{"id":"adx-324-dose-level-1","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ADAR (adenosine deaminase acting on RNA) enzymes catalyze A-to-I editing of RNA transcripts, which affects protein diversity and immune signaling. By inhibiting ADAR activity, ADX-324 alters the RNA editing landscape in immune cells and other tissues, potentially reducing pathogenic immune activation or inflammatory responses. This mechanism is being explored in autoimmune and inflammatory conditions.","oneSentence":"ADX-324 is an ADAR inhibitor that reduces adenosine-to-inosine RNA editing to modulate immune and inflammatory responses.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:00:09.876Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Autoimmune or inflammatory disease (specific indication not publicly detailed for Phase 3)"}]},"trialDetails":[{"nctId":"NCT05691361","phase":"PHASE1, PHASE2","title":"Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"ADARx Pharmaceuticals, Inc.","startDate":"2022-12-14","conditions":"Hereditary Angioedema","enrollment":53},{"nctId":"NCT07428499","phase":"PHASE3","title":"Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)","status":"NOT_YET_RECRUITING","sponsor":"ADARx Pharmaceuticals, Inc.","startDate":"2026-04-01","conditions":"Hereditary Angioedema (HAE), Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2","enrollment":90},{"nctId":"NCT06960213","phase":"PHASE3","title":"STOP-HAE: A Phase 3 Study of ADX-324 in HAE","status":"RECRUITING","sponsor":"ADARx Pharmaceuticals, Inc.","startDate":"2025-08-28","conditions":"Hereditary Angioedema, HAE, Hereditary Angioedema - Type 1","enrollment":90}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"ADX-324 Dose Level 1","genericName":"ADX-324 Dose Level 1","companyName":"ADARx Pharmaceuticals, Inc.","companyId":"adarx-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ADX-324 Dose Level 1 is being studied in a Phase 3 extension study for the treatment of Hereditary Angioedema (HAE). The study is targeting prekallikrein with ADX-324.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}