{"id":"bgb-16673","safety":{"commonSideEffects":[{"rate":null,"effect":"Hot flashes"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Vaginal dryness"}]},"_chembl":{"chemblId":"CHEMBL4209157","moleculeType":"Small molecule","molecularWeight":"478.43"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BGB-16673 functions as a SERD by binding to the estrogen receptor with high affinity and promoting its proteasomal degradation, thereby eliminating both ligand-dependent and ligand-independent estrogen receptor signaling. This mechanism is designed to overcome resistance to selective estrogen receptor modulators (SERMs) and aromatase inhibitors in hormone receptor-positive breast cancer. By completely degrading the receptor rather than merely blocking it, SERDs provide a more comprehensive suppression of estrogen receptor-mediated proliferation.","oneSentence":"BGB-16673 is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors, blocking estrogen-driven cancer cell growth.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:13.045Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer"}]},"trialDetails":[{"nctId":"NCT06846671","phase":"PHASE3","title":"A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors","status":"RECRUITING","sponsor":"BeOne Medicines","startDate":"2025-04-10","conditions":"CLL, Chronic Lymphocytic Leukemia","enrollment":250},{"nctId":"NCT05006716","phase":"PHASE1, PHASE2","title":"A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies","status":"RECRUITING","sponsor":"BeOne Medicines","startDate":"2021-09-13","conditions":"B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma","enrollment":614},{"nctId":"NCT06973187","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","status":"RECRUITING","sponsor":"BeOne Medicines","startDate":"2025-09-04","conditions":"Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma","enrollment":500},{"nctId":"NCT06634589","phase":"PHASE1, PHASE2","title":"A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","status":"RECRUITING","sponsor":"BeOne Medicines","startDate":"2024-11-27","conditions":"B-cell Malignancy, Relapsed Cancer, Refractory Cancer","enrollment":80},{"nctId":"NCT07005713","phase":"PHASE1","title":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Adults With Chronic Spontaneous Urticaria","status":"ACTIVE_NOT_RECRUITING","sponsor":"BeiGene","startDate":"2025-07-19","conditions":"Chronic Spontaneous Urticaria","enrollment":34},{"nctId":"NCT06970743","phase":"PHASE3","title":"A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors","status":"RECRUITING","sponsor":"BeOne Medicines","startDate":"2025-05-29","conditions":"Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma","enrollment":150},{"nctId":"NCT06906809","phase":"PHASE1","title":"Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants","status":"COMPLETED","sponsor":"BeiGene","startDate":"2025-04-03","conditions":"Healthy Volunteers","enrollment":37},{"nctId":"NCT06776679","phase":"PHASE1","title":"A Study of How [14C]-BGB-16673 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Participants","status":"COMPLETED","sponsor":"BeiGene","startDate":"2025-01-24","conditions":"Healthy Volunteers","enrollment":8},{"nctId":"NCT05294731","phase":"PHASE1, PHASE2","title":"Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader","status":"RECRUITING","sponsor":"BeiGene","startDate":"2022-05-06","conditions":"B-cell Malignancy, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma","enrollment":146}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"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":"BGB-16673","genericName":"BGB-16673","companyName":"BeOne Medicines","companyId":"beone-medicines","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BGB-16673 is a small molecule inhibitor of the serine/threonine-protein kinase B-raf, classified as an INHIBITOR. It is being evaluated by BeOne Medicines for the treatment of various conditions, including Chronic Spontaneous Urticaria, Chronic Lymphocytic Leukemia, and Small Lymphocytic Lymphoma, in clinical trials such as NCT07005713.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}