Ibrutinib is a Small Molecule owned by AbbVie, and is involved in 146 clinical trials, of which 70 were completed, 74 are ongoing, and 2 are planned.

Ibrutinib is a selective small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK), a signaling kinase expressed in B cells that functions downstream of the B cell antigen receptor (BCR). Ibrutinib binds to and irreversibly inhibits BTK activity, thereby preventing both B-cell activation and B-cell-mediated signaling. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is required for B cell receptor signaling, plays a key role in B-cell maturation, and is overexpressed in a number of B-cell malignancies. The expression of BTK in tumor cells is also associated with increased proliferation and survival.

The revenue for Ibrutinib is expected to reach a total of $54.3bn 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 Ibrutinib NPV Report.

Ibrutinib was originated by Celera and is currently owned by AbbVie. Johnson & Johnson is the other company associated in development or marketing of Ibrutinib.

Ibrutinib Overview

Ibrutinib (Imbruvica) is an anti-neoplastic agent. It is formulated as hard gelatin capsules, tablets, film coated tablets and suspension for oral route of administration. Ibrutinib is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) with 17p deletion and for the treatment of patients with Waldenström’s macroglobulinemia (WM). It is also indicated for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutationin patients unsuitable for chemo-immunotherapy, Waldenstrom’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy, for the treatment of small lymphocytic lymphoma (SLL), as a first-line treatment for patients with chronic lymphocytic leukemia (CLL), for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion. Imbruvica is now approved for all patients with CLL, expanding the number of patients who may benefit from this treatment. Imbruvica as a single-agent targeted therapy for previously untreated patients with active chronic lymphocytic leukemia (CLL), for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy and in combination with obinutuzumab is indicated in adults for the treatment of naive patients with active chronic lymphocytic leukemia (CLL). Imbruvica (ibrutinib) in combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL).

Ibrutinib (PCI-32765) is under development for treatment of Coronavirus disease 2019 (COVID-19) infectious disease caused by severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2), her2-positive metastatic breast cancer ( third line ), splenic, extranodal and nodal marginal zone lymphoma (MZL), relapsed and refractory classical Hodgkin lymphoma, pediatric and adolescent patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy, B-cell malignancies (including relapsed and refractory chronic lymphocytic leukemia (CLL),mantle cell lymphoma, small lymphocytic lymphoma (SLL), and diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia, untreated Waldenström’s macroglobulinemia (WM), indolent non-Hodgkin lymphoma, treatment-naive, relapsed and refractory follicular lymphoma (FL), hairy cell leukemia, T-cell lymphoma, primary CNS lymphoma, secondary CNS lymphoma, non small cell lung cancer, multiple myeloma (second and third line), relapsed and refractory marginal zone lymphoma, refractory or steroid-dependent graft versus host disease, recurrent head and neck squamous cell carcinoma, metastatic pancreatic adenocarcinoma,  renal cell carcinoma, urothelial carcinoma, colorectal cancer, gastric or gastro-esophageal junctional adenocarcinoma, refractory myelodysplastic syndrome, relapsed and refractory acute lymphocytic leukemia (ALL), metastatic melanoma, and glioblastoma multiforme. ibrutinib in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Imbruvica is indicated for the treatment of relapsed/refractory primary macroglobulinemia and lymphoplasmacytic lymphoma.

It was also under development for rheumatoid arthritis and relapsed or refractory precursor B lymphoblastic leukemia (B-ALL), Burkitt lymphoma and systemic mastocytosis.

AbbVie Overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic diseases, rheumatological diseases, neurological disorders, viral diseases, skin diseases, complications associated with cystic fibrosis, pain related to endometriosis, diseases of the gastrointestinal tract, various types of cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of cystic fibrosis, women’s health, various cancers, neurological disorders and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, health care facilities, government agencies, specialty pharmacies and independent retailers through its own distribution centers and public warehouses worldwide. AbbVie is headquartered in North Chicago, Illinois, the US.

The company reported revenues of (US Dollars) US$56,197 million for the fiscal year ended December 2021 (FY2021), an increase of 22.7% over FY2020. In FY2021, the company’s operating margin was 31.9%, compared to an operating margin of 24.8% in FY2020. In FY2021, the company recorded a net margin of 20.5%, compared to a net margin of 10.1% in FY2020. The company reported revenues of US$14,812 million for the third quarter ended September 2022, an increase of 1.6% over the previous quarter.

Quick View – Ibrutinib

Report Segments
  • Innovator (NME)
Drug Name
  • Ibrutinib
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • 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.