Sonrotoclax
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.
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.
1.Sonrotoclax occupies the BH3 groove of BCL-2
- 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: www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma. Doses are for orientation; the current label governs.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: sonrotoclax. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
- 13 May 2026ApprovalUS
Accelerated approval in MCL; priority review, Project Orbis source
Approvals
| Region | Year | Indication |
|---|---|---|
| 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) |
| Adverse event |
|---|
| Neutropenia Most common grade ≥3 event in MCL and CLL studies |
| Tumour lysis syndrome Mitigated by 4-week ramp |
| Diarrhoea, nausea Mostly low grade |
Rates read from the source. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Sonrotoclax" OR ABSTRACT:"Sonrotoclax" OR TITLE:"Beqalzi" OR ABSTRACT:"Beqalzi" OR TITLE:"BGB-11417" OR ABSTRACT:"BGB-11417") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sonrotoclax, not a curated reading list.
Pages like this
not linked directly; found by shared links- TrialCAPTIVATE
Shares MRD-guided treatment duration in CLL, BTK inhibitor + venetoclax, fixed duration, BCL-2, Venetoclax.
- ProductZanubrutinib
Shares CELESTIAL-TNCLL, MRD-guided treatment duration in CLL, BTK inhibitor + venetoclax, fixed duration, BeOne Medicines (formerly BeiGene).
- PersonAnthony Letai
Shares BH3 profiling (functional apoptosis testing), Intrinsic apoptosis (BCL-2 family), BCL-2, Venetoclax.
- ProductBGB-16673
Shares BTK degraders to pre-empt resistance in frontline CLL, BeOne Medicines (formerly BeiGene), Mantle cell lymphoma, Chronic lymphocytic leukaemia.
- ProductAcalabrutinib
Shares BTK degraders to pre-empt resistance in frontline CLL, BTK inhibitor + venetoclax, fixed duration, Mantle cell lymphoma, Chronic lymphocytic leukaemia.
- TrialVIALE-A
Shares Tumour lysis syndrome (TLS), Intrinsic apoptosis (BCL-2 family), BCL-2, Venetoclax.
- TrialGLOW
Shares BTK inhibitor + venetoclax, fixed duration, BCL-2, Venetoclax, Chronic lymphocytic leukaemia.
- TrialCLL14
Shares Tumour lysis syndrome (TLS), BCL-2, Venetoclax, Chronic lymphocytic leukaemia.