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RIBOCICLIB
RIBOCICLIB is a drug. It is currently FDA-approved (first approved 2017) for Adjuvant treatment of early breast cancer, Initial endocrine-based therapy for advanced or metastatic breast cancer.
Ribociclib, also known as LEE011, is a small molecule inhibitor of cyclin-dependent kinase 4. It is being studied in clinical trials for various indications, including metastatic breast cancer and breast cancer stage IV, and its pharmacokinetics have been evaluated in patients with normal and impaired renal function.
At a glance
| Generic name | RIBOCICLIB |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2017 |
Approved indications
- Adjuvant treatment of early breast cancer
- Initial endocrine-based therapy for advanced or metastatic breast cancer
Common side effects
- Leukocytes decreased
- Neutrophils decreased
- Lymphocytes decreased
- Hemoglobin decreased
- Aspartate aminotransferase increased
- Alanine aminotransferase increased
- Gamma-glutamyl transferase increased
- Infections
- Nausea
- Creatinine increased
- Platelets decreased
- Fatigue
Serious adverse events
- COVID-19
- Pneumonia
- Pulmonary embolism
- COVID-19 or COVID-19 pneumonia (fatal)
- Pulmonary embolism (fatal)
Drug interactions
- Strong CYP3A4 Inhibitors
- Strong CYP3A4 Inducers
- Sensitive CYP3A Substrates
- Drugs Known to Prolong QT Interval
Key clinical trials
- Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial (PHASE3)
- Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors (PHASE1, PHASE2)
- 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)
- Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME) (NA)
- Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors (PHASE1)
- Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (PHASE2)
- Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt (PHASE4)
- A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- RIBOCICLIB CI brief — competitive landscape report
- RIBOCICLIB updates RSS · CI watch RSS
Frequently asked questions about RIBOCICLIB
What is RIBOCICLIB?
What is RIBOCICLIB used for?
When was RIBOCICLIB approved?
What development phase is RIBOCICLIB in?
What are the side effects of RIBOCICLIB?
Related
- Indication: Drugs for Adjuvant treatment of early breast cancer
- Indication: Drugs for Initial endocrine-based therapy for advanced or metastatic breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing