{"id":"hmpl-523","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Elevated liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL5095034","moleculeType":"Small molecule","molecularWeight":"482.61"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FAK is a non-receptor tyrosine kinase that plays a critical role in cell adhesion, migration, and survival pathways. By inhibiting FAK, HMPL-523 impairs tumor cell motility and promotes apoptosis, potentially reducing metastatic potential and enhancing anti-tumor immunity. This mechanism is particularly relevant in solid tumors where FAK-mediated signaling supports tumor progression and the immunosuppressive microenvironment.","oneSentence":"HMPL-523 is a selective inhibitor of focal adhesion kinase (FAK) that disrupts tumor cell adhesion and migration signaling.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:56.490Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced solid tumors (Phase 3 development)"},{"name":"Non-small cell lung cancer (NSCLC)"}]},"trialDetails":[{"nctId":"NCT05535933","phase":"PHASE2, PHASE3","title":"HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hutchison Medipharma Limited","startDate":"2022-09-30","conditions":"Warm Antibody Autoimmune Hemolytic Anemia","enrollment":110},{"nctId":"NCT03779113","phase":"PHASE1","title":"An Open-label, Dose Escalation Trial to Evaluate the Safety and 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Diseases","enrollment":""},{"nctId":"NCT05029635","phase":"PHASE3","title":"Phase III Study on HMPL-523 for Treatment of ITP","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hutchison Medipharma Limited","startDate":"2021-10-27","conditions":"Primary Immune Thrombocytopenia (ITP)","enrollment":272},{"nctId":"NCT02857998","phase":"PHASE1","title":"A Study of Hutchison MediPharma Limited(HMPL)-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms","status":"COMPLETED","sponsor":"Hutchison Medipharma Limited","startDate":"2016-12-27","conditions":"Mature B-cell Neoplasms","enrollment":134},{"nctId":"NCT03951623","phase":"PHASE1","title":"The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients","status":"COMPLETED","sponsor":"Hutchison Medipharma Limited","startDate":"2019-08-12","conditions":"Immune Thrombocytopenia (ITP)","enrollment":45},{"nctId":"NCT05781906","phase":"PHASE1","title":"Human Mass Balance of [14C]HMPL-523 in Healthy Adult Male Chinese Subjects","status":"COMPLETED","sponsor":"Hutchmed","startDate":"2023-02-08","conditions":"Imumune Thrombocytopenia(ITP) Human Mass Balance","enrollment":6},{"nctId":"NCT05318820","phase":"EARLY_PHASE1","title":"A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers","status":"COMPLETED","sponsor":"Hutchison Medipharma Limited","startDate":"2022-06-01","conditions":"Healthy Subject","enrollment":39},{"nctId":"NCT05720767","phase":"PHASE1","title":"HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study","status":"COMPLETED","sponsor":"Hutchmed","startDate":"2022-11-04","conditions":"Relapsed or Refractory Lymphoma","enrollment":28},{"nctId":"NCT05571787","phase":"PHASE1","title":"HMPL-523 Food Effect and Proton Pump Inhibitor Study","status":"COMPLETED","sponsor":"Hutchmed","startDate":"2022-07-13","conditions":"Relapsed or Refractory Lymphoma","enrollment":26},{"nctId":"NCT02503033","phase":"PHASE1","title":"A Study of HMPL-523 in Relapsed or Refractory Hematologic Malignancies","status":"UNKNOWN","sponsor":"Hutchison Medipharma Limited","startDate":"2015-11","conditions":"Hematologic Malignancies","enrollment":78},{"nctId":"NCT03483948","phase":"PHASE1","title":"Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia","status":"TERMINATED","sponsor":"Hutchison Medipharma Limited","startDate":"2018-10-09","conditions":"Acute Myeloid Leukemia","enrollment":7},{"nctId":"NCT02105129","phase":"PHASE1","title":"A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523","status":"COMPLETED","sponsor":"Hutchison Medipharma Limited","startDate":"2014-05","conditions":"Rheumatoid Arthritis (RA)","enrollment":118}],"_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":["HMPL-523 Acetate","sovleplenib","Sovleplenib","HMPL-523 acetate","HMPL-523 tablets"],"phase":"phase_3","status":"active","brandName":"HMPL-523","genericName":"HMPL-523","companyName":"Hutchison Medipharma Limited","companyId":"hutchison-medipharma-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HMPL-523 is a selective inhibitor of focal adhesion kinase (FAK) that disrupts tumor cell adhesion and migration signaling. Used for Advanced solid tumors (Phase 3 development), Non-small cell lung cancer (NSCLC).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":5,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}