{"id":"bcx7353","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Upper respiratory tract infection"}]},"_chembl":{"chemblId":"CHEMBL5189739","moleculeType":"Small molecule","molecularWeight":"562.57"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"BCX7353 inhibits Factor XIIa-driven contact system activation by blocking plasma kallikrein, thereby reducing excessive bradykinin production. This mechanism is intended to prevent the inflammatory and vascular permeability effects associated with bradykinin-mediated angioedema. The drug targets the intrinsic coagulation pathway without affecting thrombin generation or fibrinolysis.","oneSentence":"BCX7353 is a selective inhibitor of plasma kallikrein that reduces bradykinin generation in the contact system pathway.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T03:22:32.810Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hereditary angioedema (HAE) with C1-inhibitor deficiency or dysfunction"},{"name":"Angioedema prevention and acute attack management"}]},"trialDetails":[{"nctId":"NCT05453968","phase":"PHASE3","title":"Berotralstat Treatment in Children With Hereditary Angioedema","status":"ACTIVE_NOT_RECRUITING","sponsor":"BioCryst Pharmaceuticals","startDate":"2022-10-25","conditions":"Hereditary Angioedema, Pediatric","enrollment":29},{"nctId":"NCT04933721","phase":"PHASE3","title":"Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies","status":"ENROLLING_BY_INVITATION","sponsor":"BioCryst Pharmaceuticals","startDate":"2021-07-23","conditions":"Hereditary Angioedema, HAE","enrollment":139},{"nctId":"NCT03873116","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2018-12-27","conditions":"Hereditary Angioedema, HAE","enrollment":19},{"nctId":"NCT03485911","phase":"PHASE3","title":"Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2018-02-06","conditions":"Hereditary Angioedema, HAE","enrollment":121},{"nctId":"NCT03472040","phase":"PHASE2, PHASE3","title":"A Long Term Safety Study of BCX7353 in Hereditary Angioedema","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2018-02-16","conditions":"Hereditary Angioedema, HAE, Prophylaxis","enrollment":387},{"nctId":"NCT03240133","phase":"PHASE2","title":"Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2017-07-31","conditions":"Hereditary Angioedema (HAE)","enrollment":58},{"nctId":"NCT02870972","phase":"PHASE2","title":"Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2016-08","conditions":"Hereditary Angioedema (HAE)","enrollment":75},{"nctId":"NCT04428632","phase":"","title":"Oral Berotralstat Expanded Access Program","status":"APPROVED_FOR_MARKETING","sponsor":"BioCryst Pharmaceuticals","startDate":"","conditions":"Hereditary Angioedema, HAE, Prophylaxis","enrollment":""},{"nctId":"NCT03202784","phase":"PHASE1","title":"A Relative Bioavailability Study of Two Formulations of BCX7353","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2017-02-27","conditions":"Hereditary Angioedema","enrollment":24},{"nctId":"NCT03136237","phase":"PHASE1","title":"A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2017-02-17","conditions":"Hereditary Angioedema","enrollment":54},{"nctId":"NCT02819102","phase":"PHASE1","title":"An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2016-03","conditions":"Hereditary Angioedema","enrollment":20},{"nctId":"NCT02448264","phase":"PHASE1","title":"First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers","status":"COMPLETED","sponsor":"BioCryst Pharmaceuticals","startDate":"2015-05","conditions":"Hereditary Angioedema","enrollment":122}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"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_2","status":"active","brandName":"BCX7353","genericName":"BCX7353","companyName":"BioCryst Pharmaceuticals","companyId":"biocryst-pharmaceuticals","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BCX7353 is a small molecule used in the treatment of Hereditary Angioedema (HAE) and its prophylaxis, particularly in pediatric patients. BCX7353 is also being studied for its potential effects on cytochrome P450 enzyme activity.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":4,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}