Drugs / Rebamipide
Rebamipide
also known as
OPC-12759 · Mucosta · AD-229 · AD-2291 · NSC-758955 · Proamipide · REB · Rebagit · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | Mucosta | dry eye syndrome | 2010-11-09 | “Based upon the results of this study, in October 2010 Otsuka Pharmaceutical applied for regulatory approval to manufacture and market rebamipide ophthalmic suspension in Japan.” otsuka.co.jp ↗ “today announced it has applied for regulatory approval in Japan to manufacture and market Mucosta (rebamipide) ophthalmic suspension for treatment of dry eye.” otsuka.co.jp ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 1 missed | ||||||
| Phase 1 | NCT07385248 | Apr → Jun 2026 overdue | gastritis | Addpharma Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04150146 | Jul 2019 | — | Korea Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04150172 | Apr → May 2019 | — | Korea Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05303961 | Jun → Nov 2016 | — | Samjin Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02632812 | Oct → Nov 2014 | — | Biolab Sanus Farmaceutica | Completed | Missed primary |
| Phase 1 | NCT02106130 | May → Jun 2013 | — | IlDong Pharmaceutical Co Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01549743 | May → Jun 2012 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01471093 | Nov → Dec 2011 | dry eye syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05166304 | Jan 2024 → Aug 2025 | rheumatoid arthritis | October 6 University | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT06084624 | Jul 2026 → Apr 2027 expected | aphthous stomatitis | Cairo University | Recruiting | No outcome recorded |
| Phase 2 | NCT02085460 | Mar 2014 → Aug 2015 | head and neck cancer | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01493180 | Dec 2011 → Nov 2012 | keratoconjunctivitis | Otsuka Pharmaceutical Co., Ltd. | Completed | Missed primary |
| Phase 2 | NCT01057147 | Feb 2010 → Jan 2011 | dry eye syndrome | Kubota Vision Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01027013 | Dec 2009 → Oct 2010 | dry eye syndrome | Kubota Vision Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00463151 | Jun 2007 → Aug 2008 | ulcerative colitis | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00475319 | May 2007 → Mar 2008 | dry eye syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 2 | NCT00233363 | Apr 2005 → Jan 2006 | Sjogren syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00234078 | Jan 2005 → Apr 2006 | dry eye syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | Missed primary |
| Phase 39 trials · 2 met primary | ||||||
| Phase 3 | NCT04649697 | Dec 2020 → Dec 2023 | rheumatoid arthritis | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT04189705 | Dec 2019 → Apr 2020 | chronic gastritis | Korea Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01660256 | Aug 2012 → Mar 2013 | dry eye syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT01632137 | Jun 2012 → Jun 2013 | dry eye syndrome | Kubota Vision Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01150162 | Oct 2010 → Jun 2012 | gastric ulcer | Otsuka Pakistan Limited | Completed | No outcome recorded |
| Phase 3 | NCT00885079 | May 2009 → Mar 2010 | dry eye syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00818324 | Jan 2009 → Sep 2010 | dry eye syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT00576706 | Dec 2007 → Mar 2010 | ankylosing spondylitis, osteoarthritis | Korea Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00996788 | Oct 2007 → Jan 2012 | chronic gastritis, dyspepsia | PT Otsuka Indonesia | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT07397949 | Mar → Dec 2026 expected | cataract, dry eye syndrome | Samsung Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07397936 | Aug 2024 → May 2025 | cataract, dry eye syndrome | Samsung Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT07297316 | Oct 2022 → Aug 2024 | dry eye syndrome | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 4 | NCT07354230 | Jan 2022 → Sep 2024 | atrial fibrillation | Pirogov Russian National Research Medical University | Completed | No outcome recorded |
| Phase 4 | NCT05072938 | Sep 2021 → Dec 2022 | gastritis | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 4 | NCT05379036 | Jun 2021 → May 2022 | irritable bowel syndrome | I.M. Sechenov First Moscow State Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT03608761 | Feb → Oct 2017 | Sjogren syndrome, dry eye syndrome | Hospital Nacional Profesor Alejandro Posadas | Completed | No outcome recorded |
| Phase 4 | NCT02134405 | Aug 2014 → Jun 2016 | dyspepsia | University of Malaya | Unknown | No outcome recorded |
| Phase 4 | NCT02755753 | Jan 2014 → Jan 2016 | gastroesophageal reflux disease | YongChan Lee | Completed | No outcome recorded |
| Phase 4 | NCT02393430 | May 2012 → Jun 2014 | gastritis | BangMao Wang | Completed | No outcome recorded |
| Phase 4 | NCT00641004 | Apr 2008 → Mar 2010 | stomach disorder | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00272467 | Jul 2005 → Apr 2008 | gastric ulcer | Korea Otsuka International Asia Arab | Completed | No outcome recorded |
| Phase 4 | NCT00233389 | Apr 2004 → Sep 2005 | gastric ulcer | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01759108 | Mar 2020 → Sep 2021 | Sjogren syndrome | University of Alexandria | Unknown | No outcome recorded |
| — | NCT00862628 | Oct 2009 → Jun 2010 | small intestine disorder | Nagoya University | Unknown | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 2 | NCT03437785 Comparator | Jan → Oct 2018 | gastritis | Chong Kun Dang Pharmaceutical | Completed | Met primary |
| Phase 3 | NCT04685395 Comparator | Dec 2019 → Jun 2021 | mucositis | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT04066530 Comparator | Sep 2019 → Feb 2020 | chronic gastritis | Addpharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03658473 Comparator | Nov 2014 | stomach disorder | Galeno Desenvolvimento de Pesquisas Clínicas | Completed | No outcome recorded |
| Phase 3 | NCT01813812 Comparator | Oct 2010 → Aug 2013 | chronic gastritis | Dong-A Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT00201981 Comparator | May 2004 → Feb 2007 | dry eye syndrome | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00201955 Comparator | May 2004 → Jul 2006 | keratoconjunctivitis | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04885751 Comparator | Jun → Dec 2021 | ankylosing spondylitis, enteritis, gastric ulcer, osteoarthritis | Seoul National University Boramae Hospital | Unknown | No outcome recorded |
| — | NCT02243618 Comparator | Jan 2015 → Apr 2016 | gastric adenoma, gastric carcinoma | Yonsei University | Completed | No outcome recorded |
| — | NCT01167101 Comparator | May 2009 → Dec 2010 | gastric ulcer | Kangdong Sacred Heart Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-11-30 | Kukje Pharma | Results 국제약품 ‘레바아이2%’, 대한안과학회서 VDT 관련 건성안 개선 효능 입증 kukjepharm.co.kr ↗
결론적으로 VDT관련 건성안 개선 효과측면에서는 레바미피드 성분의 제제가 우수함을 확인할 수 있었다 |
| 2011-05-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Phase III Study Results for Rebamipide Ophthalmic Suspension for Dry Eye Announced at ARVO 2011 otsuka.co.jp ↗ |
| 2010-11-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Pharmaceutical Files for Regulatory Approval in Japan for Mucosta Ophthalmic Suspension for Dry Eye® otsuka.co.jp ↗
Tokyo, Japan, November 9, 2010 -- Otsuka Pharmaceutical Co., Ltd. today announced it has applied for regulatory approval in Japan to manufacture and market Mucosta (rebamipide) ophthalmic suspension for treatment of dry eye. |
All press releases naming this drug 8 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rebamipide | “OBJECTIVES: This study aimed to evaluate the preventive and therapeutic effects of rebamipide gargle in comparison with benzydamine in head and neck cancer patients undergoing...” PMID 38824583 ↗ Jun 202445“Single-dose oral administration of AD-2291 (Rebamipide 100mg) in Period 1, followed by single-dose oral administration of AD-229 (Rebamipide 300mg) in Period 2.” NCT07385248 ↗ “patients in group 2 received Trimedat and Rebagit (rebamipide, marketing authorization number LP-001831 of 2012-09-12) for 2 months” NCT05379036 ↗ “Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study.” PMID 23009892 ↗ Sep 2012 “0.5% OPC-12759 (rebamipide) ophthalmic suspension” NCT00234078 ↗ “Rebamipide/Nizatidine Combination Therapy” NCT05072938 ↗ “Rebamipide 150mg” NCT04189705 ↗ |
| Known as | AD-229 | “Single-dose oral administration of AD-2291 (Rebamipide 100mg) in Period 1, followed by single-dose oral administration of AD-229 (Rebamipide 300mg) in Period 2.” NCT07385248 ↗ |
| Known as | AD-2291 | “Single-dose oral administration of AD-2291 (Rebamipide 100mg) in Period 1, followed by single-dose oral administration of AD-229 (Rebamipide 300mg) in Period 2.” NCT07385248 ↗ |
| Known as | Mucosta | “1. Brand name: Mucosta® Tab.” NCT00272467 ↗ |
| Known as | NSC-758955 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1697771 ↗ |
| Known as | OPC-12759 | “A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in...” NCT01057147 ↗8“A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo for...” NCT01027013 ↗ “Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study.” PMID 23009892 ↗ Sep 2012 |
| Known as | Proamipide | ChEMBL registry synonym — accepted as the source's own label CHEMBL1697771 ↗ |
| Known as | REB | “Rebamipide (REB), 2-(4-chlorobenzoylamino)-3-\[2(1H)-quinolinone-4-yl\]-propionic acid, is commonly used in cases of gastric ulcers, gastritis, and dry eye syndrome” NCT06084624 ↗ |
| Known as | Rebagit | “patients in group 2 received Trimedat and Rebagit (rebamipide, marketing authorization number LP-001831 of 2012-09-12) for 2 months” NCT05379036 ↗ |
| Known as | Rebamipida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1697771 ↗ |
| Known as | Rebator | ChEMBL registry synonym — accepted as the source's own label CHEMBL1697771 ↗ |
| Action | Inhibit | “Rebamipide inhibited interleukin (IL)-17” NCT05166304 ↗ |
| Modality | Small molecule | — CHEMBL1697771 ↗ |
| Route | Oral | “oral administration.” NCT00272467 ↗ |