Drugs / Acotiamide
Acotiamide
also known as
Z-338 · YM443 · Acotiamida · ACOTIAMIDE HYDROCHLORIDE · Acotiamide hydrochloride hydrate · Acotiamide hydrochloride trihydrate
Small molecule targets ACHE via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | functional diarrhea | 2010-09-29 | “機能性ディスペプシア治療剤「Z-338/YM443」の 国内製造販売承認申請について” zeria.co.jp ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00920998 | Mar → Jun 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00850746 | Feb → Apr 2009 | dyspepsia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT00458328 | Apr 2007 → Sep 2009 | dyspepsia | Zeria Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT00333372 | Apr 2006 → ? | dyspepsia | Zeria Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT00323817 | Apr 2006 → Apr 2009 | dyspepsia | Zeria Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT00298194 | Feb 2006 → Jul 2008 | dyspepsia | Zeria Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT00102310 | Mar 2004 → Mar 2006 | dyspepsia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT04526119 | Feb 2021 → Mar 2026 overdue | dyspepsia | Zeria Pharmaceutical | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01973790 | Mar 2014 → Nov 2016 | dyspepsia | Zeria Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00761358 | Sep 2008 → Jun 2010 | dyspepsia | Zeria Pharmaceutical | Completed | Met primary |
| Phase 3 | NCT00764374 | Aug 2008 → Dec 2009 | dyspepsia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07449689 | Apr → Dec 2026 expected | dyspepsia | Aga Khan University | Not yet recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03402984 | Apr → Jul 2017 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT07174297 Comparator | Oct 2025 → Dec 2026 expected | — | Getz Pharma | Not yet recruiting | No outcome recorded |
| — | NCT04697641 Comparator | Sep 2017 → May 2019 | Helicobacter pylori infectious disease, dyspepsia | Sir Ganga Ram Hospital | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2013-03-25 | Zeria Pharmaceutical | Regulatory 機能性ディスペプシア治療剤「アコファイド錠100mg」の製造販売承認取得のお知らせ （PDF ファイル 0.15MB） zeria.co.jp ↗
Zeria has obtained the marketing approval of Acofide® Tablets 100mg |
| 2013-03-25 | Astellas Pharma Inc | Regulatory Approval in Japan for Treating Functional Dyspepsia with Acofide® astellas.com ↗
Zeria has obtained the marketing approval of Acofide® Tablets 100mg |
| 2011-05-26 | Zeria Pharmaceutical | Results 機能性ディスペプシア治療剤Z-338臨床試験結果など7演題の米国消化器病週間2011における発表について （PDF ファイル 0.19MB） zeria.co.jp ↗ |
| 2010-09-29 | Zeria Pharmaceutical | Regulatory 機能性ディスペプシア治療剤「Z-338/YM443」の国内製造販売承認申請について （PDF ファイル 0.17MB） zeria.co.jp ↗ |
| 2010-09-29 | Astellas Pharma Inc | Regulatory Announcement of the NDA submission of Z-338 /YM443 for functional dyspepsia in Japan astellas.com ↗
Zeria had submitted the application for marketing approval of the therapeutic agent |
| 2010-06-28 | Zeria Pharmaceutical | Results 機能性ディスペプシア治療剤「Z-338」の国内における第III相二重盲検比較臨床試験結果について （PDF ファイル 0.15MB） zeria.co.jp ↗
Zeria Pharmaceutical announced today positive results of their Japanese Phase III study of Z-338 (acotiamide hydrochloride hydrate; “acotiamide”) for the treatment of functional dyspepsia (FD). |
| 2009-06-15 | Zeria Pharmaceutical | Results 機能性ディスペプシア治療剤Z-338の臨床薬理試験結果の米国消化器病週間2009における発表について （PDF ファイル 0.14MB） zeria.co.jp ↗ |
| 2009-03-03 | Zeria Pharmaceutical | Results 機能性ディスペプシア治療薬「Z-338」の欧州における第Ⅱ相二重盲検比較試験結果のお知らせ （PDF ファイル 0.14MB） zeria.co.jp ↗
The results have shown that acotiamide is effective compared to placebo, and has no particular concern in safety. |
All press releases naming this drug 9 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Acotiamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04526119 ↗ |
| Known as | Acotiamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107723 ↗ |
| Known as | ACOTIAMIDE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107723 ↗ |
| Known as | Acotiamide hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107723 ↗ |
| Known as | Acotiamide hydrochloride trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107723 ↗ |
| Known as | YM443 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00102310 ↗ |
| Known as | Z-338 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00323817 ↗ |
| Action | Inhibit | “an acetylcholinesterase inhibitor” PMID 22157329 ↗ Dec 20111“Acetylcholinesterase inhibitor” CHEMBL2107723 ↗ |
| Modality | Small molecule | — CHEMBL2107723 ↗ |
| Route | Oral | “Oral” NCT00761358 ↗ |
| Target | ACHE | “Acetylcholinesterase inhibitor” CHEMBL2107723 ↗ |