Remestemcel-l
As of the edition of 20 October 2026, Remestemcel-l is a cell: marketed, first approved in 2012 (CA); US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Cell
- Brand name
- ryoncil
- First approved
- 15 May 2012 (CA)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Mesoblast
- Registered trials
- 16, 3 stopped early
- Disease areas
- Digestive system; Immune system; Lungs and airways; Infections; Heart and blood vessels; Hormones
US protection
US protection ends in 2036.
US protection ends in 2036, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Mesoblast. The date is computed, not published.
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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 0 | 0 | 0 |
| Phase 2 | 7 | 5 | 0 | 2 |
| Phase 3 | 4 | 3 | 0 | 1 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mesoblast | Applicant and Lead sponsor of trials | 2012 to now |