{"id":"syl1001-ophthalmic-solution","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation or discomfort"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Eye pain"}]},"_chembl":{"chemblId":"CHEMBL2108251","moleculeType":"Oligosaccharide"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SYL1001 works by targeting and degrading TGF-β2 messenger RNA in ocular tissues, thereby reducing TGF-β2 protein levels. Elevated TGF-β2 is associated with increased intraocular pressure and glaucomatous damage. By reducing TGF-β2 expression, the drug aims to lower intraocular pressure and slow or prevent glaucomatous progression.","oneSentence":"SYL1001 is a small interfering RNA (siRNA) that silences the production of transforming growth factor-beta 2 (TGF-β2) to reduce intraocular pressure in glaucoma.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:37:00.461Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Open-angle glaucoma or ocular hypertension"}]},"trialDetails":[{"nctId":"NCT04819269","phase":"PHASE3","title":"Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome","status":"COMPLETED","sponsor":"Sylentis, S.A.","startDate":"2021-05-25","conditions":"Dry Eye Disease, Sjögren Syndrome","enrollment":203},{"nctId":"NCT05310422","phase":"PHASE3","title":"Safety Study of Tivanisiran to Treat Dry Eye","status":"COMPLETED","sponsor":"Sylentis, S.A.","startDate":"2022-03-24","conditions":"Dry Eye Disease","enrollment":301},{"nctId":"NCT03108664","phase":"PHASE3","title":"HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)","status":"COMPLETED","sponsor":"Sylentis, S.A.","startDate":"2017-05-18","conditions":"Dry Eye Disease","enrollment":330},{"nctId":"NCT02455999","phase":"PHASE2","title":"Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain","status":"COMPLETED","sponsor":"Sylentis, S.A.","startDate":"2015-06","conditions":"Ocular Pain, Dry Eye Syndrome","enrollment":66},{"nctId":"NCT01776658","phase":"PHASE1, PHASE2","title":"Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain","status":"COMPLETED","sponsor":"Sylentis, S.A.","startDate":"2012-11","conditions":"Ocular Pain, Dry Eye Syndrome","enrollment":60},{"nctId":"NCT01438281","phase":"PHASE1","title":"Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers","status":"COMPLETED","sponsor":"Sylentis, S.A.","startDate":"2011-07","conditions":"Ocular Pain, Dry Eye","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"SYL1001 ophthalmic solution","genericName":"SYL1001 ophthalmic solution","companyName":"Sylentis, S.A.","companyId":"sylentis-s-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SYL1001 is a small interfering RNA (siRNA) that silences the production of transforming growth factor-beta 2 (TGF-β2) to reduce intraocular pressure in glaucoma. Used for Open-angle glaucoma or ocular hypertension.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}