Last reviewed 2026-04-20 · How we verify

Sandimmune (cyclosporine)

Calcineurin inhibitor that suppresses T-cell activation by blocking IL-2 transcription, preventing organ transplant rejection.

Cyclosporine (Sandimmune/Neoral) revolutionized organ transplantation after its approval in 1983, discovered by Jean-François Borel at Sandoz. As the first calcineurin inhibitor, it made reliable transplant immunosuppression possible. Available generically, with the ophthalmic form (Restasis) used for dry eye disease.

At a glance

Mechanism of action

Cyclosporine revolutionized organ transplantation by enabling reliable immunosuppression. Discovered in a soil fungus sample by Jean-François Borel at Sandoz, it binds cyclophilin and the complex inhibits calcineurin, blocking T-cell activation and IL-2 production. Before cyclosporine, organ transplant survival rates were poor. It transformed transplantation into a routine procedure and also treats severe autoimmune conditions.

Approved indications

• Kawasaki's disease
• Keratoconjunctivitis sicca
• Prevention of Cardiac Transplant Rejection
• Prevention of Kidney Transplant Rejection
• Prevention of Liver Transplant Rejection
• Rheumatoid arthritis
• Severe Recalcitrant Psoriasis
• Tear film insufficiency

Common side effects

• Ocular burning
• Conjunctival hyperemia
• Discharge
• Epiphora
• Eye pain
• Foreign body sensation
• Pruritus
• Stinging
• Visual disturbance

Serious adverse events

• Severe angioedema
• Hypersensitivity
• Eye swelling
• Urticaria
• Face swelling
• Tongue swelling
• Pharyngeal edema
• Dyspnea
• Superficial injury of the eye

Key clinical trials

• Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis. (Phase 1)
• Multicenter Randomized Two Arms Study Evaluating the Efficacy of Prophylactic Rituximab in Adult EBV Negative Kidney Transplant Recipients on Incidence of EBV Primary Infection and Post-transplant Lym (Phase 4)
• Topical Cyclosporine and Disease Progression (Phase 4)
• A PHASE I/II STUDY OF RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH METHOTREXATE (MTX) AND CYCLOSPORINE (CPS) IN PATIENTS UNDERGOING MARROW TRANSPLANTATION FROM RELATED DONORS MISMATCHED FOR ONE HLA ANTIG (Phase 1)
• Prospektivt Randomiseret Dobbeltblindt Placebo-kontrolleret Studie af, Calciumkanalblokade påbegyndt Inden Operation: Med Henblik på at Forebygge Ciclosporin Induceret Nefropati Efter Lungetransplanta (Phase 4)
• A Multicenter, Randomized, Controlled, Open Phase Ib/ Ⅱ Study Evaluating the Efficacy and Safety of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Primary Membranous Nep (Phase 1)
• Ciclosporin + Antithymocyte Immunoglobulin + Avatrombpag Versus Ciclosporin + Avatrombpag for the Treatment of Severe Aplastic Anemia in the Elderly (Phase 4)
• Calcineurin Inhibitors Among Egyptian Renal Transplant Patients: a Pharmacognetic Based Study. (N/A)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Sandimmune CI brief — competitive landscape report
• Sandimmune updates RSS · CI watch RSS
• Novartis AG (originally Sandoz) portfolio CI