Drugs / Tegoprazan
Tegoprazan
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | — | — | “At present, the marketing authorization application for Tegoprazan has been accepted by China's Center for Drug Evaluation (CDE).” luoxin.cn ↗ |
Trials 60
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 125 trials | ||||||
| Phase 1 | NCT07853248 | Oct 2026 → Jan 2027 expected | — | HK inno.N Corporation | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07277712 | Dec 2025 → May 2026 overdue | — | HK inno.N Corporation | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06332638 | Mar → Jul 2024 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT06164834 | Dec 2023 → Nov 2024 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT05915871 | Mar → Apr 2023 | — | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05723510 | Mar → Jul 2023 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT05883306 | Jun → Jul 2022 | — | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05353010 | May → Jul 2022 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT04568772 | Nov 2020 → Jul 2021 | gastroesophageal reflux disease | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT04587011 | Sep 2020 → Mar 2021 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT04494269 | Sep 2020 → Jun 2023 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT04231136 | Jan → Jul 2020 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04221321 | Jan → Mar 2020 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04171687 | Oct 2019 → Feb 2020 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03863938 | Mar → Apr 2019 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03814642 | Jan → Jul 2019 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03530228 | May → Aug 2018 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT03458650 | Mar → Apr 2018 | — | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03378284 | Dec 2017 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03011996 | May 2016 → Feb 2017 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03043521 | May → Aug 2015 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03009760 | Jan 2015 → Apr 2016 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02052336 | Oct 2013 → Jan 2014 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01830309 | Jan → Feb 2013 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01473173 | Nov 2011 → Aug 2012 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT07708545 | Jul → Dec 2026 expected | peptic ulcer disease | Indonesia University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05933031 | Feb 2023 → Dec 2024 | Helicobacter pylori infectious disease | HK inno.N Corporation | Unknown | Met primary |
| Phase 2 | NCT02028663 | May 2013 → May 2014 | esophagitis, gastroesophageal reflux disease | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07242456 | Feb → Nov 2025 overdue | Helicobacter pylori infectious disease | First People's Hospital of Hangzhou | Recruiting | No outcome recorded |
| Phase 314 trials · 6 met primary | ||||||
| Phase 3 | NCT07687706 | Jan 2026 → Jun 2027 expected | transient ischemic attack | Hanyang University Guri Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05577468 | Oct 2022 → Sep 2023 | Helicobacter pylori infectious disease | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05010954 | Oct 2021 → Sep 2022 | duodenal ulcer | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04840550 | May 2021 → Jul 2025 | peptic ulcer disease | HK inno.N Corporation | Completed | Met primary |
| Phase 3 | NCT04128917 | Jan → Dec 2020 | Helicobacter pylori infectious disease | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 3 | NCT04022096 | Jun 2019 → Jun 2021 | esophagitis | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03591653 | Oct 2018 → Oct 2019 | gastroesophageal reflux disease | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03615677 | Oct 2018 → Oct 2019 | esophagitis | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03498456 | Jun 2018 → Dec 2019 | Helicobacter pylori infectious disease | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03317223 | Oct 2017 → Jan 2019 | Helicobacter pylori infectious disease | HK inno.N Corporation | Completed | Met primary |
| Phase 3 | NCT03006874 | May 2016 → Mar 2017 | esophagitis | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02761512 | May 2016 → Jul 2018 | gastric ulcer | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02556021 | Sep 2015 → Nov 2016 | gastroesophageal reflux disease | HK inno.N Corporation | Completed | Met primary |
| Phase 3 | NCT02456935 | May 2015 → Jul 2016 | esophagitis | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 412 trials · 1 met primary | ||||||
| Phase 4 | NCT07826455 | Sep 2026 → Jul 2028 expected | gastroesophageal reflux disease | HK inno.N Corporation | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06743243 | Jul 2025 → Oct 2026 expected | — | Seok Kyeong Oh | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06523764 | Nov 2024 → Aug 2025 overdue | chronic gastritis | Xijing Hospital of Digestive Diseases | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06991348 | Jul 2024 → Nov 2025 overdue | gastroesophageal reflux disease | Carnot Laboratories | Recruiting | No outcome recorded |
| Phase 4 | NCT05647278 | Nov 2023 → Sep 2025 | Helicobacter pylori infectious disease | Zhang Xiaofeng,MD | Completed | No outcome recorded |
| Phase 4 | NCT05701540 | Mar 2023 → Dec 2024 | gastroesophageal reflux disease | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 4 | NCT05438550 | Feb → Dec 2023 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT05586113 | Feb → Oct 2023 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT04416581 | May 2021 → Dec 2027 expected | acute coronary syndrome, coronary artery disorder, myocardial infarction | Duk-Woo Park, MD | Recruiting | No outcome recorded |
| Phase 4 | NCT05267743 | Feb 2021 → May 2022 | gastroesophageal reflux disease | HK inno.N Corporation | Completed | Met primary |
| Phase 4 | NCT04449185 | Jun 2020 → Oct 2021 | dyspepsia | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT04309916 | May 2020 → Nov 2021 | gastroesophageal reflux disease | HK inno.N Corporation | Completed | No outcome recorded |
| Phase not applicable5 trials · 1 met primary | ||||||
| — | NCT06977841 | Jun 2025 → Mar 2026 | — | Zhongshan Hospital (Xiamen), Fudan University | Completed | No outcome recorded |
| — | NCT06894992 | May → Dec 2025 overdue | active peptic ulcer disease | Mario Steffanus | Recruiting | No outcome recorded |
| — | NCT05870683 | May → Oct 2023 | Helicobacter pylori infectious disease | Yanqing Li | Unknown | Met primary |
| — | NCT04674774 | Mar 2021 → Feb 2022 | Helicobacter pylori infectious disease | Incheon St.Mary's Hospital | Unknown | No outcome recorded |
| — | NCT06382493 | Feb 2021 → Dec 2026 expected | Helicobacter pylori infectious disease | Seoul National University Bundang Hospital | Recruiting | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT06561542 Comparator | Aug 2024 → Nov 2025 overdue | — | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT04639804 Comparator | Jun → Jul 2020 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04066257 Comparator | Jan → Feb 2019 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02995239 Comparator | Apr 2015 | esophagitis | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 3 | NCT05871398 Comparator | Oct 2019 → Dec 2021 | gastroesophageal reflux disease | Pusan National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT07405697 Comparator | Feb 2026 → Dec 2027 expected | Helicobacter pylori infectious disease | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07405684 Comparator | Feb 2026 → Dec 2027 expected | Helicobacter pylori infectious disease | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07242443 Background | Nov 2025 → Oct 2026 expected | Helicobacter pylori infectious disease | First People's Hospital of Hangzhou | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06318104 Comparator | Apr → Nov 2024 | Helicobacter pylori infectious disease | Hospital General de México Dr. Eduardo Liceaga | Unknown | No outcome recorded |
| Phase 4 | NCT06351891 Background | Apr → Dec 2024 | Helicobacter pylori infectious disease | Qilu Hospital of Shandong University | Unknown | Met primary |
| Phase 4 | NCT05786807 Background | Mar 2022 → Nov 2023 | functional gastric disease | Wonkwang University Hospital | Unknown | No outcome recorded |
| — | NCT06340334 Background | Mar 2024 → Sep 2025 | Helicobacter pylori infectious disease | Nanjing First Hospital, Nanjing Medical University | Completed | Met primary |
| — | NCT07855497 Comparator | Feb 2021 → Sep 2026 overdue | Helicobacter pylori infectious disease | Seoul National University Bundang Hospital | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-07-27 | HK inno.N Corporation | Regulatory HK inno.N Adds Sixth Indication for K-CAB — Broadest Label among P-CABs in South Korea inno-n.com ↗
The company announced on the 27th that the Ministry of Food and Drug Safety (MFDS) granted approval for a new indication of K-CAB, “the prevention of NSAID-associated peptic ulcers” |
| 2026-05-06 | HK inno.N Corporation | Results K-CAB, HK inno.N’s New GERD Treatment, Announces U.S. Phase 3 Clinical Trial Results at the 2026 DDW inno-n.com ↗
Following last year's release of key results, Sebela disclosed the full study data for the first time at this event. |
| 2026-01-19 | HK inno.N Corporation | Regulatory K-CAB, HK inno.N’s new novel drug for GERD treatment, submits an NDA to the U.S. FDA. inno-n.com ↗
K-CAB, HK inno.N’s new novel drug for GERD treatment, submits an NDA to the U.S. FDA. |
| 2025-11-27 | HK inno.N Corporation | Results Dr. Felice Schnoll-Sussman, Highlights K-CAB’s U.S. Market Potential at KDDW 2025 inno-n.com ↗
Tegoprazan showed non-inferiority to lansoprazole across all patient groups (LA Grades A–D) and even achieved statistically superior results. |
| 2025-10-15 | HK inno.N Corporation | Results HK inno.N Presents Clinical Results of Novel GERD Drug ‘K-CAB’ for H. pylori Eradication at UEGW inno-n.com ↗
K-CAB Achieves Over 80% Eradication Rates Across All Dose Groups, Demonstrating Superior Therapeutic Efficacy |
| 2025-08-08 | HK inno.N Corporation | Results HK inno.N’s Novel Drug K-CAB Succeeds in U.S. Phase 3 Trial … Moving Toward FDA Submission inno-n.com ↗ |
| 2025-04-23 | HK inno.N Corporation | Results HK inno.N Announces Positive Topline Results from US Phase 3 Trials of K-CAB (tegoprazan) inno-n.com ↗
K-CAB achieved all primary and secondary endpoints in trials for both erosive esophagitis (EE) and non-erosive reflux disease (NERD). |
| 2024-09-26 | HK inno.N Corporation | Regulatory K-CAB, HK inno.N’s new GERD treatment approved in Malaysia inno-n.com ↗
HK inno.N announced on September 26 that K-CAB (tegoprazan) obtained marketing authorization (MA) from National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. |
| 2024-09-02 | HK inno.N Corporation | Regulatory K-CAB reports substantial progress of its market expansion in Central and South America inno-n.com ↗
The six countries from which the MA for K-CAB (tegoprazan) has been obtained are: ▲Dominican Republic ▲Nicaragua ▲ Honduras ▲ Guatemala ▲ El Salvador ▲ Colombia. |
| 2024-07-02 | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Regulatory 重磅！罗欣药业注射用LX22001获批开展临床试验 luoxin.cn ↗
近日，罗欣药业（002793.SZ）下属子公司山东罗欣药业集团股份有限公司、罗欣药业（上海）有限公司收到国家药品监督管理局下发的注射用LX22001的《药物临床试验批准通知书》。 |
| 2024-05-27 | HK inno.N Corporation | Results HK inno.N presents newest research findings of its new drug “K-CAB” at the DDW 2024 inno-n.com ↗
The results of these two studies were unveiled for the first time through poster presentations in this DDW conference. |
| 2024-05-21 | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Results 罗欣药业替戈拉生片幽门螺杆菌III期临床研究入选2024 DDW口头报告 luoxin.cn ↗
FAS中替戈拉生组和艾司奥美拉唑组的幽门螺杆菌根除率分别为93.5%（257/275）和86.4%（242/280）（差值7%；95%CI，2.06-11.99%）。 |
| 2024-02-20 | HK inno.N Corporation | Regulatory K-CAB, HK inno.N’s new drug for GERD treatment, obtains marketing authorization from Chile inno-n.com ↗
HK inno.N announced on the 20th that K-CAB (ingredient: tegoprazan), a new drug for GERD treatment, recently obtained marketing authorization from the National Drug Agency (Departamento Agencia Nacional de Medicamentos, ANAMED) under the Public Health Institute (ISP) of Chile. |
| 2023-11-20 | HK inno.N Corporation | Results At KDDW 2023, HK inno.N’s K-CAB has emerged as a trailblazer in strengthening its global position inno-n.com ↗
This gastroenterology-centered symposium took place from November 16th to November 18th, during which the company shared significant clinical findings related to K-CAB, featuring the active ingredient tegoprazan. |
| 2023-07-24 | HK inno.N Corporation | Regulatory HK inno.N's new drug for gastroesophageal reflux disease K-CAB, receives approval in Peru inno-n.com ↗
HK inno.N announced on the 24th that a new drug for gastroesophageal reflux disease, K-CAB (ingredient name: Tegoprazan), received product approval from the Peruvian General Directorate of Medicines, Supplies, and Drugs (DIGEMID), as of the 21st. |
| 2023-07-03 | HK inno.N Corporation | Regulatory National Health Insurance to reimburse K-CAB’s H.pylori Eradication Indication Prescription inno-n.com ↗
HK inno.N announced on Jul. 3rd that starting from Jul. 1st, K-CAB will be eligible for national health insurance coverage when used in combination therapy with antibiotics for Helicobacter pylori eradication in patients with peptic ulcers. |
| 2023-05-17 | HK inno.N Corporation | Results HK inno.N presents latest research results of K-CAB to gastroenterologists worldwide inno-n.com ↗
As a result, K-CAB proved non-interiority in the healing of iatrogenic ulcer compared to esomeprazole, a PPI and showed a higher healing rate (30.3% vs 22.1%)at the 4-week mark. |
| 2022-11-28 | HK inno.N Corporation | Results HK inno.N presents K-CAB big data hepatotoxicity inno-n.com ↗
The study showed that K-CAB had a 27% lower risk of hepatotoxicity compared to six competitor PPI drugs. |
| 2021-06-08 | HK inno.N Corporation | Regulatory HK inno.N’s new drug K-CAB is approved of a phase1 inno-n.com ↗
HK inno.N announced that it recently received approval of a phase 1 clinical trial of K-CAB Tab.(ingredient: tegoprazan) in the U.S. from the U.S. FDA. |
| 2021-05-17 | HK inno.N Corporation | Regulatory K-CAB h.pylori eradication indication added inno-n.com ↗
CJ HealthCare (CEO Kang, Seok - Hee), a subsidiary Kolmar Korea, recently announced that it has been approved by the Ministry of Food and Drug Safety for the additional indication of K-CAB Tab. (ingredient: tegoprazan). |
| 2019-11-27 | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Results 罗欣药业发布钾离子竞争性酸阻滞剂LXI-15028临床III期研究进展 luoxin.cn ↗
Topline data suggested the cumulative healing rate of LXI-15028 arm during up to 8-week treatment as assessed by endoscopy is non-inferior to that of Esomeprazole arm. |
| 2019-03-18 | HK inno.N Corporation | Results CJ Healthcare host K-CAB launch symposium inno-n.com ↗
K-CAB tablets showed gastric acid secretion inhibition on the first day of intake. |
| 2017-08-07 | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Regulatory 罗欣药业LXI-15028获得国家食品药品监督管理总局（CFDA）的临床试验批准 luoxin.cn ↗
2017 年 6 月 27 日，山东罗欣药业集团股份有限公司（以下简称“罗欣药业”）申报的 LXI-15028 获得 CFDA 的临床试验批准。 |
All press releases naming this drug 24 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tegoprazan | “Based on the susceptibility results and penicillin-allergic test, a tailored 7-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin,...” NCT07405697 ↗57“This study evaluates the effect of food consumption on the pharmacokinetic and pharmacodynamic properties of tegoprazan after a single oral dose in healthy men.” PMID 34246485 ↗ Jul 2021 “including Tegoprazan , Amoxicillin, Clarithromycin, Levofloxacin, Bismuth Potassium Citrate, Metronidazole, Doxycycline or Minocycline.” NCT07405684 ↗ “Tegoprazan (LXI-15028), a novel potassium-competitive acid blocker, has shown great efficacy in treating acid-related disorders.” PMID 40349123 ↗ May 2025 “Efficacy and safety of tegoprazan (LXI-15028) vs . esomeprazole in patients with erosive esophagitis” PMID 39474720 ↗ Oct 2024 “Tegoprazan (50mg twice/day before breakfast and supper)” NCT06351891 ↗ “P-CAB (tegoprazan 50mg once daily)” PMID 40188976 ↗ Apr 2025 “Tegoprazan 50 mg 1 tab twice daily” NCT05786807 ↗ “tegoprazan 50 mg twice daily” NCT07855497 ↗ |
| Known as | CJ-12420 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01473173 ↗ |
| Known as | IN-A001 | “IN-A001 50mg(Tegoprazan 50mg” NCT05353010 ↗ |
| Known as | K-CAB | “A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in...” NCT03863938 ↗ |
| Known as | LXI-15028 | “Tegoprazan (LXI-15028), a novel potassium-competitive acid blocker, has shown great efficacy in treating acid-related disorders.” PMID 40349123 ↗ May 2025 |
| Action | Inhibit | “potassium-competitive acid blocker that suppresses gastric acid secretion” PMID 34227708 ↗ Jul 2021 |
| Modality | Other / unclassified | “Tegoprazan is a potassium-competitive acid blocker used for gastric acid suppression” PMID 35787943 ↗ Jul 2022 |
| Route | Oral | “multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.” NCT01473173 ↗ |