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Mycophenolate mofetil, Standard dose
Mycophenolate mofetil inhibits inosine monophosphate dehydrogenase (IMPDH), selectively suppressing T and B lymphocyte proliferation to prevent organ rejection and autoimmune responses.
Mycophenolate mofetil inhibits inosine monophosphate dehydrogenase (IMPDH), selectively suppressing T and B lymphocyte proliferation to prevent organ rejection and autoimmune responses. Used for Prevention of organ rejection in renal, cardiac, and hepatic transplant recipients, Active lupus nephritis, Autoimmune hemolytic anemia.
At a glance
| Generic name | Mycophenolate mofetil, Standard dose |
|---|---|
| Also known as | CellCept |
| Sponsor | Hoffmann-La Roche |
| Drug class | Inosine monophosphate dehydrogenase (IMPDH) inhibitor |
| Target | IMPDH type II |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
MMF is a prodrug that is rapidly hydrolyzed to mycophenolic acid (MPA), which preferentially inhibits IMPDH type II, the predominant isoform in lymphocytes. This blocks the de novo pathway of guanosine nucleotide synthesis, depleting guanosine nucleotides required for lymphocyte DNA synthesis and proliferation. The selective effect on lymphocytes makes it useful as an immunosuppressant with relatively sparing effects on other cell types.
Approved indications
- Prevention of organ rejection in renal transplant recipients
- Prevention of organ rejection in cardiac transplant recipients
- Prevention of organ rejection in hepatic transplant recipients
- Active lupus nephritis (in combination with corticosteroids)
Common side effects
- Diarrhea
- Leukopenia
- Infection
- Anemia
- Thrombocytopenia
- Nausea
- Vomiting
- Abdominal pain
Key clinical trials
- Tocilizumab in Lung Transplantation (PHASE2)
- Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation (PHASE2)
- Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies (PHASE2)
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation (PHASE1, PHASE2)
- Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY) (PHASE4)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mycophenolate mofetil, Standard dose CI brief — competitive landscape report
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- Hoffmann-La Roche portfolio CI