{"id":"pl-asa","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal bleeding"},{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PL-ASA uses PLx Pharma's proprietary Phospholipid Surfactant (PLS) technology to coat aspirin, which protects the gastric mucosa from direct contact with aspirin crystals. This formulation aims to preserve aspirin's antiplatelet mechanism of action (inhibition of cyclooxygenase and thromboxane A2 production) while significantly reducing upper gastrointestinal adverse events such as ulcers and bleeding.","oneSentence":"PL-ASA is a combination formulation of aspirin with a protective coating designed to reduce gastrointestinal irritation and bleeding risk while maintaining antiplatelet efficacy.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:00:30.790Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cardiovascular event prevention in patients at risk for aspirin-related gastrointestinal bleeding"}]},"trialDetails":[{"nctId":"NCT06710262","phase":"","title":"T-TAS® wS Method Comparison","status":"COMPLETED","sponsor":"Hikari Dx, Inc.","startDate":"2024-08-21","conditions":"Antiplatelet Therapy, Healthy Donors, Von Willebrand Disease (VWD)","enrollment":115},{"nctId":"NCT06803186","phase":"NA","title":"High Power Laser on Suboccipital Myoelectrical Activities and Quality of Life in Patients With Cervicogenic Headache","status":"NOT_YET_RECRUITING","sponsor":"Cairo University","startDate":"2025-01-31","conditions":"Cervicogenic Headache","enrollment":40},{"nctId":"NCT05870826","phase":"NA","title":"The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Low Back Pain","status":"COMPLETED","sponsor":"Istituto Ortopedico Rizzoli","startDate":"2022-03-21","conditions":"Non-specific Low Back Pain","enrollment":50},{"nctId":"NCT01646814","phase":"PHASE2","title":"Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects","status":"COMPLETED","sponsor":"PLx Pharma","startDate":"2012-09","conditions":"Gastroduodenal Ulceration","enrollment":247},{"nctId":"NCT05055752","phase":"PHASE1","title":"Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.","status":"COMPLETED","sponsor":"PLx Pharma","startDate":"2020-05-07","conditions":"Bioequivalence","enrollment":24},{"nctId":"NCT04811625","phase":"PHASE4","title":"Pharmacodynamic and Pharmacokinetic Study of PL-ASA","status":"COMPLETED","sponsor":"PLx Pharma","startDate":"2021-04-28","conditions":"Healthy Volunteers","enrollment":36},{"nctId":"NCT03621020","phase":"","title":"Clinical Performance Evaluation of T-TAS 01 PL Chip","status":"COMPLETED","sponsor":"Hikari Dx, Inc.","startDate":"2018-09-01","conditions":"Platelet Dysfunction, Von Willebrand Diseases, Healthy","enrollment":307},{"nctId":"NCT04008979","phase":"PHASE1","title":"Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex","status":"COMPLETED","sponsor":"PLx Pharma","startDate":"2008-02-11","conditions":"Bioequivalence","enrollment":32},{"nctId":"NCT01058902","phase":"PHASE3","title":"The Effect Of Aspirin On Survival in Lung Cancer","status":"WITHDRAWN","sponsor":"Liverpool Heart and Chest Hospital NHS Foundation Trust","startDate":"2010-08","conditions":"Non Small Cell Lung Cancer, Survival, Aspirin","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Enteric-coated Aspirin (EC-ASA)"],"phase":"marketed","status":"active","brandName":"PL-ASA","genericName":"PL-ASA","companyName":"PLx Pharma","companyId":"plx-pharma","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PL-ASA is a combination formulation of aspirin with a protective coating designed to reduce gastrointestinal irritation and bleeding risk while maintaining antiplatelet efficacy. Used for Cardiovascular event prevention in patients at risk for aspirin-related gastrointestinal bleeding.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}