Drugs / Moviprep
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MOVIPREP | — | 2006-08-02 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00896246 | Sep → Oct 2006 | — | Norgine | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT01714466 | Oct 2012 → Jul 2013 | colon carcinoma | Norgine | Completed | Met primary |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT01732692 | Nov 2012 → Apr 2013 | — | Takeda | Completed | Met primary |
| Phase 3 | NCT00427089 | Sep 2004 → May 2005 | — | Norgine | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT00618930 | Feb → Dec 2008 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT00605228 | May → Dec 2007 | digestive system disorder | Norgine | Completed | No outcome recorded |
| Phase not applicable2 trials · 1 met primary | ||||||
| — | NCT05140057 | Dec 2021 → Oct 2023 | — | Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. | Unknown | No outcome recorded |
| — | NCT02178033 | Jan → Dec 2014 | colon adenoma | Valduce Hospital | Unknown | Met primary |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT01834742 Comparator | Apr → Sep 2011 | colorectal cancer | Norgine | Completed | No outcome recorded |
| Phase 1/2 | NCT02504554 Background | Jul 2014 → Apr 2016 | autism spectrum disorder, digestive system disorder | Arizona State University | Completed | No outcome recorded |
| Phase 2 | NCT04988841 Background | Jan 2022 → Aug 2024 | melanoma | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT03408886 Background | Jan 2018 → Apr 2022 overdue | autism spectrum disorder, digestive system disorder | Arizona State University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03332485 Comparator | Nov 2017 → Mar 2018 | — | Sebela Pharmaceuticals Development LLC | Completed | No outcome recorded |
| Phase 2/3 | NCT04759885 Comparator | Jun 2020 → Jul 2021 | — | NTC srl | Completed | No outcome recorded |
| Phase 3 | NCT03794310 Comparator | Jan → Jun 2019 | — | Nihon Pharmaceutical Co., Ltd | Completed | Met primary |
| Phase 3 | NCT02273167 Comparator | Oct 2014 → Aug 2015 | colorectal carcinoma | Norgine | Completed | Mixed |
| Phase 4 | NCT04708366 Comparator | Feb 2021 → Mar 2022 | colonic disorder | University of Bologna | Unknown | No outcome recorded |
| Phase 4 | NCT01719653 Comparator | Oct 2012 → Sep 2014 | — | Gastroenterology Services, Ltd. | Completed | No outcome recorded |
| — | NCT05242562 Comparator | May 2022 → Feb 2023 | colorectal cancer, polyp of colon | Radboud University Medical Center | Completed | No outcome recorded |
| — | NCT04225793 Comparator | Jun 2019 → Jun 2020 | large intestine disorder | Russian Society of Colorectal Surgeons | Unknown | No outcome recorded |
| — | NCT01978509 Comparator | Sep 2013 → Mar 2019 | — | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01519609 Comparator | Sep 2011 → Nov 2012 | colorectal cancer | Randers Regional Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-07-19 | Norgine | Results Endoscopy publishes the MORA phase III trial for PLENVU® (NER1006), the only 1 LITRE PEG based bowel preparation[i] norgine.com ↗
PLENVU® is the first low volume preparation to demonstrate superior colon cleansing efficacy versus MOVIPREP®, with comparable safety and tolerability. |
| 2018-02-22 | Norgine | Results Positive new data show superiority of PLENVU® (1 LITRE PEG preparation) compared to MOVIPREP® (2 LITRE PEG + ASCORBATE) norgine.com ↗
Both PLENVU® PM/AM and PLENVU® AM/AM attained higher mean overall BBPS scores than MOVIPREP® PM/AM (6.7 and 6.6 versus 6.3; P=0.0001 and P=0.0058 respectively). |
All press releases naming this drug 2 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Moviprep | “Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG +...” NCT04708366 ↗23“All participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®, Norgine, Harefield, United Kingdom);” NCT02178033 ↗ “The Moviprep® solution should be taken in the one-time use regimen in morning before procedure.” NCT04225793 ↗ “the new 2 liter gut cleansing solution (Moviprep) and NaP preparation” NCT00427089 ↗ “Two litres of Moviprep® taken according to split-dose regimen” NCT04759885 ↗ “Moviprep bowel preb” NCT01519609 ↗ |
| Known as | Polyethylene glycol plus ascorbate solution (2L PEG ASC) | “Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC) (Moviprep®)” NCT04759885 ↗ |
| Modality | Other / unclassified | “a PEG-based bowel cleansing solution (MOVIPREP®)” NCT01714466 ↗ |
| Route | Oral | “PEG+Asc was taken the evening before and morning of the colonoscopy” PMID 25180609 ↗ Sep 2014 |