Tacrolimus is marketed as PROGRAF and is a calcineurin-inhibitor immunosuppressant used in combination regimens to prevent allogeneic organ transplant rejection in liver, kidney, heart, and lung recipients. It remains a core transplant immunosuppressive therapy. U.S. initial approval was in 1994.
The global CNS biomarkers market is projected to reach USD 26.13 billion by 2035, amyloid beta therapeutics USD 26.50 billion, and calcineurin inhibitors USD 20.88 billion. AI integration is driving innovation across all three markets.
Interim results from the ABC phase 1/2b trial show a calcineurin inhibitor-free GVHD prevention regimen combining posttransplant cyclophosphamide, bortezomib, and abatacept achieved low GVHD rates and favorable survival outcomes. The approach enables earlier introduction of posttransplant maintenance therapies while reducing toxicity associated with conventional immunosuppressants.
Obinutuzumab demonstrated superior efficacy in two separate phase 3 trials for systemic lupus erythematosus and primary membranous nephropathy, with statistically significant improvements in remission rates and disease response measures.
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
The Phase III MAJESTY study met its primary endpoint, showing significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy.
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.
Genentech's Phase III MAJESTY study showed Gazyva achieved statistically significant complete remission rates versus tacrolimus in primary membranous nephropathy, a chronic autoimmune kidney disease affecting over 96,000 people in the U.S.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07582172 |
Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome |
NOT_YET_RECRUITING | PHASE2 |
| NCT07566377 |
Cord Blood Transplantation in Children and Young Adults With Blood Cancer |
RECRUITING | PHASE2 |
| NCT07548983 |
Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation |
NOT_YET_RECRUITING | PHASE1 |
| NCT07524530 |
Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers |
NOT_YET_RECRUITING | PHASE2 |
| NCT07519174 |
A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% in Patients With Mild to Moderate Atopic Dermatitis Over 8 Weeks |
NOT_YET_RECRUITING | NA |
| NCT07493538 |
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 |
RECRUITING | PHASE2 |
| NCT07412470 |
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation |
RECRUITING | PHASE2/PHASE3 |
| NCT07359859 |
A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant |
RECRUITING | PHASE2 |
| NCT07352566 |
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
NOT_YET_RECRUITING | PHASE4 |
| NCT07349771 |
Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial |
NOT_YET_RECRUITING | PHASE2 |
