# Sonrotoclax

Source: https://onco.cc/drugs/sonrotoclax/  
OnCo record `sonrotoclax` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- 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: China 2025: Relapsed/refractory MCL and CLL/SLL after BTK inhibitor; US 2026: Relapsed/refractory mantle cell lymphoma after ≥2 lines including a BTK inhibitor (accelerated)
- Dosing: Oral; 4-week ramp-up then 320 mg once daily until progression (MCL label); CLL trials use 160-320 mg with zanubrutinib lead-in

## Sources

- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Sonrotoclax

## Connected records

- drugs: [Venetoclax](https://onco.cc/drugs/venetoclax/)
- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Chronic lymphocytic leukaemia, first treatment](https://onco.cc/cancers/cll-treatment-naive/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Mantle cell lymphoma](https://onco.cc/cancers/mantle-cell-lymphoma/), [Relapsed or refractory chronic lymphocytic leukaemia](https://onco.cc/cancers/cll-relapsed/)
- technologies: [BCL-2 inhibitors](https://onco.cc/technologies/bcl2-inhibitors/), [BH3 profiling (functional apoptosis testing)](https://onco.cc/technologies/bh3-profiling/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BAX](https://onco.cc/targets/bax/), [BCL-2](https://onco.cc/targets/bcl2/), [BIM (BCL2L11)](https://onco.cc/targets/bim/)
- companies: [BeOne Medicines (formerly BeiGene)](https://onco.cc/companies/beone/)
- pathways: [Intrinsic apoptosis (BCL-2 family)](https://onco.cc/pathways/apoptosis-bcl2/)
- terms: [Tumour lysis syndrome (TLS)](https://onco.cc/terms/tumor-lysis-syndrome/)
- trials: [A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Darat](https://onco.cc/trials/nct04973605/), [A Study of BGB-11417 in Participants With Myeloid Malignancies](https://onco.cc/trials/nct04771130/), [A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia](https://onco.cc/trials/nct05952037/), [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)](https://onco.cc/trials/nct06943872/), [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](https://onco.cc/trials/nct06634589/), [A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia](https://onco.cc/trials/nct07277231/), [A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia](https://onco.cc/trials/nct06637501/), [A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refrac](https://onco.cc/trials/nct06742996/), [A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.](https://onco.cc/trials/nct06697184/), [CELESTIAL-TNCLL](https://onco.cc/trials/celestial-tncll/), [Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma](https://onco.cc/trials/nct05479994/), [Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma](https://onco.cc/trials/nct05471843/)
- pairings: [BTK inhibitor + venetoclax, fixed duration](https://onco.cc/pairings/btki-plus-venetoclax-fixed-duration/)
- ideas: [BTK degraders to pre-empt resistance in frontline CLL](https://onco.cc/ideas/idea-btk-degrader-frontline/), [MRD-guided treatment duration in CLL](https://onco.cc/ideas/idea-mrd-guided-stop-cll/)
- biomarkers: [BCL2 G101V and the other venetoclax binding-site mutations](https://onco.cc/biomarkers/bcl2-g101v/)

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