Voruciclib is under clinical development by MEI Pharma and currently in Phase II for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase II drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Voruciclib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Voruciclib overview

Voruciclib (P-1446) is under development for the treatment of B-cell malignancies, refractory or relapsed chronic lymphoid leukemia and diffuse large B-cell lymphoma. As a third line therapy for follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia(CLL), diffuse large B-cell lymphoma (DLBCL) and relapsed/refractory acute myeloid leukemia. The drug candidate is administered orally and it acts by targeting Cdk9. The drug candidate is developed based on CIVO technology. It was also under development for the treatment of malignant melanoma, advanced refractory solid tumor, hematological malignancies, head and neck cancer, pancreatic cancer, mantle cell lymphoma and triple negative breast cancer.

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. It 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.

For a complete picture of Voruciclib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.