Tegoprazan

Phase 3Small molecule

SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Tegoprazan is a small molecule that works as a Potassium-Transporting Atpase Blocker.[2] It is being investigated across 9 indications, with its most advanced program in Phase 3.[1]

Tegoprazan is one of 189 small molecule programs targeting Duodenal Ulcer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

188

Competitors

Pipeline

Status by Indication[3][1]

Indication

Duodenal UlcerActive, not recruiting

Gastric UlcerActive, not recruiting

Peptic UlcerUnknown

Laryngopharyngeal RefluxActive, not recruiting

Gastroesophageal Reflux DiseaseUnknown

Liver DiseaseActive, not recruiting

EsophagitisActive, not recruiting

Ischemic StrokeRecruiting

Helicobacter Pylori Infectious DiseaseActive, not recruiting

Duodenal UlcerPhase 3

Active, not recruiting

Gastric UlcerPhase 3

Active, not recruiting

Peptic UlcerPreclinical

Unknown

Laryngopharyngeal RefluxPhase 3

Active, not recruiting

Gastroesophageal Reflux DiseasePreclinical

Unknown

Liver DiseasePhase 1

Active, not recruiting

EsophagitisPhase 3

Active, not recruiting

Ischemic StrokePhase 3

Recruiting

Helicobacter Pylori Infectious DiseasePhase 3

Active, not recruiting

Competition

Competitive Landscape

430 competitors in Ischemic Stroke

#DrugCompanyPhaseTrials

Tegoprazan

SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Phase 3

1 2

Proamatine

Takeda

Preclinical

2 3

Repatha

Amgen

Preclinical

2 4

Levaquin

WWim Janssens

Preclinical

3 5

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 6

Tylenol

KKenvue Brands

Preclinical

1 7

Xylocaine

CCitius Pharmaceuticals, Inc.

Preclinical

1 8

Statins

Sanofi

Preclinical

1 9

Urokinase

Mmedac GmbH

Preclinical

3 10

Drug Therapy

MMassachusetts General Hospital

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Adult

NCT07277712

Q4 2026

Post-ApprovalNot yet recruiting

TED

NCT07242443

Q4 2027

Phase 3Recruiting

Ischemic Stroke

NCT07687706

Clinical

Trials by Indication[1]

Efficacy and Safety4 trials

Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

Completed·HHK inno.N Corporation·Phase 4·NCT04309916·46 enrolled

Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment

Active, not recruiting·XXijing Hospital of Digestive Diseases·Phase 4·NCT06523764·208 enrolled

A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

Unknown status·HHK inno.N Corporation·Phase 4·NCT05701540·338 enrolled

Show 1 more trial

Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole

Not yet recruiting·HHospital General de México Dr. Eduardo Liceaga·Phase 4·NCT06318104·160 enrolled

Oral4 trials

Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT04066257·32 enrolled

PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects

Enrolling by invitation·HHK inno.N Corporation·Phase 1·NCT06332638·36 enrolled

Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

Completed·HHK inno.N Corporation·Phase 1·NCT03863938·12 enrolled

Show 1 more trial

Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT04231136·19 enrolled

Interaction3 trials

Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT04639804·60 enrolled

Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin

Completed·SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.·Phase 1·NCT05915871·22 enrolled

PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT05723510·87 enrolled

Clopidogrel3 trials

Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

Unknown status·HHK inno.N Corporation·Phase 1·NCT06164834·48 enrolled

Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants

Completed·HHK inno.N Corporation·Phase 1·NCT03814642·25 enrolled

Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT04171687·36 enrolled

Helicobacter Pylori Infection2 trials

Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection （SHARE2301）

Unknown status·YYanqing Li·N/A·NCT05870683·368 enrolled

Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Unknown status·IIncheon St.Mary's Hospital·N/A·NCT04674774·217 enrolled

17 more indications

Peptic ulcer1 trial

Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment

Recruiting·MMario Steffanus·N/A·NCT06894992·162 enrolled

Gastroesophageal Reflux Disease1 trial

Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole

Recruiting·CCarnot Laboratories·Phase 4·NCT06991348·128 enrolled

General Anesthesia1 trial

Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia

Enrolling by invitation·SSeok Kyeong Oh·Phase 4·NCT06743243·174 enrolled

Adult1 trial

A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

Not yet recruiting·HHK inno.N Corporation·Phase 1·NCT07277712·74 enrolled

Randomized Controlled Trial1 trial

Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial

Completed·ZZhongshan Hospital (Xiamen), Fudan University·N/A·NCT06977841·640 enrolled

Laryngopharyngeal Reflux1 trial

The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease

Completed·PPusan National University Hospital·Phase 3·NCT05871398·36 enrolled

Esophagitis1 trial

Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis

Completed·HHK inno.N Corporation·Phase 3·NCT04022096·351 enrolled

Safety and Efficacy1 trial

Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease

Completed·HHK inno.N Corporation·Phase 4·NCT05267743·218 enrolled

Bismuth Quadruple Therapy1 trial

Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori

Completed·SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.·Phase 3·NCT05577468·561 enrolled

Phase 11 trial

A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

Unknown status·HHK inno.N Corporation·Phase 1·NCT03530228·44 enrolled

Atorvastatin1 trial

Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT04221321·32 enrolled

TED1 trial

Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）

Not yet recruiting·FFirst People's Hospital of Hangzhou·Phase 4·NCT07242443·240 enrolled

Hepatic Impairment1 trial

A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls

Unknown status·HHK inno.N Corporation·Phase 1·NCT04494269·28 enrolled

Tics1 trial

Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

Completed·SSeoul National University Hospital·Phase 1·NCT04568772·19 enrolled

Prevention1 trial

Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs

Unknown status·HHK inno.N Corporation·Phase 3·NCT04840550·390 enrolled

Ischemic stroke1 trial

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 (TegoStroke)

Recruiting·HHanyang University Guri Hospital·Phase 3·NCT07687706·1,524 enrolled

Unspecified5 trials

Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

Completed·HHK inno.N Corporation·Phase 3·NCT04128917·102 enrolled

Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication

Recruiting·FFirst People's Hospital of Hangzhou·Phase 2/3·NCT07242456·240 enrolled

Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients

Unknown status·HHK inno.N Corporation·Phase 2·NCT05933031·381 enrolled

Show 2 more trials

A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT03378284·16 enrolled

A Phase I Study of LX22001 for Injection in Healthy Subjects

Recruiting·SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.·Phase 1·NCT06561542·70 enrolled

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Tegoprazan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tegoprazan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tegoprazan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Potassium-Transporting Atpase Blocker[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Tegoprazan

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q4 2027

Trials by Indication[1]

Efficacy and Safety4 trials

Oral4 trials

Interaction3 trials

Clopidogrel3 trials

Helicobacter Pylori Infection2 trials

Peptic ulcer1 trial

Gastroesophageal Reflux Disease1 trial

General Anesthesia1 trial

Adult1 trial

Randomized Controlled Trial1 trial

Laryngopharyngeal Reflux1 trial

Esophagitis1 trial

Safety and Efficacy1 trial

Bismuth Quadruple Therapy1 trial

Phase 11 trial

Atorvastatin1 trial

TED1 trial

Hepatic Impairment1 trial

Tics1 trial

Prevention1 trial

Ischemic stroke1 trial

Unspecified5 trials

References

Drug Info

Quick Facts

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