Drugs / Sonrotoclax
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed mantle cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | — | mantle cell lymphoma | 2025-11-26 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax” beonemedicines.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | BEQALZI | — | 2026-05-13 | fda.gov ↗ |
| Filed | China (NMPA) | — | relapsed/refractory CLL | 2025-05-07 | “Sonrotoclax BGB-11417-202: Filed in China for the treatment of relapsed/refractory (R/R) CLL.” beonemedicines.com ↗ |
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT07855991 | Oct 2026 → Feb 2027 expected | — | BeOne Medicines | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07628881 | Jun → Sep 2026 overdue | — | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT07548255 | Apr 2026 → Mar 2029 expected | mantle cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07141511 | Sep 2025 → Feb 2026 | — | BeOne Medicines | Completed | No outcome recorded |
| Phase 1 | NCT06859008 | Aug 2025 → Jan 2029 expected | MALT lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma +2 | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06543043 | Aug → Oct 2024 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT05844111 | May → Jun 2023 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04883957 | Jul 2021 → Sep 2026 | neoplasm of mature B-cells | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04277637 | Mar 2020 → May 2027 expected | neoplasm of mature B-cells | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 1/27 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07687004 | Aug 2026 → Aug 2027 expected | plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07638787 | Jun 2026 → Sep 2027 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06697184 | Jan 2025 → Nov 2029 expected | B-cell chronic lymphocytic leukemia, mantle cell lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06634589 | Nov 2024 → Dec 2028 expected | B-cell non-Hodgkin lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05471843 | Sep 2022 → Jul 2025 overdue | mantle cell lymphoma | BeOne Medicines | Active not recruiting | Met primary |
| Phase 1/2 | NCT04973605 | Sep 2021 → Nov 2026 expected | refractory plasma cell neoplasm | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04771130 | May 2021 → Aug 2028 expected | acute myeloid leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 220 trials · 1 met primary | ||||||
| Phase 2 | NCT07812246 | Aug 2027 → Aug 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | City of Hope Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07674810 | Dec 2026 → Apr 2027 expected | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07799220 | Sep 2026 → Sep 2028 expected | mantle cell lymphoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07341191 | Aug 2026 → Dec 2029 expected | mantle cell lymphoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07508995 | Aug 2026 → Jul 2031 expected | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07682415 | Jun 2026 → Dec 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Yi Shuhua | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07671378 | Jun 2026 → Dec 2027 expected | B-cell chronic lymphocytic leukemia | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07548710 | May 2026 → May 2027 expected | acute myeloid leukemia | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07335887 | Jan 2026 → Feb 2028 expected | AL amyloidosis | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06547866 | Dec 2025 → Dec 2028 expected | Waldenstrom macroglobulinemia | French Innovative Leukemia Organisation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06839053 | Jun 2025 → Aug 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06849713 | May 2025 → Mar 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06854003 | Apr 2025 → Nov 2029 expected | mantle cell lymphoma | Christine Ryan | Recruiting | No outcome recorded |
| Phase 2 | NCT06637501 | Nov 2024 → Nov 2026 expected | B-cell chronic lymphocytic leukemia | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06497062 | Oct 2024 → Oct 2027 expected | acute myeloid leukemia | Shanghai Jiao Tong University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06463691 | Aug 2024 → Dec 2028 expected | — | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06367374 | May 2024 → Feb 2030 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05952037 | Oct 2023 → Sep 2026 overdue | Waldenstrom macroglobulinemia | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05479994 | Oct 2022 → Jan 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeiGene | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04271956 | Feb 2020 → Aug 2026 overdue | Richter transformation | German CLL Study Group | Recruiting | Met primary |
| Phase 35 trials | ||||||
| Phase 3 | NCT07321652 | Apr 2026 → Sep 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT07277231 | Jan 2026 → Feb 2031 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06943872 | Jun 2025 → Sep 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06742996 | Mar 2025 → Aug 2028 expected | mantle cell lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06073821 | Nov 2023 → Feb 2032 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | BeOne Medicines | Results BeOne Medicines’ Foundational Hematology Franchise Leads Next Era of B-Cell Cancer Innovation at EHA 2026 beonemedicines.com ↗
These data are complemented by results from the all-oral combination of BRUKINSA® (zanubrutinib) plus next-generation BCL2 inhibitor BEQALZI™ (sonrotoclax; ZS), which continue to demonstrate rapid, deep, durable responses across multiple B-cell malignancies. |
| 2026-05-29 | BeOne Medicines | Results BeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 2026 beonemedicines.com ↗
BRUKINSA plus next-generation BCL2 inhibitor sonrotoclax (ZS) delivered deep, durable, and rapid uMRD responses, raising the bar for potential time-limited treatments in CLL |
| 2026-05-21 | BeOne Medicines | Results BeOne Medicines Sets the Pace in Oncology at ASCO and EHA 2026 with 60+ Abstracts beonemedicines.com ↗
First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetect |
| 2026-05-13 | BeOne Medicines | Regulatory BeOne Medicines’ BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma beonemedicines.com ↗ |
| 2026-01-06 | BeOne Medicines | Regulatory BeOne Medicines’ Novel BCL2 Inhibitor, Sonrotoclax, Achieves First-in-World Approval in R/R MCL and R/R CLL/SLL beonemedicines.com ↗
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced the first-in-world approval of sonrotoclax, its foundational, next-generation BCL2 inhibitor, for adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) globally. |
| 2025-12-07 | BeOne Medicines | Results Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies beonemedicines.com ↗
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies. |
| 2025-11-26 | BeOne Medicines | Regulatory U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma beonemedicines.com ↗ |
| 2025-10-13 | BeOne Medicines | Regulatory BeOne Medicines’ Sonrotoclax Granted Breakthrough Therapy Designation by U.S. FDA beonemedicines.com ↗
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). |
| 2025-08-29 | BeOne Medicines | Results BeOne Medicines Announces Positive Topline Results for Sonrotoclax in Relapsed or Refractory Mantle Cell Lymphoma (MCL) beonemedicines.com ↗
Study met its primary endpoint of overall response rate (ORR), demonstrating clinically meaningful responses in rare B-cell lymphoma with high unmet need |
| 2025-06-26 | BeOne Medicines | Results BeOne Medicines Showcases Groundbreaking Oncology Pipeline at R&D Day beonemedicines.com ↗
Meanwhile, early data show the combination of sonrotoclax and BRUKINSA has demonstrated compelling efficacy and the potential to offer a best-in-class fixed-duration treatment in CLL, setting the stage for a possible new standard of care. |
| 2025-06-12 | BeOne Medicines | Results BeOne Medicines Showcases Breakthrough Data in CLL and MCL at EHA 2025 beonemedicines.com ↗
Phase 1 study of BCL2 inhibitor sonrotoclax plus BRUKINSA® elicited deep responses – 96% ORR in R/R CLL and 79% ORR in R/R MCL patients – with no new safety signals in the latest results |
| 2024-12-09 | BeOne Medicines | Results BeiGene Advances Leadership in CLL at ASH 2024 with New Data From Its Hematology Franchise Including BRUKINSA® and Novel Pipeline Assets beonemedicines.com ↗ |
| 2024-11-05 | BeOne Medicines | Results BeiGene Highlights Innovative Hematology Portfolio Across B-cell Malignancies at ASH 2024 beonemedicines.com ↗
Oral presentation highlights continued deep and durable responses and manageable tolerability observed in Phase 1 study of BCL2 inhibitor, sonrotoclax, in combination with BRUKINSA for patients with treatment-naïve CLL/SLL |
| 2024-05-14 | BeOne Medicines | Results BeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024 beonemedicines.com ↗
Oral presentation of a Phase 1 study of BeiGene’s novel BCL2 inhibitor sonrotoclax (BGB-11417) in combination with BRUKINSA, demonstrating deep and durable responses with a tolerable safety profile in patients with R/R CLL/SLL |
| 2023-11-28 | BeOne Medicines | Results BeiGene to Present New Data Highlighting Hematology Portfolio and Pipeline Strengths at ASH 2023 beonemedicines.com ↗
Presentations highlight promising clinical activity of sonrotoclax, BeiGene’s investigational B-cell lymphoma 2 (BCL2) inhibitor, in three Phase 1/2 studies |
| 2023-06-09 | BeOne Medicines | Results BeiGene Highlights Promising Data from Blood Cancer Portfolio and Pipeline at the European Hematology Association Hybrid Congress beonemedicines.com ↗
Early results for BTK-targeted CDAC (BGB-16673) and BCL-2 inhibitor (BGB-11417) in various B-cell malignancies illustrate promise of pipeline |
| 2023-05-25 | BeOne Medicines | Results BeiGene Presentations at the 2023 ASCO Annual Meeting Reinforce Promise Across Oncology Portfolio beonemedicines.com ↗
These results include data for BeiGene’s cornerstone therapies, BRUKINSA® (zanubrutinib) and tislelizumab, as well as early results for BeiGene’s OX40 agonist and BCL-2 inhibitor. |
| 2022-06-10 | BeOne Medicines | Results BeiGene Highlights Growing Portfolio and Pipeline Targeting Hematologic Malignancies at European Hematology Association 2022 Congress beonemedicines.com ↗
Preliminary data from an ongoing Phase 1b/2 global, multi-center dose escalation and expansion study evaluating BGB-11417 plus azacytidine in patients with AML demonstrated the combination to be generally well-tolerated with the majority of complete responses observed by the end of Cycle 1. |
All press releases naming this drug 18 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sonrotoclax | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07674810 ↗ |
| Known as | BGB-11417 | “A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone...” NCT04973605 ↗ |
| Known as | SON | “For all the participants who are eligible for this trial, Sonrotoclax (SON): 20 mg/day on Day 1, 40 mg/day on Day 2, 80 mg/day on Day 3, 160 mg/day on Day 4, and 320 mg/day on...” NCT07548710 ↗ |
| Action | Inhibit | “Sonrotoclax（BGB-11417), a Bcl-2 Inhibitor” NCT04271956 ↗ |
| Modality | Other / unclassified | “A BCL 2 Protein Inhibitor” NCT06854003 ↗ |
| Route | Oral | “Sonrotoclax 320 mg QD po” NCT04271956 ↗ |
| Target | BCL2 | “Bcl-2 Inhibitor Sonrotoclax (BGB-11417)” NCT04277637 ↗ |