Mycophenolate Mofetil: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Mycophenolate Mofetil appears in the FDA drug-label database. Marketed as mycophenolate mofetil.
- Boxed warning
- The FDA label for Mycophenolate Mofetil carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ] , heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ], in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product — Par Pharmaceutical, Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2019-04-30 |
| Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water. — VistaPharm LLC | Class III (FDA: unlikely to cause harm) | Terminated | 2023-10-26 |
| Presence of precipitate — MYLAN PHARMACEUTICALS INC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2026-07-02 |
Phase breakdown
Conditions being studied
Recruiting trials involving Mycophenolate Mofetil
- A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
- Allo HSCT for High Risk Hemoglobinopathies
- Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
- Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
- Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease
- The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
Common questions
Is Mycophenolate Mofetil FDA-approved?
Yes, marketed as mycophenolate mofetil. Its FDA label carries a boxed warning.
How many recruiting trials involve Mycophenolate Mofetil?
7 recruiting trials across 9 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.