Drugs / Plenvu
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PLENVU | — | 2018-05-04 | fda.gov ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03437265 | Sep → Oct 2020 | — | Norgine | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07218523 | Dec 2025 → Jan 2027 expected | — | Norgine | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05436054 | Oct 2022 → Dec 2025 overdue | colonic disorder | Aalborg University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04297423 | Mar 2020 → Jun 2022 | colorectal cancer | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05242562 | May 2022 → Feb 2023 | colorectal cancer, polyp of colon | Radboud University Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2018-10-22 | Norgine | Results PLENVU® (NER1006) the first 1 litre bowel preparation to show superior high-quality segmental cleansing of the colon compared to standard of care norgine.com ↗ |
| 2018-10-19 | Norgine | Results Norgine to present data for PLENVU® and XIFAXAN® at the United European Gastroenterology Week (UEG) norgine.com ↗
Seven PLENVU® related posters – one poster demonstrating PLENVU® higher efficacy compared to standard of care[i] |
| 2018-07-24 | Norgine | Results Endoscopy publishes the DAYB phase III trial for PLENVU® (NER1006), the first ONE LITRE PEG bowel preparation norgine.com ↗
PLENVU® was as effective as sodium picosulfate and magnesium salt solution at achieving overall bowel cleansing success: 62% vs. 53.8%, P = 0.038 (LCL*: -0.5 %) |
| 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. |
| 2018-05-07 | Norgine | Regulatory Norgine announces US FDA approval for PLENVU® (NER1006) – 1 LITRE PEG based bowel cleansing preparation for colonoscopy norgine.com ↗
Norgine B.V. today announced that the US Food and Drug Administration (FDA) has approved PLENVU® (NER1006), an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. |
| 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). |
| 2018-02-08 | Norgine | Regulatory Norgine’s PLENVU® (NER1006) receives approval in Germany for bowel cleansing in adults prior to any procedure requiring a clean bowel norgine.com ↗
Norgine B.V. today announced that the marketing authorisation for PLENVU® for bowel cleansing in adults prior to any procedure requiring a clean bowel, has been granted by the German regulatory authority. |
| 2018-01-15 | Norgine | Regulatory Norgine’s PLENVU® (NER1006) receives Austrian, Australian, French, Irish, Italian and Portuguese approvals for bowel cleansing in adults prior to any procedure requiring a clean bowel norgine.com ↗
Norgine B.V. today announced marketing authorisation for PLENVU® for bowel cleansing in adults prior to any procedure requiring a clean bowel has been granted by the Austrian, French, Irish, Italian and Portuguese regulatory authorities. |
All press releases naming this drug 14 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Plenvu | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04297423 ↗ |
| Route | Oral | “Oral administration of 1 sachet (115.96 g) PLENVU Dose 1” NCT03437265 ↗ |