{"id":"nova22007-ciclosporin-0-1","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation/burning"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Foreign body sensation"},{"rate":null,"effect":"Blurred vision"}]},"_chembl":{"chemblId":"CHEMBL335019","moleculeType":"Small molecule","molecularWeight":"339.48"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ciclosporin binds to cyclophilin and inhibits calcineurin, a phosphatase required for T-cell receptor signaling and IL-2 production. This suppresses the activation and proliferation of T-lymphocytes in ocular tissues, reducing inflammation. NOVA22007 is a 0.1% ophthalmic formulation designed for improved ocular penetration and therapeutic effect in dry eye disease.","oneSentence":"Ciclosporin is a calcineurin inhibitor that suppresses T-cell activation and reduces inflammatory cytokine production in the eye.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:23:13.426Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease (keratoconjunctivitis sicca)"}]},"trialDetails":[{"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}],"_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 0.1%)","genericName":"NOVA22007 (Ciclosporin 0.1%)","companyName":"Santen SAS","companyId":"santen-sas","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ciclosporin is a calcineurin inhibitor that suppresses T-cell activation and reduces inflammatory cytokine production in the eye. Used for Dry eye disease (keratoconjunctivitis sicca).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}