Beqalzi

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

LymphomaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaNewly DiagnosedMantle Cell LymphomaRelapsed/refractory Multiple MyelomaLarge B-Cell LymphomaMacroglobulinemiaRichter TransformationB-Cell MalignancyMultiple Myeloma (MM)Large B-Cell Lymphoma (LBCL)CLLMature B-Cell MalignanciesAL Amyloidosis (AL)

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

1

Beqalzi

BBeOne Medicines

Phase 3

12

Zofran

Novartis

Preclinical

23

Norvir

AbbVie

Preclinical

14

Cabenuva

GSK

Preclinical

15

Emend

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

Preclinical

16

Kenalog

BBausch Health Americas, Inc.

Preclinical

17

Nuvigil

NNuvo Research GmbH

Preclinical

18

Elitek

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

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—Show 33 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia8 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

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

Show 5 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

A Multicenter Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax (BOSon) or Tacabrutideg (BGB-16673), Obinutuzumab, and Sonrotoclax (DOSon) in Treatment-Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruiting·MMassachusetts General Hospital·Phase 2·NCT06849713·80 enrolled

A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.

Recruiting·BeiGene·Preclinical·NCT06697184·258 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

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 Lymphoma4 trials

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

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT07341191·40 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

Show 1 more trial

A Phase II Study of MRD-guided Zanubrutinib, Obinutuzumab, and Sonrotoclax (BOSon) for Previously Untreated Transplant-ineligible Patients With Mantle Cell Lymphoma

Not yet recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07799220·45 enrolled

Acute Myeloid Leukemia3 trials

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

A Phase 1/2a, Open-Label, Dose Finding and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sonrotoclax (BGB-11417) in Combination With Other Agents in Pediatric Patients Aged 6 Months to 17 Years, With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia

Not yet recruiting·BBeOne Medicines·Preclinical·NCT07770698·30 enrolled

Clinical Study of Sonrotoclax Combined With Azacitidine Plus Individualized Targeted Drugs in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia

Recruiting·RRuijin Hospital·Phase 2·NCT07548710·205 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

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

13 more indications

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

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

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

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Phase 2 Study of Fixed-Duration Zanubrutinib and Sonrotoclax (Z+S) All-Oral Combination Therapy in CLL/SLL Patients in 1st Relapse After Initial Fixed-Duration Novel Therapy (ZeuS-2 Trial)

Not yet recruiting·CCity of Hope Medical Center·Phase 2·NCT07812246·44 enrolled

Richter Transformation1 trial

A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of Zanubrutinib (BGB-3111), a BTK Inhibitor, Plus Tislelizumab (BGB-A317), a PD1 Inhibitor, for Treatment of Patients With Richter Transformation With or Without Sonrotoclax（BGB-11417), a Bcl-2 Inhibitor (CLL-RT1-trial of the GCLLSG).

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

Large B-Cell Lymphoma (LBCL)1 trial

A Single-Center, Single-Arm, Open-Label, Phase II Clinical Trial of Sonrotoclax, Glofitamab, Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Large B-Cell Lymphoma

Not yet recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT07774234·39 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

AL Amyloidosis (AL)1 trial

An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis

Recruiting·PPeking University People's Hospital·Phase 2·NCT07335887·39 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·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·Phase 1·NCT06543043·30 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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