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 · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 35 · a red edge is where a trial was stopped
| 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 | ||||||
| Phase 1 | NCT01807000 | Mar → Apr 2013 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00903747 | Jan → Apr 2009 | constipation disorder | Movetis | Completed | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT06474286 | Jul → Dec 2026 expected | schizophrenia | University of Pittsburgh | 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 |
Also used as a comparator or background therapy in 29 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 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 1/22 trials | ||||||
| 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 26 trials | ||||||
| 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 2/31 trial | ||||||
| Phase 2/3 | NCT04757493 Comparator | Mar → Oct 2021 | irritable bowel syndrome | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 310 trials | ||||||
| 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 | No outcome recorded |
| 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 |
| 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 | NCT00485940 Comparator | Mar 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 44 trials | ||||||
| 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 |
| Phase 4 | NCT01424228 Comparator | Apr 2011 → Dec 2012 | constipation disorder | Shire | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02047045 Comparator | Apr 2014 → Aug 2016 | constipation disorder | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-12-17 | Takeda | FDA approves Shire’s Motegrity™ (prucalopride), the only serotonin-4 receptor agonist for adults with Chronic Idiopathic Constipation (CIC) takeda.com ↗ |
| 2018-10-18 | Takeda | FDA Advisory Committee Recommends Approval of Shire’s Prucalopride (SHP555) for Chronic Idiopathic Constipation takeda.com ↗ |
| 2018-06-03 | Takeda | New Data on the Cardiovascular Safety of Prucalopride Presented at 2018 Digestive Disease Week Annual Meeting takeda.com ↗ |
| 2018-03-05 | Takeda | U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation takeda.com ↗ |
| 2015-06-03 | Takeda | Shire Receives European Approval to Use Resolor® (prucalopride) in Men for the Symptomatic Treatment of Chronic Constipation takeda.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 67 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 ↗63 |
| 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 ↗ |