Overview
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.
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。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/27 | Phase 4 | Recruiting | Carnot Laboratories | ||
2025/05/18 | Not Applicable | Not yet recruiting | Zhongshan Hospital (Xiamen), Fudan University | ||
2025/03/26 | Not Applicable | Recruiting | Mario Steffanus | ||
2024/12/19 | Phase 4 | Not yet recruiting | Kim, Young Sung | ||
2024/08/20 | Phase 1 | Recruiting | |||
2024/07/26 | Phase 4 | Active, not recruiting | Xijing Hospital of Digestive Diseases | ||
2024/03/27 | Phase 1 | ENROLLING_BY_INVITATION | |||
2024/03/19 | Phase 4 | Not yet recruiting | |||
2023/12/11 | Phase 1 | Not yet recruiting | |||
2023/07/06 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| K-CAB FILM-COATED TABLETS 50MG | SIN16672P | TABLET, FILM COATED | 50.0mg | 1/11/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tegoprazan Tablets | 国药准字H20220008 | 化学药品 | 片剂 | 4/8/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||