Acalabrutinib maleate is a Small Molecule owned by AstraZeneca, and is involved in 85 clinical trials, of which 27 were completed, 52 are ongoing, and 6 are planned.

Acalabrutinib maleate is a small-molecule inhibitor of BTK. Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acalabrutinib inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and survival.

The revenue for Acalabrutinib maleate is expected to reach a total of $51bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Acalabrutinib maleate NPV Report.

Acalabrutinib maleate was originated by Acerta Pharma and is currently owned by AstraZeneca.

Acalabrutinib maleate Overview

Acalabrutinib maleate (Calquence) is an anti-neoplastic agent. It is formulated as hard gelatin capsules and film coated tablets for oral route of administration. Calquence is indicated for the treatment of of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) either as initial therapy or subsequent therapy.. and also in combination with obinutuzumab or as a monotherapy is indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia. Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Acalabrutinib is under development for the treatment of peanut food allergy, recurrent or refractory central nervous system lymphoma (CNSL), anti-MAG mediated neuropathy, Hodgkin lymphoma, multiple myeloma, Burkitt lymphoma, hairy cell leukemia, graft-versus-host disease, primary, secondary central nervous system lymphoma and secondary diffuse large B-cell lymphoma (DLBCL), first line diffuse large B-cell lymphoma, relapsed or refractory small lymphocytic lymphoma, refractory or relapsed or untreated mantle cell lymphoma, marginal zone B-cell lymphoma, Waldenstrom macroglobulinemia, recurrent glioblastoma multiforme, relapsed and refractory multiple myeloma, follicular lymphoma, marginal zone lymphoma, B-cell lymphoproliferative disorder, splenic marginal zone lymphoma nodal marginal zone lymphoma and extranodal marginal zone lymphoma, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, follicular lymphoma and relapsed, refractory and untreated chronic lymphocytic leukemia, relapsed or refractory mantle cell lymphoma, primary mediastinal [thymic] large B-cell lymphoma (PMBCL) and other B-cell malignancies, coronavirus disease 2019 (COVID-19), primary and secondary central nervous system lymphoma. It was also under development for metastatic bladder cancer, metastatic pancreatic cancer, metastatic squamous lung adenocarcinoma, rheumatoid arthritis, metastatic urothelial carcinoma, recurrent, metastatic, unresectable head and neck squamous cell carcinoma coronavirus disease 2019 (COVID-19), pneumonia and cytokine storm.

AstraZeneca Overview

AstraZeneca is a biopharmaceutical company, which is focused on discovery, production and commercialization of a range of prescription drugs. It develops products related to therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals and vaccines. AstraZeneca sells its products through wholly-owned local marketing companies, distributors and local representative offices. The company markets its products to primary care and specialty care physicians. The COVID-19 Vaccine AstraZeneca has been approved for conditional marketing or emergency use. The company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.

The company reported revenues of (US Dollars) US$37,417 million for the fiscal year ended December 2021 (FY2021), an increase of 40.6% over FY2020. In FY2021, the company’s operating margin was 2.8%, compared to an operating margin of 19.4% in FY2020. In FY2021, the company recorded a net margin of 0.3%, compared to a net margin of 12% in FY2020. The company reported revenues of US$10,982 million for the third quarter ended September 2022, an increase of 2% over the previous quarter.

Quick View – Acalabrutinib maleate

Report Segments
  • Innovator (NME)
Drug Name
  • Acalabrutinib maleate
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Immunology
  • Infectious Disease
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.