{"id":"de-117","safety":{"commonSideEffects":[{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Eye irritation"},{"rate":null,"effect":"Blurred vision"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ROCK inhibitors modulate the cytoskeleton and cell contractility in ocular tissues, particularly enhancing conventional outflow facility in the eye. By inhibiting ROCK signaling, DE-117 increases the relaxation of trabecular meshwork cells and endothelial cells lining Schlemm's canal, thereby facilitating drainage of aqueous humor and lowering intraocular pressure. This mechanism differs from prostaglandin analogs and beta-blockers, offering a novel approach to glaucoma management.","oneSentence":"DE-117 is a selective rho kinase (ROCK) inhibitor that reduces intraocular pressure by improving aqueous humor outflow through the trabecular meshwork and Schlemm's canal.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:53.135Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Open-angle glaucoma"},{"name":"Ocular hypertension"}]},"trialDetails":[{"nctId":"NCT02981446","phase":"PHASE3","title":"A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT","status":"COMPLETED","sponsor":"Santen Pharmaceutical Co., Ltd.","startDate":"2017-01","conditions":"Open Angle Glaucoma or Ocular Hypertension","enrollment":370},{"nctId":"NCT03691649","phase":"PHASE3","title":"A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2018-09-14","conditions":"Glaucoma and Ocular Hypertension","enrollment":426},{"nctId":"NCT03697811","phase":"PHASE3","title":"DE-117 Spectrum 5 Study","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2018-09-27","conditions":"Primary Open-angle Glaucoma and Ocular Hypertension","enrollment":107},{"nctId":"NCT03691662","phase":"PHASE3","title":"A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2018-09-27","conditions":"Glaucoma and Ocular Hypertension","enrollment":417},{"nctId":"NCT03858894","phase":"PHASE2","title":"Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2019-01-28","conditions":"Primary Open-angle Glaucoma and Ocular Hypertension","enrollment":98},{"nctId":"NCT01654484","phase":"PHASE1, PHASE2","title":"A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2012-07","conditions":"Glaucoma and Ocular Hypertension","enrollment":60},{"nctId":"NCT02179008","phase":"PHASE2","title":"Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2014-06","conditions":"Open-angle Glaucoma, Ocular Hypertension","enrollment":184},{"nctId":"NCT01868126","phase":"PHASE2","title":"Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2013-05","conditions":"Open-angle Glaucoma or Ocular Hypertension","enrollment":91},{"nctId":"NCT02822729","phase":"PHASE3","title":"A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study","status":"COMPLETED","sponsor":"Santen Pharmaceutical Co., Ltd.","startDate":"2016-07-01","conditions":"Open Angle Glaucoma or Ocular Hypertension","enrollment":125},{"nctId":"NCT02822742","phase":"PHASE3","title":"A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study","status":"COMPLETED","sponsor":"Santen Pharmaceutical Co., Ltd.","startDate":"2016-07-02","conditions":"Primary Open Angle Glaucoma or Ocular Hypertension","enrollment":26},{"nctId":"NCT02623738","phase":"PHASE2, PHASE3","title":"A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-","status":"COMPLETED","sponsor":"Santen Pharmaceutical Co., Ltd.","startDate":"2015-12-06","conditions":"Primary Open Angle Glaucoma, Ocular Hypertension","enrollment":253},{"nctId":"NCT02650063","phase":"PHASE1","title":"A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -","status":"COMPLETED","sponsor":"Santen Pharmaceutical Co., Ltd.","startDate":"2015-12","conditions":"Healthy Male Adults","enrollment":14}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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":"DE-117","genericName":"DE-117","companyName":"Santen Inc.","companyId":"santen-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"DE-117 is a selective rho kinase (ROCK) inhibitor that reduces intraocular pressure by improving aqueous humor outflow through the trabecular meshwork and Schlemm's canal. Used for Open-angle glaucoma, Ocular hypertension.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}