Wednesday, July 8, 2026

Drug profile · INN

abemaciclib

abemaciclib (VERZENIO) is a cyclin-dependent kinase 6 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EF03
US status approved
Patents linked 20
Pipeline programs 43
News articles 0
Drug details — abemaciclib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
20
Programs
43
Data quality
0.84

Quick answer

abemaciclib (VERZENIO) is a cyclin-dependent kinase 6 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN abemaciclib
Brand VERZENIO
Mechanism Cyclin-dependent kinase 6 inhibitor
Target Cyclin-dependent kinase 4
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EF03

Mechanism of action

Cyclin-dependent kinase 6 inhibitor

Primary target: Cyclin-dependent kinase 4

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. ABEMACICLIB , FULVESTRANT Phase 3 · Eli Lilly and · Breast cancer
  2. Abemaciclib Phase 3 · United Therapeutics Europe · Breast Cancer Female
  3. Abemaciclib Phase 3 · Eli Lilly and · Breast Cancer
  4. Abemaciclib Phase 3 · Eli Lilly and · Non Small Cell Lung Cancer
  5. Bemnifosbuvir (BEM) Phase 3 · Atea Pharmaceuticals · Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2
  6. C4391024 Phase 3 · First Biotech (Australia) · Advanced/Metastatic Breast Cancer
  7. CO44657 Phase 3 · HOFFMANN-LA ROCHE · Estrogen receptor (ER)-positive, HER2-negative advanced brea
  8. D8534C00001 Phase 3 · AstraZeneca · Estrogen Receptor-Positive, HER-2 negative Advanced Breast C

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

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Frequently asked questions

What is abemaciclib?

abemaciclib (VERZENIO) is a cyclin-dependent kinase 6 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for abemaciclib?

VERZENIO is a marketed brand name for abemaciclib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of abemaciclib?

abemaciclib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.