13 completed, 8 unknown, 4 not yet recruiting, 1 recruiting. 10 Phase 1, 9 Phase 3, 4 Not applicable, 1 Phase 2, 1 Phase 4.
Follow fexuprazan: new trials by email Literature Review of fexuprazan trials Research Report on fexuprazan
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) Fexuprazan, NOAC therapy - Atrial Fibrillation (AF), Upper Gastrointestinal Bleeding (UGIB) | Not applicable | Not yet recruiting | Ewha Womans University Mokdong Hospital | 1000 | 2026-12-01 | 2026-03-27 |
| Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer DWP14012 40mg (Fexuprazan), Lansoprazole 30mg - Gastric Ulcer | Phase 3 | Not yet recruiting | Daewoong Pharmaceutical Co. LTD. | 384 | 2026-10-15 | 2026-07-28 |
| Efficacy and Safety of DWP14012 for Long-Term Maintenance Therapy in Patients With Healed Erosive Esophagitis DWP14012 20mg, DWP14012 20 mg placebo, DWC202517 15 mg - Healed Erosive Esophagitis | Phase 3 | Not yet recruiting | Daewoong Pharmaceutical Co. LTD. | 420 | 2026-09-01 | 2026-08-13 |
| Study to Evaluate the Efficacy and Safety of Fexuprazan in Prevention of NSAIDs Induced Peptic Ulcer Fexuprazan 20mg, Lansoprazole 15 mg placebo, Lansoprazole 15 mg - NSAID (Non-Steroidal Anti-Inflammatory Drug) | Phase 4 | Not yet recruiting | Daewoong Pharmaceutical Co. LTD. | 360 | 2026-04-01 | 2026-04-16 |
| Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy Fexuprazan 40mg, Lansoprazole 30mg - Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD) | Not applicable | Recruiting | SUK MIN SEO | 200 | 2024-10-24 | 2026-10-19 |
| Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease Fexuprazan, Esomeprazole - Gastro Oesophageal Reflux Disease | Phase 3 | Completed | Universitas Indonesia | 145 | 2024-08-28 | 2026-08-24 |
| to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection Fexuprazan Injection, Fexuprazan Injection placebo, Fexuprazan Injection_part 2 - Erosive Gastroesophageal Reflux Disease | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 40 | 2024-07-01 | 2024-06-03 |
| Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori DWP14012 40mg, DWC202301 30mg, Amoxicillin 1000mg - Helicobacter Pylori Infection, Helicobacter Pylori Infected Patients | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 461 | 2024-02-06 | 2025-12-08 |
| Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease (NERD) DWP14012 20mg, DWP14012 40mg, Placebo - Non-erosive Reflux Disease, Non-Erosive Gastro-Esophageal Reflux Disease | Phase 3 | Unknown | Daewoong Pharmaceutical Co. LTD. | 324 | 2023-08-31 | 2023-11-08 |
| Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects DWP14012, DWC202201 - Drug Drug Interaction | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 36 | 2022-10-26 | 2023-04-13 |
| Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects DWP14012, DWC202202, DWC202203 - Drug Drug Interaction | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 36 | 2022-09-21 | 2023-04-04 |
| Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab Fexuprazan - Gastroesophageal Reflux Disease | Completed | Daewoong Pharmaceutical Co. LTD. | 10067 | 2022-07-06 | 2025-01-24 | |
| Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects DWP14012, Aspirin - Drug Drug Interaction | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 24 | 2022-03-21 | 2023-04-05 |
| Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers DWP14012 injection - Healthy Volunteers | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 33 | 2022-01-10 | 2024-07-18 |
| The Efficacy and Safety of DWP14012 in Chinese Patients With Reflux Esophagitis DWP14012 - Reflux Esophagitis | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 332 | 2021-12-30 | 2023-04-14 |
| Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer DWP14012 20mg, Lansoprazole 15 mg, DWP14012 20mg placebo - Peptic Ulcer | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 423 | 2021-05-21 | 2024-07-08 |
| Treatment Effect According to Timing of Administration of DWP14012 40 mg DWP14012 - Erosive Esophagitis | Not applicable | Unknown | Konkuk University Medical Center | 186 | 2021-02-01 | 2021-05-17 |
| Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers Normal saline, DWJ1521, DWP14012 Tablet - Healthy | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 36 | 2021-01-20 | 2021-06-10 |
| Treatment Effect According to Timing of Administration of DWP14012 40 mg DWP14012 - Erosive Esophagitis | Not applicable | Unknown | Daewoong Pharmaceutical Co. LTD. | 186 | 2020-11-17 | 2020-11-03 |
| Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers DWC202005, alone, DWP14012 + DWC202005, DWP14012 + DWC202005, after multiple doses of DWP14012 - Drug-drug Interaction | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 36 | 2020-09-06 | 2021-08-16 |
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Gastroesophageal Reflux (2) · Peptic Ulcer (2) · Acute Coronary Syndrome (1) · Atrial Fibrillation (1) · Coronary Artery Disease (1) · Drug-Related Side Effects and Adverse Reactions (1) · Duodenal Ulcer (1) · Esophagitis, Peptic (1) · Gastrointestinal Hemorrhage (1) · Non-Erosive Reflux Disease (1) · Stomach Ulcer (1)
Daewoong Pharmaceutical Co. LTD. (22) · Ewha Womans University Mokdong Hospital (1) · Konkuk University Medical Center (1) · SUK MIN SEO (1) · Universitas Indonesia (1)
South Korea (21) · Indonesia (2) · Australia (1) · China (1)
Ari Fahrial Syam, MD, PhD (1) · In Jin Jang, MD, PhD (1) · Injin Jang, MD, PhD (1) · Jang In-Jin, MD, PhD (1) · Seungyoung Seo (1) · Suk Seo, MD, PhD (1)