Colesevelam
As of the edition of 20 October 2026, Colesevelam is a drug: marketed, first approved in 2000 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Unknown
- Brand name
- Welchol
- First approved
- 26 May 2000 (US)
- Approvals on record
- 8 in 3 regions
- Holder of the most recent approval
- Cosette Pharmaceuticals; 3 holders in all
- Registered trials
- 48, 1 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Digestive system; Inherited and neonatal; Cancer; Heart and blood vessels
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 5 | 0 | 0 |
| Phase 1 | 3 | 2 | 1 | 0 |
| Phase 2 | 9 | 6 | 2 | 0 |
| Phase 3 | 12 | 11 | 0 | 1 |
| Phase 4 | 19 | 19 | 0 | 0 |
| All trials | 48 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Daiichi Sankyo | Later holder, Earlier holder and Lead sponsor of trials | 2000 to now |
| Cheplapharm Arzneimittel | Applicant | 2004 to now |
| Bausch Health | Acquired holder | 2011 to now |
| Cosette Pharmaceuticals | Acquired holder | 2022 to now |