Plecanatide
As of the edition of 20 October 2026, Plecanatide is a protein: marketed, first approved in 2017 (US); acts on GUCY2C; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Protein
- Brand name
- Trulance
- First approved
- 19 January 2017 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Bausch Health
- Registered trials
- 10, 0 stopped early
- Disease areas
- Digestive system; Cancer; Immune system; Lungs and airways
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Bausch Health.
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 Plecanatide.
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 |
|---|---|---|
| GUCY2C | Guanylyl cyclase C | P25092 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 2 | 1 | 0 |
| Phase 3 | 5 | 5 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder and Lead sponsor of trials | 2011 to now |