Lubiprostone
As of the edition of 20 October 2026, Lubiprostone is a small molecule: marketed, first approved in 2006 (US); acts on CLCN2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Amitiza
- First approved
- 31 January 2006 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Byk-Mallinckrodt CIL; 2 holders in all
- Registered trials
- 36, 4 stopped early
- Disease areas
- Digestive system; Chemically induced; Mental health; Cancer; Hormones; Immune system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
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 Lubiprostone.
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 |
|---|---|---|
| CLCN2 | Chloride channel protein 2 | P51788 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 1 | 2 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 1 | 2 | 1 |
| Phase 3 | 21 | 20 | 1 | 0 |
| Phase 4 | 5 | 4 | 0 | 1 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Byk-Mallinckrodt CIL | Originator, Applicant and Lead sponsor of trials | 2005 to now |