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Priya Life Science Compound trial record
Compound · clinical trials

Sonrotoclax clinical trials

Also listed in trial records as BGB-11417, Sonrtotoclax, BGB11417, BCL-2 indibitor
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 28 trials in our China, USA, Italy, UK, Germany, France, Spain, Australia, Brazil, Poland, Canada, South Korea, Israel, Austria, Netherlands, Sweden, Czechia, Japan, Turkey, Belgium, Denmark, Ireland and Singapore registers that name Sonrotoclax as an intervention. Synced 9 Nov 2026
28Current trials
15Recruiting now
15Lead sponsors
23Country registers
At a glance

Sonrotoclax is named as an intervention in 28 current clinical trials in our China, USA, Italy, UK, Germany, France, Spain, Australia, Brazil, Poland, Canada, South Korea, Israel, Austria, Netherlands, Sweden, Czechia, Japan, Turkey, Belgium, Denmark, Ireland and Singapore registers. 15 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is BeOne Medicines (12). The most-studied condition is Chronic Lymphocytic Leukemia.

Where Sonrotoclax is approved

All regulators →

Of the three regulators tracked here, the first to approve Sonrotoclax was the US, on 13 May 2026.

USUnited States (FDA)
13 May 2026
Beqalzi
NDA220711 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Sonrotoclax patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Sonrotoclax, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Beqalzi
  • 1 listed patent; the last listed expires 29 Apr 2039 (US 11420968).
  • Latest patent on the drug substance itself: 29 Apr 2039 (US 11420968).
  • Exclusivity NCE: New chemical entity, until 13 May 2031.
See the Orange Book listing for NDA 220711

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

How Sonrotoclax works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • B-cell chronic lymphocytic leukemiaPhase 3
  • Mantle cell lymphomaPhase 3
  • AL amyloidosisPhase 2
  • Richter transformationPhase 2
  • Waldenstrom macroglobulinemiaPhase 2
  • Acute myeloid leukemiaPhase 2
  • Follicular lymphomaPhase 2
  • Myelodysplastic syndromePhase 1/2
  • Plasma cell myelomaPhase 1/2
  • Acute myeloid leukemia by FAB classificationPhase 1
12 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL5314951, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13354, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Sonrotoclax

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting1554%
  • Not yet open621%
  • Active, closed725%

Trials by phase

  • Phase 21450%
  • Phase 1/2829%
  • Phase 3518%
  • Phase 114%
01

Clinical trials of Sonrotoclax

28 trials
StudyPhaseStatusLead sponsorRegisters
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
NCT06742996 · Mantle Cell Lymphoma, B Cell Lymphoma
Phase 3 Recruiting BeOne Medicines UK, USA, China, Germany, France, Spain, Italy, Poland, Austria, Turkey, Brazil, Japan, South Korea, Australia
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)
NCT06943872 · Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase 3 Recruiting BeOne Medicines Ireland, UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Sweden, Denmark, Poland, Austria, Czechia, Canada, Brazil, Japan, South Korea, Australia, Israel
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT07277231 · Chronic Lymphocytic Leukemia
Phase 3 Recruiting BeOne Medicines UK, USA, China, Germany, France, Spain, Italy, Netherlands, Sweden, Poland, Czechia, Canada, Brazil, South Korea, Australia
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL
NCT07321652 · ClinicalTrials.gov ↗ · Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Phase 3 Recruiting Alliance for Clinical Trials in Oncology Israel
Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment With or Without Sonrotoclax for Patients With Richter Transformation
NCT04271956 · ClinicalTrials.gov ↗ · Richter Transformation
Phase 2 Recruiting German CLL Study Group Germany, Denmark, Austria
Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
NCT06463691 · ClinicalTrials.gov ↗ · MCL
Phase 2 Recruiting Tianjin Medical University Cancer Institute and Hospital China
BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma
NCT06854003 · ClinicalTrials.gov ↗ · Mantle Cell Lymphoma, Lymphoma
Phase 2 Recruiting Christine Ryan Israel
Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis
NCT07335887 · ClinicalTrials.gov ↗ · AL Amyloidosis (AL), t(11;14) Positive
Phase 2 Recruiting Peking University People's Hospital China
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
NCT07341191 · ClinicalTrials.gov ↗ · Mantle Cell Lymphoma
Phase 2 Recruiting Canadian Cancer Trials Group Canada
Study of SA+X in the Treatment of Newly Diagnosed AML
NCT07548710 · ClinicalTrials.gov ↗ · Acute Myeloid Leukemia
Phase 2 Recruiting Ruijin Hospital China
A Study of BGB-11417 in Participants With Myeloid Malignancies
NCT04771130 · Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm
Phase 1/2 Recruiting BeOne Medicines UK, USA, China, Germany, France, Spain, Italy, South Korea, Australia
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
NCT04973605 · Relapsed/Refractory Multiple Myeloma
Phase 1/2 Recruiting BeOne Medicines UK, USA, China, Germany, France, Spain, Italy, Canada, Brazil, South Korea, Singapore, Australia
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
NCT06634589 · B-cell Malignancy, Relapsed Cancer, Refractory Cancer
Phase 1/2 Recruiting BeOne Medicines USA, China, Germany, Italy, Poland, Brazil, Australia
A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
NCT06697184 · Chronic Lymphocytic Leukemia, CLL, Mantle Cell Lymphoma
Phase 1/2 Recruiting BeOne Medicines UK, USA, China, France, Brazil, Australia
Sonrotoclax Plus Azacitidine in Patients With MDS-IB2
NCT07885397 · ClinicalTrials.gov ↗ · Myelodysplastic Syndromes, High Risk
Phase 1/2 Recruiting Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine China
Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia
NCT06547866 · ClinicalTrials.gov ↗ · Waldenstrom Macroglobulinemia
Phase 2 Not yet open French Innovative Leukemia Organisation France
A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia
NCT07573670 · Newly Diagnosed Mixed Phenotype Acute Leukemia
Phase 2 Not yet open The First Affiliated Hospital of Soochow University China
Zanubrutinib Induction Followed by Delayed Fixed-Duration Combination With Sonrotoclax for CLL/SLL:Stop Trial 2.0
NCT07682415 · ClinicalTrials.gov ↗ · CLL / SLL
Phase 2 Not yet open Yi Shuhua China
Sonrotoclax, Glofitamab, Gemcitabine, and Oxaliplatin for Relapsed or Refractory Large B-Cell Lymphoma
NCT07774234 · ClinicalTrials.gov ↗ · Large B-Cell Lymphoma (LBCL), High-grade B-cell Lymphoma
Phase 2 Not yet open The First Affiliated Hospital of Soochow University China
Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL
NCT07638787 · ClinicalTrials.gov ↗ · Large B-cell Lymphoma
Phase 1/2 Not yet open Ruijin Hospital China
Sonrotoclax and BCMA Bispecific Antibody in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Genetic Stratification
NCT07687004 · ClinicalTrials.gov ↗ · Multiple Myeloma (MM)
Phase 1/2 Not yet open Institute of Hematology & Blood Diseases Hospital, China China
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) Phase 3 Active, closed BeOne Medicines UK, USA, China, Germany, France, Spain, Italy, Netherlands, Sweden, Poland, Austria, Czechia, Turkey, Canada, Brazil, Japan, South Korea, Australia, Israel
Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT05479994 · ClinicalTrials.gov ↗ · Leukemia, Lymphoma, Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Phase 2 Active, closed BeiGene China
A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
NCT05952037 · Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
Phase 2 Active, closed BeOne Medicines UK, USA, China, France, Spain, Italy, Canada, Australia
Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
NCT06497062 · ClinicalTrials.gov ↗ · Acute Myeloid Leukemia
Phase 2 Active, closed Shanghai Jiao Tong University School of Medicine China
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT06637501 · Chronic Lymphocytic Leukemia
Phase 2 Active, closed BeOne Medicines USA, China, Spain, Italy, Poland, Brazil
Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
NCT05471843 · Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma
Phase 1/2 Active, closed BeOne Medicines UK, USA, China, Germany, France, Spain, Italy, Belgium, Poland, Turkey, Brazil, Israel
Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
NCT04277637 · Mature B-Cell Malignancies
Phase 1 Active, closed BeOne Medicines UK, USA, Germany, Spain, Italy, Australia

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Sonrotoclax

34 conditions
Chronic Lymphocytic Leukemia5Mantle Cell Lymphoma5Acute Myeloid Leukemia3Small Lymphocytic Lymphoma2Waldenstrom Macroglobulinemia2CLL2MCL2Lymphoma2B Cell Lymphoma1Refractory Mantle Cell Lymphoma (MCL)1Relapsed Mantle Cell Lymphoma1Mature B-Cell Malignancies1
All 34 conditions
Condition (as registered)Trials
Chronic Lymphocytic Leukemia5
Mantle Cell Lymphoma5
Acute Myeloid Leukemia3
Small Lymphocytic Lymphoma2
Waldenstrom Macroglobulinemia2
CLL2
MCL2
Lymphoma2
B Cell Lymphoma1
Refractory Mantle Cell Lymphoma (MCL)1
Relapsed Mantle Cell Lymphoma1
Mature B-Cell Malignancies1
Waldenstrom's Macroglobulinemia Recurrent1
Waldenstrom's Macroglobulinemia Refractory1
Relapsed/Refractory Multiple Myeloma1
Myelodysplastic Syndromes1
Myelodysplastic/Myeloproliferative Neoplasm1
B-cell Malignancy1
Relapsed Cancer1
Refractory Cancer1
B-cell Lymphoma1
Myelodysplastic Syndromes, High Risk1
AL Amyloidosis (AL)1
t(11;14) Positive1
Leukemia1
Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma1
Large B-cell Lymphoma1
Multiple Myeloma (MM)1
Newly Diagnosed Mixed Phenotype Acute Leukemia1
CLL / SLL1
Large B-Cell Lymphoma (LBCL)1
High-grade B-cell Lymphoma1
Richter Transformation1
Small Lymphocytic Leukemia1
05

Related compounds

06

Questions about Sonrotoclax trials

How many clinical trials are testing Sonrotoclax?

28 current trials in our China, USA, Italy, UK, Germany, France, Spain, Australia, Brazil, Poland, Canada, South Korea, Israel, Austria, Netherlands, Sweden, Czechia, Japan, Turkey, Belgium, Denmark, Ireland and Singapore registers name Sonrotoclax (also registered as BGB-11417) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Sonrotoclax trials recruiting patients?

Yes. 15 of the 28 trials are recruiting: 11 with sites in China, 7 with sites in USA, 6 with sites in Italy, 6 with sites in UK, 7 with sites in Germany, 6 with sites in France, 5 with sites in Spain, 7 with sites in Australia, 6 with sites in Brazil, 4 with sites in Poland, 4 with sites in Canada, 5 with sites in South Korea, 3 with sites in Israel, 3 with sites in Austria, 2 with sites in Netherlands, 2 with sites in Sweden, 2 with sites in Czechia, 2 with sites in Japan, 1 with sites in Turkey, 1 with sites in Belgium, 2 with sites in Denmark, 1 with sites in Ireland and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Sonrotoclax clinical trials?

BeOne Medicines (12), Ruijin Hospital (2), The First Affiliated Hospital of Soochow University (2) and Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (1), among 15 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Are there Sonrotoclax clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Sonrotoclax works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Sonrotoclax works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Sonrotoclax (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.