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tacrolimus, ATG
Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation, while ATG (antithymocyte globulin) is a polyclonal antibody that depletes T lymphocytes, together providing potent immunosuppression.
Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation, while ATG (antithymocyte globulin) is a polyclonal antibody that depletes T lymphocytes, together providing potent immunosuppression. Used for Prevention of organ rejection in solid organ transplantation, Prevention and treatment of graft-versus-host disease (GVHD) in hematopoietic stem cell transplantation.
At a glance
| Generic name | tacrolimus, ATG |
|---|---|
| Also known as | Thymoglobuline |
| Sponsor | University Hospital, Toulouse |
| Drug class | Calcineurin inhibitor and polyclonal antithymocyte antibody |
| Target | Calcineurin (tacrolimus); T-cell surface antigens including CD2, CD3, CD4, CD8, CD25 (ATG) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus binds to FK-binding protein and inhibits calcineurin phosphatase, preventing T-cell receptor signaling and IL-2 production. ATG is a polyclonal immunoglobulin derived from immunized animals that binds to T-cell surface antigens, leading to complement-mediated lysis and T-cell depletion. This combination provides synergistic immunosuppression for transplant rejection prevention.
Approved indications
- Prevention of organ rejection in solid organ transplantation
- Prevention and treatment of graft-versus-host disease (GVHD) in hematopoietic stem cell transplantation
Common side effects
- Nephrotoxicity
- Neurotoxicity (tremor, headache, seizures)
- Hyperglycemia
- Hypertension
- Infection
- Serum sickness (ATG)
- Thrombocytopenia
Key clinical trials
- A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (PHASE2, PHASE3)
- Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations (PHASE2)
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation (PHASE2)
- Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation (PHASE3)
- Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders (PHASE2)
- Allo HSCT for High Risk Hemoglobinopathies (PHASE2)
- A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal 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, ATG CI brief — competitive landscape report
- tacrolimus, ATG updates RSS · CI watch RSS
- University Hospital, Toulouse portfolio CI