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Tacrolimus/MMF
Tacrolimus and mycophenolate mofetil (MMF) together suppress T-cell and B-cell activation to prevent organ rejection after transplantation.
Tacrolimus and mycophenolate mofetil (MMF) together suppress T-cell and B-cell activation to prevent organ rejection after transplantation. Used for Prevention of organ rejection in solid organ transplant recipients (kidney, heart, liver, lung), Graft-versus-host disease (GVHD) prophylaxis in hematopoietic stem cell transplantation.
At a glance
| Generic name | Tacrolimus/MMF |
|---|---|
| Sponsor | University of Miami |
| Drug class | Immunosuppressant combination |
| Target | Calcineurin (tacrolimus); IMPDH type II (MMF) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus is a calcineurin inhibitor that blocks T-cell activation by inhibiting IL-2 production, while MMF is an inosine monophosphate dehydrogenase (IMPDH) inhibitor that selectively suppresses B-cell and T-cell proliferation. This combination is commonly used as part of immunosuppressive regimens in solid organ transplantation to prevent acute and chronic rejection.
Approved indications
- Prevention of organ rejection in solid organ transplant recipients (kidney, heart, liver, lung)
- Graft-versus-host disease (GVHD) prophylaxis in hematopoietic stem cell transplantation
Common side effects
- Nephrotoxicity
- Neurotoxicity (tremor, headache)
- Hyperglycemia
- Hypertension
- Gastrointestinal disturbances (diarrhea, nausea)
- Infections
- Leukopenia
Key clinical trials
- Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
- Tocilizumab in Lung Transplantation (PHASE2)
- A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (PHASE2, PHASE3)
- Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases (PHASE1, PHASE2)
- MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases (PHASE2)
- US Study of ECT-001-CB in Pediatric and Young Adult Patients With High-Risk Myeloid Malignancies (PHASE1, PHASE2)
- Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations (PHASE2)
- Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation (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:
- Tacrolimus/MMF CI brief — competitive landscape report
- Tacrolimus/MMF updates RSS · CI watch RSS
- University of Miami portfolio CI