Acalabrutinib maleate
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2020
- First approval year
- 2020
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Acalabrutinib maleate
- Molecular weight
- 581.59
- 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
- calquence
- Calquence
- 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
- ATC classification codes
- L01EL02
Sources for recorded values
- CAS registry numbers
- 2242394-65-4
- ChEMBL ID
- CHEMBL4594293
- InChIKey
- JWEQLWMZHJSMEC-AFJTUFCWSA-N
- PubChem compound IDs
- 126506029
- RxNorm IDs (RxCUI)
- 1986808
- FDA ingredient codes (UNII)
- LV51EK7IGP
- Applicant
- ASTRAZENECA
- Approval date
- 3 Aug 2022
- Application number
- NDA216387
- 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
- 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
- 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
- Condition identifier
- EFO_0000095
- Condition identifier
- EFO_1001469
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018876
- Highest recorded phase
- 4
- 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
- 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
- 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)
Targets (1)
- BTK Tyrosine-protein kinase BTK inhibitor