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Calcineurin inhibitor therapy
Calcineurin inhibitors suppress T-cell activation by blocking the phosphatase calcineurin, preventing the dephosphorylation and nuclear translocation of NFAT transcription factors required for cytokine production.
Calcineurin inhibitors suppress T-cell activation by blocking the phosphatase calcineurin, preventing the dephosphorylation and nuclear translocation of NFAT transcription factors required for cytokine production. Used for Organ transplant rejection prophylaxis, Autoimmune and inflammatory disorders.
At a glance
| Generic name | Calcineurin inhibitor therapy |
|---|---|
| Also known as | tacrolimus, cyclosporine |
| Sponsor | Andrew B Adams |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
These agents inhibit calcineurin, a serine/threonine phosphatase essential for T-cell receptor signaling. By blocking calcineurin, they prevent the activation and proliferation of T lymphocytes, thereby reducing immune-mediated inflammation and rejection responses. This mechanism makes them effective immunosuppressants in transplantation and autoimmune conditions.
Approved indications
- Organ transplant rejection prophylaxis
- Autoimmune and inflammatory disorders
Common side effects
- Nephrotoxicity
- Hypertension
- Neurotoxicity (tremor, headache)
- Hyperglycemia
- Gingival hyperplasia
- Infections
Key clinical trials
- Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation (PHASE1, PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (PHASE2)
- Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
- Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction (PHASE4)
- A Study to Evaluate Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN) (PHASE2, PHASE3)
- Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) (PHASE1, PHASE2)
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:
- Calcineurin inhibitor therapy CI brief — competitive landscape report
- Calcineurin inhibitor therapy updates RSS · CI watch RSS
- Andrew B Adams portfolio CI