NDAORALTABLETPriority Review
Approved
Mar 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KISQALI (ribociclib) is an oral small-molecule CDK4/6 inhibitor approved by the FDA on March 13, 2017, for the treatment of hormone receptor-positive, HER2-negative breast cancer. The drug works by inhibiting cyclin-dependent kinases 4 and 6, which are key drivers of cell cycle progression in cancer cells. KISQALI is typically used in combination with endocrine therapy and represents a standard-of-care option in the HR+/HER2- breast cancer treatment landscape.
$0.4BPart D
9.9 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Started Apr 2026
80 enrolled
Breast Cancer
Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice
Started Jan 2026
240 enrolled
Breast Cancer
Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia
Started Dec 2025
2,766 enrolled
Breast Cancer
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
Started Dec 2025
3,902 enrolled
Breast Cancer
Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.
Started Dec 2025
3,000 enrolled
Breast Cancer
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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.