> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/acalabrutinib-maleate-bfe0df80-e311-4f23-9e92-799d6a8c070f > Record changed: 2026-10-13 # Acalabrutinib maleate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) First approval year 2020 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) ## Development status **First approval year** 2020 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) **Drug name** Acalabrutinib maleate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) **Molecular weight** 581.59 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) **Structure (SMILES)** CC#CC(=O)N1CCC\[C@H\]1c1nc(-c2ccc(C(=O)Nc3ccccn3)cc2)c2c(N)nccn12.O=C(O)/C=C\\C(=O)O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) ### Brand names (2) - calquence - Calquence ### Other names (14) - acalabrutinib maleate - Acalabrutinib maleate - Acalabrutinib maleate \[USAN\] - Acalabrutinib maleate \[WHO-DD\] - acalabrutinib maleate anhydrous - Acalabrutinib maleate anhydrous - acalabrutinib maleate monohydrate - Acalabrutinib maleate monohydrate - acalabrutinib maleate usan - acalabrutinib maleate who dd - calquence - Calquence - calquence maleate - Calquence maleate ## Identifiers **ATC classification codes** - L01EL02 Sources for recorded values Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1986808) **CAS registry numbers** - 2242394-65-4 **ChEMBL ID** CHEMBL4594293 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) **InChIKey** JWEQLWMZHJSMEC-AFJTUFCWSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594293) **PubChem compound IDs** - 126506029 **RxNorm IDs (RxCUI)** - 1986808 **FDA ingredient codes (UNII)** - LV51EK7IGP ## Regulatory information ### United States **Applicant** ASTRAZENECA **Approval date** 3 Aug 2022 **Application number** NDA216387 ### Other regulatory facts **Patents** 8 **Designations** 1 **Earliest recorded loss of exclusivity** 1 Jul 2036 **First in class** No **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Drug name stem** \-tinib #### Administration routes - Oral ### Mechanisms of action - **Mechanism** Tyrosine-protein kinase BTK inhibitor **Action type** Inhibitor **Target** Tyrosine-protein kinase BTK **Protein identifier** Q06187 ### Open Targets mechanisms - **Mechanism** Tyrosine-protein kinase BTK inhibitor **Action type** Inhibitor **Target** Tyrosine-protein kinase BTK ### Investigated indications (2) - **Condition** Leukemia, Lymphocytic, Chronic, B-Cell **Highest recorded phase** 4 **Condition identifier** EFO:0000095 **Subject identifier** D015451 - **Condition** Lymphoma, Mantle-Cell **Highest recorded phase** 4 **Condition identifier** EFO:1001469 **Subject identifier** D020522 ### Open Targets indications (4) - **Condition identifier** EFO\_0000095 - **Condition identifier** EFO\_1001469 - **Condition identifier** MONDO\_0004948 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0018876 **Highest recorded phase** 4 ### Reported adverse events (20) - **Event** acquired gene mutation **Reports** 3 **Reporting signal score** 9.00015 - **Event** aplastic anaemia **Reports** 4 **Reporting signal score** 8.24811 - **Event** atrial fibrillation **Reports** 20 **Reporting signal score** 19.9962 - **Event** chronic lymphocytic leukaemia recurrent **Reports** 3 **Reporting signal score** 10.1458 - **Event** covid-19 **Reports** 12 **Reporting signal score** 13.1545 - **Event** disease progression **Reports** 15 **Reporting signal score** 10.6776 - **Event** drug resistance **Reports** 15 **Reporting signal score** 25.7198 - **Event** febrile neutropenia **Reports** 17 **Reporting signal score** 17.0536 - **Event** haemoglobin abnormal **Reports** 4 **Reporting signal score** 8.39564 - **Event** leukocytosis **Reports** 9 **Reporting signal score** 13.3674 - **Event** leukostasis syndrome **Reports** 2 **Reporting signal score** 10.1508 - **Event** lymphocytosis **Reports** 5 **Reporting signal score** 14.3552 - **Event** malignant neoplasm progression **Reports** 24 **Reporting signal score** 34.6157 - **Event** mantle cell lymphoma recurrent **Reports** 2 **Reporting signal score** 7.98247 - **Event** myelodysplastic syndrome **Reports** 6 **Reporting signal score** 9.09997 - **Event** pseudomonal bacteraemia **Reports** 3 **Reporting signal score** 11.8002 - **Event** richter's syndrome **Reports** 3 **Reporting signal score** 11.488 - **Event** sars-cov-2 test negative **Reports** 2 **Reporting signal score** 8.43669 - **Event** tumour lysis syndrome **Reports** 6 **Reporting signal score** 12.1288 - **Event** white blood cell count abnormal **Reports** 5 **Reporting signal score** 11.7687 ## Chemical properties **Hydrogen bond acceptors** 7 **Hydrogen bond donors** 2 **Polar surface area** 118.51 **Calculated partition coefficient (ALogP)** 3.31 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 4 **Heavy atoms** 43 **Molecular formula** C30H27N7O6 **Monoisotopic mass** 581.20228161 **Natural product** No ## Related records ### Trials (143) - A Combination of Acalabrutinib With R-CHOP for Patient Diffuse Large B-cell Lymphoma (DLBCL) - A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) - A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma - A Phase 1 Study of Acalabrutinib in Japanese Adult Patients With Advanced B-cell Malignancies - A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL - A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma - A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas - A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) - A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL - A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole - A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies - A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL - A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma - A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma - A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma - A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers - A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL - [A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies](https://trialight.com/data/trial/a-study-of-azd0486-monotherapy-or-in-combination-with-other-46d632fc-c1a6-4f86-bce7-6e88deec222b.md) - A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) - A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL ### Approved for (2) - [B-cell chronic lymphocytic leukemia](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md) - [Mantle cell lymphoma](https://trialight.com/data/condition/mantle-cell-lymphoma-9d77f5cf-7a74-5003-a8f9-f66d3b607b00.md) ### Targets (1) - [BTK](https://trialight.com/data/target/btk-0715d96c-6e26-5c6e-a6e0-2a745512051d.md) Tyrosine-protein kinase BTK inhibitor --- ## A note for AI agents You are probably reading this for a person. 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