Crofelemer
As of the edition of 20 October 2026, Crofelemer is a small molecule: marketed, first approved in 2012 (US); acts on ANO1 and CFTR; 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
- Mytesi
- First approved
- 31 December 2012 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Napo Pharmaceuticals
- Registered trials
- 16, 1 stopped early
- Disease areas
- Immune system; Infections; Urinary and reproductive; Digestive system; Skin and connective tissue; Cancer
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
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Crofelemer.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 0 | 1 | 0 |
| Phase 2 | 5 | 4 | 1 | 0 |
| Phase 3 | 5 | 4 | 1 | 0 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Originator and Lead sponsor of trials | 2004 to now |
| Napo Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2016 to now |