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FKS518
FKS518 is a calcineurin inhibitor that suppresses T-cell activation by blocking the phosphatase calcineurin, thereby reducing immune-mediated rejection.
FKS518 is a calcineurin inhibitor that suppresses T-cell activation by blocking the phosphatase calcineurin, thereby reducing immune-mediated rejection. Used for Organ transplant rejection prevention, Autoimmune diseases (investigational).
At a glance
| Generic name | FKS518 |
|---|---|
| Also known as | Denosumab biosimilar |
| Sponsor | Fresenius Kabi SwissBioSim GmbH |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (via FKBP12 binding) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
FKS518 binds to FK-binding protein 12 (FKBP12) and inhibits calcineurin phosphatase activity, which prevents dephosphorylation and nuclear translocation of NFAT transcription factors required for T-cell cytokine production. This mechanism is similar to tacrolimus but with potentially improved pharmacokinetic properties. It is being developed as an immunosuppressant for transplantation and autoimmune conditions.
Approved indications
- Organ transplant rejection prevention
- Autoimmune diseases (investigational)
Common side effects
- Nephrotoxicity
- Neurotoxicity
- Hypertension
- Hyperglycemia
- Infections
Key clinical trials
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:
- FKS518 CI brief — competitive landscape report
- FKS518 updates RSS · CI watch RSS
- Fresenius Kabi SwissBioSim GmbH portfolio CI