Last reviewed · How we verify
ABEMACICLIB
At a glance
| Generic name | ABEMACICLIB |
|---|---|
| Drug class | Kinase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2017 |
Approved indications
Common side effects
- Diarrhea
- Neutropenia
- Nausea
- Abdominal pain
- Infections
- Fatigue
- Anemia
- Leukopenia
- Decreased appetite
- Vomiting
- Headache
- Alopecia
Serious adverse events
- Fatal adverse reactions
- Cardiac failure
- Cardiac arrest
- Myocardial infarction
- Ventricular fibrillation
- Cerebral hemorrhage
- Cerebrovascular accident
- Pneumonitis
- Hypoxia
- Mesenteric artery thrombosis
Key clinical trials
- Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors (PHASE1)
- Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma (PHASE1, PHASE2)
- Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer (PHASE1)
- A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PHASE1)
- A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer (PHASE2)
- Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer (PHASE1)
- BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease (PHASE3)
- Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ABEMACICLIB CI brief — competitive landscape report
- ABEMACICLIB updates RSS · CI watch RSS