{"id":"nova22007-ciclosporin","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation or burning"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Systemic immunosuppression (with systemic use)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ciclosporin binds to cyclophilin and inhibits the phosphatase calcineurin, preventing dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This blocks the transcription of pro-inflammatory cytokines such as IL-2, TNF-α, and IFN-γ, leading to broad immunosuppression. It is used in conditions where immune-mediated inflammation drives pathology.","oneSentence":"Ciclosporin suppresses T-cell activation and proliferation by inhibiting calcineurin, thereby reducing inflammatory immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:33.017Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease (keratoconjunctivitis sicca)"},{"name":"Uveitis"},{"name":"Other immune-mediated ocular inflammatory conditions"}]},"trialDetails":[{"nctId":"NCT04144413","phase":"PHASE3","title":"3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)","status":"COMPLETED","sponsor":"Santen SAS","startDate":"2019-05-31","conditions":"Dry Eye Disease With Severe Keratitis","enrollment":350},{"nctId":"NCT01751126","phase":"PHASE3","title":"Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis","status":"COMPLETED","sponsor":"Santen SAS","startDate":"2013-04-29","conditions":"Vernal Keratoconjunctivitis","enrollment":169},{"nctId":"NCT00328653","phase":"PHASE2, PHASE3","title":"Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)","status":"COMPLETED","sponsor":"Santen SAS","startDate":"2006-05","conditions":"Conjunctivitis, Vernal","enrollment":118},{"nctId":"NCT00739349","phase":"PHASE2","title":"NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye","status":"COMPLETED","sponsor":"Santen SAS","startDate":"2008-08","conditions":"Dry Eye","enrollment":132},{"nctId":"NCT00814515","phase":"PHASE3","title":"Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome","status":"COMPLETED","sponsor":"Santen SAS","startDate":"2007-09","conditions":"Moderate to Severe Dry Eye Syndrome","enrollment":482},{"nctId":"NCT00426023","phase":"PHASE3","title":"Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis","status":"COMPLETED","sponsor":"Campus Bio-Medico University","startDate":"2007-02","conditions":"Vernal Keratoconjunctivitis","enrollment":48}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"NOVA22007 ''Ciclosporin''","genericName":"NOVA22007 ''Ciclosporin''","companyName":"Santen SAS","companyId":"santen-sas","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ciclosporin suppresses T-cell activation and proliferation by inhibiting calcineurin, thereby reducing inflammatory immune responses. Used for Dry eye disease (keratoconjunctivitis sicca), Uveitis, Other immune-mediated ocular inflammatory conditions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}