NDAORALTABLETPriority Review
Approved
Sep 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
VERZENIO (abemaciclib) by Eli Lilly and Company is kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2017.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VERZENIO (abemaciclib) is an oral small-molecule kinase inhibitor approved by the FDA on September 28, 2017, and marketed by Eli Lilly and Company. It is indicated for the treatment of hormone receptor-positive, HER2-negative breast cancer in combination with endocrine therapy or as monotherapy. The drug works by inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), thereby blocking cell cycle progression and reducing tumor growth. VERZENIO competes in the well-established CDK4/6 inhibitor class, which has become standard-of-care in early and metastatic breast cancer treatment.
$0.8BPart D
5.4 years to LOEMechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Started Oct 2025
285 enrolled
Breast Cancer
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
Started Mar 2025
191 enrolled
Non Small Cell Lung CancerGlioma Glioblastoma MultiformeGlioma, Malignant+4 more
Abemaciclib in Newly Diagnosed Meningioma Patients
Started Mar 2025
72 enrolled
Meningioma
Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma
Started Mar 2025
18 enrolled
Retroperitoneal Sarcoma
A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)
Started Feb 2025
43 enrolled
Metastatic Renal Cell CarcinomaTranslocation Renal Cell Carcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.