Rebamipide
As of the edition of 20 October 2026, Rebamipide is a small molecule: marketed, first approved in 2011 (JP).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Mucosta
- First approved
- 26 September 2011 (JP)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Otsuka
- Registered trials
- 40, 0 stopped early
- Disease areas
- Eye; Digestive system; Skin and connective tissue; Bones, joints and muscles; Immune system; Mouth and teeth
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 1 | 0 | 0 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 10 | 9 | 0 | 0 |
| Phase 3 | 9 | 8 | 0 | 0 |
| Phase 4 | 11 | 9 | 1 | 0 |
| All trials | 40 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Applicant and Lead sponsor of trials | 2004 to now |