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Tacrolimus and Mycophenolate-mofetil
Tacrolimus and mycophenolate mofetil together suppress T-cell and B-cell activation to prevent organ rejection and autoimmune responses.
Tacrolimus and mycophenolate mofetil together suppress T-cell and B-cell activation to prevent organ rejection and autoimmune responses. Used for Organ transplant rejection prophylaxis (renal, cardiac, hepatic), Autoimmune diseases (lupus nephritis, vasculitis).
At a glance
| Generic name | Tacrolimus and Mycophenolate-mofetil |
|---|---|
| Sponsor | University of Giessen |
| Drug class | Immunosuppressant combination (calcineurin inhibitor + antimetabolite) |
| Target | Calcineurin (tacrolimus); IMPDH type II (mycophenolate mofetil) |
| 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 mycophenolate mofetil (MMF) is an inosine monophosphate dehydrogenase (IMPDH) inhibitor that selectively suppresses B-cell and T-cell proliferation. Together, they provide complementary immunosuppression through different mechanisms, commonly used in combination for transplant rejection prevention and autoimmune disease management.
Approved indications
- Organ transplant rejection prophylaxis (renal, cardiac, hepatic)
- Autoimmune diseases (lupus nephritis, vasculitis)
Common side effects
- Nephrotoxicity
- Neurotoxicity (tremor, headache)
- Gastrointestinal disturbances (diarrhea, nausea)
- Infections (opportunistic)
- Hyperglycemia
- Hypertension
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)
- 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)
- Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations (PHASE2)
- Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies (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 and Mycophenolate-mofetil CI brief — competitive landscape report
- Tacrolimus and Mycophenolate-mofetil updates RSS · CI watch RSS
- University of Giessen portfolio CI