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Tacrolimus targeted half-dose
Tacrolimus targeted half-dose is a Calcineurin inhibitor Small molecule drug developed by University Hospital, Tours. It is currently FDA-approved for Organ transplant rejection prophylaxis (kidney, heart, liver transplantation), Graft-versus-host disease prevention and treatment. Also known as: Advagraf®.
Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation by blocking the transcription of pro-inflammatory cytokines, thereby reducing immune rejection.
Tacrolimus is a small molecule inhibitor of the FK506-binding protein 1A, which is involved in the regulation of the immune system. It is used to treat conditions such as solid tumors, hematologic malignancies, delayed graft function, and de novo transplant disease, among others.
At a glance
| Generic name | Tacrolimus targeted half-dose |
|---|---|
| Also known as | Advagraf® |
| Sponsor | University Hospital, Tours |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus binds to the immunophilin FKBP12 and inhibits calcineurin phosphatase, preventing dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This blocks the transcription of interleukin-2 and other cytokines essential for T-cell proliferation and differentiation. The 'half-dose' formulation refers to a reduced-dose strategy, likely employed to minimize nephrotoxicity and other adverse effects while maintaining immunosuppressive efficacy in transplant recipients.
Approved indications
- Organ transplant rejection prophylaxis (kidney, heart, liver transplantation)
- Graft-versus-host disease prevention and treatment
Common side effects
- Nephrotoxicity / renal impairment
- Hypertension
- Hyperglycemia / new-onset diabetes
- Neurotoxicity (tremor, headache, confusion)
- Infections
- Hyperkalemia
- Gastrointestinal disturbances
Key clinical trials
- The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients (PHASE2)
- Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation (PHASE2)
- Belatacept Therapy for the Failing Renal Allograft (PHASE3)
- A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys (PHASE2, PHASE3)
- Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence (EARLY_PHASE1)
- Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE) (PHASE4)
- Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE) (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:
- Tacrolimus targeted half-dose CI brief — competitive landscape report
- Tacrolimus targeted half-dose updates RSS · CI watch RSS
- University Hospital, Tours portfolio CI
Frequently asked questions about Tacrolimus targeted half-dose
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Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin (protein phosphatase 2B)
- Manufacturer: University Hospital, Tours — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Organ transplant rejection prophylaxis (kidney, heart, liver transplantation)
- Indication: Drugs for Graft-versus-host disease prevention and treatment
- Also known as: Advagraf®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing