{"id":"lotilaner-ophthalmic-solution-0-25","safety":{"commonSideEffects":[{"rate":null,"effect":"Instillation site irritation"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Eye discomfort"},{"rate":null,"effect":"Blurred vision"}]},"_chembl":{"chemblId":"CHEMBL3707310","moleculeType":"Small molecule","molecularWeight":"596.76"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Lotilaner works by antagonizing sigma receptors, which are involved in inflammatory pathways on the ocular surface. By blocking these receptors, it reduces the inflammatory response triggered by Demodex mites and their byproducts, thereby alleviating symptoms of ocular rosacea and blepharitis. The drug is formulated as a topical ophthalmic solution for direct application to the eye.","oneSentence":"Lotilaner is a non-selective sigma receptor antagonist that reduces ocular surface inflammation and irritation associated with Demodex mites.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:53:05.473Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Demodex blepharitis"},{"name":"Ocular rosacea"}]},"trialDetails":[{"nctId":"NCT05454956","phase":"PHASE2","title":"Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD","status":"COMPLETED","sponsor":"Tarsus Pharmaceuticals, Inc.","startDate":"2022-08-03","conditions":"Meibomian Gland Dysfunction, Blepharitis, Demodex Infestation","enrollment":39},{"nctId":"NCT06182358","phase":"PHASE4","title":"Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers","status":"COMPLETED","sponsor":"Tarsus Pharmaceuticals, Inc.","startDate":"2023-12-27","conditions":"Demodex Blepharitis","enrollment":145},{"nctId":"NCT05138861","phase":"PHASE1","title":"A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects","status":"COMPLETED","sponsor":"Tarsus Pharmaceuticals, Inc.","startDate":"2021-02-09","conditions":"Healthy","enrollment":24},{"nctId":"NCT06054217","phase":"PHASE2","title":"Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tarsus Pharmaceuticals, Inc.","startDate":"2023-08-01","conditions":"Meibomian Gland Dysfunction, Demodex Infestation of Eyelid, Blepharitis","enrollment":36},{"nctId":"NCT04475432","phase":"PHASE2, PHASE3","title":"Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis","status":"COMPLETED","sponsor":"Tarsus Pharmaceuticals, Inc.","startDate":"2020-09-09","conditions":"Blepharitis","enrollment":421},{"nctId":"NCT04784091","phase":"PHASE3","title":"Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis","status":"COMPLETED","sponsor":"Tarsus Pharmaceuticals, Inc.","startDate":"2021-04-29","conditions":"Blepharitis","enrollment":412}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":24,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Lotilaner ophthalmic solution, 0.25%","genericName":"Lotilaner ophthalmic solution, 0.25%","companyName":"Tarsus Pharmaceuticals, Inc.","companyId":"tarsus-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lotilaner is a non-selective sigma receptor antagonist that reduces ocular surface inflammation and irritation associated with Demodex mites. Used for Demodex blepharitis, Ocular rosacea.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}