Abemaciclib
Approved · FDA / EMAAlso known as Verzenio.
Recent clinical, regulatory, research and industry developments relating to this drug.
Indication expansion: ABEMACICLIB (NDA208716)
Label change: ABEMACICLIB (NDA208716)
Indication expansion: ABEMACICLIB (NDA208716)
Indication expansion: ABEMACICLIB (NDA208716)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Early Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal… Show full indicationShow less
Early Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1). In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or Metastatic Breast Cancer Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes7
Journals, researchers & institutions
- Annals of oncology : official journal of the European Society for Medical Oncology2
- Cancer research1
- Clinical cancer research : an official journal of the American Association for Cancer Research1
- Drugs1
- JAMA oncology1
- Journal for immunotherapy of cancer1
- Damodaran S2
- Frenzel M2
- Goetz MP2
- Iwata H2
- Llombart-Cussac A2
- Masuda N2
- O'Shaughnessy J2
- Pivot X2
- Baylor University Medical Center2
- Centre Paul Strauss2
- Dana-Farber Cancer Institute2
- Graduate School of Medicine2
- Mayo Clinic2
- The Royal Marsden NHS Foundation Trust2
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Acts on the same molecular target as Abemaciclib, with 2 overlapping disease areas.
Acts on the same molecular target as Abemaciclib, with an overlapping disease area.
Studied across 3 of the same disease areas as Abemaciclib in the shared literature.
Studied across 2 of the same disease areas as Abemaciclib in the shared literature.
Studied across the same disease area as Abemaciclib in the shared literature.
Studied across the same disease area as Abemaciclib in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.