Prucalopride
As of the edition of 20 October 2026, Prucalopride is a small molecule: marketed, first approved in 2009 (EU); acts on HTR4; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Motegrity
- First approved
- 14 October 2009 (EU)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- LABORATÓRIOS BAGÓ DO BRASIL S/A; 3 holders in all
- Registered trials
- 38, 3 stopped early
- Disease areas
- Digestive system; Cancer; Mental health; Ear, nose and throat; Nutrition and metabolism; Hormones
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Takeda.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Prucalopride.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HTR4 | 5-hydroxytryptamine receptor 4 | Q13639 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 5 | 2 | 2 |
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 4 | 3 | 0 | 0 |
| Phase 3 | 12 | 9 | 1 | 1 |
| Phase 4 | 7 | 2 | 1 | 0 |
| All trials | 38 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant and Lead sponsor of trials | 2009 to now |