Abemaciclib is under clinical development by Eli Lilly and Co and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Abemaciclib’s likelihood of approval (LoA) and phase transition for Bile Duct Cancer (Cholangiocarcinoma) took place on 19 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Abemaciclib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Abemaciclib overview

Abemaciclib (Verzenio / Verzenios) 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 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.

Quick View Abemaciclib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Abemaciclib
Administration Pathway
  • Oral
Therapeutic Areas
  • Genetic Disorders
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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.