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sirolimus versus mycophenolate mofetil
This is a comparative study of two immunosuppressive agents: sirolimus (mTOR inhibitor) and mycophenolate mofetil (IMPDH inhibitor), used to prevent organ rejection.
This is a comparative study of two immunosuppressive agents: sirolimus (mTOR inhibitor) and mycophenolate mofetil (IMPDH inhibitor), used to prevent organ rejection. Used for Prevention of organ rejection in transplant recipients, Renal transplantation.
At a glance
| Generic name | sirolimus versus mycophenolate mofetil |
|---|---|
| Sponsor | EUROSPK Study Group |
| Drug class | Immunosuppressive agents |
| Target | mTOR (sirolimus); IMPDH (mycophenolate mofetil) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | Phase 3 |
Mechanism of action
Sirolimus inhibits the mammalian target of rapamycin (mTOR), blocking T-cell and B-cell proliferation by preventing progression through the cell cycle. Mycophenolate mofetil inhibits inosine monophosphate dehydrogenase (IMPDH), selectively suppressing lymphocyte proliferation. Both are used as immunosuppressive agents in transplant recipients, but differ in mechanism and side effect profiles.
Approved indications
- Prevention of organ rejection in transplant recipients
- Renal transplantation
Common side effects
- Hyperlipidemia
- Thrombocytopenia
- Anemia
- Gastrointestinal disturbances
- Infection
- Delayed wound healing
Key clinical trials
- 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)
- 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)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (PHASE2)
- Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies (PHASE1, PHASE2)
- Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies (PHASE1, PHASE2)
- Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation (PHASE2)
- A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease (PHASE2)
- A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) (PHASE3)
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:
- sirolimus versus mycophenolate mofetil CI brief — competitive landscape report
- sirolimus versus mycophenolate mofetil updates RSS · CI watch RSS
- EUROSPK Study Group portfolio CI