Overview
Prucalopride is a dihydrobenzofurancarboxamide derivative from the benzofurane family that selectively stimulates 5-HT4 receptors and thus, it presents enterokinetic properties. The high selectivity of prucalopride allowed further development as it prevented the cardiac adverse reactions observed due to non-target effects of precedent therapies. Prucalopride was developed by Shire Development LLC and approved for use in Europe in 2009, in Canada on December 7, 2011 and by the FDA on December 17, 2018.
Indication
Prucalopride is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. CIC is one of the most common chronic functional gastrointestinal disorders worldwide. The diagnosis of this agent is very hard and it can be confirmed if the patient experience at least two of the following: -Straining during more than 25% of the bowel movements. -Lumpy or hard stools in 25% of the bowel movements. -Sensation of incomplete evacuation in more than 25% of all bowel movements. -Sensation of anorectal blockage or obstruction in more than 25% of the bowel movements. -Manual maneuvers required in more than 25% of the bowel movements. -Fewer than 3 bowel movements per week.
Associated Conditions
- Opioid Induced Constipation (OIC)
- Chronic idiopathic constipation (CIC)
- Refractory Chronic idiopathic constipation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/10 | Phase 3 | Recruiting | |||
2024/06/25 | Not Applicable | Not yet recruiting | |||
2023/02/13 | Phase 3 | Completed | |||
2022/08/11 | Phase 1 | Completed | |||
2022/07/13 | Phase 4 | Not yet recruiting | |||
2022/05/17 | Phase 1 | Completed | Universidade de Passo Fundo | ||
2022/02/02 | Not Applicable | Completed | |||
2021/08/12 | Phase 2 | UNKNOWN | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2021/08/02 | Phase 4 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2021/02/18 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 54092-546 | ORAL | 1 mg in 1 1 | 11/30/2020 | |
| Takeda Pharmaceuticals America, Inc. | 54092-547 | ORAL | 2 mg in 1 1 | 11/30/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/14/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Resolor Film-coated Tablet 2 mg | SIN14104P | TABLET, FILM COATED | 2mg | 2/14/2012 | |
| Resolor Film-coated Tablet 1 mg | SIN14103P | TABLET, FILM COATED | 1mg | 2/14/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Prucalopride Succinate Tablets | 国药准字H20203020 | 化学药品 | 片剂 | 2/5/2020 | |
| Prucalopride Succinate Tablets | 国药准字H20203310 | 化学药品 | 片剂 | 7/16/2020 | |
| Prucalopride Succinate Tablets | 国药准字H20213358 | 化学药品 | 片剂 | 5/11/2021 | |
| Prucalopride Succinate Tablets | 国药准字H20213915 | 化学药品 | 片剂 | 11/30/2021 | |
| Prucalopride Succinate Tablets | 国药准字H20253129 | 化学药品 | 片剂 | 1/14/2025 | |
| Prucalopride Succinate Tablets | 国药准字H20203603 | 化学药品 | 片剂 | 11/24/2020 | |
| Prucalopride Succinate Tablets | 国药准字H20203604 | 化学药品 | 片剂 | 11/24/2020 | |
| Prucalopride Succinate Tablets | 国药准字H20213914 | 化学药品 | 片剂 | 11/30/2021 | |
| Prucalopride Succinate Tablets | 国药准字H20213359 | 化学药品 | 片剂 | 5/11/2021 | |
| Prucalopride Succinate Tablets | 国药准字H20183482 | 化学药品 | 片剂 | 10/7/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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