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

Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Clopidogrel 75 mg
Drug: Esomeprazole 20 mg
Drug: Tegoprazan 50 mg

First Posted Date: 2019-01-24

Last Posted Date: 2019-10-21

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 25

Registration Number: NCT03814642

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

Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis

Phase 3

Completed

Conditions: Erosive Esophagitis (EE)

Interventions: Drug: LXI-15028 50mg
Drug: Esomeprazole 40mg

First Posted Date: 2018-08-06

Last Posted Date: 2020-04-15

Lead Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Target Recruit Count: 261

Registration Number: NCT03615677

Locations: 🇨🇳
Shanghai First People's Hospital, Shanghai, Shanghai, China

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Phase III Study to Evaluate the Efficacy and Safety of LXI-15028 in Non-erosive Reflux Disease in Chinese Patients for 4 Weeks

Phase 3

Completed

Conditions: Non-erosive Reflux Disease

Interventions: Drug: Placebo
Drug: LXI-15028

First Posted Date: 2018-07-19

Last Posted Date: 2020-04-08

Lead Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Target Recruit Count: 291

Registration Number: NCT03591653

Locations: 🇨🇳
Shanghai East Hospital, Shanghai, Shanghai, China

A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

Phase 1

Conditions: Pharmacodynamics
Healthy Male Volunteers
Pharmacokinetics

Interventions: Drug: Tegoprazan (C1)
Drug: Tegoprazan (C2)
Drug: Tegoprazan (C3)
Drug: Esomeprazole (C2)

First Posted Date: 2018-05-21

Last Posted Date: 2018-05-21

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 44

Registration Number: NCT03530228

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

A Phase I Study of LuoXin Innovate (LXI-15028) in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: LXI-15028 50mg
Drug: LXI-15028 100mg
Drug: LXI-15028 200mg
Drug: Placebo

First Posted Date: 2018-03-08

Last Posted Date: 2018-05-30

Lead Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Target Recruit Count: 38

Registration Number: NCT03458650

Locations: 🇨🇳
Huashan Hospital, Fudan University, Shanghai, Shanghai, China

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

Phase 1

Completed

Conditions: Pharmacodynamics
Healthy Male Volunteers

Interventions: Drug: Tegoprazan
Drug: Revaprazan

First Posted Date: 2017-12-19

Last Posted Date: 2018-03-30

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 16

Registration Number: NCT03378284

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

Pharmacodynamic Properties of CJ-12420 on Evening Dosing

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: CJ-12420 100mg
Drug: CJ-12420 200mg
Drug: CJ-12420 50mg
Drug: Dexlansoprazole 60 MG

First Posted Date: 2017-02-06

Last Posted Date: 2017-02-06

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 24

Registration Number: NCT03043521

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

To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration

Phase 1

Completed

Conditions: Drug Interaction
Pharmacokinetic
Pharmacodynamic

Interventions: Drug: CJ-12420 100mg
Drug: CLR 500mg
Drug: CJ-12420 50mg
Drug: Pantoprazole 40mg
Drug: AMX 1g

First Posted Date: 2017-01-06

Last Posted Date: 2017-05-12

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 60

Registration Number: NCT03011996

Locations: 🇰🇷
Inje University Busan Baik Hospital, Busan, Korea, Republic of

To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: CJ-12420 100mg(HP+)
Drug: CJ-12420 50mg(HP+)
Drug: CJ-12420 50mg(HP-)
Drug: CJ-12420 100mg(HP-)

First Posted Date: 2017-01-04

Last Posted Date: 2017-01-20

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 16

Registration Number: NCT03009760

Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Phase 3

Completed

Conditions: Erosive Esophagitis

Interventions: Drug: CJ-12420 100mg QD
Drug: CJ-12420 50mg QD
Drug: Esomeprazole 40mg

First Posted Date: 2016-12-30

Last Posted Date: 2017-09-12

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 302

Registration Number: NCT03006874

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

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