{"entity":{"id":"sonrotoclax","kind":"drug","name":"Sonrotoclax","aka":[],"tldr":"Sonrotoclax is a more potent, shorter-acting successor to venetoclax. It was approved for mantle cell lymphoma in May 2026 and is in late-stage trials with zanubrutinib for CLL.","summary":"Approved in China (late 2025) for relapsed MCL and CLL/SLL after BTK inhibitor, and in the US on 13 May 2026 (accelerated) for relapsed/refractory MCL after ≥2 lines including a BTK inhibitor (BGB-11417-201: ORR 52%, median DOR 15.8 months). In treatment-naive CLL, sonrotoclax + zanubrutinib (BGB-11417-101) produced uMRD in nearly all patients by 96 weeks; phase 3 CELESTIAL-TNCLL (vs venetoclax-obinutuzumab) completes 2026. Shorter half-life allows faster ramp-up and less overlapping myelosuppression.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Sonrotoclax"}],"tags":[],"related":["venetoclax"],"cancers":["cll","dlbcl"],"sections":[],"technologies":["kinase-inhibitors","bcl2-inhibitors"],"targets":["bcl2"],"drugs":[],"companies":["beone"],"institutions":[],"pathways":["apoptosis-bcl2"],"terms":["tumor-lysis-syndrome"],"trials":["celestial-tncll","nct06742996","nct06697184","nct05471843","nct04973605","nct06943872","nct04771130","nct07277231","nct05479994","nct06634589","nct06637501","nct05952037"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Beqalzi","code":"BGB-11417","modality":"Small-molecule BCL-2 inhibitor (second generation)","mechanism":"Selective BH3-mimetic BCL-2 inhibitor with higher potency and shorter half-life than venetoclax; active against venetoclax-resistant G101V BCL2 in preclinical models.","approvals":[{"region":"China","year":2025,"indication":"Relapsed/refractory MCL and CLL/SLL after BTK inhibitor"},{"region":"US","year":2026,"indication":"Relapsed/refractory mantle cell lymphoma after ≥2 lines including a BTK inhibitor (accelerated)"}],"mechanismSteps":["Sonrotoclax occupies the BH3 groove of BCL-2","Sequestered BIM/BAX are released","Mitochondrial outer membrane permeabilises; caspases activate","Rapid apoptosis of CLL/MCL cells (TLS precautions during 4-week ramp)"],"dosing":{"route":"Oral","schedule":"4-week ramp-up then 320 mg once daily until progression (MCL label); CLL trials use 160-320 mg with zanubrutinib lead-in","monitoring":"TLS during ramp-up, neutropenia, infections","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma"},"toxicity":[{"event":"Neutropenia","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma","note":"Most common grade ≥3 event in MCL and CLL studies"},{"event":"Tumour lysis syndrome","note":"Mitigated by 4-week ramp"},{"event":"Diarrhoea, nausea","note":"Mostly low grade"}],"access":[],"regulatoryEvents":[{"date":"2026-05-13","type":"accelerated-approval","region":"US","note":"Accelerated approval in MCL; priority review, Project Orbis The confirmatory requirement was still open 0.3 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma","indication":"Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor."}]},"route":"/drugs/sonrotoclax/","neighbours":{"drug":[{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"cll-treatment-naive","kind":"cancer","name":"Chronic lymphocytic leukaemia, first treatment","route":"/cancers/cll-treatment-naive/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-lymphoma/"},{"id":"cll-relapsed","kind":"cancer","name":"Relapsed or refractory chronic lymphocytic leukaemia","route":"/cancers/cll-relapsed/"}],"technology":[{"id":"bcl2-inhibitors","kind":"technology","name":"BCL-2 inhibitors","route":"/technologies/bcl2-inhibitors/"},{"id":"bh3-profiling","kind":"technology","name":"BH3 profiling (functional apoptosis testing)","route":"/technologies/bh3-profiling/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"bax","kind":"target","name":"BAX","route":"/targets/bax/"},{"id":"bcl2","kind":"target","name":"BCL-2","route":"/targets/bcl2/"},{"id":"bim","kind":"target","name":"BIM (BCL2L11)","route":"/targets/bim/"}],"company":[{"id":"beone","kind":"company","name":"BeOne Medicines (formerly BeiGene)","route":"/companies/beone/"}],"pathway":[{"id":"apoptosis-bcl2","kind":"pathway","name":"Intrinsic apoptosis (BCL-2 family)","route":"/pathways/apoptosis-bcl2/"}],"term":[{"id":"tumor-lysis-syndrome","kind":"term","name":"Tumour lysis syndrome (TLS)","route":"/terms/tumor-lysis-syndrome/"}],"trial":[{"id":"nct04973605","kind":"trial","name":"A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Darat","route":"/trials/nct04973605/"},{"id":"nct04771130","kind":"trial","name":"A Study of BGB-11417 in Participants With Myeloid Malignancies","route":"/trials/nct04771130/"},{"id":"nct05952037","kind":"trial","name":"A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia","route":"/trials/nct05952037/"},{"id":"nct06943872","kind":"trial","name":"A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)","route":"/trials/nct06943872/"},{"id":"nct06634589","kind":"trial","name":"A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","route":"/trials/nct06634589/"},{"id":"nct07277231","kind":"trial","name":"A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia","route":"/trials/nct07277231/"},{"id":"nct06637501","kind":"trial","name":"A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia","route":"/trials/nct06637501/"},{"id":"nct06742996","kind":"trial","name":"A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refrac","route":"/trials/nct06742996/"},{"id":"nct06697184","kind":"trial","name":"A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.","route":"/trials/nct06697184/"},{"id":"celestial-tncll","kind":"trial","name":"CELESTIAL-TNCLL","route":"/trials/celestial-tncll/"},{"id":"nct05479994","kind":"trial","name":"Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","route":"/trials/nct05479994/"},{"id":"nct05471843","kind":"trial","name":"Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma","route":"/trials/nct05471843/"}],"pairing":[{"id":"btki-plus-venetoclax-fixed-duration","kind":"pairing","name":"BTK inhibitor + venetoclax, fixed duration","route":"/pairings/btki-plus-venetoclax-fixed-duration/"}],"idea":[{"id":"idea-btk-degrader-frontline","kind":"idea","name":"BTK degraders to pre-empt resistance in frontline CLL","route":"/ideas/idea-btk-degrader-frontline/"},{"id":"idea-mrd-guided-stop-cll","kind":"idea","name":"MRD-guided treatment duration in CLL","route":"/ideas/idea-mrd-guided-stop-cll/"}],"biomarker":[{"id":"bcl2-g101v","kind":"biomarker","name":"BCL2 G101V and the other venetoclax binding-site mutations","route":"/biomarkers/bcl2-g101v/"}]}}