CALQUENCE (acalabrutinib)
CALQUENCE is indicated for the treatment of Previously untreated mantle cell lymphoma in patients ineligible for autologous hematopoietic stem cell transplantation (in combination with bendamustine and rituximab); Mantle cell lymphoma in patients who have received at least one prior therapy; Chronic lymphocytic leukemia; Small lymphocytic lymphoma.
How CALQUENCE Works
Acalabrutinib and its active metabolite function as small-molecule inhibitors of Bruton tyrosine kinase (BTK) by forming a covalent bond with a cysteine residue in the BTK active site. BTK is a critical signaling molecule in the B-cell antigen receptor and cytokine receptor pathways that regulate B-cell proliferation, trafficking, and adhesion. By blocking BTK enzymatic activity, the drug inhibits these downstream signaling pathways, thereby preventing the growth and survival of malignant B cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-10-31
- Patent Cliff
- 2036
- Revenue
- $967M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
CALQUENCE Approval History
What CALQUENCE Treats
4 indicationsCALQUENCE is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Previously untreated mantle cell lymphoma in patients ineligible for autologous hematopoietic stem cell transplantation (in combination with bendamustine and rituximab)
- Mantle cell lymphoma in patients who have received at least one prior therapy
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
CALQUENCE Target & Pathway
ProTarget
A kinase essential for B-cell development and signaling. BTK inhibitors block B-cell receptor signaling, making them highly effective in B-cell malignancies like chronic lymphocytic leukemia and mantle cell lymphoma.
CALQUENCE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CALQUENCE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CALQUENCE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CALQUENCE
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
112 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02362035 KEYNOTE145 results posted | ACE-LY-005 | Ph 1, Ph 2 | completed | ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies |
| NCT07582159 | 25409 NCI-2026-03205, 25409 | Ph 2 | not yet recruiting | Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT06136559 | 1026-011 2022-501697-19-00, U1111-1281-7895 | Ph 3 | recruiting | A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011) |
| 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 |
| NCT04657094 results posted | 20311 NCI-2020-10529, 20311 | Ph 2 | active not recruiting | Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia |
| NCT06564038 Soundtrack-E | D7407C00001 2024-515034-33-00 | Ph 1, Ph 2 | recruiting | A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies |
| NCT04115631 | EA4181 NCI-2019-05536, EA4181 | Ph 2 | active not recruiting | A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma |
| NCT02029443 results posted | ACE-CL-001 2023-509346-35-00, 2014-000440-15 | Ph 1, Ph 2 | active not recruiting | ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia |
| NCT05952024 ACRUE | D8227C00002 | Ph 2 | recruiting | Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL |
| NCT04978584 | 2021-0046 NCI-2021-04298, 2021-0046 | Ph 2 | active not recruiting | Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study |
| NCT04002947 | 190116 19-C-0116 | Ph 2 | recruiting | Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma |
| NCT03863184 results posted | 1807019439 | Ph 2 | active not recruiting | Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL |
| NCT03623373 results posted | 201809111 | Ph 2 | completed | Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma |
| NCT03328273 | ACE-CL-110 2016-003737-15 | Ph 1 | active not recruiting | A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) |
| NCT03932331 results posted | D8220C00007 2018L02939 | Ph 1, Ph 2 | active not recruiting | Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies |
| NCT07257055 | 2025-0423 NCI-2025-08762 | Ph 2 | recruiting | Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study |
| NCT04404088 | 2020-0034 NCI-2020-01922, 2020-0034 | Ph 2 | active not recruiting | Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma |
| NCT04189757 | 2019-0421 NCI-2019-07927, 2019-0421 | Ph 2 | active not recruiting | Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma |
| NCT06651970 | D8223C00016 | Ph 4 | recruiting | Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure |
| NCT04169737 | 2019-0565 NCI-2019-06675, 2019-0565 | Ph 2 | recruiting | Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT04560322 | 19-743 | Ph 2 | recruiting | Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL |
| NCT06428019 | M24-287 2024-512147-23-00 | Ph 3 | recruiting | A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL) |
| NCT04722172 | 20-503 | Ph 2 | active not recruiting | A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL |
| NCT04646395 | IELSG49 2019-004396-38 | Ph 2 | active not recruiting | Study of Acalabrutinib and Tafasitamab in MZL Patients |
| NCT04529772 ESCALADE | D8227C00001 2019-001755-39 | Ph 3 | active not recruiting | A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) |
| NCT02477696 results posted | ACE-CL-006 2023-509347-27-00, 2014-005530-64 | Ph 3 | active not recruiting | Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) |
| NCT05388006 | MC198B NCI-2022-02068, 20-006487 | Ph 2 | recruiting | Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT04462328 | 202009139 | Ph 1 | active not recruiting | Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma |
| NCT05256641 | 21-000979 NCI-2021-12421 | Ph 1, Ph 2 | recruiting | Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma |
| NCT04075292 results posted | D822BC00001 | Ph 3 | active not recruiting | Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia |
| NCT04624633 results posted | 20-394 | Ph 2 | active not recruiting | Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL |
| NCT04906902 | 21-059 | Ph 1, Ph 2 | active not recruiting | Acalabrutinib in CNSL |
| NCT05336812 | OSU-21193 NCI-2022-01752 | Ph 2 | recruiting | Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia |
| NCT05057494 MAJIC | D8220C00027 2023-505866-27-00, 2021-003936-10 | Ph 3 | active not recruiting | A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT02972840 | ACE-LY-308 2023-509354-58-00, 2015-005220-26 | Ph 3 | active not recruiting | A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL |
| NCT03946878 | 2018-0935 NCI-2019-02354, 2018-0935 | Ph 2 | active not recruiting | Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma |
| NCT03580928 AVO results posted | 18-226 1R01CA266298-01A1 | Ph 2 | active not recruiting | Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL |
| NCT04883437 | STUDY00002247 NCI-2021-00894, STUDY00002247 | Ph 2 | recruiting | Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas |
| NCT03516617 | MC168E NCI-2018-00591, 17-008161 | Ph 2 | recruiting | Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT07377578 | LP-168-CN302 | Ph 3 | recruiting | A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma |
| NCT04624906 BRAWM | 3242 | Ph 2 | active not recruiting | Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia |
| NCT05583149 results posted | 21-422 | Ph 2 | active not recruiting | Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas |
| NCT07024706 MAVRiC | D8220C00036 | Ph 2 | not yet recruiting | Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab |
| NCT04855695 | 21-040 | Ph 1, Ph 2 | recruiting | Avo In R/R And Previously Untreated MCL |
| NCT07014917 ESR-23-22182 | UCCC-HEM-23-01 | Ph 2 | recruiting | Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL |
| NCT06054776 | 22402 NCI-2023-06838, 22402 | Ph 2 | recruiting | Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma |
| NCT04604067 | SAKK 38/19 2020-003876-42 | Ph 2 | active not recruiting | Assessing a ctDNA and PET-oriented Therapy in Patients With DLBCL A Multicenter, Open-label, Phase II Trial. |
| NCT04505254 | 2019-1141 NCI-2020-05262, 2019-1141 | Ph 2 | active not recruiting | Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia |
| NCT02296918 | ACE-CL-003 | Ph 1 | completed | Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL |
| NCT06757647 | OSU-23058 NCI-2024-10481 | Ph 2 | recruiting | Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
Showing 50 of 112 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CALQUENCE FDA Label Details
Indications & Usage
FDA Label (PDF)CALQUENCE is indicated for the treatment of Previously untreated mantle cell lymphoma in patients ineligible for autologous hematopoietic stem cell transplantation (in combination with bendamustine and rituximab); Mantle cell lymphoma in patients who have received at least one prior therapy; Chronic lymphocytic leukemia; Small lymphocytic lymphoma.
CALQUENCE Patents & Exclusivity
Patents (10 active)
Exclusivity
Pro Intelligence Preview
Deep insights for CALQUENCE
Revenue Insights
- • Q4-2025: $967M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 73 active patents
Trial Analysis
- • 112 total trials
- • Stage: Growth
Competitive Landscape
- • 16 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment