Drugs / Plecanatide
Plecanatide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TRULANCE | — | 2018-01-24 | fda.gov ↗ |
| Approved | US (FDA) | TRULANCE | — | 2017-01-19 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05107219 | Nov 2022 → Feb 2026 | Barrett esophagus, digestive system cancer, gastroesophageal reflux disease | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07723924 | Aug 2026 → Oct 2027 expected | constipation disorder | Bausch Health Americas, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT03596905 | Jun 2018 → Nov 2024 | irritable bowel syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03120520 | Jan 2017 → Sep 2018 | constipation disorder | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01429987 | Oct 2011 → Dec 2012 | constipation disorder | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT05151328 | Mar 2022 → Oct 2023 | constipation disorder | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02706483 | Jan 2016 → May 2017 | irritable bowel syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02122471 | Apr 2014 → May 2015 | constipation disorder | Bausch Health Americas, Inc. | Completed | Met primary |
| Phase 3 | NCT01919697 | Aug 2013 → Jan 2016 | constipation disorder | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT01722318 Comparator | Nov 2012 → Apr 2014 | irritable bowel syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02493452 Comparator | Jun 2015 → Nov 2016 | irritable bowel syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02387359 Comparator | Dec 2014 → Dec 2016 | irritable bowel syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01982240 Comparator | Nov 2013 → Apr 2015 | constipation disorder | Bausch Health Americas, Inc. | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Plecanatide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02493452 ↗ |
| Known as | Guanilib | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103867 ↗ |
| Known as | Plecanatida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103867 ↗ |
| Known as | SP-304 (SYNERGY) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103867 ↗ |
| Known as | Trulance | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103867 ↗ |
| Action | Activate | “Heat-stable enterotoxin receptor agonist” CHEMBL2103867 ↗1“a guanylate cyclase-C (GC-C) agonist” PMID 28169285 ↗ Feb 2017 |
| Modality | Peptide | “Plecanatide, with the exception of a single amino acid replacement, is identical to human uroguanylin” PMID 29147135 ↗ Oct 2017 |
| Route | Oral | “Repeat, Oral Dose Ranging” NCT01429987 ↗ |
| Target | GUCY2C | “Heat-stable enterotoxin receptor agonist” CHEMBL2103867 ↗ |