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Placebo to Mycophenolate mofetil
Mycophenolate mofetil is an immunosuppressant that selectively inhibits inosine monophosphate dehydrogenase (IMPDH), reducing proliferation of T and B lymphocytes.
Mycophenolate mofetil is an immunosuppressant that selectively inhibits inosine monophosphate dehydrogenase (IMPDH), reducing proliferation of T and B lymphocytes. Used for Prevention of organ rejection in renal, cardiac, and hepatic transplant recipients, Active lupus nephritis, Autoimmune conditions (off-label use in various settings).
At a glance
| Generic name | Placebo to Mycophenolate mofetil |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | Immunosuppressant; IMPDH inhibitor |
| Target | Inosine monophosphate dehydrogenase (IMPDH) type II |
| Modality | Small molecule |
| Therapeutic area | Immunology; Transplantation |
| Phase | FDA-approved |
Mechanism of action
MMF is a prodrug that is rapidly hydrolyzed to mycophenolic acid (MPA), its active form. MPA preferentially inhibits IMPDH type II, an enzyme critical for guanosine nucleotide synthesis in lymphocytes. By depleting guanosine nucleotides, it suppresses T and B cell proliferation while having minimal effects on other cell types, making it useful for preventing organ rejection and treating autoimmune conditions.
Approved indications
- Prevention of organ rejection in renal, cardiac, and hepatic transplant recipients
- Active lupus nephritis
- Autoimmune conditions (off-label use in various settings)
Common side effects
- Gastrointestinal disturbances (diarrhea, nausea, vomiting, abdominal pain)
- Leukopenia
- Anemia
- Infection
- Headache
- Tremor
- Hypertension
Key clinical trials
- Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis (PHASE2)
- Tocilizumab in Lung Transplantation (PHASE2)
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study (PHASE2)
- A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) (PHASE2)
- 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 (PHASE2)
- Tocilizumab in Cardiac Transplantation (PHASE2)
- A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis (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:
- Placebo to Mycophenolate mofetil CI brief — competitive landscape report
- Placebo to Mycophenolate mofetil updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI