Zandelisib is a Small Molecule owned by MEI Pharma, and is involved in 11 clinical trials, of which 3 were completed, 7 are ongoing, and 1 is planned.

Zandelisib (ME-401) acts by inhibiting PI3K delta. PI3K delta is uniquely involved in inflammation signals in both B and T cells, as well as myeloid cells (signaling from BCR, TCR, FceR ), which co-operate in pathogenesis of inflammatory disorders. PI3K signaling pathways is dysregulated during the progression of the disease. The drug candidate works by inhibiting the production of the secondary messenger phosphatidylinositol-3, 4, 5-trisphosphate (PIP3). It prevents the activation of the PI3K signaling pathway and thus inhibiting tumor cell proliferation, motility, and survival.

The revenue for Zandelisib is expected to reach a total of $945m 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 Zandelisib NPV Report.

Zandelisib was originated by Pathway Therapeutics and is currently owned by MEI Pharma. Kyowa Kirin is the other company associated in development or marketing of Zandelisib.

Zandelisib Overview

Zandelisib (ME-401) is under development for the treatment of relapsed or refractory b-cell non-Hodgkin’ss lymphoma, chronic lymphocytic leukemia (CLL), Marginal zone B-cell lymphoma (splenic, nodal, or extra-nodal), hematological B cell malignancies such as B-cell non-Hodgkin's lymphoma and follicular non-Hodgkin’s lymphoma (follicular lymphoma). It is administered through oral route. The drug candidate acts by targeting phosphoinositide 3-kinase (PI3K) delta. It was also under development for the treatment of collagen induced arthritis, respiratory disorders, high grade non-Hodgkin's lymphoma, relapsed and refractory chronic lymphocytic leukemia (CLL), diffuse large cell B-cell lymphoma and Mantle cell lymphoma.

Kyowa Kirin Overview

Kyowa Kirin, a subsidiary of Kirin Holdings Co Ltd, is a biotechnology company focused on research and development. It is involved in the discovery, development, production and commercialization of pharmaceuticals and biotechnology products. The company offers drugs in the areas of nephrology, oncology, immunology and allergy, central nervous system among others. Its development pipeline consists of various protein, antibody and small molecule formulations for the treatment of neutropenia, anemia, chronic idiopathic thrombocytopenic purpura, hypertension, angina pectoris, allergic rhinitis, epilepsy, behavioral or personality disorders and others. The company operates through a network of subsidiaries in the US, Europe and Asia. Kyowa Kirin is headquartered in Tokyo, Japan.

The company reported revenues of (Yen) JPY352,246 million for the fiscal year ended December 2021 (FY2021), an increase of 10.6% over FY2020. In FY2021, the company’s operating margin was 17%, compared to an operating margin of 15.9% in FY2020. In FY2021, the company recorded a net margin of 14.9%, compared to a net margin of 14.8% in FY2020. The company reported revenues of JPY98,504 million for the third quarter ended September 2022, an increase of 1% over the previous quarter.

Quick View – Zandelisib

Report Segments
  • Innovator
Drug Name
  • Zandelisib
Administration Pathway
  • Oral
Therapeutic Areas
  • Immunology
  • Musculoskeletal Disorders
  • Oncology
  • Respiratory
Key Companies
  • Sponsor Company: MEI Pharma
  • Originator: Pathway Therapeutics
Highest Development Stage
  • Phase III

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.