DeepMed Research

Tegoprazan

Generic Name: Tegoprazan

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₁₉F_₂N_₃O_₃

CAS Number: 942195-55-3

Unique Ingredient Identifier: W017G7IF4S

Background: Tegoprazan (also known as CJ-12420) is a novel therapeutic developed by CJ Healthcare Corp for treating acid-related gastrointestinal diseases. This drug is a potent and high-selective potassium-competitive acid blocker (P-CAB) with a fast onset of action and the ability to control gastric pH for a prolonged period of time. Tegoprazan’s strong and sustained effect is due to its ability to be slowly cleared from the gastric glands and exertion of effects independent of acid levels. It has also been observed to be efficacious independent of food intake.

Indication: 用于治疗胃食管反流病、糜烂性食管炎及消化性溃疡等酸相关疾病。

Clinical Trials

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

Phase 1

Conditions: Hepatic Impairment
Healthy

Interventions: Drug: Tegoprazan 50mg

First Posted Date: 2020-07-31

Last Posted Date: 2020-11-09

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 28

Registration Number: NCT04494269

Locations: 🇰🇷
CHA Bundang Medical Center, Seongnam-si, Korea, Republic of
🇰🇷
Gachon University Gil Medical Center, Incheon, Korea, Republic of
🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

Phase 4

Conditions: Dyspepsia

Interventions: Drug: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

First Posted Date: 2020-06-26

Last Posted Date: 2020-06-26

Lead Sponsor: Asan Medical Center

Target Recruit Count: 60

Registration Number: NCT04449185

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

Phase 4

Completed

Conditions: Erosive Reflux Disease

Interventions: Drug: Esomeprazole
Drug: Tegoprazan

First Posted Date: 2020-03-17

Last Posted Date: 2022-02-25

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 46

Registration Number: NCT04309916

Locations: 🇰🇷
Severance Hospital, Seoul, Korea, Republic of

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tegoprazan 50 mg
Drug: EAPA115
Drug: RAPA115

First Posted Date: 2020-01-18

Last Posted Date: 2020-12-01

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 19

Registration Number: NCT04231136

Locations: 🇰🇷
Seoul National University Hospital, Clinical Trial Center, Seoul, Korea, Republic of

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Atorvastatin 40 mg
Drug: Tegoprazan 50 mg
Drug: RAPA114

First Posted Date: 2020-01-09

Last Posted Date: 2020-12-01

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 32

Registration Number: NCT04221321

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Clopidogrel 75mg
Drug: Tegoprazan 50 mg
Drug: RAPA113

First Posted Date: 2019-11-21

Last Posted Date: 2020-05-08

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 36

Registration Number: NCT04171687

Locations: 🇰🇷
Severance Hospital, Seoul, Korea, Republic of

Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

Phase 3

Completed

Conditions: Helicobacter Pylori Infection

Interventions: Drug: RAPAE01
Drug: Tegoprazan

First Posted Date: 2019-10-16

Last Posted Date: 2021-05-12

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 102

Registration Number: NCT04128917

Locations: 🇰🇷
Chung-Ang University Hosptial, Seoul, Korea, Republic of

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Metronidazole
Drug: Tegoprazan
Drug: Tetracycline
Drug: Bismuth

First Posted Date: 2019-08-26

Last Posted Date: 2019-08-28

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 32

Registration Number: NCT04066257

Locations: 🇰🇷
Chonbuk National University Hospital, Jeonju, Korea, Republic of

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

Phase 3

Completed

Conditions: Healed Erosive Esophagitis

Interventions: Drug: Lansoprazole 15mg QD
Drug: Tegoprazan 25mg QD

First Posted Date: 2019-07-16

Last Posted Date: 2023-01-27

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 351

Registration Number: NCT04022096

Locations: 🇰🇷
Hanyang University Seoul Hospital, Seoul, Korea, Republic of

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tegoprazan 50mg

First Posted Date: 2019-03-05

Last Posted Date: 2019-08-22

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 12

Registration Number: NCT03863938

Locations: 🇰🇷
Seoul National University Hospital, Clinical Trial Center, Seoul, Korea, Republic of

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