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Tacrolimus modified-release
Tacrolimus modified-release works by inhibiting calcineurin, which is involved in the activation of T-lymphocytes.
Tacrolimus modified-release works by inhibiting calcineurin, which is involved in the activation of T-lymphocytes. Used for Prevention of organ rejection in kidney transplant patients.
At a glance
| Generic name | Tacrolimus modified-release |
|---|---|
| Also known as | Advagraf, FK506MR, MR4 |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting calcineurin, tacrolimus modified-release suppresses the immune system's response, which can help prevent organ rejection in transplant patients. This is achieved by blocking the transcription of interleukin-2, a key cytokine involved in T-cell activation.
Approved indications
- Prevention of organ rejection in kidney transplant patients
Common side effects
- Diarrhea
- Nausea
- Headache
- Tremor
- Hypertension
Key clinical trials
- Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients (PHASE4)
- Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE) (NA)
- Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (PHASE2)
- Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants (PHASE4)
- Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant (PHASE3)
- Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation (PHASE3)
- A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids (PHASE4)
- A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule (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 modified-release CI brief — competitive landscape report
- Tacrolimus modified-release updates RSS · CI watch RSS
- Hospital de Clinicas de Porto Alegre portfolio CI