Beqalzi

(Sonrotoclax)

Phase 3Small molecule

BBeOne Medicines

Beqalzi is one of 292 small molecule programs targeting Macroglobulinemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

291

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

MacroglobulinemiaActive, not recruiting

AL AmyloidosisActive, not recruiting

LymphomaActive, not recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Mantle Cell LymphomaRecruiting

Multiple MyelomaActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Chronic Lymphocytic LeukemiaActive, not recruiting

Large B-Cell LymphomaNot yet recruiting

MacroglobulinemiaPhase 2

Active, not recruiting

AL AmyloidosisPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaPhase 3

Active, not recruiting

Myelodysplastic SyndromePhase 1

Active, not recruiting

Mantle Cell LymphomaPhase 3

Recruiting

Multiple MyelomaPhase 1

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 3

Active, not recruiting

Large B-Cell LymphomaPreclinical

Not yet recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Beqalzi

BBeOne Medicines

Phase 3

1 2

Velban

EEastern Cooperative Oncology Group

Preclinical

15 3

Oncaspar

SServier

Preclinical

15 4

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 5

Tafasitamab

Incyte

Preclinical

7 6

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

Nuvigil

NNuvo Research GmbH

Preclinical

1 9

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—10

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Richter Transformation

NCT04271956

Q4 2026

PreclinicalRecruiting

Relapsed/refractory Multiple Myeloma

NCT04973605

Q2 2027

Phase 1Active, not recruiting

Mature B-Cell Malignancies

NCT04277637

Q4 2027

Phase 1/2Active, not recruiting

Blood Cancer

NCT06697184

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia6 trials

Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT06839053·20 enrolled

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Recruiting·BBeOne Medicines·Phase 3·NCT07277231·500 enrolled

A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia

Active, not recruiting·BBeOne Medicines·Phase 2·NCT06637501·94 enrolled

Show 3 more trials

A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Recruiting·BBeOne Medicines·Phase 3·NCT06943872·630 enrolled

Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT07321652·466 enrolled

A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07674810·40 enrolled

Mantle Cell Lymphoma3 trials

Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy

Not yet recruiting·CCanadian Cancer Trials Group·Phase 2·NCT07341191·40 enrolled

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

Recruiting·CChristine Ryan·Phase 2·NCT06854003·60 enrolled

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Recruiting·BBeOne Medicines·Phase 3·NCT06742996·300 enrolled

Blood Cancer1 trial

A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

Active, not recruiting· BeiGene logo

BeiGene·Phase 1/2·NCT06697184·56 enrolled

Richter Transformation1 trial

Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation

Recruiting·GGerman CLL Study Group·Phase 2·NCT04271956·83 enrolled

AL amyloidosis1 trial

Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT07335887·39 enrolled

13 more indications

Acute Myeloid Leukemia1 trial

Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Not yet recruiting·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT06497062·47 enrolled

Macroglobulinemia1 trial

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Active, not recruiting·BBeOne Medicines·Phase 2·NCT05952037·114 enrolled

Newly Diagnosed1 trial

MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06367374·66 enrolled

Adult1 trial

A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy Adults

Completed·BBeOne Medicines·Phase 1·NCT07141511·24 enrolled

SLL1 trial

Zanubrutinib, Obinutuzumab, and Sonrotoclax in Previously Untreated Patients With CLL or SLL

Recruiting·MMassachusetts General Hospital·Phase 2·NCT06849713·40 enrolled

Lymphoma1 trial

Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Recruiting·—·Phase 1·NCT06859008·37 enrolled

B-cell Malignancy1 trial

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Recruiting·BBeOne Medicines·Preclinical·NCT06634589·80 enrolled

Relapsed/Refractory Multiple Myeloma1 trial

A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone, Dexamethasone/Carfilzomib, Dexamethasone/Daratumumab, and Dexamethasone/Pomalidomide in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)

Recruiting·BBeOne Medicines·Preclinical·NCT04973605·246 enrolled

CLL1 trial

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Active, not recruiting·BBeOne Medicines·Phase 3·NCT06073821·652 enrolled

Multiple Myeloma (MM)1 trial

A Phase Ib/II, Non-Randomized, Biomarker-Stratified Umbrella Study of Chemotherapy-Free Strategies in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Status: Sonrotoclax and a BCMA/CD3 Bispecific Antibody (AL-005)

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07687004·50 enrolled

Large B-cell Lymphoma1 trial

A Single-Arm, Prospective Study of Pola-R-CHP Plus Sonrotoclax in Patients With Previously Untreated Large B-Cell Lymphoma (LBCL) With High BCL2 Expression / Double-Hit Lymphoma

Not yet recruiting·RRuijin Hospital·Preclinical·NCT07638787·40 enrolled

Mature B-cell Malignancies1 trial

A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

Active, not recruiting· BeiGene logo

BeiGene·Phase 1·NCT04277637·437 enrolled

Unspecified1 trial

A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers

Completed· BeiGene logo

BeiGene·Phase 1·NCT06543043·30 enrolled

Regulatory

FDA Approval Timeline[4]

May 13, 2026

BEQALZI

NDA NDA220711

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Sonrotoclax. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sonrotoclax compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sonrotoclax. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220711). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Beqalzi. U.S. Food & Drug Administration.
[6]
SEC EDGAR — BeOne Medicines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBeOne Medicines

Patent Landscape[5]

Patent Cliff

Apr 29, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11420968Apr 29, 2039

Beqalzi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Chronic Lymphocytic Leukemia6 trials

Mantle Cell Lymphoma3 trials

Blood Cancer1 trial

Richter Transformation1 trial

AL amyloidosis1 trial

Acute Myeloid Leukemia1 trial

Macroglobulinemia1 trial

Newly Diagnosed1 trial

Adult1 trial

SLL1 trial

Lymphoma1 trial

B-cell Malignancy1 trial

Relapsed/Refractory Multiple Myeloma1 trial

CLL1 trial

Multiple Myeloma (MM)1 trial

Large B-cell Lymphoma1 trial

Mature B-cell Malignancies1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News