Drugs / Sodium Picosulfate
Sodium Picosulfate
also known as
Pico Salax · sodium picosulphate · Picosulfate sodium · sodium picosulphate/magnesium citrate · Dulcolax · Laxoberal · magnesiumoxid + sodium picosulfate · Picoprep · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PREPOPIK | — | 2012-07-16 | fda.gov ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07700277 | Aug 2026 → Aug 2027 expected | intestinal disorder | Ottawa Hospital Research Institute | Not yet recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02211911 | Feb → May 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02979223 | Nov 2016 → Jun 2017 | — | National Cancer Center, Korea | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT05726097 | Feb → Oct 2023 | colorectal cancer, inflammatory bowel disease, polyp of colon | Region Skane | Completed | No outcome recorded |
| Phase 3 | NCT01984008 | Oct 2013 → Mar 2014 | — | Universal Integrated Corp. | Completed | No outcome recorded |
| Phase 3 | NCT01655095 | Jul → Oct 2012 | polyp | Queen's University | Completed | No outcome recorded |
| Phase 3 | NCT01065857 | Jan → Jun 2010 | — | Laboratorios Casen-Fleet S.L.U. | Completed | No outcome recorded |
| Phase 3 | NCT00576810 | Oct 2007 → Jan 2009 | constipation disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT04161599 | Mar 2022 → Jun 2024 | — | Hospital Universitari Vall d'Hebron Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT02070341 | Feb → Jul 2014 | — | Queen's University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01627171 | Sep 2012 → Dec 2013 | — | St. Joseph's Healthcare Hamilton | Unknown | No outcome recorded |
| Phase 4 | NCT01481714 | Nov 2011 → Mar 2012 | — | Infante, Javier Molina, M.D. | Unknown | No outcome recorded |
| Phase 4 | NCT01603654 | Jan → Jun 2011 | — | ASST Fatebenefratelli Sacco | Completed | No outcome recorded |
| Phase 4 | NCT00885274 | Nov 2008 → Mar 2011 | — | Queen's University | Completed | No outcome recorded |
| Phase 4 | NCT00885430 | Jul 2008 | — | Queen's University | Completed | No outcome recorded |
| Phase 4 | NCT00380497 | Sep 2006 → Sep 2007 | colonic duplication | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04033250 | Sep 2019 → Sep 2020 | — | Rambam Health Care Campus | Unknown | No outcome recorded |
| — | NCT01093274 | — | — | Rabin Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 2 | NCT07756255 Background | Aug 2026 → Aug 2028 expected | attention deficit-hyperactivity disorder | University of Calgary | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04593446 Comparator | Nov 2020 → Dec 2021 | colorectal cancer | National Cancer Center, Korea | Unknown | No outcome recorded |
| Phase 3 | NCT07218523 Comparator | Dec 2025 → Jan 2027 expected | — | Norgine | Recruiting | No outcome recorded |
| Phase 3 | NCT05144295 Comparator | Jan → Aug 2022 | — | Alexandria University | Completed | No outcome recorded |
| Phase 3 | NCT04767633 Comparator | Apr 2021 → Apr 2022 | intestinal disorder | Azienda Ospedaliera "Sant'Andrea" | Unknown | No outcome recorded |
| Phase 3 | NCT02273141 Comparator | Nov 2014 → Aug 2015 | colorectal carcinoma | Norgine | Completed | Missed primary |
| Phase 3 | NCT03074448 Comparator | May → Sep 2014 | — | Kaiser Clinic and Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01415687 Comparator | May → Dec 2011 | — | University of Calgary | Completed | No outcome recorded |
| Phase 4 | NCT06339697 Comparator | Dec 2022 → Jun 2023 | polyp of colon | Zhang Yanli | Completed | No outcome recorded |
| Phase 4 | NCT05148494 Comparator | Mar 2022 → Aug 2026 overdue | colorectal neoplasm | Nova Scotia Health Authority | Recruiting | No outcome recorded |
| Phase 4 | NCT02024022 Comparator | Feb 2014 → Sep 2015 | — | Clinical Hospital Colentina | Completed | No outcome recorded |
| Phase 4 | NCT01554111 Comparator | Mar 2012 → Sep 2015 | colonic disorder | Queen's University | Completed | No outcome recorded |
| Phase 4 | NCT01649674 Comparator | Nov 2011 → Dec 2024 | — | National Cancer Institute, Naples | Unknown | No outcome recorded |
| Phase 4 | NCT00677794 Comparator | Mar 2008 → Aug 2013 | — | Queen's University | Completed | No outcome recorded |
| Phase 4 | NCT00410215 Comparator | Feb 2006 → Jan 2008 | — | Queen's University | Completed | No outcome recorded |
| — | NCT01596686 Comparator | May → Dec 2012 | — | Clinical Hospital Colentina | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| 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 ↗ |
| 2018-07-24 | 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 %) |
All press releases naming this drug 3 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sodium Picosulfate | “A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops...” NCT00576810 ↗12“Sodium Picosulfate and Magnesium Salt (SP+MS) Solution” NCT02273141 ↗ “compound sodium picosulfate” NCT06339697 ↗ |
| Known as | Dulcolax | “A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops...” NCT00576810 ↗ |
| Known as | Laxoberal | “A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Sodium Picosulfate [Dulcolax®, Laxoberal®]Drops...” NCT00576810 ↗ |
| Known as | magnesiumoxid + sodium picosulfate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05726097 ↗ |
| Known as | Pico Salax | “Patient is to take Pico Salax oral bowel preparation which is a combination product consisting of 10 mg picosulfate sodium, 3.5 g magnesium oxide, and 12 g citric acid per...” NCT05148494 ↗ |
| Known as | Picoprep | “Sodium Picosulfate solution (Picoprep)” NCT03074448 ↗ |
| Known as | PicosolutionⓇ | “Sodium Picosulfate Solution(PicosolutionⓇ)” NCT04593446 ↗ |
| Known as | Picosulfate sodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01554111 ↗ |
| Known as | PMC | “sodium picosulphate/magnesium citrate (PMC)” NCT01603654 ↗ |
| Known as | sodium picosulphate | “comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol (PEG)” PMID 23799210 ↗ Jun 20136“bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate” NCT02024022 ↗ |
| Known as | sodium picosulphate/magnesium citrate | “sodium picosulphate/magnesium citrate (PMC)” NCT01603654 ↗ |
| Route | Oral | “two sachets of picosalax taken orally the day prior to colonoscopy” NCT00410215 ↗ |