Linaclotide
As of the edition of 20 October 2026, Linaclotide is a protein: marketed, first approved in 2012 (US); acts on GUCY2C; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Protein
- Brand name
- Linzess
- First approved
- 30 August 2012 (US)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- AbbVie; 4 holders in all
- Registered trials
- 40, 2 stopped early
- Disease areas
- Digestive system; Cancer; Chemically induced; Inherited and neonatal; Lungs and airways; Mental health
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by AbbVie.
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 product13 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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Linaclotide.
See the 3 companies 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 | 2 | 1 | 0 | 0 |
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 11 | 9 | 1 | 1 |
| Phase 3 | 15 | 14 | 0 | 0 |
| Phase 4 | 6 | 2 | 2 | 1 |
| All trials | 40 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Actavis | Originator and Lead sponsor of trials | 2008 to now |
| Astellas | Applicant and Lead sponsor of trials | 2010 to now |
| AbbVie | Applicant, Acquired holder and Lead sponsor of trials | 2012 to now |
| AstraZeneca | Applicant and Lead sponsor of trials | 2013 to now |