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Prograf (SOC)
Prograf (tacrolimus) inhibits calcineurin phosphatase, suppressing T-cell activation and proliferation to prevent organ rejection.
Prograf (tacrolimus) inhibits calcineurin phosphatase, suppressing T-cell activation and proliferation to prevent organ rejection. Used for Prevention of organ rejection in kidney transplant recipients, Prevention of organ rejection in heart transplant recipients, Prevention of organ rejection in liver transplant recipients.
At a glance
| Generic name | Prograf (SOC) |
|---|---|
| Sponsor | University of Alberta |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (via FKBP12 binding) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus binds to the immunophilin FKBP12, and this complex inhibits calcineurin, a key phosphatase required for T-cell receptor signaling and IL-2 production. By blocking calcineurin, the drug prevents the transcription of cytokine genes essential for T-cell proliferation, thereby suppressing the immune response that would otherwise reject transplanted organs.
Approved indications
- Prevention of organ rejection in kidney transplant recipients
- Prevention of organ rejection in heart transplant recipients
- Prevention of organ rejection in liver transplant recipients
Common side effects
- Nephrotoxicity (renal dysfunction)
- Hypertension
- Hyperglycemia
- Neurotoxicity (tremor, headache)
- Infections
- Hyperkalemia
Key clinical trials
- Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation (PHASE2)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation (PHASE2)
- Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (PHASE3)
- BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR) (PHASE2)
- A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant (PHASE2)
- Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) (PHASE2, PHASE3)
- REgulatory T Cell Therapy to Achieve Immunosuppression REduction (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:
- Prograf (SOC) CI brief — competitive landscape report
- Prograf (SOC) updates RSS · CI watch RSS
- University of Alberta portfolio CI