Drugs / Prucalopride
Prucalopride
also known as
R093877 · R108512 · dihydrobenzofurancarboxamide · Motegrity · Prucaloprida · Prucalopride (as succinate) · Prucalopride succinate · Resolor
Small molecule targets HTR4 via activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic duodenal ileus 1 milestone | |||||
| Filed | US (FDA) | — | chronic duodenal ileus | 2018-03-05 | “the U.S. Food and Drug Administration (FDA) has accepted the submission of a New Drug Application (NDA) for prucalopride” takeda.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | MOTEGRITY | — | 2025-07-10 | fda.gov ↗ |
| Approved | US (FDA) | MOTEGRITY | — | 2018-12-14 | fda.gov ↗ |
| Approved | EU (EMA) | Resolor | — | 2009-10-14 | europa.eu ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07127237 | Sep 2025 → Feb 2026 overdue | — | Hospital de Clínicas Dr. Manuel Quintela | Not yet recruiting | No outcome recorded |
| Phase 15 trials · 1 met primary | ||||||
| Phase 1 | NCT01807000 | Mar → Apr 2013 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00903747 | Jan → Apr 2009 | constipation disorder | Movetis | Completed | Met primary |
| Phase 1 | NCT01674166 | Nov 1998 → May 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 1 | NCT01674192 | Jul 1997 → Aug 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 1 | NCT00793429 | — | — | Movetis | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05377619 | Jan → Mar 2022 | dyspepsia | Universidade de Passo Fundo | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT05001763 | Sep 2021 → Sep 2023 | paralytic ileus, urinary bladder cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Unknown | No outcome recorded |
| Phase 2 | NCT03244553 | Oct 2017 → Dec 2019 | dyskinesia of esophagus | University of Calgary | Completed | No outcome recorded |
| Phase 2 | NCT02004652 | Nov 2013 → Dec 2014 | ileus | Jinling Hospital, China | Completed | Met primary |
| Phase 2 | NCT00793247 | — | chronic intestinal pseudoobstruction | Movetis | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02031081 | Mar 2014 → Jun 2018 | diabetes mellitus, gastroparesis | University of Calgary | Completed | No outcome recorded |
| Phase 310 trials · 2 missed | ||||||
| Phase 3 | NCT06816407 | Mar → May 2025 overdue | — | Future University in Egypt | Recruiting | No outcome recorded |
| Phase 3 | NCT05726097 | Feb → Oct 2023 | colorectal cancer, inflammatory bowel disease, polyp of colon | Region Skane | Completed | No outcome recorded |
| Phase 3 | NCT04759833 | Jul 2021 → Nov 2023 | constipation disorder | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT02947269 | Oct 2017 → Aug 2020 | ileus | University of Auckland, New Zealand | Completed | Missed primary |
| Phase 3 | NCT04190173 | Jul 2017 → Jan 2020 | critical illness polyneuropathy, paralytic ileus | Prince of Songkla University | Unknown | No outcome recorded |
| Phase 3 | NCT01864915 | Jun 2013 → Oct 2014 | — | Queen's University | Completed | No outcome recorded |
| Phase 3 | NCT01330381 | Apr 2011 → Mar 2013 | constipation disorder | Shire | Completed | Missed primary |
| Phase 3 | NCT01116206 | May 2010 → Mar 2011 | constipation disorder | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00987844 | Jul 1998 → Nov 2000 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 3 | NCT01070615 | Jun 1998 → Nov 2000 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 47 trials · 1 met primary | ||||||
| Phase 4 | NCT05455359 | Feb 2025 → May 2027 expected | aspiration pneumonia, dyskinesia of esophagus, functional gastric disease, gastroesophageal reflux disease | Boston Children's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04985669 | Aug 2021 → Feb 2022 | — | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 4 | NCT03676374 | Feb 2019 → Apr 2021 | gastroesophageal reflux disease | Universitaire Ziekenhuizen KU Leuven | Unknown | No outcome recorded |
| Phase 4 | NCT02806206 | Jul 2016 → May 2017 | Crohn disease, celiac disease | University of British Columbia | Unknown | No outcome recorded |
| Phase 4 | NCT02781493 | Jun 2016 → Mar 2017 | — | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT02228616 | Oct 2014 → Sep 2016 | constipation disorder | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01707667 | Feb → Nov 2013 | constipation disorder | Shire | Completed | Met primary |
| Phase not applicable7 trials | ||||||
| — | NCT06474286 | May 2027 → May 2028 expected | schizophrenia | University of Pittsburgh | Not yet recruiting | No outcome recorded |
| — | NCT07848477 | Oct 2026 → Jul 2028 expected | major depressive disorder | University of Oxford | Not yet recruiting | No outcome recorded |
| — | NCT05966246 | Jan 2022 → Jun 2023 | gastric cancer | Gangnam Severance Hospital | Completed | No outcome recorded |
| — | NCT05220228 | Jan 2022 → Nov 2023 | depressive disorder | University of Oxford | Completed | No outcome recorded |
| — | NCT03572790 | Jun 2018 → May 2019 | depressive disorder | University of Oxford | Completed | No outcome recorded |
| — | NCT03863366 | Feb → Aug 2017 | depressive disorder | University of Oxford | Completed | No outcome recorded |
| — | NCT04429802 | Sep 2013 → Jun 2015 | dyspepsia, intestinal motility disease | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Comparator or background therapy29 trials | ||||||
| Phase 1 | NCT01870674 Comparator | Aug 2013 → Apr 2015 | — | Yuhan Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01134185 Comparator | May 2010 → Feb 2011 | — | Movetis | Completed | No outcome recorded |
| Phase 1 | NCT01036893 Comparator | Dec 2009 → Feb 2010 | — | Movetis | Completed | No outcome recorded |
| Phase 1 | NCT00488215 Comparator | Jan → Mar 2000 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 1 | NCT01670669 Comparator | Nov 1998 → Jul 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 1/2 | NCT05496179 Comparator | Aug 2022 → Jun 2023 | food protein-induced enterocolitis syndrome | Ain Shams University | Completed | No outcome recorded |
| Phase 1/2 | NCT02538367 Comparator | Aug 2015 → Sep 2016 | constipation disorder | Yuhan Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00627692 Comparator | Feb 1999 → May 2000 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 2 | NCT00575614 Comparator | Apr 1997 → Mar 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 2 | NCT00596596 Comparator | Sep 1996 → Jun 1997 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 2 | NCT00631813 Comparator | Nov 1995 → Apr 1997 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 2 | NCT00617513 Comparator | Mar 1995 → Mar 1996 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 2 | NCT00576511 Comparator | Dec 1994 → Feb 1996 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 2/3 | NCT04757493 Comparator | Mar → Oct 2021 | irritable bowel syndrome | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 3 | NCT01655095 Background | Jul → Oct 2012 | polyp | Queen's University | Completed | No outcome recorded |
| Phase 3 | NCT01251822 Comparator | Nov 2010 → Sep 2011 | constipation disorder | Norgine | Completed | Met primary |
| Phase 3 | NCT01147926 Comparator | Sep 2010 → Oct 2013 | — | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01117051 Comparator | May 2010 → Aug 2012 | opioid-induced constipation | Shire | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00598338 Comparator | Apr 1999 → Feb 2000 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 3 | NCT00487422 Comparator | Oct 1998 → Sep 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 3 | NCT00577018 Comparator | Aug 1998 → Sep 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 3 | NCT00483886 Comparator | Apr 1998 → May 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 3 | NCT00488137 Comparator | Mar 1998 → Jul 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 3 | NCT00485940 Comparator | Mar 1998 → May 1999 | constipation disorder | Movetis | Completed | No outcome recorded |
| Phase 4 | NCT02425774 Comparator | Jul 2014 → Feb 2016 | ileus | KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT03279341 Comparator | Dec 2012 → Mar 2016 | constipation disorder | University Hospital, Gasthuisberg | Completed | No outcome recorded |
| Phase 4 | NCT02510976 Comparator | Nov 2011 → Jan 2021 | gastroparesis | Universitaire Ziekenhuizen KU Leuven | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01424228 Comparator | Apr 2011 → Dec 2012 | constipation disorder | Shire | Completed | No outcome recorded |
| — | NCT02047045 Comparator | Apr 2014 → Aug 2016 | constipation disorder | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2018-12-17 | Takeda | Regulatory FDA approves Shire’s Motegrity™ (prucalopride), the only serotonin-4 receptor agonist for adults with Chronic Idiopathic Constipation (CIC) takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) has announced that the U.S. Food and Drug Administration (FDA) has approved Motegrity™ (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation (CIC). |
| 2018-10-18 | Takeda | Regulatory FDA Advisory Committee Recommends Approval of Shire’s Prucalopride (SHP555) for Chronic Idiopathic Constipation takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee voted unanimously (10 to 0) that the risk-benefit profile of prucalopride supports the approval of this New Drug Application (NDA). |
| 2018-06-03 | Takeda | Results New Data on the Cardiovascular Safety of Prucalopride Presented at 2018 Digestive Disease Week Annual Meeting takeda.com ↗
Findings were consistent with no evidence of an overall increase in the risk of major adverse cardiovascular events (MACE) in patients using prucalopride compared with polyethylene glycol (PEG) 1 |
| 2018-03-05 | Takeda | Regulatory U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the U.S. Food and Drug Administration (FDA) has accepted the submission of a New Drug Application (NDA) for prucalopride (also known as SHP555). |
| 2015-06-03 | Takeda | Regulatory Shire Receives European Approval to Use Resolor® (prucalopride) in Men for the Symptomatic Treatment of Chronic Constipation takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that Resolor (prucalopride) has been approved by the European Commission for use in adults for the symptomatic treatment of chronic constipation in whom laxatives fail to provide adequate relief. |
All press releases naming this drug 8 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Prucalopride | “This phase II, double-blind, placebo-controlled, two-treatment four periods cross-over trial investigated the clinical safety, tolerability and the efficacy of R093877...” NCT00793247 ↗ |
| Known as | dihydrobenzofurancarboxamide | “Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4 receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride” NCT05966246 ↗ |
| Known as | Motegrity | ChEMBL registry synonym — accepted as the source's own label CHEMBL117287 ↗ |
| Known as | Prucaloprida | ChEMBL registry synonym — accepted as the source's own label CHEMBL117287 ↗ |
| Known as | Prucalopride (as succinate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL117287 ↗ |
| Known as | Prucalopride succinate | “Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4 receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride” NCT05966246 ↗ |
| Known as | R093877 | “This phase II, double-blind, placebo-controlled, two-treatment four periods cross-over trial investigated the clinical safety, tolerability and the efficacy of R093877...” NCT00793247 ↗2“A Double-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Efficacy and Safety of Prucalopride (R093877) in Subjects With Chronic Idiopathic Constipation” NCT00596596 ↗ “Single Dose Pharmacokinetic Trial of Oral Prucalopride (R093877) in Subjects With Mild, Moderate and Severe Renal Impairment” NCT01674192 ↗ |
| Known as | R108512 | “A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.” NCT00483886 ↗1“0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution” NCT01670669 ↗ |
| Known as | Resolor | “60 patients with refractory GERD symptoms will receive either placebo or prucalopride (Resolor®) 2 mg for a period of 4 weeks.” NCT03676374 ↗ |
| Action | Activate | “Prucalopride is a high-affinity 5-HT4 receptor agonist for the treatment of chronic constipation.” PMID 25581251 ↗ Jan 20151“Serotonin 4 (5-HT4) receptor agonist” CHEMBL117287 ↗ |
| Modality | Small molecule | “Prucalopride, a substituted benzamide with selective 5-HT4 agonist activity” NCT02004652 ↗ |
| Route | Oral | “Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis.” PMID 24917940 ↗ Feb 2013 |
| Target | HTR4 | “Serotonin 4 (5-HT4) receptor agonist” CHEMBL117287 ↗ |