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Very Low Tacrolimus
Very Low Tacrolimus is a reduced-dose formulation of tacrolimus that suppresses T-cell activation by inhibiting calcineurin, thereby reducing transplant rejection while minimizing immunosuppressive toxicity.
Very Low Tacrolimus is a reduced-dose formulation of tacrolimus that suppresses T-cell activation by inhibiting calcineurin, thereby reducing transplant rejection while minimizing immunosuppressive toxicity. Used for Prevention of organ rejection in solid organ transplant recipients (kidney, heart, liver, pancreas).
At a glance
| Generic name | Very Low Tacrolimus |
|---|---|
| Also known as | Very low Prograf |
| Sponsor | Ronaldo de Matos Esmeraldo, MD |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus is a calcineurin inhibitor that blocks the dephosphorylation of nuclear factor of activated T cells (NFAT), preventing T-cell proliferation and cytokine production. The 'Very Low' designation indicates a dosing strategy or formulation designed to achieve therapeutic immunosuppression at lower systemic exposures, potentially reducing nephrotoxicity, neurotoxicity, and metabolic complications associated with standard tacrolimus dosing. This approach is used in solid organ transplantation to balance rejection prevention with tolerability.
Approved indications
- Prevention of organ rejection in solid organ transplant recipients (kidney, heart, liver, pancreas)
Common side effects
- Nephrotoxicity / renal impairment
- Neurotoxicity (tremor, headache, confusion)
- Hyperglycemia / new-onset diabetes
- Hypertension
- Infection
- Hyperkalemia
Key clinical trials
- Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation (PHASE2)
- Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation (PHASE2)
- Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant (PHASE4)
- A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients (PHASE4)
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:
- Very Low Tacrolimus CI brief — competitive landscape report
- Very Low Tacrolimus updates RSS · CI watch RSS
- Ronaldo de Matos Esmeraldo, MD portfolio CI