Sonrotoclax
Also known as Beqalzi
BeOne Medicines Ltd. ONC BEIGF · Chronic Lymphocytic Leukemia; B Cell Lymphoma; CLL; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
4
From ClinicalTrials.gov
Latest FDA action
Approved
NDA220711,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- BeOne Medicines Ltd. ONC BEIGF Source: Company record for BeOne Medicines Ltd. (opens in a new tab)
- Indications
- Chronic Lymphocytic Leukemia; B Cell Lymphoma; CLL; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 220711 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 220711 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 11 Nov 20234 linked trials
- Filed Completed
- Approved Current stageFirst approval 13 May 2026
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Sonrotoclax. Editors add each one with its source.
Filed application
No filed application is on record for Sonrotoclax. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Sonrotoclax.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07277231ClinicalTrials.gov record for NCT07277231 (opens in a new tab) | A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia | Phase 3 | Recruiting | 500 (estimated) | Feb 2031 (estimated) | No |
| NCT06943872ClinicalTrials.gov record for NCT06943872 (opens in a new tab) | 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) | Phase 3 | Recruiting | 630 (estimated) | 30 Sep 2029 (estimated) | No |
| NCT06742996ClinicalTrials.gov record for NCT06742996 (opens in a new tab) | 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) | Phase 3 | Recruiting | 300 (estimated) | 31 Aug 2028 (estimated) | No |
| NCT06073821ClinicalTrials.gov record for NCT06073821 (opens in a new tab) | Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) | Phase 3 | Active, not recruiting | 652 (estimated) | Feb 2032 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA220711Action letter for NDA220711 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Sonrotoclax.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 220711 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07277231 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06943872 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06742996 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06073821 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA220711 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.