Abemaciclib is under clinical development by Eli Lilly and Co and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Abemaciclib’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.

Abemaciclib overview

Abemaciclib (Verzenio / Verzenios / Yulareb) is a benzimidazole derivative, acts as an anti-tumor or anti-neoplastic agent. It is formulated as tablets and film coated tablets for the oral route of administration. Verzenio is indicated in combination with fulvestrant for the treatment of women with hormone receptor positive and HER2 negative advanced or metastatic breast cancer with disease progression following endocrine therapy. It is also indicated as monotherapy for the treatment of adult patients with hormone receptor positive and HER2 negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting and also indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor positive and HER2 negative advanced or metastatic breast cancer. Verzenio is indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, nodepositive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20% as determined by an FDA approved test.

It is under development for the treatment of high-risk metastatic hormone-sensitive prostate cancer, Kaposi sarcoma, metastatic gastroesophageal junction adenocarcinoma, neuroblastoma, platinum-resistant ovarian cancer, adenocarcinoma of the prostate, neurofibromatosis 1, metastatic biliary tract carcinoma, esophageal cancer, cholangiocarcinoma, urothelial cancer, metastatic castration-resistant prostate cancer, advanced and metastatic solid tumors such as colorectal cancer, relapsed/ refractory multiple myeloma, metastatic melanoma, glioblastoma multiforme, astrocytoma, meningioma, ependymoma, oligodendroglioma, lymphoma, primary CNS lymphoma, IDH mutant glioma, recurrent head, and neck squamous cell carcinoma, Hormone receptor positive and HER2 negative breast cancer, metastatic breast cancer, HER2 positive breast cancer, endometrial cancer, malignant mesothelioma,  relapsed or refractory mantle cell lymphoma, non-small cell lung cancer including squamous non-small cell lung cancer, neuroendocrine tumors, metastatic renal cell carcinoma, pediatric diffuse intrinsic pontine glioma, dedifferentiated liposarcoma, gastric cancer,  Ewing's sarcoma, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer and gastroesophageal junction adenocarcinoma. The drug candidate is a new chemical entity (NCE). It was under development for the treatment of pancreatic ductal adenocarcinoma, hepatocellular carcinoma and human epidermal growth factor receptor 2 (HER2) positive, early breast cancer.

Eli Lilly and Co overview

Eli Lilly and Co (Lilly) is a healthcare company that is engaged in the discovery, development, and marketing of human healthcare products. The company offers medicines for cardiovascular conditions, diabetes, endocrinology, cancer, neurological problems, immune disorders, men’s health, and musculoskeletal problems. The company distributes its pharmaceutical health products through independent wholesale distributors. Lilly conducts research and development activities to discover and deliver innovative medicines. It also promotes products through sales representatives and marketing agreements with other pharmaceutical companies. The company also offers its products in North America, South America, Europe, South Asia, the Middle East, Africa, and North Asia-Pacific. Lilly is headquartered in Indianapolis, Indiana, the US.

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

This content was updated on 2 September 2023

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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 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.