TheraRadar
Data updated: May 26, 2026

BEQALZI (sonrotoclax)

Approved 2026-05-13
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2026-05-13
Routes
ORAL
Dosage Forms
TABLET

Companies

BEONE MEDICINES USA
Active Ingredient: SONROTOCLAX

BEQALZI Approval History

Original
New Indication
New Form
Label Update
4 FDA actions from 2026 to 2026
May 2026 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter

What BEQALZI Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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Clinical Trial Registry

23 trials
Trial Sponsor ID Phase Status Title
NCT06943872 BGB-11417-303 2024-517131-52-00, CLL-RR1 Ph 3 recruiting 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)
NCT07277231 BGB-11417-304 2025-524366-21-00 Ph 3 recruiting A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT04973605 BGB-11417-105 2023-507751-30-00, 2021-003614-39 Ph 1, Ph 2 recruiting 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
NCT06634589 BGB-16673-104 2024-516234-35-00, CTR20244676 Ph 1, Ph 2 recruiting A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
NCT06073821 BGB-11417-301 CTR20241195 Ph 3 active not recruiting Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
NCT06742996 BGB-11417-302 2024-515593-27-00, CTR20250207 Ph 3 recruiting 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)
NCT06497062 BGB-11417-2001-IIT Ph 2 active not recruiting Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
NCT07548710 SAXUM_2026 Ph 2 recruiting Study of SA+X in the Treatment of Newly Diagnosed AML
NCT06839053 RG1124587 NCI-2025-00319, 20623 Ph 2 recruiting Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
NCT07141511 BG-71332-101 Ph 1 completed 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
NCT06637501 BGB-11417-204 2024-513970-23-00 Ph 2 active not recruiting A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT06859008 24273 NCI-2025-01388, 24273 Ph 1 recruiting Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
NCT04277637 BGB-11417-101 2024-515592-35-00, 2020-004641-37 Ph 1 active not recruiting Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
NCT07341191 I245 Ph 2 recruiting Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
NCT06854003 BRAZAN 24-654 Ph 2 recruiting 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
NCT07335887 2025PHD030-002 Ph 2 not yet recruiting Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis
NCT07321652 A042302 Ph 3 not yet recruiting Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL
NCT05952037 BGB-11417-203 U1111-1291-4524, CTR20232718 Ph 2 active not recruiting A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
NCT06697184 BGB-11417-108 Ph 1, Ph 2 active not recruiting A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
NCT06849713 BOSon 25-007 Ph 2 recruiting Zanubrutinib, Obinutuzumab, and Sonrotoclax in Previously Untreated Patients With CLL or SLL
NCT04271956 CLL-RT1 CLL-RT1 2023-504653-12-00 Ph 2 recruiting Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation
NCT06543043 BGB-11417-107 QSC302214 Ph 1 completed A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
NCT06367374 BGB-11417-2002-IIT；BDH-CLL-004 Ph 2 not yet recruiting MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BEQALZI FDA Label Details

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Data Sources

FDA Approval: NDA220711 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.