Drugs / ABEPRAZAN
ABEPRAZAN
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT06437951 | Jul 2024 → Jan 2025 | gastroesophageal reflux disease | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT05868967 | Feb → May 2023 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT05812404 | Oct 2022 → Mar 2023 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT05574374 | Sep 2022 → Mar 2023 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT05304845 | Mar → May 2022 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT06508645 | Jan → Mar 2022 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT04827472 | Jan → Jun 2021 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04328766 | Sep → Nov 2020 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT04490434 | Jun → Aug 2020 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04185805 | Dec 2019 → Feb 2020 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04167267 | Nov → Dec 2019 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04003441 | Jun → Aug 2019 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT03574415 | Nov 2018 → Jan 2019 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03487562 | Apr 2018 → Jan 2019 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT02757144 | Mar 2016 → Feb 2017 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03184324 | Aug 2017 → Apr 2018 | gastroesophageal reflux disease | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 39 trials · 3 met primary | ||||||
| Phase 3 | NCT07326904 | Sep → Oct 2024 | gastroesophageal reflux disease | Indonesia University | Completed | No outcome recorded |
| Phase 3 | NCT06751121 | Feb 2024 → Apr 2025 | Helicobacter pylori infectious disease | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT06121830 | Aug 2023 → Jan 2025 | gastroesophageal reflux disease | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT05813561 | Dec 2021 → Jul 2022 | peptic esophagitis | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 3 | NCT04784910 | May 2021 → Nov 2023 | peptic ulcer disease | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 3 | NCT04341428 | Jul 2020 → Aug 2021 | esophagitis | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT04341454 | Jun 2020 → Aug 2021 | chronic gastritis | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 3 | NCT03811080 | Feb 2019 → Feb 2020 | gastroesophageal reflux disease | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT03736369 | Dec 2018 → Aug 2019 | esophagitis | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07533266 | Apr 2026 → Dec 2027 expected | — | Daewoong Pharmaceutical Co. LTD. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05946135 | Nov 2023 → Sep 2025 | — | Yonsei University | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07497893 | Dec 2026 → Nov 2029 expected | atrial fibrillation | Ewha Womans University Mokdong Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07479056 | Oct 2024 → Apr 2028 expected | acute coronary syndrome, coronary artery disorder | SUK MIN SEO | Recruiting | No outcome recorded |
| — | NCT04888819 | Feb → Jul 2021 | esophagitis | Konkuk University Medical Center | Unknown | No outcome recorded |
| — | NCT04613895 | Nov 2020 → May 2021 | esophagitis | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05149274 Comparator | Oct 2021 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2023-08-08 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical submits a new drug application for Fexuprazan in China… challenging the world’s largest market for anti-ulcer drugs daewoong.co.kr ↗
Daewoong Pharmaceutical submits a new drug application for Fexuprazan in China… challenging the world’s largest market for anti-ulcer drugs |
| 2023-01-27 | Daewoong Pharmaceutical Co. LTD. | Regulatory “Expected to change GERD drug market landscape” Daewoong Pharmaceutical submitted NDA for its global new drug Fexuclue in 11 countries... only 1 year after approval in Korea daewoong.co.kr ↗
The company said on the 25th that it recently submitted a new drug application (NDA) for Fexuclue, a GERD drug, in Saudi Arabia. |
| 2022-05-02 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical submitted NDA for its global new drug Fexuclue Tablets to the Philippines daewoong.co.kr ↗
Daewoong Pharmaceutical submitted NDA for its global new drug Fexuclue Tablets to the Philippines |
| 2021-01-06 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s gastroesophageal reflux disease drug Fexuprazan obtained approval for a phase-3 trial in China daewoong.co.kr ↗
Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced on December 30 that a phase-3 protocol for its gastroesophageal reflux disease drug Fexuprazan was approved by the National Medical Products Administration (NMPA), the pharmaceutical regulator of China. |
| 2020-11-17 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Announces Publication of Novel P-CAB Fexuprazan Phase 1 Bridging Study daewoong.co.kr ↗
In this study, Daewoong examined the drug blood concentrations and inhibitory effect on gastric acid secretion after single and repeated dosing, which showed no pharmacokinetic and pharmacodynamic differences exist between the races. |
| 2020-09-21 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains phase-1 clinical trial approval for P-CAB injection Fexuprazan for the first time in Korea daewoong.co.kr ↗
Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced that the company obtained approval from the Ministry of Food and Drug Safety (MFDS) for a phase-1 clinical trial to develop the gastroesophageal reflux disease injection Fexuprazan. |
| 2020-05-06 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Unveils Phase 3 Clinical Data of Gastric Acid Blocker Fexuprazan for the First Time daewoong.co.kr ↗
According to the results, Fexuprazan showed 99% in the treatment rate up to 8 weeks of endoscopic mucosal defect treatment and confirmed good tolerability and safety with little discomfort and side effect when taken by patients. |
| 2019-10-24 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical presented the multiracial phase 1 clinical test results of ‘DWP14012,’ a drug for gastroesophageal reflux disease, at the United European Gastroenterology (UEG Week). daewoong.co.kr ↗
We tested blood concentration and inhibition of gastric secretion in the stomach through placebo control, single and repeated administration and confirmed that there is no racial difference in the pharmacokinetic and pharmacodynamic responses. |
All press releases naming this drug 14 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABEPRAZAN | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594445 ↗ |
| Known as | DWP14012 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04328766 ↗ |
| Known as | Fexuprazan | “Fexuprazan, a novel potassium-competitive acid blocker, is expected to be used for the prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) induced ulcer.” PMID 38700290 ↗ May 20247“Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis.” PMID 36789577 ↗ Feb 2023 |
| Known as | Fexuprazan Hydrochloride | “Drug: Fexuprazan Hydrochloride” NCT05946135 ↗ |
| Action | Inhibit | “Fexuprazan, a novel P-CAB, inhibits gastric acid secretion through reversible and potassium-competitive inhibition of the H⁺/K⁺-ATPase” NCT07326904 ↗ |
| Modality | Other / unclassified | “Fexuprazan group(P-CAB)” NCT07479056 ↗ |
| Modality | Small molecule | — CHEMBL4594445 ↗ |
| Route | Oral | “DWP14012 Amg, tablets, orally, single dose administration” NCT02757144 ↗ |