Volasertib is under clinical development by Notable Labs and currently in Phase III for Myelodysplastic Syndrome. According to GlobalData, Phase III drugs for Myelodysplastic Syndrome have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Volasertib’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.

Volasertib overview

Volasertib (BI 6727) is under development for the treatment of myelodysplastic syndrome, rhabdomyosarcoma, acute myeloid leukemia (AML) and solid tumors including leukemia, lymphoma. The drug candidate is administered as intravenous infusion. The drug targets polo-like kinase 1 (PLK-1). It is a new chemical entity (NCE).

It was also under development for the treatment of refractory anemia with excess blasts, chronic myelomonocytic leukemia (CMML), metastatic urothelial cancer, acute myeloid leukemia, ovarian cancer, non-small cell lung cancer, acute lymphoblastic leukemia, relapsed and refractory cutaneous T-cell lymphoma, peripheral T-cell lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma and burkitt lymphoma.

Notable Labs overview

Notable Labs is a provider of precision therapeutics that develops oncology medicines. The company’s product pipeline includes NBL-001(Volasertib) which is a potent Polo-like kinase 1 (PLK-1) inhibitor and Fosciclopirox which is a pro-drug of ciclopirox. Notable Labs volasertib is used for the treatment of acute myeloid leukemia, pediatric leukemia solid tumors, and fosciclopirox is used for the treatment of acute myeloid leukemia. Its predictive precision platform bio-simulates a patient’s cancer treatment and predicts whether a patient will respond to a specific treatment. Notable Labs is headquartered in Foster City, California, the US.

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


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

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.