{"id":"arct-810","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"ARCT-810 delivers self-amplifying RNA that produces arginase-1, an enzyme that depletes arginine in the tumor microenvironment. By reducing arginine availability, the drug suppresses T cell function and promotes an immunosuppressive state, potentially enhancing anti-tumor immunity through immune modulation. This approach leverages RNA technology to achieve localized protein production with potential systemic effects.","oneSentence":"ARCT-810 is a self-amplifying RNA (saRNA) therapeutic that encodes a secreted form of arginase-1 to modulate immune responses in cancer.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T03:57:06.742Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced solid tumors (Phase 2 development)"}]},"trialDetails":[{"nctId":"NCT05526066","phase":"PHASE2","title":"Study for Adolescents and Adults With Ornithine Transcarbamylase Deficiency to Evaluate Safety and Tolerability of ARCT-810","status":"TERMINATED","sponsor":"Arcturus Therapeutics, Inc.","startDate":"2022-10-17","conditions":"Ornithine Transcarbamylase Deficiency, OTC Deficiency, OTCD","enrollment":8},{"nctId":"NCT06488313","phase":"PHASE2","title":"A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD","status":"RECRUITING","sponsor":"Arcturus Therapeutics, Inc.","startDate":"2024-11-04","conditions":"OTC Deficiency, Ornithine Transcarbamylase Deficiency, OTCD","enrollment":9},{"nctId":"NCT04442347","phase":"PHASE1","title":"Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency","status":"COMPLETED","sponsor":"Arcturus Therapeutics, Inc.","startDate":"2020-11-03","conditions":"Ornithine Transcarbamylase Deficiency","enrollment":16},{"nctId":"NCT04416126","phase":"PHASE1","title":"Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Arcturus Therapeutics, Inc.","startDate":"2020-06-01","conditions":"Ornithine Transcarbamylase Deficiency","enrollment":30}],"_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_2","status":"active","brandName":"ARCT-810","genericName":"ARCT-810","companyName":"Arcturus Therapeutics, Inc.","companyId":"arcturus-therapeutics-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"ARCT-810 is a self-amplifying RNA (saRNA) therapeutic that encodes a secreted form of arginase-1 to modulate immune responses in cancer. Used for Advanced solid tumors (Phase 2 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}