Mycophenolic acid
As of the edition of 20 October 2026, Mycophenolic acid is a small molecule: marketed, first approved in 2003 (FR); acts on IMPDH1 and IMPDH2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2005
- Kind
- Small molecule
- Brand name
- Myfortic
- First approved
- 10 October 2003 (FR)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 139, 19 stopped early
- Disease areas
- Immune system; Pregnancy and women's health; Urinary and reproductive; Skin and connective tissue; Blood and lymph; Cancer
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.
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 Mycophenolic acid.
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 | 17 | 5 | 1 | 4 |
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 22 | 13 | 4 | 2 |
| Phase 3 | 37 | 28 | 3 | 5 |
| Phase 4 | 57 | 44 | 1 | 8 |
| All trials | 139 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator and Lead sponsor of trials | 1999 to now |