Mycophenolate mofetil
As of the edition of 20 October 2026, Mycophenolate mofetil is a small molecule: marketed, first approved in 1995 (US); acts on IMPDH1 and IMPDH2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Cellcept
- First approved
- 3 May 1995 (US)
- Approvals on record
- 16 in 4 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 6 holders in all
- Registered trials
- 653, 125 stopped early
- Disease areas
- Immune system; Blood and lymph; Cancer; Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health
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
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Mycophenolate mofetil.
See the 1 company-target row 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 | 73 | 39 | 6 | 12 |
| Phase 1 | 80 | 46 | 11 | 19 |
| Phase 2 | 321 | 171 | 65 | 69 |
| Phase 3 | 86 | 59 | 6 | 17 |
| Phase 4 | 93 | 58 | 5 | 8 |
| All trials | 653 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 1995 to now |
| Azurity Pharmaceuticals | Later holder | 2024 to now |