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 $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 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.

MEI Pharma Overview

MEI Pharma, formerly Marshall Edwards, develops drugs for the treatment of cancer. The company’s drug candidates include pracinostat, an oral histone deacetylase inhibitor, intended for the treatment of advanced hematological diseases including myelodysplastic syndrome; ME-344, a mitochondrial inhibitor intended for the treatment of HER2-negative breast cancer and solid tumors; and Zandelisib (ME-401), an oral PI3K delta inhibitor for relapsed or refractory B-cell malignancies. The company also develops and commercializes Voruciclib, an oral and selective cyclin-dependent kinase (CDK) inhibitor intended for the treatment of acute myeloid leukemia (AML) and B-cell malignancies through an agreement with Presage. MEI Pharma is headquartered in San Diego, California, the US.

The company reported revenues of (US Dollars) US$40.7 million for the fiscal year ended June 2022 (FY2022), an increase of 17% over FY2021. The operating loss of the company was US$75.5 million in FY2022, compared to an operating loss of US$60.4 million in FY2021. The net loss of the company was US$54.5 million in FY2022, compared to a net loss of US$41.3 million in FY2021. The company reported revenues of US$8.7 million for the first quarter ended September 2022, a decrease of 23.5% 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.