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TacroBell SR cap.
TacroBell SR is a sustained-release formulation of tacrolimus that suppresses T-cell activation and proliferation by inhibiting calcineurin phosphatase.
TacroBell SR is a sustained-release formulation of tacrolimus that suppresses T-cell activation and proliferation by inhibiting calcineurin phosphatase. Used for Organ transplant rejection prophylaxis (renal, cardiac, hepatic), Autoimmune and inflammatory conditions (atopic dermatitis, psoriasis).
At a glance
| Generic name | TacroBell SR cap. |
|---|---|
| Also known as | Tacrolimus SR cap. |
| Sponsor | Chong Kun Dang Pharmaceutical |
| 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 inhibits calcineurin, a phosphatase required for dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This prevents IL-2 and other cytokine gene transcription, thereby suppressing T-cell mediated immune responses. The SR (sustained-release) formulation provides prolonged drug exposure with potentially improved tolerability and compliance compared to immediate-release formulations.
Approved indications
- Organ transplant rejection prophylaxis (renal, cardiac, hepatic)
- Autoimmune and inflammatory conditions (atopic dermatitis, psoriasis)
Common side effects
- Nephrotoxicity
- Neurotoxicity (tremor, headache)
- Hypertension
- Hyperglycemia
- Infection
- Gastrointestinal disturbances
Key clinical trials
- Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients (PHASE4)
- Study to Evaluate the Efficacy and Safety of Tacrolimus in Kidney Transplant Recipients (BLOSSOM) (PHASE4)
- Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL) (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:
- TacroBell SR cap. CI brief — competitive landscape report
- TacroBell SR cap. updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI