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This mechanism is particularly relevant in cancers with FGFR alterations, including certain lung, gastric, and other solid malignancies.","oneSentence":"AK0529 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:00:21.774Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"FGFR-altered solid tumors (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT06942299","phase":"PHASE2","title":"A Study of AK0529 in Adults Patients Hospitalized With RSV Infection","status":"COMPLETED","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2023-07-20","conditions":"Respiratory Syncytial Virus Infections","enrollment":25},{"nctId":"NCT06775405","phase":"PHASE3","title":"A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants","status":"RECRUITING","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2024-02-29","conditions":"Respiratory Synctial Virus Infections","enrollment":180},{"nctId":"NCT02654171","phase":"PHASE2","title":"Viral Inhibition in Children for Treatment of RSV","status":"COMPLETED","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2016-05-27","conditions":"RESPIRATORY SYNCYTIAL VIRUS INFECTIONS","enrollment":72},{"nctId":"NCT04231968","phase":"PHASE3","title":"A Study of AK0529 in Chinese Infants Hospitalized With RSV","status":"COMPLETED","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2020-09-22","conditions":"Respiratory Syncytial Virus Infections","enrollment":311},{"nctId":"NCT04788017","phase":"PHASE1","title":"A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects","status":"COMPLETED","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2021-03-24","conditions":"Healthy Subjects","enrollment":24},{"nctId":"NCT03322800","phase":"PHASE1","title":"A Study of AK0529 to Evaluate Pharmacokinetics and Safety in Chinese Healthy Volunteers","status":"COMPLETED","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2017-10-23","conditions":"Healthy","enrollment":51},{"nctId":"NCT03699202","phase":"PHASE2","title":"Anti-RSV Study in Chinese Patients (ASCENT)","status":"UNKNOWN","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2019-03-29","conditions":"Respiratory Syncytial Virus Infections","enrollment":160},{"nctId":"NCT03400995","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529","status":"COMPLETED","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2018-01-05","conditions":"Healthy","enrollment":7},{"nctId":"NCT02460016","phase":"PHASE1","title":"A Study of AK0529 in Infants Hospitalized With RSV","status":"TERMINATED","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2015-08-28","conditions":"Respiratory Syncytial Virus Infections","enrollment":1},{"nctId":"NCT02297594","phase":"PHASE1","title":"Safety, Tolerability and PK Study of AK0529 in Healthy Human","status":"COMPLETED","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2014-10","conditions":"Respiratory Syncytial Virus Infections","enrollment":74}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["AK0529 pellets","ziresovir","Ziresovir","AK0529 capsule"],"phase":"phase_3","status":"active","brandName":"AK0529","genericName":"AK0529","companyName":"Shanghai Ark Biopharmaceutical Co., Ltd.","companyId":"shanghai-ark-biopharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AK0529 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells. Used for FGFR-altered solid tumors (Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":6,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}