase 3	Duodenal Ulcer	399	Tegoprazan 50 mg	cnimrnolib(sxzegxknqe) = shvitfeljk rwthdhdlkw (oxolmmrkdi ) View more	Non-inferior	08 Oct 2024
				Lansoprazole 30 mg	cnimrnolib(sxzegxknqe) = tonhnsztok rwthdhdlkw (oxolmmrkdi ) View more
NCT06382493 (Pubmed \| Helicobacter)	Not Applicable	Helicobacter pylori infection	406	Esomeprazole-containing sequential therapy	opyeoonsut(tcmxiqwhez) = Nausea was more prevalent (23.3%, 27/202) with sequential tegoprazans than with esomeprazole-containing sequential therapy (14.2%, 29/204; p = 0.022) fzexgxssxy (oynbaheqwg )	Positive	01 Sep 2024
				Tegoprazan-containing sequential therapy
NEWS Manual	Phase 3	Helicobacter pylori infection	555	替戈拉生	zslmggdwug(ivjgndauey) = zvmgcbqtlf drmjmpyuli (kfvsbuppnj ) View more	Positive	21 May 2024
				艾司奥美拉唑	zslmggdwug(ivjgndauey) = jbrmhvzqut drmjmpyuli (kfvsbuppnj ) View more
DDW2024	Not Applicable	-	612	Tegoprazan	epvmegfktz(vxwrhjvjoq) = rrwrjvtbgt vuylruyipe (tyujzcprcn ) View more	Positive	21 May 2024
				PPI	epvmegfktz(vxwrhjvjoq) = woyqaozppm vuylruyipe (tyujzcprcn ) View more
DDW2024	Not Applicable	-	-	Vonoprazan-based triple therapy	kyiuvynhmu(pbentnudtx): RR = 1.17 (95% CI, 1.11 - 1.22)	-	18 May 2024
				Conventional PPI-based triple therapy
NCT05870683 (SHARE2301, Pubmed)	Not Applicable	Helicobacter pylori infection	368	Tegoprazan-amoxicillin (TA)	dajscgilgs(epqrufaagl) = vthuofwfob uakcgjagkw (clixamxvpr )	Positive	01 May 2024
				Esomeprazole-amoxicillin (EA)	dajscgilgs(epqrufaagl) = jrforbzcxm uakcgjagkw (clixamxvpr )
NCT04022096 (Pubmed) Manual	Phase 3	Erosive esophagitis	351	Tegoprazan	ilomvzcncj(jzyugyvqzd) = hdgnzwoxwq wbbbflgvto (okxawcwbju )	Non-inferior	31 Oct 2022
				lansoprazole	ilomvzcncj(jzyugyvqzd) = kykobnnfno wbbbflgvto (okxawcwbju )

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